2.1 Deciding to patent

A range of factors are taken into account when considering whether to patent an invention. A potential applicant will need to consider the benefits that may flow from patenting. Perhaps the most obvious benefit is that because a patent confers an exclusive right to make, use, and sell the patented invention for a period of up to 20 years, it provides the owner with associated monopoly profits. It should be noted that the economic value derived from a patent will vary according to the type of invention in question. For example, where competitors are able to develop new ways of achieving the same result that fall outside the scope of the monopoly (known as ‘inventing around the patent’), the economic benefits are reduced. Another benefit associated with patenting flows from the fact that patenting translates inventions from the world of science and technology to the world of commerce. In so doing, patenting enables inventions to be included on the balance sheets of organizations and on the research returns of publicly funded institutions. This may be particularly important in attracting funds to pay for research.

Other less obvious benefits flow from patenting. These include the esteem or symbolic capital that flow from being recognized as an inventor. Indeed, in some cases it is the romantic appeal of becoming an inventor that encourages a person to enter into the p. 437↵patent system in the first place.¹ Another benefit of patenting is that it enables manufacturers to enhance the image of their goods. By advertising that their goods are patented, sellers are able to represent to consumers that they are buying cutting-edge technologies. There is also a sense in which the mere fact that something has been patented carries with it the belief that the product has public approval; this has been particularly important in relation to the patenting of life forms.

The benefits that flow from patenting need to be weighed against the associated costs. The financial costs of patenting include patent agent fees, the administrative charges imposed by national and international institutions as a condition of grant,² and (where a patent is sought in a non-English-speaking country) the costs of translation. A 2012 study commissioned by the European Patent Office (EPO) showed that the average cost of obtaining a patent directly at the EPO was €32,000.³ Non-financial costs, such as the time and effort involved in transforming a practical technical idea into the form required by the patent system, also need to be taken into account. Another cost associated with patenting relates to the fact that the applicant must make their invention available to the public. While competitors may not be able to copy the patented invention, the disclosure of the invention makes it easier for them to invent around the patent. Another factor to be taken into account is whether the benefits that flow from patenting can be achieved through other means with fewer of the associated costs.⁴ An important factor here is that an inventor (or owner) may be able to rely upon other techniques to protect their creations that do not require the invention to be disclosed to the public. These include contractual restrictions on the use or disclosure of the process, the law relating to breach of confidence, or non-legal techniques such as secrecy. The problem with these techniques is that they carry with them the risk that if the information is disclosed to the public (even if through a breach of contract or confidentiality), in most cases the invention becomes part of the public domain, free for all to use.⁵ Another factor that may influence the decision to seek a patent is the ease with which the details of the invention can be ascertained or reverse-engineered when the invention or the products thereof are made available to the public.

Given that the decision to patent is influenced by a range of factors, it is not surprising that patenting practices vary from industry to industry. For example, in the pharmaceutical industry, where research and development costs are high and the products are readily and cheaply copied, the patent process is commonly relied on to protect inventions. In other industries, such as in the aviation field, where the expense of copying is very high, greater emphasis is placed on secrecy as a mode of protection.

2.2 Role of patent agents

It is common for decisions concerning patent applications to be made in consultation with a patent agent. Since emerging as a discrete profession during the nineteenth p. 438↵century,⁶ patent agents have come to play a central role in the operation of the patent system. Under the European Patent Convention (EPC), a new breed of expert, the ‘European patent agent’, has developed to deal with the intricacies of the European patent system.⁷ Patent agents normally have knowledge of the law, the patent administration process, and a particular branch of science. As well as assisting in the drafting and processing of patents, patent agents also offer advice as to whether a patent should be taken out and where and how patents are best exploited. In some cases, they are also able to litigate on behalf of patentees. In a sense, patent agents act as go-betweens who unite the technical–scientific domains with the legal and commercial.

2.3 Choice of routes to grant

Once the decision is made to protect an invention in the United Kingdom by patent, it is then necessary to decide the particular route to take to secure grant of the patent. In particular, it is necessary to decide whether to take out a British patent or a European patent (UK).⁸ In turn, it is necessary to decide whether to apply directly to the UK Intellectual Property Office (UK IPO) or the EPO, or whether it would be better to make use of the application system provided by the Patent Cooperation Treaty (PCT).⁹ It should be noted that if the proposed unitary patent package is implemented, it will introduce yet another option: the unitary patent, which will provide uniform protection across 25 participating member states. The particular route that is chosen depends on a variety of factors; perhaps the most important are the countries where protection is desired.

When deciding whether to bring an application to the United Kingdom or the EPO, commercial and strategic considerations may come into play. From a commercial point of view, the primary variable is the fees charged by the respective patent offices. Because the cost of an application to the EPO is greater than to the UK IPO, if an applicant only wishes to file in the United Kingdom or in a few countries, it will be cheaper for them to apply to the respective national offices. There comes a point, however, where the cumulative cost of applying to several national offices will exceed the cost of a European application.¹⁰p. 439↵

Applicants may also be influenced by strategic considerations when they are considering whether to apply to the EPO or to national offices. An important factor relates to the fact that although the substantive law of the national systems and the EPC are largely the same, there are a number of other important differences.¹¹ In particular, while the EPC has a full examination system, some national offices do not require examination at all,¹² some allow for deferred examination, and some require patent agents to provide the examination service, while others will only reject applications on limited grounds (such as novelty).¹³ Another factor that may influence the route taken is the relative vulnerability of the patent. In particular, while a national patent can only be challenged in national tribunals, the EPC allows for a central challenge to be made against a European patent (which takes the form of an ‘opposition’ to the grant and can be brought within the nine-month period after grant).¹⁴ If a would-be-patentee believes that the application is likely to be challenged, the applicant might prefer to maximize the survival chances of the patent by registering in a range of national offices rather than to risk the possibility of a successful central attack, which would deprive the applicant of protection in all of the designated states.

Similar factors will influence inventors when they are considering whether to apply directly to the UK IPO or the EPC, or whether they want to make use of the international filing system provided by the PCT.¹⁵ While the PCT does not issue patents, it does provide an alternative starting point by which both UK and European patents (UK) can be obtained.¹⁶ Under the PCT,¹⁷ an international application can be made to the patent office of one of the contracting states, which is called the ‘receiving office’.¹⁸ The application must contain a request, a description, at least one claim, drawings (where appropriate), and an abstract.¹⁹ Prior to 1 January 2004, applicants also had to designate the states in which protection was sought.²⁰ This is no longer necessary, p. 440↵however, because the filing of a request automatically applies in all contracting states to the PCT (unless the applicant specifies otherwise).²¹ Applicants can apply to their designated international offices for an international search and an international preliminary examination to be carried out, (this is the EPO for UK and EPO applicants).²² At this point, the applicant can shift to the designated national offices, which will decide whether to grant national patents.²³ At this stage, the national office treats the application as if it has been filed in that office. Instead of going directly to the national stage, an applicant may ask for an international preliminary examination by an international preliminary examining authority.²⁴ The examining authority issues an international preliminary examination report indicating whether the invention appears to meet international standards of novelty, inventive step, or industrial applicability.²⁵ It should be noted that the examination is merely advisory and not binding on designated countries.²⁶

The procedures are useful for countries in which the patent office is not capable of carrying out its own examination. Another factor in favour of the PCT is convenience. Rather than having to apply in each individual country, a single application can be submitted to a relevant PCT body. The PCT is also attractive because of the lengthy period between the initial application to the international office and the time when the application is forwarded to the relevant national offices, at which time the expensive process of translation must be completed.

3.1 Requirement of registration

Registration has long been a prerequisite for grant of a patent in the United Kingdom. In modern times, this is largely explained by reference to the type of monopoly that a patent confers. The decision to make patent protection dependent upon registration is said to result from the fact that patents confer an absolute monopoly that enables the patentee to prevent all others from practising the invention. This is the case even if the infringer developed the same invention independently from the patented invention. Consequently, as a matter of fairness, it is necessary to have a register that is open to the public. This p. 441↵ensures that third parties are able to ascertain whether they are infringing someone else’s rights. The process of filing also helps to establish the priority of the invention and is a prerequisite to systems of pre-grant examination such as those that operate in the United Kingdom and EPO.

3.2 First-to-file

Most patent systems, including that of the United Kingdom and the EPC, operate on the basis that the first person to file an (acceptable) application for an invention should be granted a patent over the invention. The fact that patents are granted via a system of registration does not necessarily mean that the patent ought to be granted to the first person to file an application.²⁸

While the first-to-file system may be incompatible with a regime of intellectual property predicated on natural rights, it avoids the need to consider difficult questions about who was the first person to have a particular idea or to reduce the idea to a working model (as occurs in first-to-invent systems).²⁹ Instead, the first-to-file system replaces such investigations with an administrative practice that delivers rough, but simple, justice.³⁰ The first-to-file system is also justified on the basis that it provides inventors with an incentive to disclose (or a reward for having disclosed) the invention: the first applicant to disclose the invention obtains the patent.³¹ As we will see, the adoption of a first-to-file system has certain consequences that need to be taken into account later in the grant process.³²

3.3 Examination

Another notable feature of the patent application processes in the United Kingdom and the EPO is that applications are subject to a full examination.³³ That is, all applications are examined to ensure that they comply with the formalities of filing, as well as the requirements of subject matter, novelty, non-obviousness, and sufficiency.

For most of their long history, British patents were granted without examination. The question whether examination as a prerequisite for grant should be introduced into the United Kingdom was considered and rejected on a number of occasions during the nineteenth century.³⁴ One of the main arguments against examination was that it would have made the recognition of property rights subject to the discretion of government officials. p. 442↵Examination would also have added to the cost and time of obtaining a patent³⁵—changes that would have run counter to the spirit of much nineteenth-century reform, which aimed to simplify the system and to reduce the ‘taxes’ imposed on inventors.

After much deliberation, a limited system of examination was introduced into the United Kingdom in 1905.³⁶ An important factor that helped to support the case for examination was the finding of the 1901 Fry Committee that 40 per cent of the patents registered at the time were for inventions that had already been described in previous patents.³⁷ Because these patents would not have withstood litigation, they were theoretically harmless. Nevertheless, it was believed that they deterred others from working in the same field. Moreover, the lack of examination brought the system into disrepute and undermined the trust placed in valid patents. For some, the prospect of an examination system sanctioned and controlled by the state was attractive because it would have created a legal (and thus a commercial) presumption that any patents that had been granted were valid. Another factor that supported the case for examination was that fears of arbitrary or self-seeking exercise of discretion on behalf of those in charge of the register had been allayed by a growing trust in bureaucracy³⁸—a trend that was cemented by the increased use of experts.³⁹

The limited examination system established in 1905 was maintained until the passing of the Patents Act 1977, when the current full examination system was introduced.⁴⁰ While the examination system currently forms an integral part of the British patent system, there may come a time when the United Kingdom may wish to follow other countries in the EPC who, in the face of falling national applications, have abandoned full examination as part of national procedure. If this were to happen, it would provide applicants with greater choice, the alternatives being an unexamined national patent or an examined European patent.

3.4 Amendment

Another notable feature of the grant system is that applicants are able to alter or amend their initial applications both during and after grant of the patent. The decision to give patentees the opportunity to amend their patents recognizes that the first-to-file system may encourage applicants to register without a full understanding of the invention or complete familiarity with the relevant prior art. It is also based on the fact that subsequent examination, either by the applicant or the patent office, may reveal the existence of a p. 443↵piece of prior art that requires the application to be reformulated to ensure its validity.⁴¹ Similarly, an applicant may wish to amend the application (as filed) in light of subsequent experiments carried out on the invention. Where a patent is found to be partially valid,⁴² it is desirable that the patent be amended by the deletion of the invalid claims, which otherwise might remain as a potential nuisance to industry.⁴³ At the end of this chapter, we look at the situations in which applicants and patentees are able to amend their applications and the restrictions under which they operate.

4.1 Who is entitled to apply for a patent?

There are virtually no restrictions on who may apply for a patent. In contrast with the rules relating to copyright and trade marks, there are no limitations as regards the nationality or residency of the applicant.⁴⁴ Where appropriate, an application for a patent may be made by two or more applicants. While anyone may apply for a patent, there are a number of restrictions placed on those who are entitled to be granted a patent. The issue of entitlement to grant is dealt with later.⁴⁵

During the application process, disputes over who is entitled to a patent that may subsequently be granted are dealt with differently, depending on whether it is a British or a European application.⁴⁶ For the purposes of proceedings before the EPO, it is assumed that the applicant is entitled to exercise the right to the European patent; issues about entitlement are determined elsewhere.⁴⁷ The EPO will only take account of the question of entitlement if a decision is made by an appropriate national court that a person other than the applicant is entitled to the patent.⁴⁸p. 444↵

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Fig. 16.1 Flowchart of a patent application

As with the EPC, an applicant for a British patent is presumed to be entitled to grant of the patent.⁴⁹ However, in contrast with the EPC, the Comptroller is able to consider issues of entitlement that are raised before grant.⁵⁰ If a person ‘properly entitled’ to a patent decides to submit a new application, they may be able to use the wrongful applicant’s priority date.⁵¹ The Comptroller of the UK IPO is given similar powers to determine entitlement where a patent has already been granted.⁵²

4.2 Filing a patent application

Applications for British patents are filed online, in person, or by post. The contents of all documents included in an application for a British patent must be in English or Welsh.⁵³ Applications for a European patent may be filed either with the EPO in Munich p. 445↵or in The Hague, or with national patent offices in the contracting states.⁵⁴ Unlike the EPC 1973, under which applications had to be in one of three official languages and the text of the patent had to be in that language, the EPC 2000 allows European patent applications to be filed in any language.⁵⁵ If the application is not made in an official language of the EPO (English, German, or French), the applicant is given two months in which to translate the application into an official language.⁵⁶

Applicants at the UK IPO and the EPO are faced with the choice of either making a ‘full application’ or alternatively of taking advantage of the facility that allows for ‘early filing’.⁵⁷ A full application for a patent must contain a request for grant of a patent, a description of the invention, one or more claims, any drawings referred to in the description or the claims, and an abstract.⁵⁸

In order to provide applicants with greater flexibility, the patent systems provide that instead of filing a full application, applicants are able to make an ‘early filing’.⁵⁹ Early filing occurs where an applicant supplies an indication that a patent is sought, information identifying the applicant, and a description of the invention.⁶⁰ Essentially, early filing provides applicants with a 12-month breathing space in which they can decide whether they wish to pursue a patent, decide whether they are able to carry out further experiments on the invention, look for investors, and consider the countries in which they wish to seek patents.⁶¹

The applicant must file the claims and abstract within 12 months of the early filing (the so-called ‘filing date’) if an early application is not to lapse.⁶² While early filing offers a breathing space ‘for completion of the formalities and the interim preservation of priority’, early filing was not intended ‘to provide a cover for making improvements in the disclosed invention by bringing in new material not covered by the disclosure whilst preserving for it the priority conferred by the original filing date’.⁶³

4.3 Priority date of the application

The initial application is important in that it sets in play the sequence of steps that may ultimately result in the grant of the patent. Irrespective of whether the filing is an early filing or a full application, filing is also important since it establishes the ‘priority date’ of the patent. In the absence of a claim to an earlier date, the priority date is the filing date of the application.⁶⁴ As we will see, the priority date is the date when the novelty, p. 446↵inventiveness, and other aspects of the invention are assessed. As such, it is often of critical importance for the validity of the patent. The priority date is of practical significance in several other ways. First, because novelty is assessed as of the priority date, once the date is established, an applicant is able to exploit their invention without fear of invalidating the patent. Second, applicants are able to use the priority date established by filing in the United Kingdom or EPO as the priority date for applications in other countries.

4.4 Preliminary examination and search

The next formal step in the process of grant is the preliminary examination and search.⁶⁵ Once the full application has been filed (description, claims, and abstract) and the application fee paid (if any), the Comptroller will refer the application to preliminary examination. Once preliminary examination is over, the applicant must request a search.⁶⁶

On preliminary examination, the application is examined to see whether it complies with certain formal requirements.⁶⁷ These are that the application contains a request for grant, a description of the invention, one or more claims, any drawings referred to in the description or claim, and an abstract. In addition, the preliminary examination also ensures that the inventor(s) have been identified and that the application accords with other formalities (such as meeting the language requirements).⁶⁸

Applicants are alerted to any problems that may have been identified in the preliminary examination in a report that is issued to them.⁶⁹ Applicants are then given the opportunity to respond to the report or, if necessary, to amend their application to overcome the problems. If an applicant fails to change their application in a manner that satisfies the respective patent offices, the application may be refused.

The examiner or (at the EPO) the Search Division also carries out a limited search of the existing literature for relevant prior art—that is, information similar to the invention in question.⁷⁰ The aim of the search is to identify the documents that may be used at the substantive examination stage when the application is examined for novelty and inventive step.⁷¹ The applicant is informed of the findings of the search by way of an examiner’s report or, as it is known at the EPO, the ‘European search report’.⁷²

As well as identifying the documents that may be relied upon when the application is examined for novelty and inventive step, the application is also examined during the search stage to ensure that it relates to one invention or to a group of inventions that form a single inventive concept.⁷³ That is, it is examined to ensure that it meets the requirement of ‘unity of invention’.⁷⁴

p. 447↵Where two or more inventions are claimed in the one application, the application will fail to comply with the requirement of unity of invention unless it can be shown that the inventions form a single inventive concept.⁷⁵ To do this, it is necessary to show that the inventions share the same ‘special technical features’. Special technical features are the features that define the contribution that each of the claimed inventions considered as a whole makes to the claimed advance over the prior art.⁷⁶ There are at least two reasons for limiting patent applications to a single inventive concept. The first is that patent protection should not be available for two inventions for the price of one. The second, and more important, is that to allow more than one inventive concept to be included in a single patent is likely to undermine the administrative systems for locating, identifying, and searching for patents.

If it is found that the application contains more than one invention, the search is limited to the first invention that is set out in the claims.⁷⁷ In the face of a finding that an application contains more than one patent, applicants may simply pursue a patent for one of the inventions. Alternatively, they may divide the initial application into two (or more) fresh applications. So long as additional fees are paid and no new material is added, they may use the priority date for the original application for the new applications.⁷⁸

Along with the search report, the EPO also provides applicants with a report into the patentability of the invention. This is called the ‘Extended European Search Report’.⁷⁹ The report is to help applicants decide whether to proceed to the substantive examination of the application. If the application decides to progress, the report becomes the first examination report.

4.5 Publication

The next stage in the grant process is the publication of the patent application. The application will be published and made available for public inspection 18 months from the date of filing.⁸⁰ This process informs third parties that the application has been made. While third parties are not able to oppose the grant of a patent at this stage, they are able to make observations as to whether the patent should be granted.⁸¹

The documents published in the United Kingdom and the EPO include the description, claims, and drawings (if any) that have been filed. In the United Kingdom, the publication must include the original claims and any amendments that have been made to the claims, as well as any new claims. The UK IPO is also given power not to publish parts of the application that are offensive or disparaging,⁸² or which might be prejudicial to p. 448↵national security.⁸³ At the EPO, the abstract and (where available) the search report are also published.⁸⁴

Publication is important for two reasons. First, since the act of publication discloses the invention to the public, an unwanted publication may prevent applicants from relying on other ways of protecting their invention (such as confidentiality). Similarly, once a patent application has been published, the application can no longer be resubmitted (whereas if the application is withdrawn prior to publication, it is possible to make a later application).⁸⁵ Second, if the patent proceeds to grant, the date of publication is the date from which the patentee is able to sue for infringement of the patent. This is on the condition that the act would have infringed both the patent as granted and the claims in the form in which they were published.⁸⁶ In these circumstances, the patentee is only entitled to damages for infringement in the period between publication and grant.

As mentioned, a third party may respond to the publication of the application by submitting ‘observations’ to the patent office (at any time before grant).⁸⁷ Such observations should focus on whether the invention is a patentable invention.⁸⁸ Observations may be made by ‘any person’ and must be submitted in writing accompanied by appropriate reasons. The Comptroller of the UK IPO is instructed to consider the observations, whereas the EPO is merely required to communicate the observations to the proprietor, who, in turn, is permitted to comment on them. If the EPO wishes, it can take account of such observations when examining the application.⁸⁹ In both fora, the party submitting the observations does not become party to the proceedings and so will not be asked to any hearing, nor be made to pay the costs of any proceedings.

4.6 Substantive examination

Once the requirements of preliminary examination and search have been satisfied, the next stage in the application process is the ‘substantive examination’.⁹⁰ The applicant must request this within six months from the date of publication of the application or, at the EPO, the publication of the search report.⁹¹ In some situations, it is possible for an applicant to request that the examination process is accelerated or fast-tracked.⁹²

p. 449↵The purpose of the substantive examination is to ascertain whether the application complies with the requirements of the Patents Act 1977 or, in the case of the EPO, the EPC 2000.⁹³ Unlike the preliminary examination, which is mainly concerned with ensuring the presence of certain documents, during the substantive examination the application is scrutinized to ensure that it is valid in all aspects. In particular, the invention is examined to ensure that it does not consist of subject matter excluded from patentability—that is, that it is novel, involves an inventive step, and is industrially applicable. The substantive examination also ensures that the application has been sufficiently disclosed, that the claims are concise, and that they are supported by the description.

The substantive examination takes the form of a dialogue between the examiner and the applicant. When examining the application, the examiner should consider whether if the matter in issue were to be fully investigated at trial with the aid of expert evidence, it would be resolved in the applicant’s favour.⁹⁴ After the examination has taken place, the examiner draws up a report, which outlines any objections to the application that have been identified. The report is supplied to the applicant, who is given an opportunity to comment on the objections, often in the hope of persuading the examiner that any doubts they have about the application are ill-founded. Alternatively, the applicant may respond to the objections by amending the patent application.⁹⁵ If they think it necessary, the examiners may make or require further searches. Ultimately, the dialogue may lead in the United Kingdom to a hearing before the Senior Examiner or, at the EPO, before the full Examining Division of the EPO, and from there by way of appeal to the UK Patents Court or the Boards of Appeal of the EPO.⁹⁶

4.7 Grant of the patent

If the respective patent office is not satisfied that the application satisfies the various requirements for grant, the application will be refused.⁹⁷ If the respective patent office is satisfied that all of the necessary requirements have been satisfied, the patent will be granted.⁹⁸ The decision to grant a patent does not take effect until the date on which it is mentioned in the Official Journal (for a UK patent) or the European Patent Bulletin (for a European patent).⁹⁹ The protection afforded by a patent can last up to 20 years from the filing date.¹⁰⁰ Renewal fees must be paid after four years.¹⁰¹ As we will see, the protection may extend beyond the 20-year period if a supplementary protection certificate is issued. The extent of protection conferred by a patent will be considered later.¹⁰²

The date of the grant of a European patent is also the date of its transition from a European application to a bundle of separate national rights.¹⁰³ With the exception of opposition proceedings, questions of validity and infringement are thereafter considered at a national level.¹⁰⁴ Once granted, a European patent (UK) is given the same level of protection as those granted by the national patent office.¹⁰⁵ As discussed earlier, it is no p. 450↵longer necessary to translate European patents in French or German into English within three months of grant at the EPO for them to be valid in the United Kingdom.¹⁰⁶

4.8 Revocation

While the patent examination processes at the UK IPO and EPO are relatively rigorous, they are not conclusive. As such, it is possible for patents to be revoked after grant on a limited number of grounds. The grounds on which a patent may be revoked are set out in section 72 of the 1977 Act and Article 138 of the EPC 2000. These are that:

In addition, the UK IPO has limited power to revoke patents on its own initiative.¹¹¹

One of the notable features of section 72 is that it says that ‘any person’ can apply to have a patent revoked. This has been taken to mean that there is no need for a person to have any interest, whether commercial or otherwise, in the outcome of proceedings to bring an action to revoke a patent.¹¹² Unlike the position under the Patents Act 1949, a person who has no interest in the revocation is nevertheless entitled to apply to have the patent revoked. As Jacob J said: ‘Parliament purposively made patents vulnerable to attack from anyone.’¹¹³

4.9 Opposition proceedings at the EPO

While the grant of a European patent generally brings the European stage to an end, a central challenge can be made to the validity of the European patent in the nine-month period following grant of the patent.¹¹⁴ This process, known as ‘opposition’, has a number of advantages over leaving decisions about the validity of patents exclusively to national offices or courts. The most obvious advantage is cost: it is cheaper to launch or defend a single attack in one place than it is to engage in revocation proceedings in each of the countries in which the patent was issued.

p. 451↵Any person may file a notice of opposition. For a period, it was common for the proprietor to file oppositions in order to make post-grant amendments (which otherwise would have to be made at national level).¹¹⁵ This practice has now been curtailed.¹¹⁶ Opposition has to be filed within nine months from grant and must be based on one of three grounds.¹¹⁷ These are that:

Any opposition to a European patent is communicated to the patent proprietor, who may contest the opposition, make observations, and/or make amendments. The opposition proceedings will determine whether the patent should be revoked, maintained, or maintained in an amended form.¹²¹ If the proceedings result in revocation, the patent is deemed from its outset not to have had any of the effects specified in the EPC.¹²²

5.1 Restrictions on amendment

In order to ensure that any amendments that are made comply with the overriding aims of the patent system,¹³² a number of restrictions are placed on an owner’s ability to amend their application/patent. The amended patent must comply with the requirements that have to be met by all patents. These include the requirements of subject matter, novelty, and inventive step. The amended claims must also be clear and concise, be supported by the description, and relate to one invention or group of inventions that are linked to form a single inventive concept.

There are a number of other provisions that restrict an owner’s ability to amend either the application or the patent. Perhaps the most important of these, with which we deal in Chapter 20, strike at the validity of the patent. Under these provisions, if the amendment introduces subject matter that was not in the original application or the amendment p. 453↵extends the scope of protection beyond the initial application, the amended patent is liable to be revoked.¹³³ In this section, we focus on the situations in which validity is not at stake.

A post-trial application to amend a patent following revocation proceedings (in which the validity of the patent was at stake) will also be refused if it would lead to a second trial on validity (primarily because procedural fairness requires the parties to put forward their cases prior to trial).¹³⁴ Another important factor that limits the owner’s ability to amend their application as filed arises from the fact that post-grant amendment is at the discretion of the Comptroller and the courts.¹³⁵ The onus is on the patentee to establish that the amendment should be allowed.¹³⁶ As a result of changes made in 2004, when deciding whether to allow an amendment, the courts and the Comptroller are directed to take account of ‘any relevant principles applicable’ under the EPC 2000.¹³⁷

The courts have tended to use their discretion to deny amendments where the owner has not acted innocently. As Jacob J noted: ‘No patent office is there for the purpose of enabling people deliberately to impose bogus monopolies on the public.’¹³⁸ There are two situations in which the discretion has been exercised against the patentee. The first is where a patentee knowingly and deliberately obtained claims that were wider than justified by what was invented.¹³⁹ The second situation in which discretion has not been exercised is where knowing of the doubtful validity of the patent, a patentee has been slow to take action to amend.¹⁴⁰ In Raleigh Cycle v. Miller,¹⁴¹ the House of Lords emphasized that a patentee who suspects that a patent is too widely drawn should amend it promptly. If they do not, the discretion to amend will be refused. Lord Normand explained that ‘the public interest is injured when invalid claims are persisted in so that inventors are illegitimately warned off an area ostensibly monopolised by the claims’.¹⁴² In this situation, patentees should either litigate or amend. However, if they choose to litigate, they should not be permitted to amend later. It is reasonable for a patentee to delay where they believed on reasonable grounds that the patent was valid.¹⁴³

p. 454↵Another factor that regulates the way in which patents are amended arises from the fact that the courts may limit the damages that are awarded where an amended patent is infringed. There are two situations in which this may occur. If an amended application expands the claims beyond those that were reasonably to be expected from the application as it was initially published, the courts may limit the damages that are available to the patentee. The question of whether the inference is reasonable is decided objectively. As such, it does not matter what the defendant (subjectively) thought.¹⁴⁴ Another factor that regulates the way patents are amended arises from the fact that when the court assesses damages prior to the date of the amendment it may take into account whether the specification was framed in good faith and with reasonable skill and knowledge.¹⁴⁵ In practice, it is rare for the courts to find that patents were not framed in these terms.

5.2 Errors and clerical mistakes

Instead of amending a patent, a patentee may seek to have the patent altered to correct errors and clerical mistakes.¹⁴⁶ Such corrections take effect retroactively. The ability to correct mistakes does not conflict with the general policy of protecting third parties, which forbids amendments that extend the patent beyond the scope of the application as filed. The reason for this is that ‘if the mistake was obvious, it cannot have misled’.¹⁴⁷

If the request to correct a mistake concerns the description, claims, or drawings, the correction must be obvious. A correction will be obvious where it is immediately evident that nothing else would have been intended other than what is offered as the correction.¹⁴⁸ If there are any doubts, a correction will not be allowed. A useful example of the limits imposed on a patentee’s ability to correct mistakes can be seen in PPG Industries Patent.¹⁴⁹ In this case, it was said that faced with the proposition ‘2 + 2 = 5’, a person might readily presume that this was obviously incorrect and that, to correct the mistake, the ‘5’ should be changed to a ‘4’. However, as Dillon and Slade LJJ pointed out, since an alternative solution was to change one of the ‘2s to a 3’, in the absence of an indication as to where the mistake lay, the correction was not obvious within the meaning of the 1977 Act.

6.1p. 455 Unitary patent system

As we saw in Chapter 14, there are plans under way to introduce a new unitary European patent, which will provide uniform protection across the 25 participating member states. While the new unitary patent which will be issued by the EPO will build upon existing procedures at the EPO, a number of changes will need to be made to the procedures by which patents are granted to allow this to happen.

6.2 Traditional knowledge and prior informed consent

In recent years, there has been increased attention given to the information that applicants have to disclose in their patent applications, particularly as a way of attempting to regulate the way in which indigenous knowledge is used by patentees. Discussions are taking place at the national, community, and international levels about the possibility of requiring inventors who draw upon or utilize genetic resources in the development of their inventions to disclose information in their patent application, such as the fact that they have prior informed consent to use the genetic resources. These discussions have been prompted by Article 15 of the Convention on Biological Diversity (CBD) (which recognizes equitable benefit sharing for access providers) and by Article 8(j) of the CBD which encourages the equitable sharing of benefits arising from the use of indigenous knowledge.¹⁵⁰ The discussions have also been prompted by the growing concern about biopiracy and the general misuse of genetic resources in the biodiscovery process. The idea that applicants should be required to disclose information about their invention builds upon the idea that patent law has the potential to modify behaviour to promote good corporate and scientific conduct.¹⁵¹ The fact that an organization might not be able to patent products derived from genetic resources if it does not have the informed consent of the access provider in advance will act as a powerful incentive for such organizations to ensure that they have the necessary prior consent. As we mentioned earlier, debates are presently taking place over whether or not prior informed consent should be incorporated into patent law, and if so, how.¹⁵²

This question has taken on a new significance following the adoption in 2012 of the Nagoya Protocol to the CBD (discussed earlier). This is because the Protocol requires parties to adopt legislative, administrative, or policy measures to monitor and enhance transparency about the utilization of genetic resources. This system includes the designation of checkpoints at which specified information regarding prior informed consent and mutually agreed terms may be required. It envisages the establishment of a standardized international system of certificates of compliance to act as evidence of prior informed consent and mutually agreed terms. Proposals for the inclusion in the Protocol of a disclosure-of-origin system requiring disclosure of information on prior informed consent and mutually agreed terms as a condition for the grant of patent rights were not included in the final text.

p. 456↵Discussions have been taking place within Europe for some time about the best way in which the goals of the CBD might be achieved.¹⁵³ The issue of prior informed consent has already been recognized in Europe in the Biotechnology Directive, albeit only in the non-binding Recitals. In particular, Recital 27 encourages patent applications to include information on the geographical origin of biological material. In turn, Recital 55 requires member states to recognize Article 8(j) of the CBD when developing laws and regulations. To date, these have had minimal impact on member states.¹⁵⁴

Early responses to the Convention were not positive. At one stage, the Commission suggested that there should be a debate over the unilateral development under EC law of ‘a self-standing obligation for patent applicants to disclose the origin of genetic resources’.¹⁵⁵ This built upon existing requirements that encourage disclosure of information—namely, enabling disclosure, disclosure of relevant prior art for novelty examination, and the disclosure of the inventors.¹⁵⁶ Initial proposals by the Commission were fairly modest. These provided that prior informed consent would not be treated as an additional or formal requirement for patentability; rather, the Commission suggested that failure to comply with the requirement for prior informed consent would carry consequences outside patent law. For example, it might prompt civil law claims for compensation or administrative sanctions (such as a fee for refusal to submit relevant information). The Commission was also looking at introducing a similar requirement for plant variety rights.¹⁵⁷ Despite the modest nature of these proposals, they were not implemented.

Discussions about the way in which European law should deal with the question of access to genetic resources and related questions were reopened following the adoption of the Nagoya Protocol. In December 2012, the European Union published a draft legislative proposal for implementation of the Protocol. A modified version was adopted by the European Union on 16 April 2014.¹⁵⁸ While the Union, has taken the lead in the development of legislation to implement the Protocol, it seems that this is not being done in the spirit in which the Protocol was drafted. Indeed, the original draft law was criticized for, among other things, primarily focusing on enabling economic utilization of genetic resources and traditional knowledge, and restricting its temporal scope to genetic resources and traditional knowledge accessed after the Protocol comes into force.¹⁵⁹ Criticism has also been made of the law’s adoption of a very narrow definition of protectable traditional knowledge,¹⁶⁰ which renders it almost meaningless as a tool for the protection of traditional knowledge rights. It has also been criticized for its failure to take into consideration customary law in both its preparation and redaction.¹⁶¹ As such, p. 457↵it seems that little will change in the way in which European law deals with traditional knowledge and access to genetic resources.

6.3 Patent examination

Another area where reform might be considered is in relation to examination. Here, there are two issues that are currently attracting interest. The first relates to the rigour with which examinations are conducted. Some argue that, given the fact that the number of patent applications vastly exceeds the number of commercially significant inventions, it is a waste of resources to examine every application in detail. The most efficient approach, it is said, is to perform a cursory examination of all applications and to review seriously the validity of any grant that has commercial significance.¹⁶² Because the validity of any commercially valuable patent will be subjected to a thorough review in any litigation, we should not bother to waste resources on pre-grant examination of patents. On the other hand, some argue that examination is important to protect the public—in particular, small traders—from threats of patent litigation on the basis of granted patents of dubious validity by well-resourced claimants. Essentially, the argument is that even invalid patents can be used to chill activity of legitimate traders or to extort settlements from risk-averse or poorly financed potential defendants. A related problem is said to be the activity of ‘patent trolls’—that is, commercial organizations that acquire patents specifically with a view to bringing actions in the hope of making money by forcing settlements.¹⁶³ Although the causes and effects of patent trolling are controversial, some argue that the impact has been made much worse by the practices of some patent offices in granting patents that rigorous examination would have shown related to subjects that lacked novelty or were obvious.

The second issue that has arisen in relation to examination arises from increasing backlogs in the processing of applications. Filings at the EPO, for example, have more than quadrupled over the last 30 years to more than 296,000 in 2016, leaving substantial backlogs. As a result of a series of controversial ‘efficiency’ reforms, the EPO granted nearly 96,000 patents in 2016; a staggering increase of 40 per cent over 2015. While this has eased the pressure on the examination backlog, it has triggered other issues, one of which is a concern about the quality of the patents that have been granted.¹⁶⁴