p. 63622. Infringement
- L. Bently, L. BentlyHerchel Smith Professor of Intellectual Property, University of Cambridge
- B. Sherman, B. ShermanProfessor of Law, University of Queensland
- D. GangjeeD. GangjeeAssociate Professor of Intellectual Property Law, University of Oxford
- and P. JohnsonP. JohnsonProfessor of Commercial Law, Cardiff University
This chapter deals with patent infringement and the scope of protection that the law provides to patent owners. It discusses three criteria that are used to determine whether a patent has been infringed: the types of activity that constitute an infringement; whether the activity in question falls within the scope of the patent monopoly; and whether the defendant is able to invoke any of the defences that are available to them. After noting the distinction between direct and indirect infringement based on patent law, the chapter turns to the scope of protection for biotechnological inventions, patents for a process, and novelty-of-use patents. It then considers the grounds on which patentees may find liability for infringement. Relevant provisions that are found in the Patents Act 1977 and the European Patents Convention are also addressed.
Patent infringement is a notoriously complex area of law.1 In part, this is a consequence of the evidential nature of the inquiry, which often makes it difficult to generalize beyond the particular case in hand. Another factor that has added to this complexity (while simultaneously enhancing the effectiveness of the patent system) is that it has long been accepted that the scope of the patent monopoly should not be limited to situations where the infringing act takes place in relation to a product or process that is exactly the same as the patented invention. While extending the scope of the monopoly beyond a strict reading of the claims may have satisfied the law’s desire to protect the equity of the patent, it generated a new question: how broadly can the patent be read? Similarly, when it was agreed that not all of an invention needed to be taken for a patent to be infringed, the question arose: how much of the invention needs to be taken? The difficulties that these questions generate further accentuate the problems that arise in understanding patent infringement.2
The complexity of the topic is also a consequence of Britain’s entry into the European Patent Convention. When the EPC 1973 was drafted, it was decided that questions about the infringement of patents issued by the European Patent Office (EPO) were better dealt with by national courts.3 Nonetheless, the close relationship between validity and infringement has meant that decisions at the EPO (particularly in relation to novelty) have impacted on the British law of infringement. These transitions have proved to be all the more problematic because of the absence of a common tribunal dealing with infringement.
As we mentioned earlier, this situation will change if the unitary patent package is implemented. One of the notable features of the unified patent package is that questions of infringement will no longer be the exclusive domain of national courts, nor of national law. Currently, infringement of European patents is a matter for national courts to be decided on the basis of the Patents Act 1977. Under the Agreement on a Unified Patent p. 637↵Court4 (the ‘UPC Agreement’), however, this will shift to the unitary patent courts (which will also have exclusive authority in relation to the infringement of the proposed new ‘unitary patent’). In line with this, the UPC Agreement also sets out the relevant law rules to be used when deciding whether a bundled or a unitary patent is infringed.5 The UPC Agreement also provides a series of defences that will apply (including acts done for private and non-commercial purpose, acts done for experimental purposes, situations in which biological material is used for the purpose of breeding or discovering and developing new plant varieties, the pharmaceutical preparation of medicines, certain on-farm uses of patented plants and animals, and certain uses in relation to patented computer programs, such as decompilation and interoperability).6 While UK courts will still have jurisdiction over national patents issued by the UK Intellectual Property Office (IPO), the Patents Act 1977 will need to be modified to ensure that UK law complies with the infringement provisions for European bundle patents and unitary patents under the UPC Agreement.
Despite its complex and often uncertain nature, determining patent infringement can be separated into three tasks.
First, it is necessary to determine the types of activity that constitute an infringement.
Next, it is necessary to ascertain whether the activity complained of falls within the scope of the patent monopoly.
Finally, it needs to be determined whether the defendant is able to make use of any of the defences that are available to them.
Each of these tasks will be dealt with in turn.
2 Types of infringing activity
It is important to note at the outset that patent law draws a general distinction between direct and indirect infringement. The main difference between them is that direct infringement involves some immediate engagement with the patented product or process,7 whereas indirect infringement applies where a person facilitates the act of infringement8—in effect, patent law’s version of aiding and abetting. Before looking at direct and indirect infringement in more detail, it is important to note that to infringe, the activity must be carried out without the consent of the patentee (that is, the activity must not be covered by licence),9 must occur within the United Kingdom,10 and must take place during the duration of the patent.11
2.1p. 638 Direct infringement
For a patentee to succeed in an infringement action, they must show on the balance of probabilities that the defendant performed one of the activities that falls within the patent owner’s control.12 The primary rights given to a patent owner are set out in section 60(1) of the 1977 Act. As we will see, section 60(1) covers a wide array of activities, from the making or using of a product or a process, through to the sale or import of the product. As a result most, if not all, commercially valuable activities fall within the owner’s control.
The rights given to an owner differ depending on whether the patent is for a product, a process, or a product obtained directly from a process. With the exception of the situation in which an infringer uses a process or ‘offers a process for use’ under section 60(1)(b), direct infringement takes place irrespective of the knowledge of the defendant. This means that liability is absolute in relation to a patent for a product, or where a product has been obtained directly from a patented process. As such, there is no need for a patentee to show that the defendants knew that they were infringing. In these cases, independent, accidental, or unintentional creation of the same invention will infringe.
2.2 Patent for a product
The owner of a patent for a product is given the right to make, dispose of, offer to dispose of, use, import, or keep the product, whether for disposal or otherwise.13 It is important to note that in this context, liability is absolute: the knowledge of the defendant is not relevant when deciding whether they have carried out one of the activities within the owner’s control.14 While intention to infringe is not relevant to the determination of liability, mens rea might play a significant role in relation to the remedies granted by the court.15
Three different rationales are usually given to explain why patent liability is absolute.16 The first is that the principle is necessary to allow patentees full enjoyment of their monopoly rights.17 This is often said to be more pressing because of the onerous nature of the validity requirements imposed on patent applicants. When thinking about assertions of this nature, it is important to remember that property rights are never absolute and that the rights recognized in patents are no exception to this.18 For example, patents are limited in terms of duration, scope of operation, subject matter, and types of activity p. 639↵that are protected. As such, there is little, if anything, in this argument that demands that infringement ought to be absolute.
A second explanation offered as to why the intention of the defendant is not relevant when determining whether someone has infringed can be traced to the so-called ‘reverse-infringement test’, which is used to determine whether an invention is novel.19 Under this test, which conceives of the novelty examination as a mirror of the test for infringement, the court asks the following hypothetical question: if the disclosure were to be made or take place after grant, would it infringe the patent (if granted)? If so, then the disclosure is anticipatory.20 The next step in the argument is to remind us that when considering whether information in the public domain anticipates an invention, the intention of the person who made that information public is irrelevant (that is, novelty is decided objectively). On the basis that novelty and infringement are mirrors of each other and that novelty is determined objectively, it is therefore suggested that infringement should also be decided objectively. However, while the ‘reverse-infringement’ test may have brought conceptual clarity to the novelty examination, it offers little real guidance when considering whether intention should be a factor taken into account when deciding infringement.
A third argument in support of the principle that the intention of the defendant is irrelevant in deciding infringement focuses on the existence of the patent register and the information function performed by the patent system more generally. Here, the potential harm that third parties might endure as a result of infringement being absolute is mitigated by the fact that as part of the patent process, the invention is made available to the public. More specifically, it is argued that because information about the patented invention is in the public domain, third parties are able to access the information and subsequently alter their behaviour (or license the patent), and thus avoid infringing the patent. While this rationale might carry some weight in relation to mechanical inventions, it is not as easily applied to biological inventions. This is because the rationale for strict liability is based on an image of the invention as something inert, static, and (largely) immutable. In the case of mechanical inventions (in which it is the behaviour of the defendant that determines whether they infringe), would-be defendants are able to modify their conduct to ensure that they do not do so. However, in the case of (some) biological inventions, which are dynamic and active, there may be very little (if anything) that a defendant can do to avoid infringing. Given that the infringement might be traced to the action of the invention (rather than the defendant), this may be the case even if the defendant had known about the patented invention.
The potential problems that arise in relation to biological inventions were highlighted by the Canadian decision Monsanto v. Schmeiser,21 in which a farmer was successfully sued for infringing Monsanto’s patent for glyphosate-resistant plants, when patented plants were found growing on his property. Importantly, it was held that the principle of strict liability meant that it did not matter whether the defendant farmer had planted the infringing plants or whether, as he claimed, the plants were there as a result of conduct outside his control (including cross-field breeding by wind or insects, seed blown from passing trucks with loose tarpaulins, seed dropped from farm equipment, and seed that had escaped when a neighbour dropped a bag of Monsanto’s seed from his truck); all that mattered was that there had been an unauthorized use of the patented invention. The decision is important since it highlights the possibility of, and some of the problems p. 640↵associated with, what could be called ‘passive infringement’ of biological inventions. This is the fact that farmers, through no fault of their own, may be liable for patent infringement when a patented plant ‘invades’ their property and cross-pollinates with one of their plants. (Similar problems could arise with genetically modified animals.) The possibility of passive infringement has important ramifications for the traditional farming practice whereby seeds saved from one year’s harvest are used to sow crops in the following year. Even if this does not occur, the mere possibility of passive infringement of biological inventions will increase the pressure on farmers to obtain licences to use patented inventions of this nature. It is, however, a problem that could easily be remedied through the introduction of a defence for passive infringement.
2.2.1 The right to make the product
Perhaps the most important right given to the owner of a patent for a product is the exclusive right to ‘make’ the product. Few problems have arisen in determining what is meant by the right to make a product. One exception to this is where the defendant repairs or modifies the patented product. Patent law has long recognized that purchasers of patented products should be able to repair and modify those products. As Lord Hoffmann said in United Wire,22 ‘repair is one of the concepts (like modifying or adapting) which shares a boundary with “making” but does not trespass on its territory’. He added that:
[A]s a matter of ordinary language, the notions of making and repair may well overlap. But for the purposes of the statute, they are mutually exclusive. The owner’s right to repair is not an independent right conferred upon him by licence, express or implied. It is a residual right, forming part of the right to do whatever does not amount to making the product.23
At the same time, however, patent law has been keen to ensure that while a person who obtains a patented product is able to repair or modify the product, they may not go so far as to make the product anew.24 In these circumstances, the question arises: how much of a product is a person able to repair or modify before they infringe the owner’s right to make the product? To put it another way: when does the legitimate act of repair or modification switch to become the illegitimate making of the patented product?
These questions were considered at length by the Supreme Court in Schütz v. Werit.25 This was an infringement action brought by Schütz in relation to a patent for an intermediate bulk container—that is, a device used to transfer large quantities (around 1,000 litres) of liquids (such as chemicals, soft drinks, or cosmetics). The patent consisted of two parts: the large plastic bottle, which held the liquid; and the metal cage, which protected the bottle in transit and storage (see Fig. 22.1).26 The novel and inventive part of Schütz’s patented intermediate bulk container was the particular way in which the cage was made. One of the notable things about intermediate bulk containers is that it was often necessary to replace the plastic containers, either because the bottle had become damagedp. 641↵
or because they contained residue of a toxic material. Many secondary organizations, known as ‘reconditioners’, undertake this work. This usually consists of them removing the old bottles, repairing the cage if needed, and putting in a new bottle (either of the same type as that which had been removed or a different one). Delta and Werit worked in the reconditioning industry. Delta purchased second-hand intermediate bulk containers that had been made by Schütz. Delta replaced the plastic bottles made by Schütz with new bottles that it had bought from Werit. The resulting reconditioned intermediate bulk containers were a mixture of the old Schütz cage and a new Werit bottle. Schütz objected to this, arguing that, in producing the reconditioned intermediate bulk container, Werit and Delta had infringed its exclusive right to ‘make’ the patented invention.
In considering this issue, the Supreme Court was called upon to determine how much of a product a person could modify before they infringed the owner’s right to make the product. Lord Neuberger stressed that the answer to this question depended on how ‘make’ was interpreted. He also emphasized the ‘somewhat slippery nature of the meaning of the word, and the very important role which context plays in determining whether a particular activity involves “making” an article’.27 Thus while placing a Schütz bottle in a Schütz cage would clearly have been a ‘making’, replacing the detachable lid would not.28 What, then, of the situation in which someone placed a Werit bottle in a Schütz cage?
p. 642↵In answering this question, Lord Neuberger began by critically examining some of the approaches that had previously been used to determine whether, in replacing part of an article, a person had repaired or made the article. One approach that has been used to answer this question focuses on the inventive concept of the patented article. Under this approach, if the defendant’s activities were to relate to the inventive part of the patented article, they would infringe. Conversely, if their conduct were limited to replacing the non-inventive parts of the article, they would be engaged in non-infringing repair. Thus if a patented product were to relate to the invention of a pool table with a novel and inventive coin-operating system, it would almost certainly be legitimate for a person to replace the cloth on the pool table. Under this approach, it would probably not be legitimate, however, for them to replace an old coin-operating system with a new one, since it is likely that this would be an essential component of the invention.29 This is the approach that was adopted by Floyd J at first instance in Schütz v. Werit,30 who held that the reconstituted bulk containers were non-infringing because the defendant had only replaced the non-inventive plastic bottle and not the inventive part, which was the cage. Using the inventive part of the invention as a touchstone for determining whether someone has ‘made’ the patented invention has the advantage of providing certainty (although it may be difficult to determine the inventive element of the invention in some cases).
While Lord Neuberger was willing to accept that the question of whether a defendant had replaced the inventive part of an article was a factor to be taken into account when deciding whether a particular activity constituted a making of the article, he stressed that it was wrong to use the inventive concept as a single touchstone for deciding whether, in replacing or modifying part of an article, a person had repaired or made the article. Specifically, Lord Neuberger was critical of the ‘oversimplified approach’ adopted by Floyd J at first instance, who had said the ‘correct approach is to ask whether, when the part in question is removed, what is left embodies the whole of the inventive concept of the claim’.31
Lord Neuberger was also critical of approaches that used the relative importance of the part that had been replaced to the article as a whole to determine whether the article had been made or repaired. Under this approach, if the part replaced was a material part of the article as a whole, it would be a making. In contrast, where the part in question was an immaterial part of a product, it was less likely for a court to hold that a person has made a patented product.32 Lord Neuberger rejected this approach, saying that the ‘mere fact that an activity involves replacing a constituent part of an article does not mean that the activity involves “making” of a new article rather than constituting a repair of the original article’.33 Thus if an original Schütz intermediate bulk container was reusable except for the detachable lid, which had been damaged, Lord Neuberger said that it ‘could not be plausibly contended that the replacement of the lid constituted “making” the claimed article, even though the [intermediate bulk container] would be unusable without the new ‘lid’.34
It is important to note that Lord Neuberger did not reject out of hand the use of the inventive concept or the relative importance of the part taken as tools for determining whether replacing part of an article constituted a making of the article. Instead, what he objected to were situations in which these factors were treated as the only factor to be taken into account. Drawing upon the idea that ‘making’ was to be decided contextually, Lord Neuberger said that it was important to focus on a range of factors, which would p. 643↵vary from case to case. On the facts before him, Lord Neuberger found that placing a Werit bottle in a Schütz cage did not constitute a ‘making’ of the patented article and, as such, was non-infringing. In reaching this conclusion, Lord Neuberger drew on a number of factors, including the fact that the bottle was a free-standing replaceable part of the patented article and that it had no connection to the claimed ‘inventive’ part of the intermediate bulk containers—namely, the metal cage. Another important factor was that the bottle had a much shorter life expectancy than the metal cage. It was also important that the bottle could not be described as the main component of the article. Lord Neuberger also said that it was important that apart from replacing the bottle and undertaking very minor repairs, Delta did not undertake any additional work on the bulk container.
In light of Schütz v. Werit, the question of whether something is ‘made’ or whether it is merely repaired or modified is decided by looking at the facts of the case as a whole. This will include quantitative factors, such as the amount of the product that is repaired and the relative life expectancy of the part that is being replaced. It will also include qualitative considerations, such as whether the inventive part of the patented invention has been replaced and the relative importance of the part of the patented product that has been repaired. While the test for determining whether someone has made a patented article takes account of a wide range of factors, there are limits. For example, it is does not matter who carries out the work,35 nor how a party views or markets its products (such as claiming that it is ‘re-manufactured’).36 While the courts now need to take a more holistic approach when deciding whether something has been repaired or made, it seems that this is unlikely to lead to different results.37
Where purchasers of a patented article are entitled to repair the product:
[They] must be entitled to carry out what is a genuine repair whether it is economical to do so or not, and whether the part repaired or replaced in the course of what is truly a repair is crucial to the function of the patented article or not.38
It also seems that if the repaired article does not work as well or as safely as the original product, this will not affect the decision as to whether the repair is legitimate.39
2.2.2 The right to dispose of the product
Another important right given to the owner of a product patent is the right to sell (or vend) the product. The right to sell, which is part of the general right to dispose of the invention,40 includes the sale of individual articles.41 It also applies where the patented product is sold to people who intend to use the article in non-infringing activities (such as sale to a p. 644↵person who intends to use the article for experimental purposes).42 A patent owner’s right to dispose of a product will be infringed where a person supplies the product in kit form. As with all infringement actions, the kit must fall within the scope of the claims.43 If the kit partially falls outside the claims, a patentee will have to rely on indirect or contributory infringement to prevent sale of the kits.44 These matters are discussed later.45
Implied licences and exhaustion46 A patent owner’s ability to control the way patented products are disposed of is limited by the common law doctrine of implied licence and the doctrine of exhaustion as developed under EU law.47 According to the doctrine of implied licence, in the absence of any limitation to the contrary, where the patentee sells a patented product, the patentee is unable to rely on the patent to prevent the resale of the article. This is because the sale of a product carries with it an implied licence to keep, use, and resell the product.48 However, where there is an express limitation, it will bind those who receive the goods with notice of the limitation—unless the limitation contravenes Article 34 or 101 of the Treaty on the Functioning of the European Union.
Under the doctrine of exhaustion,49 a patentee is unable to use a patent to prevent the further disposal of an article that has been placed on the market in the European Economic Area (EEA) with the patentee’s consent.50 Consequently, an express limitation on further disposal of a patented article will contravene Article 34 and thus be void if it prevents import into or resale in another member state. However, such a limitation might enable a UK patentee to prevent export to Australia, or perhaps further disposal within the United Kingdom.51
2.2.3 The right to import the product
The patentee has the right to control the import of products that fall within the scope of the product. It seems that where the patented product is passively imported (that is, where the patented product is of no importance as far as any question of carriage is concerned), p. 645↵the patent will not be infringed.52 As Tomlin J said: ‘I cannot think … that the employment of a patented cutting blow-pipe or a patented hammer in the manufacture of some part of a locomotive would necessarily render the importation of the locomotive an infringement.’53 A person will infringe where they deal with the patented product in the course of trade or for the purposes of profit.54 Because an importer must have a legal and beneficial interest in the infringing goods, foreign parties will not infringe where they transfer their interests in the infringing object outside the United Kingdom (although they might be liable as a joint tortfeasor).55 As with the right to dispose of the product, the patentee’s right to prevent import is limited by the common law principle of implied consent and by the doctrine of EU/EEA exhaustion.
2.2.4 The right to keep the product
The patentee’s monopoly also includes situations where an infringer keeps the product, whether for disposal or otherwise. The scope of this right was considered in SKF v. Harbottle,56 where the court was called upon to decide whether the storage of a product in a London warehouse fell within the meaning of ‘keep’ in section 60(1) of the Patents Act 1977. This decision arose from the fact that British Airways, which was in the process of transporting an antihistamine drug called Cimetidine from Italy to Nigeria, stored 20 kg of the drug in a warehouse in London. While the drug was being stored, a patent infringement action was brought by the UK patentees (SKF) against the owner and importer of the drug, Harbottle. British Airways was joined as co-defendant in the infringement action on the basis that it had infringed the owner’s right to keep the product. Finding in favour of British Airways, the court held that the act of passively storing a patented drug in a warehouse in London could not be construed as the ‘keeping of a product’ within the meaning of section 60(1). While declining to arrive at a definitive meaning of the term ‘keep’, the court was strongly influenced by the ‘very much more limited’ terms employed in Article 29(a) of the Community Patent Convention (CPC), where the equivalent wording refers to ‘stocking’ a patented product. On this basis, it was said that ‘keep’ implied ‘keeping in stock’ rather than acting as a custodian.
Despite the approach adopted in Harbottle, a broader interpretation of the right to keep a product was adopted in McDonald v. Graham.57 In this case, the patentee asserted that the defendant (a marketing consultant who had been introduced to the patentee), who retained certain articles (and later made them available to a third party), had infringed their right to ‘keep’ the patented product. In response, the defendant argued that the materials had not been kept ‘for disposal or otherwise’. The Court of Appeal held that the defendant had kept the product ‘in the sense of keeping them in stock for the purposes of his business in order to make use of them as and when it would be beneficial to him to do so’.58 As such, the patent had been infringed.
p. 646↵In circumstances where the patentee has placed the product on the market, a person will be free from liability under the implied licence theory. However, if no such licence is implied, liability for mere possession or use is absolute (irrespective of knowledge or intent).
2.2.5 The scope of protection for biotechnological inventions
In the lead-up to the Biotechnology Directive,59 questions arose about the scope of protection for biotechnological inventions. The issues were dealt with by Articles 8–10 of the Directive. The Patents Act 1977 has been amended to take account of these provisions.60 The scope of protection of product patents for biological material is dealt with in Articles 8(1) and 9 of the Directive.
Article 8(1) provides that the protection conferred by a patent on biological material (possessing specific characteristics) extends to any biological material derived from that biological material by propagation or multiplication in an identical or divergent form. This would apply, for example, to inventions for herbicide-resistant plants and genetically manipulated animals.61 For the derivative biological material to be covered by the patent, it must possess the same characteristics as the patented biological material. This means that a patent for a genetically modified animal would extend to include future generations (so long as they retain the ‘specific characteristics’ of the ‘original’ animal).62
Article 9 (which is mirrored in the United Kingdom in paragraph 9 of Schedule A2 to the Patents Act 1977)63 deals with the scope of protection for a product that contains genetic information. More specifically, it provides that the protection conferred on a patent containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1),64 in which the product is incorporated and in which the genetic information is contained or performs its function.
In recent years, there has been a growing concern about the nature of the protection granted to biotechnological inventions, particularly in relation to product patents granted for genes, DNA sequences, and the like. The main problem with product patents is that they give the patentee control over subsequent uses of the product, even for uses that they did not envisage or know about. For example, if a research team were to discover that the ABC gene caused acne, it might be possible for them to obtain a product patent over the isolated ABC gene. If another research team were subsequently to discover that the ABC gene also played a role in the development of skin cancer, this would be covered by the earlier product patent. One objection to a situation such as this is that the reward granted to the patentee outweighs the benefits that flow from their disclosure. Another related problem is that product patents may stifle research into new uses of a patented product In Monsanto v. Cefetra65 the Court of Justice considered the scope of Article 9. It concluded that where an isolated DNA sequence is protected as a patented product and it is contained in the material, but it no longer performs its function (the enzyme made the plant roundup ready and so resistant to that herbicide during its lifetime) then it falls outside the scope of protection conferred even if the product could be taken from the biological material and used again.66 There is therefore no absolute protection granted and if modified crops are grown outside Europe and once grown, provided the function p. 647↵is no longer performed, they can be sold within the EU without infringing the patent.67 In 2016, an Expert Group appointed by the European Commission published a report which considered two interpretations of Monsanto.68 The minority view of the Group was that the decision took DNA sequences out of the scope of protection of patents.69 The majority of the Expert Group said the relevant question was whether the patented product was capable of performing the function protected by the patent. The example they used was the sale of DNA in a dry state, where it could not perform its function; however, if the dry substance was put in an aqueous environment, it was able to perform its function once more. The sequence was ‘capable’ of performing its function, but it was not performing the function during the manufacture, sale, or importation of the product and so would not infringe.70 However, if it is used after being rehydrated then that use would infringe. While special defences have been introduced to minimize the impact of product patents for biological inventions,71 many commentators believe that further action is necessary. One solution that has been suggested is that the scope of protection for gene patents should be limited to the use that is actually disclosed in the patent.72 To continue with the example mentioned earlier, this would mean that the initial patent would only be granted for the ABC gene insofar as it triggers acne. In this situation, the protection reflects the disclosure. The more limited protection also means that the patent would not act as a disincentive for others to look for other uses of the ABC gene. It has been suggested that this proposal is supported by Recital 25 of the Biotechnology Directive insofar as it limits product claims to the parts of the product that are essential to the invention—that is, it restricts the scope of DNA-product patents based on their disclosed function.73 Another more radical suggestion, which harks back to the way in which chemical inventions were treated in the early part of the twentieth century, is to limit gene patents to process claims—that is, product production would simply not be available for gene-based inventions.
2.3 Patents for a process
The owner of a patent for a process is given the right to use the process or to offer it for use in the United Kingdom.74 This is subject to the proviso that the right is only infringed where it can be shown that the defendant knew, or it would have been obvious to a reasonable person in the circumstances that the unauthorized use of the process would be an infringement of the patent. It is important to note that in contrast with the rights given to owners of patents for products (discussed earlier) and the rights given to patents for products derived from processes (discussed later), liability for infringement of a patent for a process75 is not absolute—that is, liability depends upon the owner proving that the defendant knew, or that it would have been obvious to a reasonable person in the circumstances, that the unauthorized use of a process would be an infringement of the patent. In p. 648↵essence, the owner of a patent for a process is given the right to practise the invention or to put the invention into effect. For the most part, there have been few problems in interpreting this provision (although discovering how a defendant makes a particular product may be one).76 Problems may arise, however, in relation to patents for ‘novelty-of-use’ claims, which are discussed later in this chapter.
2.3.1 Direct products of patented processes
It has long been accepted that where a patent is granted over a process, the protection includes both the process in question and the products that flow from that process. This principle is now to be found in section 60(1)(c) of the Patents Act 1977, which provides that a person infringes a process patent if they dispose of, offer to dispose of, use, import, or keep any product derived from that process.77 This protection is particularly important where no claim has been made to a product as such. It is also important where the process is carried on outside the United Kingdom and a product derived from that process is imported into the United Kingdom.78 As we have already looked at the way these terms are construed, there is no need to examine them again.
The protection given to process patents is potentially very wide. In part, this is because where a range of different products flow from a single process, all of the products fall within the remit of the patent. It is also because the scope of protection not only includes the products that flow from the process, but also the products that are based upon the products that flow from the process—that is, the derivatives of the derivative. To ensure that the scope of the monopoly is kept within justifiable limits, an important restriction is placed on the products that are protectable by process patents. This has been done by stipulating that for protection to arise, there must be a direct relationship between the process and the product in question.79
The question of what is meant by a ‘direct’ relationship was considered by the Court of Appeal in Pioneer Electronics v. Warner Music.80 This action arose when the claimant argued that its process patent for a method of manufacturing compact discs had been infringed after the defendant imported optical discs into the United Kingdom that were a by-product of the patented process. While there was no doubt that the imported discs had been derived from the patented invention, it was unclear whether there was a ‘direct’ relationship between the process patent and the imported discs.
After considering the way equivalent provisions were interpreted in other European jurisdictions, the Court of Appeal concluded that ‘directly’ meant ‘without intermediary’. More specifically, Nourse LJ said that when the Patents Act 1977 stipulated that for protection to arise, there had to be a direct relationship between the process and product, this meant that there were no material or important steps that intervened between the process and the product in question. In situations where material and important steps did intervene, the process patent could not be used to control the use that was made of the product. This situation would only change if it could be shown that the intervening steps were immaterial or trivial.
p. 649↵The process patent for the production of the master discs was not infringed when the final discs were imported into the United Kingdom. The reason for this was that a number of important and material steps separated the product from the process. A key factor in the finding of non-infringement was that the production of the master discs was only an initial stage in the production of the final optical discs. The master discs were used to produce ‘mothers’, which in turn were converted into ‘sons’, which subsequently acted as the basis from which the moulding of the final discs took place. While the patented invention may have acted as a platform that aided in the production of the final discs, because there were a number of important and material steps that separated them, there was not a direct relationship and thus no infringement. The requirement that there be a direct relationship is in accord with the general logic of patent law. While a product may draw upon a process patent, if the product only comes into existence as a result of material steps that occur outside the process, the products are no longer derivative; rather, they are new products that warrant separate patent protection. If patentees were able to regulate the use that was made of such products, this would extend the ambit of the monopoly beyond the scope of the invention disclosed in the patent.81
The question of what is meant by a direct relationship was also considered in Monsanto v. Cargill.82 In this case, Monsanto argued that by importing into the United Kingdom a cargo of soybean meal produced in Argentina, Cargill had infringed Monsanto’s patent for Round Up Ready soybeans—the main claim being for ‘a method of producing genetically transformed plants’. There was no doubt that the soybean meal imported into the United Kingdom (or at least a substantial part of it) was produced from Round Up Ready soybeans in Argentina. In deciding whether the method claims in the patent had been infringed, the court had to consider whether the soybean meal had been ‘directly obtained’ from the process in question under section 60(1)(c). Pumfrey J said that the phrase ‘directly obtained by means of the process’ means the ‘immediate product of the process, or where the patented process is an intermediate stage in the manufacture of some ultimate product, that product, but only if the product of the intermediate process retains its identity’.83 Following Pioneer Electronics v. Warner Music, Pumfrey J said that a product that is derived from a patented process will be directly obtained so long as the product retains its essential characteristics. However, where a product has ‘lost its identity and become something else’, it will not be directly obtained. As Pumfrey J noted, intermediate processes in chemical cases often suffer this fate.
In considering whether the method claim in Monsanto’s patent had been infringed by the importing of the soybean meal, Pumfrey J said that the method claim consisted of the isolation and insertion of a recombinant DNA molecule with prescribed characteristics into the genome of a plant cell. The DNA molecule was inserted into one original plant, which was named and identified in the patent as the parent of all Round Up Ready plants in Argentina. Pumfrey J noted that the transformation of the original plant had occurred many generations ago and that since then, soybeans had been grown by seedsmen or retained by farmers for planting. After some generations, the harvested beans were processed into the meal that had been imported in the United Kingdom. Pumfrey J was willing to accept that all of the Round Up Ready soybean plants in Argentina were lineal descendents of the original plant and also that the ‘huge mountain of soybean meal’ could be described as the ultimate product of the original transformation of the parent plant. Pumfrey J was unable to accept, however, that the soy meal was the ultimate product of the original transformation of the parent plant—a phrase that he reserved for the original transformed plant. On this basis, Pumfrey J held that the imported soybean meal was not p. 650↵‘directly obtained’ for the purposes of section 60(1)(c) and, as such, did not infringe. In so doing, Pumfrey J rejected Monsanto’s argument that the product retained its essential characteristics when it was made into meal. In rejecting the hereditary nature of the relationship between the Round Up Ready sequence (as inserted in the parent plant) and the soybean meal, Pumfrey J said that Monsanto’s argument confused the ‘informational content of what passed between the generations (the Round Up Ready genomic sequence) with the product, which is just soybean meal with no special intrinsic characteristics from one of the generations of plants’.84 As well as clarifying what it means for a product to be directly obtained, the decision is also important in that it provides some insight into the approach that UK courts may take towards the infringement of biological inventions.
2.3.2 Direct products of biotechnological processes
The question of the scope of protection for patents for biotechnological processes is dealt with in Article 8(2) of the Biotechnology Directive. A similar provision now exists in the Patents Act 1977 as a result of amendments made in July 2000.85 Article 8(2) provides that:
The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics.
As with the protection given to product patents for biological materials, the derived material must possess the same characteristics as the ‘original’ material. It should be noted that the protection under Article 8(2)/paragraph 8 of Schedule A2 to the Patents Act 1977 is limited to material ‘directly obtained’ from the patented process. It seems that ‘directly obtained’ would be construed in a way similar to how a ‘direct’ relationship was construed in Monsanto v. Cargill86 and Pioneer Electronics v. Warner Music87 (discussed earlier).
2.4 Novelty-of-use claims
For the most part, when determining whether a defendant has carried out one of the activities within the patentee’s control, the key question is the way in which the language of the patent is construed. One situation in which problems may arise, however, is in relation to patents for a new use of a known substance used in an old way, which have been recognized at the EPO and in the United Kingdom.
The decision to accept novelty-of-use patents has met with considerable resistance in the United Kingdom.88 As Lord Hoffmann said in Merrell Dow,89 the Board’s decision p. 651↵in Mobil has been criticized on the ‘ground that a patent for an old product used in an old way for a new purpose makes it difficult to apply the traditional UK doctrine of infringement’. The problem with novelty-of-use claims is that it may be difficult to ascertain when a product is being used in the relevant way. Unless use claims are confined to uses of products that are distinct, it seems that a patentee of an invention that consists of a new use must demonstrate that the infringer intended to produce the particular effect.
The reason why the recognition of use claims is incompatible with the traditional UK doctrine of infringement can be traced to the fact that the infringement of a patent turns exclusively on the physical conduct of the defendant. A person will infringe if, for example, they manufacture or sell the patented invention without permission. In so doing, the alleged infringer’s state of mind is irrelevant; it does not matter whether the alleged infringer knew that they were dealing with the patented product. In most cases, this presents few problems. For example, because claims to a new use of an old thing will be physically different from previous uses of the same thing, the earlier use can continue to be performed without infringing the subsequent patent. Problems may arise, however, in relation to novelty-of-use patents. This is because, for infringement purposes, the discovery that a known product used in a known way can be put to a new purpose is physically identical to the previous use, the only difference between the two uses being in the mind of the user. Given that the physical acts protected by a novelty-of-use patent would be the same as the steps taken during the previous use, when someone uses an old substance in an old way, there is no obvious way of telling whether they are using the substance to achieve the old purpose or whether they are using the substance to achieve the new purpose. As Lord Hoffmann said:
[L]iability for infringement is, as I have said, absolute. It depends upon whether the act in question falls within the claims and pays no attention to the alleged infringer’s state of mind. But this doctrine may be difficult to apply to a patent for the use of a known substance in a known way for a new purpose. How does one tell whether the person putting the additive into his engine is legitimately using it to inhibit rust or infringing by using it to reduce friction?90
The problem raised by novelty-of-use patents is that while the only feature that enables a novelty-of-use patent to be distinguished from the previous use is the purpose for which it is used (which exists in the mind of the user), the purpose of the alleged infringer is not taken into account when determining whether a patent has been infringed; all that matters is whether the physical act of infringement has taken place. The consequence of this is that a patent granted for the discovery of a new purpose of an old thing used in an old way could prevent someone from doing what they had done before—thus denying the user their previous right to work.91
While it has been suggested that these problems are based on an artificial distinction,92 the inherent conflict between the physical nature of infringement and the mental nature of novelty-of-use patents gives rise to real problems in the United Kingdom that will need to be resolved if such patents are allowed. If novelty-of-use patents are not to impinge upon the p. 652↵legitimate (existing) activities of others,93 it may be necessary to limit the scope of the monopoly (possibly to the making, using, and commercial supply of the thing for the specified use) or to modify the defence of prior use.94 In Warner-Lambert v. Actavis Group95, Floyd LJ reviewed the approach to purpose bound claims in countries around the world, before concluding the law was ‘far from settled’. This led Floyd LJ to consider the two candidates for a test: (a) foreseeability that the drug will intentionally be used for the patented indication and (b) a subjective intention to that effect.96 He concluded that the better way to consider the matter as to whether there is an infringement is to ascertain whether a person knows or could reasonably foresee the end use of the product being an infringing purpose.97 For these purposes the person will not be taken to have foreseen an outcome when he or she has taken all reasonable steps within their power to prevent the consequences occurring. In such circumstances his true objective is a lawful one, and one would be entitled to say that the foreseen consequences were not intended, but were an unintended incident of his otherwise lawful activity.98 The problem with use or purpose claims outside prescribed pharmaceuticals is more difficult. But we suggest that the principles outlined above should equally apply to other products.
2.5 Indirect infringement
In addition to the prohibited activities set out in section 60(1), the Patents Act 1977 also provides that a patent is infringed where a person contributes to, but does not directly take part in, the infringement.99 This is particularly important where the maker or user is difficult to detect (for example where the manufacture or use occurs in private) or they are not worth suing. Section 60(2) states that a person infringes a patent where they supply or offer to supply any means relating to an essential element of the invention for putting the invention into effect.100 Thus a patent for a glue that is produced by combining two chemicals A and B may be infringed by a person who supplies either A or B to a person who then manufactures the glue.101 The question of what it means for an online invention to be put into effect in the United Kingdom was considered by the Court of Appeal.102 The patent in question was for a gaming system consisting of a host computer, terminal p. 653↵computers, and software that operates the system. The invention enabled end-users on terminal computers to engage in interactive gaming with the host computer. The defendant, William Hill, operated an online gaming system for punters in the United Kingdom. British punters were supplied with a computer program (either via CD or downloaded from the net) that transformed their computer into a terminal computer of the defendant’s system. The claimant argued that when the defendant’s system was in use, it infringed its patent. The defendant argued that it did not infringe the patent because its host computer was located abroad and not in the United Kingdom (in Antigua, and then in Curaçao in the Netherlands Antilles). Aldous LJ said that it was ‘not straining the word “use” to conclude that the UK punter will use the claimed gaming system in the United Kingdom, even if the host computer is located in, say, Antigua’.103 Focusing on the way in which the end-user related to the invention, Aldous LJ said that a punter who used the William Hill system would be using the whole system as if it were in the United Kingdom. The punter would, in substance, use the host computer in the United Kingdom, it being irrelevant to the punter where it was situated. Aldous LJ concluded that in supplying the computer program in the United Kingdom, the defendant intended to put the invention into effect in the United Kingdom and, as such, infringed the claimant’s patent.104
For indirect infringement to take place, three criteria must be satisfied. First, the proprietor of the patent must establish that the means supplied by the defendant relate to an essential element of the invention.105 A person will also indirectly infringe where they supply a number of the essential components of a patented invention. This would occur, for example, where a patent is for an oil lamp (which is made up of a vessel holding the oil, a burner and wick, an outer glass container, and a chimney) and the defendant supplied all of the parts other than the chimney.106
Second, the supplier must know, or it must be obvious to a reasonable person in the circumstances, that the means are both ‘suitable’ for and are ‘intended’ to be used in putting the invention into effect.107 It is important to note that the Court of Appeal has said that the reference to ‘intention’ in section 60(2) is not linked to any specific person (such as the supplier, the direct customer, or the ultimate users). Instead, the inquiry is whether the means and the circumstances surrounding it being offered or supplied ‘are such that some ultimate users will intend to use or adapt the “means” so as to infringe’.108 The knowledge requirement will be satisfied if ‘at the time of supply or offer of supply, the supplier knows, or it is obvious in the circumstances, that ultimate users will intend to put the invention into effect’.109 The imposition of a knowledge requirement, which is construed objectively, ensures that parties who do not knowingly benefit from the misuse of a patent are not caught as indirect infringers. As Jacob LJ said, the section is ‘clearly intended to apply to, among other things, products which are perfectly capable of being used in a manner which will not constitute a direct infringement within s. 60(1)’.110
p. 654↵Third, in recognition of the fact that there might be legitimate reasons why a person supplies or offers to supply something that enables the means for putting the invention into effect, section 60(3) provides that the supply of a staple commercial product will not constitute an indirect infringement under section 60(2).111 The meaning of ‘staple commercial product’ is not clear, although it might be assumed that it covers basic products that are readily available.112 The staple commercial product exemption does not apply where the product is specifically supplied for the purpose of inducing an infringement.113
2.5.1 Novelty-of-use claims
Given the difficulty in establishing direct liability in relation to novelty-of-use patents (discussed earlier), indirect liability may take on a greater significance. Taking the example of a patent for the use of a substance in oil as a lubricant, where it was previously known that the substance inhibited rust, it would seem that a defendant would infringe if they supplied the oil to people and advertised it as a lubricant. However, a person would not infringe if they were to continue to supply the oil as a rust inhibitor. While it might be known that the oil could be used as a lubricant, it would be difficult to prove that the defendant ‘intended’ that the oil be used in this way (as is required under section 60(2)). In these circumstances, secondary factors may be helpful, such as the documentation that accompanies the product, which might indicate the way in which the product was expected to be used.114 It would be more difficult to determine whether a defendant indirectly infringes where they supplied the oil saying that it acted both as a rust inhibitor and a friction reducer. The liability of the defendant would also be uncertain if they were to supply the oil saying that it acted as a rust inhibitor, where it was widely known that the oil could also be used to reduce friction. In these circumstances, the likelihood of the user using the oil as a lubricant is high, but not certain. Jacob J, who has expressed doubts about the role of novelty-of-use claims, has called for these issues to be considered in detail by the European Patent Office whenever it gives further consideration to claims for uses.115 So far, these pleas have fallen on deaf ears.
2.6 Additional liability
In addition to the rights set out in sections 60(1) and 60(2), patentees are also able to make use of a limited number of provisions that exist outside the Patents Act 1977. These provisions will be particularly important where a party acts in such a way as to undermine the value of a patent, yet the activities fall outside of the scope of section 60(1) or (2).
Perhaps the most important non-statutory mechanism available to a patent owner is the concept of joint tortfeasance.116 This provides that even if a party does not fall within the scope of section 60, the patentee can enjoin the third party as a joint tortfeasor if it can be shown that they have acted in a ‘common design’ with a party who is liable for a p. 655↵statutory tort of infringement under section 60 (and that they jointly inflicted damage on a patentee).117 For a party to be liable as a joint tortfeasor, they must be ‘so involved in the commission of the tort as to make himself liable for the tort’.118
It has also been suggested that the law of restitution provides patentees with an additional ground on which to found liability. More specifically, it has been argued that independently of the rights set out in the 1977 Act, the law also recognizes unjust enrichment as a separate cause of action. Proposals of this type were considered and rejected in Union Carbide Corporation v. BP Chemicals,119 where Jacob J said that the law of restitution could not be used to supplement the law of patents to the extent of providing a cause of action for unjust enrichment. Jacob J did say, however, that there might be cases in which the strict rights set out in section 61 of the 1977 Act might not limit what a court could do in furtherance of the policy of patent law—but what this policy is and what it might mean in this context was left unclear.
3 Scope of protection
Once it is clear that a defendant has carried out one of the activities listed in section 60 of the 1977 Act, it is then necessary to consider whether in so doing they fall within the scope of the patent. The starting point for determining the scope of protection is section 125 of the Patents Act 1977, which corresponds to Article 69 of the EPC 2000 (ex Article 69 of the EPC 1973).120 This provides that the extent of the protection conferred by a patent shall be ‘taken to be that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification’. Once the scope of the patented invention has been determined, it is then necessary to compare it with the defendant’s alleged infringing process or product. Where the claimant’s invention and the alleged infringing product or process are very different, there will be no infringement. Likewise where the two are identical, the defendant will clearly infringe. A defendant will also infringe where they incorporate the patented invention into a larger process or product. This is the case even if the addition improves upon the patented invention. It is also clear that the defendant will infringe where they supply a patented product in parts or in kit form.121 A defendant will not infringe, however, if the consumer needs to exercise inventive skill in putting the kit together.122
While these situations are relatively unproblematic, problems arise where there is only a slight difference between the patented invention and the defendant’s alleged infringing product. This would be the case, for example, if, rather than adding to the patented invention, a defendant altered or omitted part of the patented invention in their product or process, and on this basis argued that their invention fell outside the scope of the monopoly.123 Problems also arise where a defendant changes one aspect of an invention, p. 656↵or uses a different means to reach the same end result as the patented invention. In these situations, the decision as to whether a defendant infringes largely turns on the way in which the scope of protection is determined.124
3.1 Determining the scope of protection
In determining how the scope of protection is to be determined, patent law is faced with a choice. The easiest and most straightforward option would be to construe the patent strictly (or literally). In this situation, the patentee’s protection would be limited to what was clearly stated in the claims. A spade would be a spade. This accords with the basic idea that a patentee should only get protection for what they have disclosed. Where this approach is applied, it would mean that a patent that said that an angle in an invention had to be at 90 degrees would not be infringed by a competing product where the angle was at 89 or 91 degrees. While this has the advantage of providing third parties with guidance about the limits of the patent, it undermines the scope of protection for the patentee. This is because as it is often very difficult to describe the invention, patentees may be forced to use language that third parties can easily avoid. While the pendulum between the competing interests of third party certainty and fairness for the patentee has constantly moved, British patent law has consistently recognized that patentees should not be limited to a strict literal reading of the claims. That is, the courts have allowed patentees to extend their monopoly beyond a strict reading of the text of the claims so as to prevent ‘the unscrupulous copyist [from making] unimportant and insubstantial changes and substitutions in the patent which, though adding nothing, would be enough to take the copied matter outside the claim, and hence outside the reach of the law’.125 While the decision to extend protection beyond a strict reading of the claims has ensured that patentees are not exposed to unscrupulous competitors who take the inventive aspect of an invention but frame it in a way that falls outside the literal reading of the claims, it also creates the possibility that patentees may get more protection than they deserve (in terms of what they have invented).
One of the consequences of the shift away from a literal reading of the claims is that it gives rise to a further question: how far outside the literal wording of the claims is it permissible to go?126 Over time, there have been numerous attempts to answer this question. The latest iteration being the 2017 Supreme Court decision of Actavis v. Eli Lilly.127 Before looking at Actavis, it may be helpful to outline recent judicial and legislative attempts to provide guidance on where and how the limits on claim drafting are to be set.128
3.1.1 Purposive interpretation
While there is an important but largely neglected pre-history,129 the history of patent claim interpretation in the United Kingdom usually begins with Lord Diplock’s celebrated 1982 p. 657↵House of Lords’ judgment in Catnic v. Hill and Smith130 (decided under the 1949 Patents Act), which held that the fundamental principal that underpins claim interpretation is the idea that the claims should be construed ‘purposively’. This means that rather than limiting the meaning of a claim to a literal or strict meaning, it was necessary to interpret claims from the perspective of the person skilled in the art.131 As Lord Hoffmann said in Kirin-Amgen, the key question to ask was:
[W]hat would a person skilled in the art have understood the patentee to have used the language of the claim to mean? … Everything else … was only guidance to a judge trying to answer that question.132
We can get a sense of the impact that a purposive interpretation can have on the way in which claims are interpreted from the facts in Catnic v. Hill and Smith.133 In Catnic, the House of Lords was called upon to decide whether in manufacturing the steel lintels, the defendants had infringed the claimant’s patent for galvanized steel lintels. (A lintel is a load-bearing beam that spans open spaces, such as doors and windows, in cavity walls.) While it was evident that the defendant’s lintel and the patented invention (see Fig. 22.2) were very similar, one issue remained unclear. This arose from the fact that while the patent specified that the rear side of the lintel should be ‘vertical’, the defendant’s lintel (see Fig. 22.3) was at an angle of 84 degrees. In order to determine whether the claimant’s patent had been infringed, the House of Lords had to decide whether a claim that specified that the rear support be vertical encompassed a lintel whose rear support was not ‘precisely’ vertical.
While a literal reading of the claims would have limited the claimant’s patent to lintels at 90 degrees (and thus to a finding of non-infringement), Lord Diplock said that the patent ought to be construed purposively. A purposive interpretation demands that the claims are to be read through the eyes of the person skilled in the art and that the purpose or function of the invention be borne in mind when the patent is interpreted.134 This meant that when deciding whether ‘vertical’ included lintels at an 84 degree angle, the person skilled in the art would take into account the function or purpose of the invention. On reading the patent, it was decided that the person skilled in the art would have understood that the reason why the patent specified that the rear support member was to be ‘vertical’ related to the load-bearing capacity of the lintel. An important factor in the finding that the patent had been infringed was that a 6 degree movement away from 90 degrees only led to a 0.6 per cent reduction in the load-bearing capacity of the lintel. This meant that the defendant’s lintel effectively performed the same purpose or function as the claimant’s lintel.p. 658↵
While the patent specification is read from the perspective of the person skilled in the art, the question of the construction of the claims is ultimately a matter for the court. In some cases, the courts will draw on external assistance to help it to determine the meaning of a claim. In some cases, a court can hear expert evidence on the meaning of technical terms.135 Although a purposive interpretation may allow the courts to extend the scope of the claims beyond that which would be allowed by a literal reading, this does not mean that a purposive approach is an open-ended and unconstrained process. Indeed, there are a number of factors that shape the way in which purposive interpretation is applied, one of which is the fact that the person skilled in the art is presumed to proceed on the basis that the purpose of the specification:
… is both to describe and demarcate the invention—a practical idea which the patentee has had for a new product or process—and not to be a textbook in mathematics or chemistry or a shopping list of chemicals or hardware.136
p. 659↵It will also be presumed that the patentee is attempting to describe something that is new, with all of its attendant problems. It is also presumed that the skilled person will read the patent specification as a whole,137 and will draw upon the description and drawings to interpret the claims.138
A lot will turn on the skill and expertise that is attributed to the person skilled in the art, which will always vary depending on the invention in question. The person skilled in the art is presumed to read the specification ‘with common general knowledge of the art available at the time of its publication’.139 It is also presumed that the notional skilled reader would be aware, and take account, of the drafting conventions by which the patent and its claims were framed.140 They are also presumed to be aware of the language conventions that have developed over time, which ascribe particular meanings to words such as ‘comprising’ and ‘suitable for’.
While the use of a purposive style of interpretation often means that the scope of the monopoly is broader than that which would arise if the claims were to be interpreted literally, purposive interpretation does not necessarily require that the claims be read broadly or indeed in the patentee’s favour. All that the purposive approach requires is that the court interprets patents through the eyes of the person skilled in the art, while taking into account the purpose of the invention—nothing more, nothing less. How broadly claims will be read in any particular case always depends on the approach undertaken by the person skilled in the art in the case in hand, which in turn is influenced by the purpose of the invention and the way in which the claims are drafted.141
3.1.2 The Protocol on the Interpretation of Article 69 EPC
One of the problems that confronted the drafters of the EPC 1973 was that some member states—notably, the United Kingdom and Germany—approached the task of interpreting patent claims differently. While the British were said to favour a strict, literal reading of the claims, it was suggested that in Germany, the claims simply acted as a guide for determining the scope of protection. Given the potentially important role that claim interpretation plays in determining the scope of protection, if these different styles of interpretation were allowed to continue under the EPC, it would have undermined the aim of a standardized pan-European patent system. In an attempt to overcome these (perceived) differences and to harmonize the way in which patents are interpreted across member states, the Protocol on Interpretation of Article 69 of the EPC 1973 was introduced to provide guidance as to how patent claims should be interpreted.142 The Protocol, p. 660↵which is said to bear ‘all the hallmarks of a compromise agreement’,143 was replicated in EPC 2000 in a slightly modified form.144
There are three notable features of the Protocol under EPC 2000. The first is that it stipulates the standpoint of interpretation that should not be adopted when interpreting a patent. In particular, it says that the courts should not read the claims literally. The Protocol also says that the claims should not be used as a mere guide to interpretation; instead, it says somewhat cryptically, that the courts should adopt a position in between these extremes.145 The second, more positive, feature of the Protocol is that it says that the courts should interpret the claims in a way that combines a fair protection for the patentee with a reasonable degree of certainty for third parties.146 The third feature of the Protocol is that it provides that when determining the scope of protection due account should be taken of any element which is equivalent to an element specified in the claims.147
3.1.3 The Improver questions
The next important intervention on claim interpretation was Hoffmann J’s 1990 judgment in Improver v. Remington.148 This decision was concerned with the potential infringement of a patented hair removal device, known as ‘Epilday’ (which operated by trapping hairs in a rotating coiled helical spring which then pulled them out of the skin) by the defendant’s device (which operated in the same way but used a slotted rubber rod to capture and remove the hairs). While the alleged infringing device clearly fell outside the scope of a strict literal reading of the claim, Hoffman J was willing to consider whether it nonetheless still infringed. Holding that the purposive interpretation outlined by Lord Diplock in Catnic was consistent with the 1977 Patents Act, the EPC 1973, and the Protocol, Hoffmann J went on to suggest a three-step approach to determine whether a patent was infringed. As he said, when the issue was whether a feature embodied in an alleged infringement fell outside the ‘primary, literal or a contextual meaning of a descriptive word or phrase in the claim’ (what he called ‘a variant’) was ‘nonetheless still within its language as properly interpreted’, three questions, which have come to be known as the Improver questions,149 should be asked:
Does the variant have a material effect on the way in which the invention works? If yes, the variant is outside the claim. If no—
Would this (i.e. that the variant has no material effect) have been obvious to a reader skilled in the art at the date of the publication of the patent? If no, the variant is outside the claim. If yes—
Would a reader skilled in the art nevertheless have understood from the language of the claim that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.150
Applying these questions to the facts of the case, Hoffmann J found that the difference between the patented invention and the allegedly infringing device (namely, the difference between the coiled helical spring and the slotted rubber bar) did not have a material effect on the way the invention worked: both functioned to capture and remove body hair. He also found that this would have been obvious to the skilled reader. However, on the p. 661↵basis that it would have been obvious to the skilled reader that the rubber had problems … which might have been difficult to overcome’, Hoffmann J found that the patentee failed to satisfy the third test and as such that there was no infringement.151
The next important development in this area was the 2005 House of Lords decision of Kirin-Amgen.152 In considering ‘whether a protein manufactured by gene-activation infringed a patent relating to production of the same protein by recombinant DNA technology’, Lord Hoffmann reviewed the existing law on patent claim interpretation. There are three notable things about the decision. The first relates to the way it promoted purposive interpretation at the expense of the Improver questions. While Lord Hoffmann thought that the purposive interpretation as outlined in Catnic was the ‘bedrock of patent construction, universally applicable’,153 he said that the Protocol and the Improver questions were ‘simply guidelines for applying [purposive interpretation] to equivalents … more useful in some cases than in others’.154 In so doing, he called into question the practice that had developed in the UK post-Improver whereby the Improver questions were routinely applied in UK patent infringement cases.155 Following Kirin-Amgen the Improver questions fell out of favour in infringement actions in the United Kingdom, to be replaced by the purposive interpretation that asked: what would the person skilled in the art have understood the patentee to mean?156
The second notable point about Kirin-Amgen was in relation to the so-called doctrine of equivalents and its place within British law.157 Prior to the passage of the Patents Act 1977, under the doctrine of equivalents, elements of an invention were not only considered to be the same when they were identical, but also when they were functionally equivalent.158 This meant that ‘there may be infringement even if the accused product falls outside the meaning of the words of the claim when understood in context’.159 Given that neither Article 69 of the EPC 1973160 nor the Protocol (under EPC 1973) made specific reference to the doctrine of equivalents,161 when the 1977 Act was passed doubts were raised as to whether the doctrine of equivalents was still applicable under the new law. In many ways, it seemed that the uncertainty about the status of the doctrine of equivalents was answered by the EPC 2000. In affirming the continued role of the doctrine of equivalents, Article 2 of the Protocol on Interpretation of Article 69 in the EPC 2000 reads that for ‘the purposes of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the p. 662↵claims’.162 As a result, it seemed clear that the doctrine of equivalents needed to be taken into account when deciding whether a patent has been infringed.
The belief that the EPC 2000 might have reinstated the doctrine of equivalents under British law was temporarily undermined by the House of Lords in Kirin-Amgen,163 when Lord Hoffmann said that the amendment changed nothing; the provision only made it clear that equivalents need to be considered, not that there was a ‘doctrine of equivalents’ allowing a court to extend protection beyond that covered in the claims (as interpreted by the person skilled in the art). As Lord Hoffmann said: ‘[It] seems to me that both the doctrine of equivalents in the United States and the pith and marrow doctrine in the United Kingdom were born of despair. Since the Catnic case we have article 69 which, firmly shuts the door on any doctrine which extends protection outside the claims’.164 One of the consequences of Kirin-Amgen was that the doctrine of equivalents was subsumed within the purposive approach to interpretation. Thus while the Court of Appeal may have been able to say in 2009 that ‘there is no general “doctrine of equivalents”’,165 nonetheless it also accepted that a purposive interpretation could ‘lead to a conclusion that a technically trivial or minor difference between an element of a claim and the corresponding element of the alleged infringement nonetheless falls within the meaning of the element when read purposively’.166 In a strange (literal) reading, this was said not to be because there was a doctrine of equivalents; rather, it was because it was the fair way to read the claims in context167—a doctrine of equivalents in all but name?
3.1.5 Actavis v. Lilly
The 2017 Supreme Court decision of Actavis v. Lilly was an infringement action that concerned a chemotherapy drug patented by Eli Lilly.168 It has long been known that while a class of chemicals known as antifolates had valuable therapeutic effects on cancerous tumours, the antifolates had a number of serious, sometimes fatal, side-effects that undermined their value as an anti-cancer drug. Eli Lilly discovered that the side-effects could be avoided if a compound called pemetrexed disodium (which was a type of antifolate) was taken with vitamin B12. Accordingly, the patent claimed the use of antifolate pemetrexed disodium in the manufacture of a medicament for use in combination with vitamin B12 (and, optionally, folic acid) for the treatment of cancer. From 2004, Eli Lilly sold a medicament that combined the antifolate, pemetrexed disodium, and vitamin B12.
The allegedly infringing products that Actavis were considering selling in the United Kingdom (France, Italy, or Spain) were similar to Eli Lilly’s in that they combined antifolates and vitamin B12 together in a single medicament. They differed however in that rather than using pemetrexed disodium with vitamin B12, Actavis used pemetrexed diacid, pemetrexed ditromethamine, or pemetrexed dipotassium.169 Actavis argued that because they did not use pemetrexed disodium, Eli Lilly’s patent would not be infringed. In contrast, Eli Lilly argued that the Actavis products infringed because they were medicaments consisting of pemetrexed diacid with vitamin B12 to be used as a treatment for cancer. At first instance, Arnold J agreed and held that none of the Actavis products either directly or indirectly infringed. While the Court of Appeal agreed that there was p. 663↵no direct infringement, they did find that there would be an indirect infringement. On appeal the Supreme Court found in favour of Eli Lilly, holding that the Actavis products would directly and indirectly infringe.
Given that the Actavis products and the Eli Lilly patent utilized different chemical compounds, it was clear that on a strict literal reading of the claims, there was no infringement.170 For Eli Lilly to sustain its infringement action, it needed to show that, despite this literal reading, the claims should be construed in a way that encompassed Activis’s medicaments. To do so, they relied on the Protocol on the Interpretation of Article 69 which, as Lord Neuberger noted, provided that the scope of protection afforded to a patentee was not limited to the literal meaning of the claims. The problem with the Protocol, however, was that ‘it was not at all clear how far a court is permitted to move away from a literal meaning’.171 In addition, while Article 2 made it clear that equivalents needed to be taken into account, it provided no guidance as to how this was to be done. As a result, in determining whether Eli Lilly’s patent had been infringed, the Supreme Court was led to consider the question at the heart of patent claim interpretation, namely: ‘how far one can go outside the wording of a claim to enable the patentee to enjoy protection against products or processes which are not within the ambit of the actual language’?
After reviewing Catnic, the Improver questions, Kirin-Amgen (all discussed earlier), and the approach to claim interpretation adopted in a number of other EPC states,172 the Supreme Court outlined what it considered to be the proper approach to claim interpretation. As Lord Neuberger said, infringement is best approached by addressing two issues,173 each of which is to be considered through the eyes of the person skilled in the art. These are:
Does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial?
If the answer to either question was yes, there is an infringement.
In relation to the first question, Lord Neuberger said that, according to the ‘normal principles of interpreting documents’ in the case at hand, there was no infringement. This was because when read normally there was ‘no sensible way’ in which pemetrexed diacid, pemetrexed ditromethamine, or pemetrexed dipotassium could ‘be said to fall within the expression, “pemetrexed disodium” in claim 1 of the Patent’.176 As a result, Lord Neuberger turned to the second question which raised a difficult matter of principle; namely, what is it that makes a variation immaterial?177 To answer this question, Lord Neuberger relied on the Improver questions; which he said were helpful guidelines, but in need of reform.
p. 664↵Lord Neuberger began by noting that the first Improver question, which asks whether the variant has a material effect on the way the invention works, requires the court to focus on whether ‘the variant achieves the same result in substantially the same way’.178 Lord Neuberger said that when answering this question, the emphasis should not be on how ‘the invention’ works, so much as on the ‘problem underlying the invention’, ‘the inventive core’, or the ‘inventive concept’.
While the first Improver question escaped any real criticism, the same cannot be said for the second Improver question which asks: would the fact that the variant has no material effect have been obvious to a reader skilled in the art at the date of the publication of the patent? For Lord Neuberger, the problem with the second question related to the information that the notional addressee was presumed to have when they asked whether it was obvious that the variant would not have a material effect on the way the invention works. The problem here was that as the notional addressee was presumed not to know whether the variant worked, it required the ‘addressee to figure out for himself whether the variant would work’. While this may have been possible with mechanical inventions, it was more problematic with certain types of chemical research where it was not possible to predict in advance whether a variant would have a material effect on the invention. As a result, this inevitably meant that in these cases the ‘second Improver test could not be answered yes’. For Lord Neuberger, this ran counter to Article 1 of the Protocol which requires fair protection for the patentee. Given this, Lord Neuberger said that the second test should be reformulated to ask: whether, on being told what the variant does, would the notional addressee consider it obvious that it achieved substantially the same result in substantially the same way as the invention?179
While Lord Neuberger thought that the third Improver question, which asks whether the notional addressee would have understood from the language of the claim that the patentee wanted to limit the claims to a strict literal reading was a valid question, he felt that it was open to misunderstanding. To prevent this, he attempted to clarify a number of issues. The first was that the notional addressee’s understanding was not limited to the language of the claim, but also extended to include the specification and ‘all the knowledge and expertise’ normally attributed to them. Second, the fact that the language of the claim did not, ‘on any sensible reading’, cover the variant was not in itself a reason why a patentee should fail the third test. Rather, it was more of a reason to ask the Improver questions in the first place. Third, while it was appropriate to ask whether the ‘component at issue’ was an essential part of the invention, this was not to be mistaken with the overall product or process which the invention was part of. And finally, when considering whether a variant was obvious at the date of infringement (rather than priority date), the notional address would be imbued with more information.180
In light of these changes, Lord Neuberger reformulated the Improver questions to read:
Notwithstanding that it is not within the literal meaning of the relevant claim(s), does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?
Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?181
p. 665↵To establish non-literal infringement, it would be necessary to answer ‘yes’ to the first two questions and ‘no’ to the third.
Lord Neuberger then applied the revised-Improver questions to the facts-at-hand. Given that the Actavis products worked in the same way as the patented invention (they all involved a medicament that combined the active pemetrexed ingredient (namely pemetrexed anion182) and vitamin B12), the answer to the first question was ‘yes’. In contrast to the lower courts, Lord Neuberger felt that the answer to the second question was also ‘yes’. The reason why Lord Neuberger differed from the lower courts was because of the knowledge imputed to the person skilled in the art. While the lower courts had followed the unmodified Improver questions (which led them to presume that the notional addressee did not know that the Actavis products worked), Lord Neuberger assumed that the notional addressee would know that the Actavis products worked. Armed with this knowledge and the fact that the notional addressee would have regarded the testing of the different pemetrexed compounds as a ‘purely routine exercise’, Lord Neuberger said that it would have been obvious to the notional addressee at the priority date that the Actavis products worked in the same way as the patented invention.
Lord Neuberger also disagreed with the Court of Appeal’s decision that the answer to third question was ‘no’. Unlike with the second question, the difference here had more to do with how the patent was interpreted than with Lord Neuberger’s modifications. For Lord Neuberger, the Court of Appeal decision had relied too much on a straightforward reading of the claims and not enough on Article 2 of the Protocol (which calls for a non-literal reading). For Lord Neuberger it was wrong to treat the third question as one of ‘normal interpretation’, not least because it made a nonsense of asking the three questions. This was because ‘if one cannot depart from the language of the claim when considering those questions, what is the point of those questions in the first place?’183 While the Court of Appeal had found reason in the specification to limit the patent to pemetrexed disodium,184 Lord Neuberger disagreed and held that there was no good reason why the patentee would have wanted to limit the patent to a literal reading of the claims. On this basis, the Supreme Court held that the Actavis products provisionally infringed Eli Lilly’s patent.
The reason for treating this conclusion as ‘provisional’ was because the court wanted to consider what effect, if any, the prosecution history (that is, the information exchanged between the applicant and the patent office during the grant of the patent) had on the way the claims were interpreted. Here, Actavis argued that the prosecution history at the EPO suggested that the claims should be limited to pemetrexed disodium. Signaling a move away from Kirin-Amgen,185 Lord Neuberger said that the UK courts should adopt a ‘sceptical, but not absolutist’ approach to the suggestion p. 666↵that the history of the patent at the patent office could be used to interpret the claims post-grant.186 Specifically, he said that reference to the file would only be appropriate where the file history unambiguously resolves a point of uncertainty, or where it would be contrary to public interest not to do so.187 In any case, as the contents of the file did not justify departing from the preliminary conclusion, the court held that the Actavis products directly infringed the Eli Lilly patent.
While it will take some time to see how Actavis is received,188 it is possible to draw some preliminary conclusions. One thing that is clear is that Actavis has reinstated the importance of the now-modified Improver questions in determining how far a patent can be construed beyond a ‘normal’ reading of the claim. While this is clear, what is less clear is the continued importance of purposive interpretation. Given some of Lord Neuberger’s sweeping claims, it would seem that the purposive interpretation has been subsumed within the second stage of his two-step infringement test.189 It will be interesting to see whether the courts follow this lead and replace the purposive test with the modified-Improver questions or whether they continue to selectively use the purposive test when dealing with more straightforward cases (as in Catnic).190 Another subtle but important consequence of Actavis is that it has increased the scope of protection for patentees, particularly in relation to chemical inventions. This is because presuming that the notional addressee knows that the variant works increases the likelihood that the second Improver question will be answered positively and thus that there is a finding of infringement. A third, as yet unexplained issue is whether the variants which might be covered under the test of equivalents outlined by Lord Neuberger can include material which formed part of the state of the art at the priority date. Such an outcome seems undesirable, and might be avoided by applying the third guideline so as to assume that in such a case the patentee would want strict compliance with the literal meaning of the claim.191 Alternatively, it might be necessary to develop a doctrine (such as the so-called ‘Formstein defence’) that equivalents cannot include matter which would not have been patentable in the light of the state of the art.192
4p. 667 Defences to proceedings for infringement
Once the claimant has proved that the defendant has performed an activity that falls within the scope of the patent monopoly, the obligation then shifts to the defendant to show that the activity is exempted from liability by one of the defences to patent infringement that are available. There has been surprisingly little discussion about the defences to patent infringement actions and the policies that inform them.193 At a general level, the exceptions balance the interests of patentees against the interests of other groups, such as competitors, previous users, traders, users, and non-profit-making bodies, as well as teaching and research establishments. In some cases, the defences operate to overcome the market failure that occurs where a patentee declines to license a socially beneficial use because of the transaction costs involved. It should be noted that if the unitary patent package is implemented, the defences will need to be revisited. With these general points in mind, we now turn to look at some of the more important defences that may exempt a defendant from liability.
4.1 Private non-commercial uses
Section 60(5)(a) of the 1977 Act provides that acts that are done privately and for non-commercial purposes do not infringe.194 The private use exception is usually explained on the basis that while private uses may increase scientific knowledge and thus be socially beneficial, high transaction costs may mean that they are unlikely to be licensed.195 Another factor in favour of the defence is that private non-commercial uses do not pose much of a threat to the patent monopoly. While private uses need not be secret or confidential, they must be ‘for the person’s own use’.196 Where an activity has both commercial and non-commercial benefits, it is necessary to ascertain the subjective intention of the user. If the infringer were motivated by commercial interests, the defence would not apply. However, if the subjective purposes were non-commercial, the defendant could rely on the immunity. This is the case even if the resulting information has a commercial benefit.197
4.2 Experimental uses
Section 60(5)(b) provides immunity for acts done for experimental purposes relating to the subject matter of the invention.198 This defence gives effect to a number of related policies, the most obvious being that the patent monopoly should not be allowed to inhibit scientific developments. It is likely that the experimental use defence will become increasingly important as patenting (especially in relation to biotechnology) enters the p. 668↵traditional domains of ‘pure’ scientific research carried out within the universities.199 For the defence to apply, a defendant must show that the act (i) was done for experimental purposes and (ii) that it relates to the subject of the invention.
(i) Experimental purpose To a large extent, the scope of the defence depends on the way in which ‘experimental purpose’ is defined.200 If it can be shown that the purpose of the activity was to discover something unknown or to test a hypothesis, it would be regarded as an experiment.201 An act will also be experimental where a person is attempting to discover whether the patented invention works.202 This may occur, for example, where a party is thinking whether to license a patent or they believe that the patent is invalid on grounds of insufficiency. Given the public interest in determining whether a monopoly has been validly granted, it is desirable that competitors undertake this kind of policing task. In the absence of an experimental use defence, such acts might require the licence of the patentee, which in the circumstances may not be forthcoming.203
If the purpose of the activity is to prove something that is already known, to demonstrate to a third party that the product works in the way in which the maker claims, or to obtain official approval for a product,204 these would not be regarded as acts done for experimental purposes.205 In one case, it was held that trials that were carried out to obtain safety clearances and to gather information to support an attempt to gain approval for a new use of a patented product (to be used once the patent had expired) were for commercial, rather than scientific, purposes.206 While the issue has yet to be considered in any detail, it seems that if there is a commercial motive behind the experimental use, or where the purpose of the trial was ‘mainly directly or indirectly to generate revenue’,207 it is more likely to fall outside the scope of the exception.208
Where an act is done for a number of purposes—such as establishing confidence in the market, generating income, and gathering information—the courts look to the p. 669↵‘preponderant purpose’ for the activity to decide whether the activity falls within the exemption.209 In CoreValve v. Edwards Lifesciences,210 the court held that clinical trials were not exempted by section 60(5)(b) because the main purpose was to ‘generate immediate revenue of a substantial character’. The standing of commercial research will undoubtedly become more pressing given the growing trend for public sector agencies that have traditionally relied upon the defence, such as universities, to commercialize their research results.211 So far, there has been no consideration given to the question of whether a person who tests an invention to improve it, to invent around the patent, or to invent something else falls within the defence.212 However, the German Supreme Court has held that experiments to discover the most appropriate form that a patented product should take to alleviate a specific disease fell within the experimental use defence under German law.213
(ii) ‘Relates to the subject matter of the invention’ Once it has been shown that a use has been carried out for an experimental purpose, it is then necessary to show that the experiment relates to the subject matter of the patent.214 This means, for example, that a person who wished to test a cure for cancer that they had developed by applying it to a genetically modified mouse could not rely on the defence against a claim by the patentee of the mouse. If the law were otherwise, the patentees of diagnostic test kits would never receive any remuneration because all uses of the kit would be experimental.215 Where a researcher wishes to use patented processes or products to test other subject matter, they would need to obtain a licence.216
In addition to the experimental use defence, researchers may also be able to rely on the more specific, but related, medical regulatory use defence in section 60(5)(i).217 This provides a defence for an act done in conducting a study, test, or trial that aims to produce medicinal products for either human218 or veterinary use.219
In 2014, the 1977 Patents Act was amended to allow clinical trials, field trials, and health technology assessments to be carried out without infringing a patent.220 The new section 60(6D) clarifies that activities that are carried out for the purposes of obtaining regulatory approval or health technology assessment for drugs fall within the scope of section 60(5)(b) of the Patents Act 1977. The new provisions do not cover commercial uses of patented medical products.221 Section 60(6D) is designed to deal with the p. 670↵patent-related problems that arise because of the fact that in order to obtain regulatory approval to market a new drug product, companies must undertake trials to demonstrate to the regulatory authorities that the product is safe and effective. It is hoped this will encourage companies to conduct clinical trials in the United Kingdom.
4.3 Prior use
As we saw earlier, one of the changes brought about by the 1977 Act was that novelty was redefined to exclude inventions that had been ‘made available to the public’. As a result, secret third-party use does not destroy novelty.222 One of the consequences of this is that the rights conferred by a patent might cover secret activities carried out by a third party prior to grant.223 In recognition that it would be wrong if patents were allowed to be used to prevent a person from carrying on an activity that they were doing prior to grant (the so-called ‘right to work’ doctrine), section 64(1) provides previous users with a personal defence.224
There are a number of points to note about the defence. The first is that it only applies where the previous acts were committed in the United Kingdom (or possibly the EEA).225 Given that the novelty standard is worldwide, this raises the possibility that a person carrying out an activity in Japan, which is then patented by another person in the United Kingdom, will not be able to practise the invention in the United Kingdom.
It is also important to note that the defence is only available where the acts were carried out in good faith. Although the notion of good faith has yet to be interpreted by the courts, this might prevent a member of a research team from relying on the prior use defence where they left the research team contrary to an understanding between them. Similarly, if a former employee was preparing to use trade secrets obtained while in employment to compete with their ex-employer, the ex-employee would not be able to rely on the preparatory acts as a defence to patent infringement actions.226
The prior use defence is only available where the defendant has done the acts or, before the priority date of the patent, made ‘serious and effective preparations’ to do an act that would be infringing if it were carried out after the grant of the patent. It has been said that the preparations ‘must be so advanced as to be about to result in the infringing act being done’.227 The defence allows a past user to continue to do the same act after the patent has been granted. While it is not necessary for a defendant to show unbroken use, they must show a clear link or a ‘chain of causation’ between the previous use and the p. 671↵infringing use.228 Because the ‘past secret use’ defence is a personal defence, the continued use must be by the same person (or partner). The exact scope of the act is therefore crucial. The defence is not available to a defendant who does a thing that is wholly different in nature. This would mean, for example, where the previous use was in relation to a process, that the previous user would not be able to use the defence for acts carried out (after grant) in relation to products of the process.229 It is important to note that some variation is allowed between the previous use and the alleged infringing act;230 the difficult question is: how much of a variation is possible?
If the act or preparations were done in the course of business, the previous user has the right to authorize the doing of the act by their business partners at that time. They also have the right to assign that right or to transmit it on death to any person who acquires the part of the business in the course of which the act was done or the preparations were made.231 Importantly, the defence does not extend to include licensees.232
4.4 Defences for biotechnological inventions
As a part of the regime dealing with biotechnological inventions, three new defences to the infringement of patents for biotechnological inventions have been formulated. These are set out in Articles 10 and 11 of the Biotechnology Directive and in changes made to the Patents Act 1977 by the Patents Regulations 2000.
4.4.1 Exhaustion of biological patents
Article 10/paragraph 10 of Schedule A2 provide that the protection conferred by a patent shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market by the owner of the patent (or with their consent) where the multiplication or propagation necessarily results from the application for which the biological material was marketed.233 This is subject to the proviso that the material obtained is not subsequently used for other types of propagation or multiplication.
In effect, Article 10 introduces a specific form of exhaustion for biological patents. For the patent rights to be exhausted under Article 10, it is necessary to establish that the multiplication or propagation (which potentially infringes the patent) is ‘an incident of what might be called the true purpose of the sale’.234 The upshot of this is that a person who used a patented yeast to make beer would, on its face, infringe the patent in the yeast. This is because the process of making the beer necessarily involves the multiplication of the yeast. However, if the patented yeast was sold in a home-brew shop for the purpose of beer making, Article 10 (and its British equivalent) would provide the defendant with a ‘defence’. Nonetheless, if the defendant was to propagate the yeast and offer it for sale, the defence would not apply.235 The defence will allow farmers to sow a patented seed, and to harvest and sell the resulting crop (for example to sell the wheat for flour); they will not be permitted, however, to sell the seed to other farmers for the purpose of propagating new crops.236
4.4.2p. 672 Farmers’ privilege
In the debates surrounding the Biotechnology Directive, one of the fears raised was that patent protection of biological inventions would have a negative impact on traditional farming practices. In particular, it was feared that patent protection would mean that farmers would not be able to use the seeds that they harvested from their crops to resow in future, nor would they be able to breed patented animals. The potential problem was that sowing and breeding carried out in relation to a patented product would infringe. To remedy problems of this sort, Article 11(1) and (2) of the Biotechnology Directive provide farmers with specific defences. These provisions have been mirrored in section 60(5)(g) and (h) of the Patent Act 1977, introduced under the Patents Regulations 2000.
Section 60(5)(g) provides a defence where a farmer uses the product of their harvest for propagation or multiplication by them on their farm after there has been a sale or other form of commercialization of plant-propagating material to the farmer by the patent owner for agricultural use. In effect, the defence enables farmers to save seeds from one year’s crop to sow crops in the following year. The defence in section 60(5)(g) only applies to the plant species and groups set out in paragraph 2 of Schedule A1 to the Patents Act 1977. This covers various types of fodder plant, cereal, potato, and oil and fibre plant. In situations where a farmer successfully relies on the defence in section 60(5)(g), the farmer must pay the relevant rights holder equitable remuneration.237 The remuneration must be ‘sensibly lower than the amount charged for the production of the protected material of the same variety on the same area with the holder’s authority’.238 The need to pay equitable remuneration does not arise if a farmer can prove that they are a ‘small farmer’.239 Where requested, the rights holder and the farmer must supply each other with certain information.240 The use of the defence is subject to a number of other restrictions (such as ability of the farmer to move protected material from their farm).
Section 60(5)(h) provides farmers with a defence in relation to the breeding of animals. More specifically, it provides that ‘the use of an animal or animal reproductive material by a farmer for an agricultural purpose … of breeding stock or other animal reproductive material which constitutes or contains the patented invention’ is non-infringing. The farmer’s defence for the breeding of animals is potentially very broad. In part, the scope of the defence will depend on how the phrase ‘use for an agricultural purpose’ is construed. The Act tells us that ‘use for an agricultural purpose’ includes situations in which the animal or animal reproductive material is made available for the purposes of pursuing the farmer’s agricultural activity; it does not include ‘sale within the framework, or for the purposes of a commercial reproduction activity’.241
It will be interesting to see what impact these defences have upon farming practices. It will also be interesting to see how the biotechnology industry responds to these defences. It has been suggested that defences such as those provided in section 60(5)(g)–(h) may act as a stimulus for the development of techniques such as terminator genes or special hybrids that operate to ensure that seeds will not regerminate.242
4.5p. 673 Miscellaneous defences
A number of other exceptions to infringement exist. Section 74(1)(a) expressly provides that the validity of a patent may be put in issue by way of a defence to proceedings for infringement. This is the most commonly used defence: an alleged infringer will normally argue that the patent is invalid because the invention lacks novelty or is obvious. A particular example of this is the so-called ‘Gillette defence’,243 where a defendant attempts to demonstrate that the infringing activity was being carried out in public before the priority date of the patent, thus forcing the patentee either to require the patent to be interpreted so as to exclude the activity or to accept that the patent covers the activity and is therefore invalid (for want of novelty).
A defence is available where a person in a pharmacy makes an extempore preparation of a medicine in accordance with a prescription.244 A defence also exists where products or processes are used on ships, aircraft, hovercraft, or vehicles that have temporarily or accidentally entered UK airspace or waters.245 The Crown has a broad immunity from infringing the exclusive rights of patentees.246 The Crown may use an invention without obtaining a licence in advance, so long as it pays compensation. More specifically, the defence permits ‘any government department and any person authorized in writing by a government department’ to do certain acts,247 in return for which the department must provide payment,248 including ‘compensation’ for loss of profits.249 In some cases, the doctrines of exhaustion of rights and implied licence, reviewed earlier, also (effectively) provide defences to accusations of infringement.
Prior to the passage of the Competition Act 1998, section 44 of the 1977 Act provided a defence where a patentee imposed a requirement on a licensee:
… to acquire from the licensor or his nominee, or prohibit him from acquiring from any specified person, or from acquiring except from the licensor or his nominee, anything other than the product which is the patented invention or (if it is a process) other than any product obtained directly by means of the process or to which the process has been applied.
The defence was available to any person against whom the licensor brought an infringement action.250 Section 44, which was widely criticized, was repealed by the Competition Act 1998.251
1 It is also potentially a very costly process. In one case, it was suggested that it cost £250,000 for a two-day trial in the county court and about £112,000 for the Court of Appeal: Warheit v. Olympia Tools  FSR 6. The cost of cases has increased significantly since then.
2 See A. Benyamini, Patent Infringement in the European Community (1993).
3 Infringement proceedings can be also brought before the Comptroller so long as both parties consent: PA 1977, s. 61(3) (but it has not happened since long before the PA 1977 came into force). The suggestion that the 1977 Act be amended to remove the need for the consent of both parties was not adopted in the proposals for reform of the 1977 Act: see Consultation on the Proposed Patents Act (Amendment) Bill: Summary of Responses and the Government’s Conclusions (Nov 2003), –.
4 Agreement on a Unified Patent Court  OJ C 175/1 (20 June 2013).
5 UPC Agreement, Arts 25, 26 (the right to prevent direct and indirect uses of the invention in certain situations).
6 Ibid., Art. 27(a)–(l).
7 PA 1977, s. 60(1).
8 PA 1977, s. 60(2); CPC, Art. 26. The PA 1977 also contains provisions in relation to contributory infringement.
10 The United Kingdom includes the Isle of Man and the territorial waters of the United Kingdom: PA 1977, s. 132(2), (3).
11 A patentee may sue only with respect to acts that occur after publication of the application and then only if the patent has been granted. PA 1977, s. 62(3), introduces certain qualifications where the patent application is amended after publication. PA 1977, s. 62(2), deals with the position where the patentee fails to renew the patent promptly. For considerations of duration and SPCs, see Chapter 24, section 3.4 ff, pp. 714–15.
12 PA 1977, s. 60(1)–(2); CPC, Arts 25–8.
13 PA 1977, s. 60(1)(a).
14 Schenck v. Universal Balancing  EWHC 1920 (Pat), .
15 PA 1977, s. 62(1). See further Chapter 49, section 5, pp. 1326–33.
16 The following cases are usually cited in support: Proctor v. Bennis (1887) RPC 333, 356–7 (no real justification given); Curtis v. Platt (1863) 3 Ch D 135, 140n; Valensi v. BRC  FSR 273, 306 (adds nothing); Stead v. Anderson (1847) 2 WPC 151, 156; Wight v. Hitchcock (1870) LR 37, 47 (argument based on a version of parallel importing: ‘if the law were otherwise … another might by merely crossing the Channel, and manufacturing abroad, and selling for far less than the original price … wholly deprive the patentee of the benefit of the invention’); Walton v. Lavater (1860) 8 CB (NS) 162, 186, 29 LJ (CP) 275, 279; Betts v. Neilson (1865) 34 LJ (Ch) 537; Elmslie v. Boursier (1869–70) LR 9 Eq 217.
17 Lishman v. Erom Roche (1996) 68 CPR (3d) 72, 77 (FCTD).
18 See R. Gordon, ‘Paradoxical Property’, in J. Brewer and S. Staves (eds), Early Modern Conceptions of Property (1995), 95. See also Lord Irvine of Lairg, ‘The Law: An Engine for Trade’ (2001) 64 MLR 333, 346:
[P]atents do not create wholly controlled monopolies. They confer on their owners the narrower benefit of exclusive commercial exploitation for a duration limited to twenty years. Even during the currency of the patent, members of the public are free to conduct experiments on the patented invention.
19 See, e.g., Synthon v. SmithKline Beecham  RPC (10) 323, ,  (HL), discussed in Chapter 18, section 4.1, p. 560; PLG Research v. Ardon International  FSR 197, 218; Robert Alfred Young and Robert Neilson v. Rosenthal (1884) RPC 29, 31–3.
20 The classic statement is provided by Sachs LJ in General Tire & Rubber v. Firestone Tyre & Rubber  RPC 457, 485–6.
21  1 SCR 902.
22 United Wire v. Screen Repair Services  4 All ER 353 (HL), 358.
23 Ibid. Prior to this decision, the right to repair had sometimes been based on the idea of implied licence: Solar Thomson Engineering v. Barton  RPC 537, 555; British Leyland v. Armstrong  RPC 279, 358, 361–2; cf. Canon v. Green Cartridge Co.  FSR 817, 822; Hazell Grove v. Euro League Leisure  RPC 529, 537–41.
24 Solar Thomson Engineering v. Barton  RPC 537; Sirdar Rubber v. Wallington Weston (1907) 24 RPC 537; British Leyland v. Armstrong  RPC 279, 376.
25  UKSC 16. See B. Whitehead, ‘Manufacture or Repair: The Final Word—Schütz v. Werit  EIPR 42.
26 There was a third part of the invention—the pallet on which the container sat—but this was not considered in the decision.
27 Schütz v. Werit  UKSC 16, .
28 Ibid., .
29 Hazell Grove v. Euro League Leisure  RPC 529. In United Wire v. Screen Repair Services  RPC 439 (HL), the inventive concept lay in the frame (which was retained) and not in the wire (which was replaced).
30 Schütz v. Werit  EWHC 660 (Pat).
31 Schütz v. Werit  UKSC 16,  (Lord Neuberger).
32 United Wire v. Screen Repair Services  RPC 439.
33 Schütz v. Werit  UKSC 16, .
34 Ibid., .
35 Ibid., .
36 Ibid., .
37 See, e.g., Nescafé v. Dualit  EWHC 923 (Pat), –, in which it was held that owners of Nespresso coffee machines did not ‘make’ the patented system when they purchased non-Nespresso capsules for their Nespresso machines. Here, what was important was the fact that the machines and the capsules had an independent commercial experience; purchasers of the machine had an expectation that they could purchase capsules from wherever they wanted; the capsules did not embody the inventive element of the patent; and the owner of the machine did nothing that could be described as repairing, let alone making.
38 Solar Thomson Engineering v. Barton  RPC 537, 555.
39 Ibid., 556–7; Dellareed v. Delkin Developments  FSR 329; approved in Hazell Grove v. Euro League Leisure  RPC 529, 541.
40 Gerber Garment v. Lectra  RPC 383. An ‘offer’ to dispose of a product in this context is not the same as ‘offer’ in contract law: ibid., 411. See also Musion Systems v. Activ8–3d  EWPCC 12, –. To be an infringing act, an ‘offer to dispose’ must be made in the United Kingdom and propose disposal within the United Kingdom: Kalman v. PCL Packaging  FSR 406. For issues relating to joint tortfeasance where the joint tortfeasor is located outside the jurisdiction, service out of the jurisdiction, and actions for infringement of foreign patents, see Chapter 48, section 3, pp. 1286–97.
41 Hadley Industries v. Metal Sections and Metsec (UK) (unreported, 13 November 1998) (Pat).
42 Hoffman La Roche v. Harris Pharmaceuticals  FSR 200 (under the PA 1949).
43 Rotocrop v. Genbourne  FSR 241; Furr v. CD Truline (Building Products)  FSR 553, 565; A. Benyamini, Patent Infringement in the European Community (1993), 68–74 (suggesting that kits are dealt with as direct infringements unless they lack one or more essential elements).
44 Rotocrop v. Genbourne  FSR 241, 258–9.
46 As Lord Hoffmann said, the difference between an implied licence and exhaustion is that ‘an implied licence may be excluded by express contrary agreement or made subject to conditions, while the exhaustion doctrine leaves no patent rights to be enforced’: United Wire v. Screen Repair Services  RPC 439, –.
47 For an overview, see HTC Corporation v. Nokia Corporation  EWHC 3247, –.
48 Betts v. Willmott (1871) 2 Ch LR 6; Incandescent Gas Light Co. v. Cantelo (1895) 12 RPC 262; National Photograph Co. of Australia v. Menck  AC 336. While the common law has tended to adopt an implied licence approach, there is some evidence that this case law may be being reinterpreted as part of an ‘exhaustion of rights’ principle like that found within European law. In Canon v. Green Cartridge  FSR 817, 822, Lord Hoffmann said that the notion of ‘a general implied licence to use the patented product at all, which is sometimes used to explain why mere user does not infringe the patentee’s monopoly … is perhaps better regarded as a consequence of the exhaustion of the patentee’s rights in respect of the particular article when it is sold’.
50 The doctrine of exhaustion has been held inapplicable to products made under a compulsory licence: Merck v. Stephar, Case C-187/80  ECR 2063.
51 Roussel Uclaf SA v. Hockley International  RPC 441 (for a limited licence applied to sales of a patented product outside the EEA to be effective, notice of it must be brought to the attention of every person down the chain of supply).
52 See SABAF SpA v. MFI Furniture Centres  RPC 209 (HL), – (on the definition of ‘importer’).
53 Wilderman v. Berk (1925) 42 RPC 79, 88.
54 This is the case irrespective of whether the ultimate destination is the United Kingdom or elsewhere: Hoffmann-La Roche v. Harris Pharmaceuticals  FSR 200 (under the PA 1949).
55 SABAF v. Meneghetti  RPC 264 (CA), –. As the Italian defendants passed legal title in the ‘infringing’ article (which was subsequently imported into the United Kingdom) to another party in Italy, it could not be said that they imported the goods into the United Kingdom, although they did organize and pay for the haulage of the articles. In so finding, the Court of Appeal expressly disregarded Waterford Wedgwood v. David Nagli  FSR 92 (re-import under TMA 1994).
56  RPC 363; M. Howe, ‘Infringing Goods and the Warehouseman’  EIPR 287.
57  RPC 407.
58 Ibid., 431.
60 Patents Regulations 2000 (SI 2000/2037). regs 8–10, were said to be declaratory of the (then) existing law.
61 S. Bostyn, ‘The Patentabilty of Genetic Information Carriers’  IPQ 1, 28.
63 Introduced by Patents Regs 2000.
64 Biotech. Dir. Art. 5(1)/PA 1977, Sch. A2, para. 3(a), states that the human body at the various stages of its formation and development, and the elements thereof (including gene sequences), cannot be patented.
65 C-428/08,  ECR I-6765.
66 Ibid., .
67 Ibid., ; also see M. Lock, ‘Patent protection for DNA sequences – to be or not to be?’ (2010) 5 JIPLP 754.
68 EU Commission, Final Report of the Expert Group on the Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering (17 May 2016).
69 Ibid., .
70 Ibid., .
72 See D. Schertenleib, ‘The Patentability and Protection of DNA-based Inventions’  EIPR 125, 136–8; A. White, ‘Gene and Compound per se Claims: An Appropriate Reward?’  6 Bioscience L Rev 239; P. Jacobs and G. Van Overwalle, ‘Gene Patents: A Different Approach’  EIPR 505.
73 Where the claimed DNA sequences ‘overlap only in parts which are not essential to the invention, each sequence will be considered as an independent sequence in patent law terms: Schertenleib, op. cit., 136.
74 PA 1977, s. 60(1)(b).
75 Warner-Lambert v. Actavis Group  RPC 665, .
76 For some of the problems that arise in proving infringement of a process patent where the process is carried out overseas, see Nutrinova Nutrition Specialties & Food Ingredients v. Sanchem UK  FSR 797.
77 CPC, Art. 25(c); EPC 2000, Art. 64(2) (ex EPC 1973, Art. 64(2)).
78 CIPA, [60.06].
79 PA 1977, s. 60(1)(c). For the common-law position, see Saccharin Corp v. Anglo Continental Chemical (1900) 17 RPC 307.
80  RPC 757 (CA). See H. Hurdle, ‘What is the Direct Product of a Patented Process?’  EIPR 322; F. Russell and H. Hurdle, ‘What is the Direct Product of a Patented Process?’  EIPR 249.
81 If a ‘patentee wants appropriate cover … they should secure a product-by-process claim’: Report of the Committee to Examine the Patent System and Patent Law (Cmnd. 4407, July 1970) (the Banks Committee), .
82 Monsanto Technology LLC v. Cargill International SA  FSR 153, –.
84 Ibid., .
85 PA 1977, Sch. A2, para. 8 (introduced by Patents Regs 2000).
86  EWHC 2257, –.
87  RPC 757 (CA).
88 To ‘hold that every new use of an old composition may be the subject of a patent upon the composition would lead to endless confusion and go far to destroy the benefits of our patent laws’: In re Thuau, 135 F.2d. 344 (CCPA 1943).
89 Merrell Dow Pharmaceuticals v. Norton  RPC 76 (HL), 92. In Mobil, it was said that the analogous problems concerning infringement would arise in relation to second and subsequent medical uses: Mobil/Friction reducing additive, G 2/88  EPOR 73, 89. However, in such cases, the regulation of packaging is often a sound indication of the intended use: Actavis v. Merck  EWCA Civ 444, . For an unusual case where such marketing rules did not clarify the purpose for which the medicine was to be used, see Warner-Lambert v. Mylan  EWCA Civ 556, , ,  ff, –, currently on appeal to the Supreme Court.
90 Merrell Dow v. Norton  RPC 76 (HL), 92. See also Bristol-Myers Squibb v. Baker Norton Pharmaceuticals  RPC 1 (CA),  (Aldous LJ said that it was unlikely that the Court of Appeal would suggest that Mobil was wrongly decided when the House of Lords ‘did not so conclude’).
91 ‘New use patents raise vexing questions about the patentee’s right to prevent others from selling the old compound’: Dawson Chemical Co. v. Rohm & Haas Co., 448 US 176 (1980).
92 Paterson, [10–31].
93 In response to arguments of this type, the EBA in Mobil offered the following unhelpful advice: ‘[T]here is a clear distinction between the protection which is conferred and the rights which are conferred by a European patent.’ While the ‘protection conferred by a patent is determined by the terms of the claims (Art. 69(1) EPC ) and in particular by the categories of such claims and their technical features … [i]n contrast, the rights conferred on the proprietor of a European patent (Art. 64(1) EPC [1973; now EPC 2000, Art. 64(1)]) are the legal rights … [conferred] upon the proprietor’: Mobil/Friction reducing additive, G 2/88  EPOR 73, 80–1.
95  RPC 665.
96 Ibid., .
97 Ibid.,  and .
98 Warner-Lambert v. Generics (UK) (t/a Mylan)  RPC 1, .
99 PA 1977, s. 60(2); CPC, 26(1); Dow Chemical v. Spence Bryson  FSR 598, 628–30 (inducing or procuring infringement by persuading infringer to adopt process, teaching how to operate it). See Chapter 48, section 3, pp. 1286–97.
100 The ‘means in question’ must contribute to implementing the technical teaching of the invention; there is no need to show that the feature in question ‘served to distinguish the subject matter of the claim from the prior art ie was novel in its own right’: Nescafé v. Dualit  EWHC 923 (Pat),  (following the German BGH decision of Impeller Flow Measure Case X ZR 48/03) (2005) 36 IIC 963.
101 The policy of expanding the patentee’s monopoly to cover contributory infringement seems to conflict with the policy underpinning the rules preventing a patentee from requiring licensees to utilize particular suppliers. On these, see Chapter 23, section 3, pp. 682–4. The connection is recognized in US jurisprudence, where the Supreme Court has observed that the ‘doctrines of contributory infringement and patent misuse have long and interrelated histories’: Dawson Chemical Co. v. Rohm & Haas Co., 448 US 176 (1980).
102 Menashe Business Mercantile v. William Hill Organization  RPC 575 (CA).
103 Ibid., 584–5, upholding Jacob J’s first-instance decision— RPC 951—but for different reasons.
104 Menashe Business Mercantile v. William Hill Organization  RPC 57.
105 Hazell Grove v. Euro League Leisure  RPC 529, 541.
106 See Wallace v. Holmes, 29 F.Cas. 74 (No. 17, 100) (CC Conn. 1871).
107 Thus, it did not matter for the purposes of indirect infringement that drugs supplied to doctors or pharmacists were not identical to the patented invention in the form they were sold, given that when the drugs were dissolved in a saline solution (which was needed for them to be administered to patients), the defendants either knew or it was obvious in the circumstances that they produced solutions that were chemically identical to the patented invention. Actavis v. Eli Lilly  UKSC 48, – (direct infringement is discussed in section 2.1, p. 638–51).
108 Grimme Maschinenfabrik v. Derek Scott  EWCA Civ 1110, .
109 Ibid., .
110 Ibid., . See P. Johnson, ‘Contributing to the Wrong: Indirect Infringement of Patents’ (2010) 5 JIPLP 514.
111 In Pavel v. Sony, C/14/93 (22 March 1996, unreported), the (then) Patents County Court defined staple commercial product as meaning ‘products of regular kind needed daily and generally available’.
112 A. Benyamini, Patent Infringement in the European Community (1993), 234–5.
113 Furr v. Truline (Building Products)  FSR 553, 565.
114 It has been said that German case law supports the view that, in this form, there is direct infringement, either because a use claim is seen as primarily a product claim and this amounts to sale of the product, or because such an act is an offering of a process for use: see A. Benyamini, Patent Infringement in the European Community (1993), 84–90 (advocating direct infringement approach). See further A. Horton, ‘Methods of Treatment and Second Medical Use’ (August 2000) Patent World 9, 12.
115 Bristol-Myers Squibb v. Baker Norton Pharmaceuticals  RPC 253, 280.
116 See CIPA, [60.28].
118 Celem SA v. Alcon Electronics  EWHC 3042 (Pat), .
119  FSR 1.
120 While the EPC 1973 version said that the scope of protection ‘shall be determined by the terms of the claims’, Art. 69(a) of the EPC 2000 simply says that the scope ‘shall be determined by the claims’.
121 Rotocrop v. Genbourne  FSR 241.
122 Virgin Atlantic v. Delta  EWHC 3094 (Pat),  (a claim to a product consisting of a number of parts was not infringed by the manufacture, disposal, etc. of an incomplete kit of parts in circumstances in which (i) the missing part/s were obtained by the defendant’s customers themselves, and (ii) the assembly was carried on outside the relevant territory).
123 A related situation arises where a defendant supplies most, but not all, of the patented invention in kit form.
124 For a summary of the approach to be taken in construing patent claims, see Mayne v. Pharmacia  EWCA Civ 137, , which is a restatement of the summary made by Jacob LJ in Rockwater v. Technip France SA  RPC 919, , following the qualified approval of Rockwater by Lord Hoffmann in Kirin-Amgen v. Hoechst Marion Roussel  RPC 169.
125 Kirin-Amgen v. Hoechst Marion Roussel  RPC 169,  (Lord Hoffmann) quoting Jackson J in Graver Tank & Manufacturing v. Linde Air Products 339 US 605, 697 (1950). See also Actavis v. Eli Lilly  UKSC 48,  (SC).
126 ‘[I]f one departs from ordinary language, it is necessary to have some guidance or to draw some lines’. Actavis v. Eli Lilly  UKSC 48,  (SC) (Neuberger LJ).
127 Ibid., .
128 For commentary, see CIPA, [125.04]–[125.30].
129 H. Laddie, ‘Kirin-Amgen: The end of equivalents in England?’ (2009) 40 IIC 3; Clark v. Adie (1877) 2 App Cas 315.
130  RPC 183.
131 Catnic v. Hill and Smith  RPC 183 (HL), 241. For the application of the purposive interpretation to ‘1 per cent’ and ‘25 per cent’ in the phrase ‘the agent being present in a concentration between 1 per cent and 25 per cent of the total volume of treatment’, see Smith & Nephew v. Convatec Technologies  EWHC 3955 (Pat) (finding that 1 per cent extended to 0.95 per cent, while 25 per cent extended to 25.5 per cent).
132 Catnic v. Hill and Smith  RPC 183 (HL), 241. As Lord Hoffmann said in Kirin-Amgen v. Hoechst Marion Roussel Ltd  RPC 169, the only compulsory factor to be taken into account when determining the extent of protection conferred by a European patent—namely, the rules as set out in EPC 2000, Art. 69, and its Protocol.
133  RPC 183. Although Catnic was decided under the PA 1949, it is still relevant under the 1977 Act. In PLG Research v. Ardon  FSR 197, 309, the Court of Appeal argued that Catnic was no longer good law under the 1977 Act. However, the promotion of Aldous LJ to the appellate court led to an immediate reversal of this view. This has been confirmed in a range of subsequent decisions, including Kirin-Amgen v. Hoechst Marion Roussel  RPC 16 9, . See, e.g., J. Turner, ‘Purposive Construction: Seven Reasons Why Catnic is Wrong’  EIPR 531; cf. the critical response by M. Franzosi, ‘In Defence of Catnic’  EIPR 242.
134 Kastner v. Rizla  RPC 585.
135 Glaverbel SA v. British Coal Corporation  RPC 269.
136 Ibid., –.
137 EMI v. Lissen (1939) 56 RPC 23; Glaverbel SA v. British Coal Corporation  RPC 255, 269. The statement of the problem that the invention is intended to solve may be particularly influential: Minnesota Mining & Manufacturing Co. v. Plastus Kreativ AB  RPC 737 (CA); SEB v. De’Longhi  EWHC 1556 (Pat),  (when one encounters a word of degree, the problem is to ascertain its function in the claim so as to obtain a handle on its meaning).
138 PA 1977, s. 125; EPC 2000, Art. 69 (ex EPC 1973, Art. 69). In Rosedale v. Carlton Tyre  RPC 59, the Court of Appeal used the drawings and descriptions in determining that ‘holes’ did not have to be round.
139 Hoechst Celanese Corporation v. BP Chemicals  FSR 319 (Aldous LJ). On common general knowledge, see Beloit Technolgies v. Valmet Paper Machinery  RPC 489, 494.
140 Virgin Atlantic Airways v. Premium Aircraft Interior  EWCA Civ 1062, , citing Kirin-Amgen v. Hoechst Marion Roussel  RPC 169, .
142 On the Protocol generally, see B. Sherman, ‘Patent Claim Interpretation: The Impact of the Protocol on Interpretation’ (1991) 54 MLR 499. See the Protocol on the Interpretation of Article 69 EPC (‘Protocol on Art. 69’), as revised by the Act Revising the Convention on the Grant of European Patents (EPC) (Munich) (29 November 2000) MR/3/00 Rev, 1e (the ‘EPC Revision Act’), Art. 2, item 2.
143 Actavis v. Eli Lilly  UKSC 48,  (SC) (Neuberger LJ).
144 The new Protocol includes, in Art. 2, provision in relation to equivalents.
145 Protocol on Art. 69, Art. 1.
146 On the background, see American Home Products v. Novartis Pharmaceuticals  RPC 547, 557.
147 Protocol on Art. 69, Art. 2 (often called the ‘doctrine of equivalents’).
148  FSR 181, 189.
149 While these were renamed the three Protocol questions in Wheatley v. Drillsafe  RPC 7, , the original name is still used.
150 Improver v. Remington  FSR 181, 189.
151 Ibid., 197.
152 Kirin-Amgen v. Hoechst Marion Roussel  UKHL 46,  RPC 169, . On this, see Virgin Atlantic Airways v. Premium Aircraft Interior  EWCA Civ 1062, .
153 Kirin-Amgen v. Hoechst Marion Roussel  UKHL 46, .
155 Actavis v. Eli Lilly  UKSC 48,  (SC) (Neuberger LJ).
156 R. Cox and S. Spink, ‘UK Claim Construction: Return of the Protocol Questions and File Wrapper Estoppel’ (2015) JIPL 167, 168.
157 For an overview of the history of the doctrine of equivalents in the UK, see Bently and Sherman, (2014), 632–4.
158 See Kirin-Amgen v. Hoechst Marion Roussel  RPC 169,  ff; Van der Lely v. Bamfords  RPC 61 (HL); Rodi & Weinenberger v. Showell  RPC 367 (HL); Beecham Group v. Bristol Laboratories  RPC 153.
159 Celltech  FSR 433, 436. See generally M. Franzosi, ‘Equivalence in Europe’  EIPR 237.
160 PA 1977, s. 125.
161 Beloit Technologies v. Valmet Paper Machinery  RPC 705, 720; Celltech  FSR 433 436 (no express provision in Europe for doctrine of equivalents).
162 Protocol on Art. 69, Art. 2, item 2.
163 Kirin-Amgen v. Hoechst Marion Roussel  UKHL 46,  RPC 169.
164 Ibid., .
165 Virgin Atlantic Airways v. Premium Aircraft Interior  EWCA Civ 1062, .
166 Kirin-Amgen v. Hoechst Marion Roussel  UKHL 46,  RPC 169, . On this, see Virgin Atlantic Airways v. Premium Aircraft Interior  EWCA Civ 1062, .
167 Kirin-Amgen v. Hoechst Marion Roussel  UKHL 46, .
168 Actavis v. Eli Lilly  UKSC 48 (SC).
169 Also known as pemetrexed ‘salts’.
170 Eli Lilly’s patent was limited to the specific chemical compound, pemetrexed disodium in combination with vitamin B12, whereas Actavis’s products combined vitamin B12 with pemetrexed diacid (or pemetrexed salt), pemetrexed ditromethamine, or pemetrexed dipotassium.
171 Actavis v. Eli Lilly  UKSC 48,  (SC) (Neuberger LJ).
172 Germany, France, Italy, and Spain. Ibid., –.
173 Ibid., . This was in contrast to Lord Hoffmann in Kirin-Amgen who suggested that there was a single question to be asked (namely, what would a purposive interpretation lead to?).
174 A ‘variant’ is the thing that is different between the patented invention and the alleged infringing product or process.
175 Although Lord Neuberger does not explain what he meant by ‘normal’ interpretation, later case law has understood it as involving no departure from ‘purposive interpretation’. See, e.g., Illumina v. Premaitha  EWHC 2930 (Pat), – (Carr J) (‘normal interpretation means purposive interpretation’).
176 Actavis v. Eli Lilly  UKSC 48,  (SC) (Lord Neuberger).
177 Ibid., .
178 Ibid., .
179 Ibid., . The reformulated test also applies to variants which rely on developments after the priority date.
180 Ibid., .
181 Ibid., .
182 This important point, about what the active ingredient was, was not discussed in any detail in the judgment.
183 Ibid., .
184 The Court of Appeal held that the fact that the specification referred to ‘anti-folates’ but only claimed ‘pemetrexed disodium’ suggested that it was limited to this specific chemical compound.
185 In Kirin-Amgen v. Hoechst Marion Roussel  RPC 169,  Lord Hoffmann indicated that the British courts generally do not look at ‘prosecution history’: The courts of the United Kingdom, the Netherlands and Germany certainly discourage, if they do not actually prohibit, use of the patent office file in aid of construction. There are good reasons: the meaning of the patent should not change according to whether or not the person skilled in the art has access to the file and in any case life is too short for the limited assistance which it can provide. Despite such an authority, counter-examples exist: Furr v. CD Truline (Building Products)  FSR 553, 560–4; Rohm and Haas v. Collag  FSR 445, 457–8 (letter to EPO held to contain objective information that was of assistance in resolving aspects of the specification that were unclear); Wesley Jessen v. Coopervison  RPC 355, 382 (prosecution history at the EPO, which showed that application was changed from pattern to dots to avoid prior art, was used to limit ‘dots’ to mean ‘small roundish marks’ and nothing else). For the position of prosecution history estoppel in the United States, see Festo Corporation v. Shoketsu Kinzouku Kogyo KK, 535 US 722 (2002),  FSR 10 (patentee bound by representations made at US patent office).
186 Actavis v. Eli Lilly  UKSC 48,  (SC) (Neuberger LJ).
187 Ibid., .
188 An important issue is whether the new approach is adopted in relation to the ‘reverse infringement’ test embraced in the context of novelty. If so, it may become harder to establish novelty, and the line between novelty and inventive step will become blurred. So far, the courts have suggested that the ‘reverse infringement’ test is to be conducted on a normal interpretation of the claim in issue, and thus without reference to equivalents: Generics (UK) v. Yeda Research  EWHC 2629 (Pat), – (Arnold J) (considering the impact of Actavis on the Synthon novelty assessment and observing, at , that it will require another decision of the Supreme Court to supply a definitive answer to the question …’; Fisher & Paykel Healthcare v. ResMed  EWHC 2748 (Ch), – (Deputy Judge Meade QC).
189 But cf. Illumina v. Premaitha  EWHC 2930 (Pat), – (Carr J).
190 In Actavis v. Eli Lilly  UKSC 48, , Lord Neuberger acknowledged that ‘normal principles of interpretation could … accommodate the notion that “vertically” extended to an item which was not at precisely 90° to another item’). It is unclear how the Actavis approach will affect the interpretative practices that have developed in relation to claim interpretation, for example, the conventions on scientific numbers and numerical ranges: see Smith & Nephew v. ConvaTec  EWCA Civ 607, –; Napp Pharmaceutical v. Dr Reddy’s Laboratories  EWHC 1517 (Pat).
191 However, if (as Actavis, , implies) the extent of protection is severed from the process of interpretation of the claim, and the question of equivalents is only relevant to infringement (and not novelty) (as started in Generics (UK) v. Yeda Research  EWHC 2629 (Pat), –), it is not obvious that a reader of the patent would necessarily conclude merely from the fact that an equivalent of a claim existed in the prior art that the patentee intended that strict compliance with the literal meaning of the relevant claim.
192 Formstein (29 April 1986)  RPC 597, 606 (BGH) (recognizing a ‘defence that the alleged infringement which is claimed to be an equivalent is not a patentable invention in the light of the prior art’).
193 D. Gilat, Experimental Use and Patents (1995); R. Eisenberg, ‘Patents and the Progress of Science: Exclusive Rights and Experimental Use’ (1989) 56 U Chi L Rev 1017; J. Karp, ‘Experimental Use as Patent Infringement’ (1991) 100 Yale LJ 2169.
194 CPC, Art. 31.
195 See D. Gilat, Experimental Use and Patents (1995), 25. The US courts have occasionally employed the principle of de minimis non curat lex (‘the law does not concern itself with trifles’): e.g. Finney v. United States 188 USPQ 33 (CCTD 1975).
196 SKF Laboratories v. Evans Medical  FSR 513, 518; McDonald v. Graham  RPC 407.
197 SKF Laboratories v. Evans Medical  FSR 513.
198 CPC, Art. 27(b). See W. Cornish, ‘Experimental Use of Patented Inventions in European Community States’ (1998) 29 IIC 735. T. Cook, A European Perspective as to the Extent to which Experimental Use and Certain Other Defences to Patent Infringement Apply to Differing Types of Research (2006).
199 E. Barash, ‘Experimental Uses, Patents and Scientific Progress’ (1997) 91 Nw UL Rev 667 (recommending expansion of experimental-use defence for non-profit research).
200 The ‘purposes for which tests or trials are carried out may in some cases be mixed and in some cases may be difficult to discern’: Monsanto v. Stauffer Chemical  RPC 515 (CA), 542.
201 Ibid., 515.
202 The decision of the SCC in Micro-Chemicals v. Smith Kline and French InterAmerican (1971) 25 DLR 79, 89 (that use by a defendant to establish that it could manufacture a quality product in accordance with the specification was not an infringement) was explicitly approved by Dillon LJ in Monsanto v. Stauffer  RPC 515, 538. Trials directed to discovering whether something that is known to work in certain conditions will work in different conditions could fairly be regarded as experiments: see section 4.2, p. 667; D. Gilat, Experimental Use and Patents (1995), 20.
203 The situation is analogous to the criticism-or-review defence in copyright law, which is based on the idea that criticism would be stifled if the law were to require a prospective critic to obtain a licence from the copyright owner before criticizing the work.
204 Auchinloss v. Agricultural and Veterinary Supplies  RPC 397, 405. Meter-Tech v. British Gas  EWHC 2278 (Pat), .
205 Monsanto v. Stauffer  RPC 515 (CA), 542.
206 Ibid., 515; Auchinloss v. Agricultural and Veterinary Supplies  RPC 649,  RPC 397 (CA). Another situation in which a person may wish to rely on the defence is where they test someone else’s patented invention for the purposes of obtaining regulatory approval, either by providing data or samples to the relevant authority. In Upjohn v. Kerfoot  FSR 1, Whitford J held that the mere application for a marketing authorization in respect of a medicinal product, even when accompanied by test results, did not constitute an infringement of the patent, since it did not amount to use of the patent. In the United States, such samples are permitted under the Drug Price Competition and Patent Term Restoration Act 1984, 35 USC §271. The European Commission argued that a similar Canadian provision, which permits making and stockpiling of the drug up to six months prior to the expiry of the patent, contravened TRIPS. The matter was referred to the WTO on 12 November 1998. See WTO, Canada: Patent Protection of Pharmaceutical Products—Report of the Panel (17 March 2000) WT/DS114/R.
207 Meter-Tech v. British Gas  EWHC 2278 (Pat), .
208 Inhale Therapeutic Systems v. Quadrant Healthcare  RPC 419, 463.
209 Corevalve v. Edwards Lifesciences  EWHC 6 (Pat), .
211 For the approach taken in the United States in this situation, see Madey v. Duke University 64 USPQ 2d 1737 (Fed. Cir. 2002) (Duke University could not rely on experimental-use defence because of the commercial nature of the university, among other things).
212 McDonald v. Graham  RPC 407 (‘no doubt the defendant would be right to submit that supplying a patented article to a designer with a request that he design a non-infringing equivalent would be, in principle, an unobjectionable use of the article if the article were a “franked” article, but the defendant used infringing articles which he was well aware were not supposed to be in his possession at the material time’).
213 Klinische Versuche (Clinical trials) II  RPC 423 (s. 11(2) of the German Patent Act). See P. Tauchner, ‘Experimental Use Exemption in Germany’ (December 1997) Patent World 23.
214 In Auchinloss v. Agricultural and Veterinary Supplies  RPC 397 (CA), 406, Aldous LJ said that the ‘subject matter’ of the invention must be ascertained from the patent as a whole.
215 SKF v. Evans  FSR 513, 523.
216 Monsanto v. Stauffer  RPC 515, 522.
217 This was added by the Medicines (Marketing Authorisations etc.) Amendment Regulations 2005 (SI 2005/2759).
218 Directive 2001/83/EC, Art. 10(1)–(4).
219 Directive 2001/82/EC, Art. 13(1)–(5).
220 Legislative Reform (Patents) Order 2014, cl. 2 introducing new PA 1977, s. 60(6D)–(6G) (with effect, 1 October 2014).
221 UK IPO, Changes to patents legislation made by the Legislative Reform (Patents) Order 2014 from 1 October 2014.
222 This reinforces the policy that the patent should be granted to the first to file and disclose the invention rather than the first to invent. See P. Hubert, ‘The Prior User Right of H.R. 400: A Careful Balancing of Competing Interests’ (1998) 14 Santa Clara Computer & High Tech LJ 189; Symposium (1996) 36 IDEA 345.
223 Paris, Art. 4(B), leaves such matters to the domestic legislation of contracting states. See R. Rohrback, ‘Prior User Rights: Roses or Thorns?’ (1993) 2 U Balt IPJ 1; N. Marterer, ‘The Prior User’s Right’ (1990) 21 IIC 521.
224 Helitune v. Stewart Hughes  FSR 171, 206.
225 The latter modification may be required to prevent the provision being contrary to Art. 28 EC (ex Art. 30 of the Treaty), as interpreted in EC Commission v. United Kingdom, Case C-30/90  RPC 283,  2 CMLR 709,  ECR I–829. There is no EU harmonization of this issue. See L. Osterborg, ‘Towards a Harmonized Prior User Right within the Common Market Patent System’ (1981) 12 IIC 447; J. Neukom, ‘A Prior Use Right for the Community Patent Convention’  EIPR 165; J. Neukom, ‘A Prior Use Right for the Community Patent Convention: An Update’  EIPR 139.
226 Subject to the ‘springboard principle’, the action for breach of confidence might not be available once the employee’s patent is published, so it is important that the ex-employee cannot rely on the s. 64 defence. See Chapter 44, section 5.2, pp. 1215–17.
227 Lubrizol Corporation v. Esso Petroleum  RPC 727 (CA), 770; Helitune  FSR 171 (serious and effective preparations required more than general research into the same field).
228 Hadley Industries v. Metal Sections (unreported, 13 November 1998) (Pat).
230 Helitune v. Stewart Hughes  FSR 171, 206; Lubrizol v. Esso Petroleum  RPC 281, 295,  RPC 727 (CA).
231 PA 1977, s. 64(2), provides an equivalent to exhaustion when a previous user disposes of the product. The person who acquires the product is entitled to deal with the product in the same way as if it had been disposed of by a sole registered proprietor.
232 PA 1977, s. 64(3).
233 As set out in Biotech. Dir. Arts 8 and 9; PA 1977, Sch. A2, paras 7–9. These were discussed in section 2.2.5, pp. 646–7.
234 See S. Bostyn, ‘Patentability of Genetic Information Carriers’  IPQ 1, 30.
236 R. Nott, ‘You Did It: The European Biotechnology Directive at Last’  EIPR 347, 349.
237 PA 1977, Sch. A1, para. 3(1) (introduced by Patents Regs 2000).
238 PA 1977, Sch. A1, para. 3(3) (introduced by Patents Regs 2000), says that a remuneration will be sensibly lower if it would be ‘sensibly lower within the meaning of Art. 14(3) third indent of the Council Regulation on Community plant variety rights’.
239 PA 1977, Sch. A1, para. 4(1)–(2) (introduced by Patents Regs 2000). A ‘small farmer’ is defined via Art. 14(3), third indent of the Council Regulation on Community plant variety rights.
240 PA 1977, Sch. A1, paras 5–11 (introduced by Patents Regs 2000).
241 PA 1977, s. 60(6B)(a)(b). Sale is defined to include any other form of commercialization: PA 1977, s. 60(6C).
242 R. Nott, ‘You Did It: The European Biotechnology Directive at Last’  EIPR 347, 349 n. 27.
243 A defence that is based on the arguments before the House of Lords in Gillette Safety Razor Company v. Anglo-American Trading Company Ltd  30 RPC 465 (HL).
244 PA 1977, s. 60(5)(c).
245 PA 1977, s. 60(5)(d)(e). See Stena Rederi v. Irish Ferries  RPC 668 (CA). A ship that sailed between Dublin and Holyhead in the United Kingdom three or four times a day (each visit, the ship was in UK waters for about three hours), was held to have temporarily entered the United Kingdom. Here, ‘temporarily’ meant ‘transient’ or ‘for a limited period of time’, rather than the frequency of the visits. See further R. Sharma and H. Forrest, ‘A Lifeline for Infringing Ships’  EIPR 430.
246 PA 1977, s. 55.
247 Listed in PA 1977, s. 55(1)(a)–(e).
248 PA 1977, s. 55(4). An exception, in which case no royalty need be paid, operates under PA 1977, s. 55(3).
249 PA 1977, s. 57A.
250 PA 1977, s. 44(3).
251 See The Competition Act 1998 (Transitional, Consequential and Supplemental Provisions) Order 2000 (SI 2000/311) for transitional provisions.