Going full circle: Bolar in Europe and the UPC

Transcription

1 Going full circle: Bolar in Europe and the UPC ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 1 Article 10(6) of the Directive provides that the following are exempt from patent infringement: 10(6) Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products. PAUL ENGLAND,* MATTHEW ROYLE* AND CHRISTOPH DE COSTER** Introduction The experimental use exemption, although based on the Community Patent Convention 1975, 1 is provided in national law by national statutes and varies from one European country to another in the precise activities that are excluded. Doubt has centred on the extent to which, if at all, protection is afforded by this exemption to the conduct of clinical trials and other tests necessary to obtain a marketing authorisation. This has been a particular concern for generic pharmaceuticals companies, facing a wait until patent expiry before performing such studies, effectively extending monopoly protection for branded drug makers until the approval for a generic can be obtained. Hence, the regulatory review defence, better known as the Bolar exemption (here referred to simply as Bolar ) after a similar provision in US law, 2 was introduced into European law by Directive 2001/83/EC ( the Directive ). The purpose of the provision was to address uncertainty about the scope of application of the experimental use exemption, specifically, to clinical studies and other potentially infringing work conducted for the purpose of obtaining an abridged marketing authorisation for a generic product under the Directive. 3 Although the Directive is intended to harmonise legislation across the Member States of the European Union, as a Directive it must be implemented by the national laws of each country concerned it does not have direct effect. As a result, varying implementations in the Member States has, much like the experimental use exemption, created Bolar provisions of widely differing scope. This is a particular feature of the application of Bolar in respect of work conducted by innovators of novel drugs to gain marketing approval, and in respect of obtaining approval for countries outside the European Union. This article examines this divergence, with a focus on the key jurisdictions of the United Kingdom and Germany. It also reviews other developments relating to Bolar in these countries, focusing on the amendment to the UK exemption regime and third-party supply. It also looks ahead at the likely impact of the Unified Patent Court ( UPC ), which appears as if it will bring the interpretation of Bolar across the contracting Member States back full circle. Scope of the Experimental Use Exemption The United Kingdom What were the limitations on the experimental use exemption that provided a need for Bolar in the United Kingdom? A starting point is the Court of Appeal decision in Monsanto v Stauffer. 4 In this case, the defendants sought the modification * Taylor Wessing, London. ** Taylor Wessing, Munich. 1) This Convention was never fully ratified. 2) In the Hatch-Waxman Act, it was introduced following the decision of the Court of Appeals of the Federal Circuit in Roche Products v Bolar Pharmaceuticals Company 733 F2d 858 (FedCir). 3) Article 10(1) to (4). 4) Monsanto Co v Stauffer Chemical Co (1985) RPC 515.

2 2 VOL 14 ISSUE 2 BSLR : ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC to an injunction that had been ordered against the manufacture and sale of their Touchdown herbicide for agricultural use. The modification was sought in order to allow the defendants to carry out experiments, specifically field trials, on Touchdown. The Court of Appeal permitted limited modifications to the injunction, so that it did not preclude the defendants from conducting experiments in laboratories or glasshouses in the United Kingdom or on their farm in Essex. But it was not modified to allow field trials for the purpose of full commercial clearance from the Pesticides Safety Precautions Scheme and approval from the Agricultural Chemicals Approval Scheme. Explaining where the line is to be drawn between exempted and non-exempted experiments under section 60(5)(b) of the Patents Act 1977, Dillon LJ explained as follows: I would regard the sort of experimental activity which was considered by the Supreme Court of Canada in Microchemicals Ltd v SmithKline and French, 5 viz, a limited experiment to establish whether the experimenter could manufacture a quality product in accordance with the specification of a patent, as being covered by the words for experimental purpose relating to the subject matter of the invention. Trials carried out in order to discover something unknown, or to test an hypothesis, or even in order to find out whether something which is known to work in specific conditions, e.g. of soil or weather, will work in different conditions can fairly be regarded as experiments. But trials carried out in order to demonstrate to a third party that a product works or, in order to amass information to satisfy a third party, whether a customer or a [regulatory] body such as the PSPS or ACAS, that the product works as its maker claims are not to be regarded as acts done for experimental purposes. Thus, the court reasons that exempted experiments are those that generate new knowledge, but not those that verifying existing knowledge. The later decision of the Court of Appeal in Auchinloss 6 is consistent with this. Auchinloss holds that making and experimenting with a patented invention merely for the purposes of gaining official approval would not fall within the experimental use exemption. Auchinloss concerned a sample of a dry water-soluble biocidal composition sent by the defendant to the Ministry of Agriculture, Fisheries and Food ( MAFF ). The defendant submitted that this activity was exempted from infringement of the plaintiff s patent as an experimental use. However, it was held by the Court of Appeal that supplying a sample to MAFF in order to obtain official approval, rather than to discover something unknown or to test a hypothesis, was not covered by the exemption. Germany In Germany, the experimental use exemption is found in the German Patent Act. 7 It states: The effects of the patent shall not extend to acts done for experimental purposes relating to the subject matter of the patented invention. The most important interpretation of this provision has come in two cases of the German Supreme Court (Clinical Trials I, 8 Clinical Trials II 9 ). The understanding of the exemption in these cases differs significantly from those in the United Kingdom. Clinical Trials I concerned patents claiming interferon-gamma. One of the defendants had obtained a compulsory licence under the patents allowing the production and sale of certain interferon-gamma containing pharmaceutical compositions, which were authorised by the German Health Agency for treatment of rheumatoid arthritis. The defendants performed clinical trials to establish further indications for the drug, with a view to also obtaining compulsory licences for those indications. The 5) Microchemicals Ltd v Smith Kline and French [1972] SCR ) Auchinloss and Another v Agricultural and Veterinary Supplies and Others [1999] RPC ) Section 11 Nr. 2. 8) Clinical Trials I [1997] RPC ) Clinical Trials II [1998] RPC 423.

3 ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 3 plaintiff objected to these experiments and asserted its patent claims against the defendants. It was held by the Bundesgerichtshof that the German Patent Act exempts all experimental acts as long as they serve to gain information and thus to carry out scientific research into the subject-matter of the invention, including its use. Furthermore, experiments are permitted in order to discover the effects of a substance or possible new uses hitherto unknown it cannot matter if the experiments are used to check the statements made in the patent or else to obtain further research results. In particular, it is immaterial that the experiments are conducted with the aim of licensing under the law relating to pharmaceuticals. In Clinical Trials II, the patent in suit claimed a recombinant erythropoietin of defined amino acid sequence. The defendant conducted clinical trials on a recombinant human erythropoietin extracted from the kidney cells of hamsters. The trials were intended to confirm the results of animal tests and to compare the effectiveness and digestion of their product with that of a product already on the market. The data obtained would assist an application for a marketing authorisation and, therefore, addressed a commercial purpose rather than a scientific one. Did this matter to the protection of the experimental use exemption in the German Act, as Clinical Trials I had suggested it might? The answer, again from the Bundesgerichtshof, was that the exemption applies if and insofar as the experiments serve the purpose of exploring the subject-matter of the invention and do not unreasonably interfere with the commercial activities of the patentee; the exemption applies regardless of any additional motivation and purposes that the results might serve; they could range from purely scientific experiments to commercially oriented trials. Given that these decisions were from the German Supreme Court, what impact would they have on English law? The answer came in CoreValve v Edwards Lifesciences, 10 in which a limited aspect of Clinical Trials I the principle that the experimental use exemption permits clinical trials to be conducted on a patented drug to ascertain its effect in non-patented medical indications was approved. CoreValve concerns clinical trials of artificial valves for implantation in the human body. However, it was held in the Patents Court that the trials fell outside the benefit of the exemption. This was because the activities in question were the supply of its valve device to selected hospitals as part of a clinical programme to train cardiologists in the use of the device, for which Corevalve invoiced a very substantial amount. This, the judge thought, illustrated an outer limit on the principle of the Clinical Trials I decision that the German court had not had to deal with, namely when the immediate purpose of the transaction in question is revenue raising, and states: The relevant statutory phrase is acts done for experimental purposes. The difficulty arises where the defendant has mixed purposes. I would reject the extreme proposition that, so long as one of the defendant s purposes is to generate further information of scientific or technical value, it is irrelevant that another of his purposes is to generate ready cash. There may be no help for it but to consider the defendant s preponderant purpose. On the evidence in this case I would hold that CoreValve s purposes are threefold: (1) to establish confidence in their product within the relevant market; (2) to generate immediate revenue of a substantial character; and (3) to gain information about clinical indications and, possibly, future modifications to be made to the physical structure of the device in the light of experience. I do not find that purpose (3) was their preponderant purpose. In summary, the English authorities draw a distinction between the application of the experimental use exemption to activity conducted for the purpose of discovering something 10) [2009] FSR 8.

4 4 VOL 14 ISSUE 2 BSLR : ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC new about the subject-matter of the invention, and merely testing what is already known. This means that trials and tests on a substance for regulatory approval of that substance are not covered by the exemption, either for novel drugs or for an abridged application. Furthermore, in the United Kingdom, a test is imposed requiring the preponderant purpose of the work to be finding out something new. In Germany, in contrast, there appears to be no such restriction to a preponderant purpose, and the result of Clinical Trials I and Clinical Trials II is that experiments will be exempted if they are conducted for the purpose of testing the subject matter of the patent to find out information, including for regulatory approval. To what extent does Bolar make a difference to the activities protected from infringement? What Does Bolar Exempt? The United Kingdom In the United Kingdom, Bolar is implemented by section 60(5)(i) Patents Act This exempts from infringement: (i) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or (ii) any other act which is required for the purpose of the application of those paragraphs. Thus, the UK implementation of Bolar is linked by explicit reference to the abridged application procedures for marketing authorisations in the Directive. Thus, the provision excludes from patent infringement activities conducted only for the purpose of such an application no more. It also follows that the exempted applications must be for the European Union market. There is no authority on the precise scope of the exemption, but the UK Intellectual Property Office (UKIPO) and the Medicines and Healthcare products Regulatory Agency (MHRA) has published a practice note to explain its understanding of the scope of application of Bolar in the United Kingdom. The note states that it considers the following to be covered: the carrying out of chemical and biological synthetic processes suitable for the making, disposal or keeping of the active substance(s) including the manufacture or the import of batches in quantities sufficient to provide material for preparing investigative batches of the medicinal product and to validate the processes to the satisfaction of the competent authorities; the development, testing and use of the associated analytical techniques for the above; the development of the final pharmaceutical composition and manufacturing processes for the medicinal product to be marketed including the making, disposal or keeping or import of product batches in quantities sufficient to conduct the necessary pre-clinical tests, clinical and bioavailability trials and stability studies of the medicinal product and to validate the processes to the satisfaction of the competent authorities; the development, testing and use of the associated analytical techniques for the above; the manufacture and supply to the competent authorities of samples of active substances, their precursors, intermediates or impurities and of finished product samples; and the compilation and submission of an MA or variation application and application for an MA. Whilst point 3 expressly includes trials as activities covered by the exemption, these are nonetheless restricted to those studies (such as bioequivalence studies and stability testing) that are necessary to allow a generic applicant to use the abridged authorisation procedure.

5 ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 5 The New Exemption in the United Kingdom The UKIPO consulted towards the end of on whether the Patents Act 1977 should be amended to include an exemption from patent infringement that covers, amongst other matters, activities involved in preparing or running clinical or field trials which use innovative drugs. The UKIPO consultation received a majority response in favour of such a broadening amendment to Bolar, particularly because it would bring the United Kingdom into alignment with a number of other EU countries. Consequently, the UKIPO sought amendment to the UK Patents Act 1977 to make it clear that the following activities should be exempt from infringement: 12 (1) the activities of preparing or running clinical or field trials involving innovative drugs and gaining regulatory approval in any country, European or non-european. For example, the amended Bolar will cover tests on new drugs that require comparison with a patented drug, and also tests on new combinations in which a patented drug is a component; and (2) conducting health technology assessments on new medicines for the purpose of recommendation to the NHS. The amendments were made by Legislative Reform (Patents) Order 2014, 13 amending section 60 of the Patents Act, and came into force on 1 October The amendments are therefore not actually made to Bolar but instead to the experimental use exemption. The Bolar provision, as such, will remain unchanged. This produces the result that whilst the United Kingdom faithfully implements Article 10(6) of the Directive, at the same time it effectively renders it redundant. This can be seen from the breadth of the new experimental use provision, which covers activity that is conducted for the purpose of a medicinal product assessment. 14 A medicinal product assessment is defined as any testing, course of testing or other activity undertaken with a view to providing data for one of the following purposes 15 (a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere); (b) complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation; (c) enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of (i) providing health care on behalf of such a government or public authority, or (ii) providing advice to, or on behalf of, such a government or public authority about the provision of health care, to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care. A further issue covered by the consultation was the question of whether Bolar should cover work undertaken in the United Kingdom in support of a regulatory filing in a country outside the EU. The Bolar exemption as presently implemented in the United Kingdom only covers work conducted for European Union filings. This is implicit in the wording of section 60(5)(i) of the Act, which makes reference to studies necessary for the purpose of the EU abridged application legislation: study, test or trial which is necessary for and is conducted with a view to the application of [the relevant Directives]. 11) The Research and Bolar Exceptions, A formal consultation on patent infringement in clinical and field trials, October ) The Research and Bolar Exception: Proposals to exempt clinical and field trials using innovative drugs from patent infringement, Government Response, February ) 2014 No ) New subsection (6D) to section ) New subsection (6E) to section 60.

6 6 VOL 14 ISSUE 2 BSLR : ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC The amendment to the experimental use exemption clearly addresses this issue in subsection (a), which provides that the exemption covers: obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere). Hence, activities conducted for the purpose of obtaining a regulatory authorisation in any country are now exempted. The result is that, as far as medical health assessments are concerned, the distinction drawn in Monsanto v Stauffer and Auchinloss between experiments designed to test for new properties and those to verify known properties no longer applies. However, there is arguably no reason why CoreValve should not continue to apply. Exempted activities under the new experimental use exemption are those for the purpose of medical health assessments and it is reasonable to suppose that this should be a preponderant purpose just as it is in other cases under the exemption. Germany In Germany, Bolar was implemented in 2005 in section 11 Nr. 2 b GPA, which reads as follows: The effects of the patent shall not extend to studies and trials and the resulting practical requirements necessary for obtaining a marketing authorisation to place a medicinal product on the market in the European Union or marketing approval for a medicinal product in the Member States of the European Union or in third countries. The German Bolar provision is broad. It does not distinguish between marketing authorisations for generic and innovative drugs and applies regardless of whether these authorisations are obtained in Europe or elsewhere. The provision covers studies and trials and the resulting practical requirements, such as the making, the import, the possession and the use of patent-protected substances if and insofar as necessary for obtaining a marketing approval in a particular jurisdiction. Furthermore, in Germany, Bolar is not limited to work done for authorisations in the European Community. In Germany it applies to: Studies and trials and the consequential practical requirements which are necessary to obtain an authorisation according to Drug Law for the marketing in the European Union or an authorisation according to the Drug Law for the marketing in the Member States of the European Union or in third countries. Hence, together with its broadly interpreted experimental use exemption, the implementation of Bolar in Germany is considerably more generous than the implementation of the same provision of the Directive in the United Kingdom. As a result, the German Bolar has come to be regarded as the gold standard in Europe. But it can be seen from the discussion above that the amendments to the experimental use exemption in the United Kingdom bring it much closer in breadth to this gold standard. This is important, because one of the advantages sought by the new exemption is to benefit UK companies by making them competitive options for conducting clinical trials. Other Key European Jurisdictions In France, the exemption was added as a defence to patent infringement in the French Intellectual Property Code Art L613-5(d). This exempts from infringement: studies and trials required in view of obtaining a marketing authorisation for a drug, as well as acts necessary to the performance thereof and to the obtaining of the authorisation. The French provision is also expressed broadly. There is no requirement in France that the activities protected by the exemption are exclusively for the purpose of obtaining an abridged application. Furthermore, the absence of any territorial restriction is understood to mean that the provision applies to activities undertaken for the purpose of gaining a

7 ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 7 marketing authorisation in any country. Therefore, although it is worded very differently, the scope of the exemption is broadly like that of Germany. Similarly, in Italy, the code on Intellectual Property Rights, Article 68(1)(a), implements Bolar to cover work conducted simply for the purpose of gaining a marketing authorisation and thus again extends beyond the abridged procedure. It also expressly states that the acts in question may be for commercial purposes and for the purpose of gaining the authorisation in any country: Acts performed privately and for non-commercial purposes, or for commercial purposes, even if aimed at obtaining an authorisation to market a medicinal product in any country, and subsequent practical requirements, including the preparation and the use of the active pharmaceutical ingredients if they are absolutely necessary. The Bolar provision in the Dutch Patent Act 1995, Article 53(4), is notable for its contrast with the above; it takes a much narrower approach, exempting from infringement: Performance of necessary studies, tests and experiments carried out in connection with the application of Article 10(1) to (4) of Directive 2001/83/EC or Article 13(1) to (5) of Directive 2001/82/EC and the ensuing practical requirements shall not be deemed to constitute an infringement of patents relating to medicinal products for human use or medicinal products for veterinary use, respectively. The scope of Bolar as implemented in the Netherlands resembles that in the United Kingdom. Like the UK Bolar, in the Netherlands only studies prepared for the purpose of an abridged application for marketing authorisation by a generic are covered, and only for authorisation in the EU. Hence, comparison of the Dutch Bolar with those of France, Germany and Italy (and now the United Kingdom) illustrates that the picture in Europe is still one of Bolar provisions of diverging scope. Is Third-party Supply of API Protected from Infringement? Despite the broad implementation of Bolar in some European countries, there is one question to which the answer is far from clear. This is whether the offer and sale of patent protected active pharmaceutical ingredient ( API ) by a third party to a generic company is also covered by Bolar, even in circumstances where the supply is in fact restricted to purposes that are protected. The question is crucial for the API suppliers and the generics industry in Europe. If a supply in the development phase is not possible under Bolar, European API suppliers will be forced out of Europe and the supply sources for generic companies and their ability to enter the market immediately after patent expiry will be seriously limited. The objectives of Bolar to strengthen the generic industry in Europe and allow immediate market entry of generic products after patent expiry would be at risk. Recently, the Düsseldorf District Court dealt with this question by ruling that the exemption applies only to those who themselves have an interest in obtaining a marketing approval. 16 This would mean the supply of actives for tests and studies under Bolar is not exempted, unless the supplier can demonstrate their own interest in the marketing approval and not only commercial interest in the sales of the API. However, the case was appealed to the Court of Appeal in Düsseldorf. The Düsseldorf Court of Appeal disagreed with the first instance decision, holding that third-party supply should be allowed under certain conditions, namely if the supply is aimed at the privileged purposes. 17 Since the necessary interpretation of Article 10(6) of the Directive 2001/83/EC could only be provided by the CJEU, the Düsseldorf Court of Appeal referred the question on whether, and under what conditions, the supply of patent protected substances by a third party to a generic company, which intends to use the substance for obtaining a marketing authorisation, is covered by Bolar. 16) Decision of 26 July 2012 (4a O 282/10) in Astellas Pharma Inc./Polpharma S.A. Pharmaceutical Works. 17) Decision of 5 December 2013 (I-2 U 68/12) Polpharma S.A. Pharmaceutical Works/Astellas Pharma Inc.

8 8 VOL 14 ISSUE 2 BSLR : ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC Upon the referral the plaintiff withdrew its initial action and the case was terminated before the CJEU could make a preliminary ruling, and so the question remains without an answer at the European level. In fact, the issue is even more pressing given that the Polish Supreme Court recently confirmed decisions of its lower instance courts and decided that third-party supply is not covered by the Polish implementation of Bolar. Having refused to refer the case to the CJEU, this places the Polish interpretation of the exemption at odds with that of the Court of Appeal in Düsseldorf/Germany. This raises the issue of whether the amended experimental use exemption in the United Kingdom would cover such activities. Until the new provisions are tested there can be no definitive answer to this. However, the exemption for activities conducted for the purpose of a medicinal product assessment would seem to suggest that the provision covers third-party supply of patented active ingredient, provided it is for the exempted purposes, and a UK court may take a very similar approach to the Düsseldorf Court of Appeal s interpretation of its Bolar provision. Coming Full Circle: Bolar in the UPC Given the context of diverging implementations of Bolar in Europe, and the efforts of the United Kingdom to broaden the exception available under the UK Patents Act 1977 to meet those available in Germany, it is important to look ahead to the treatment that the Bolar provisions of the Directive will receive in the UPC. Bolar is in fact implemented by the Unified Patent Court Agreement ( the UPC Agreement ) as one of the limitations of the effects of a patent in Article 27(d), as follows: The acts allowed pursuant to Article 13(6) of Directive 2001/82/EC or Article 10(6) of Directive 2001/83/EC in respect of any patent covering the product within the meaning of either of those Directives. This treatment of Bolar, by reference to the Directive, is remarkably similar to that in the UK Patents Act But how will the UPC interpret it? This is far from clear at present. As regards European patents in the UPC, the court has all of the national laws of the contracting Member States to choose from. 18 As regards the law that applies to the new European patent with Unitary Effect ( Unitary Patent ), this is determined by Article 5(3) of the Unitary Patent Regulation 19 as follows: The acts against which the [Unitary] patent provides protection referred to in paragraph 1 and the applicable limitations shall be those defined by the law applied to European patents with unitary effect in the participating Member States whose national law is applicable to the European patent with unitary effect as an object of property in accordance with Article 7. The reference to national law applicable to a Unitary Patent in accordance with Article 7 is a circuitous way of referring to the UPC Agreement, meaning that the UPC again has the choice of national laws with which to interpret Article 27(d). However, the UPC then has the obvious problem of which national law to use when, as we have seen, they present different implementations of Article 10(6) of the Directive. For those countries that have implemented Bolar in a broader way than Article 27(d) allows, the national decisions are particularly unlikely to be helpful. Hence the UPC is left with little to interpret Article 27(d) without seeking assistance by referring the matter to the CJEU for a preliminary ruling. We do not know how the CJEU would rule. However, it would be surprising if the court were to interpret the exemption any more broadly than the clear and limited application that it has to activities conducted for the purpose of obtaining an abridged marketing application by generics. This would also imply that the exemption applies only to authorisations for the purpose of marketing in the European Union: a result that the United Kingdom has just made efforts to avoid. 18) Article 24(1)(e) Agreement on a Unified Patent Court ( the UPC Agreement ). 19) Regulation (EU) No 1257 / 2012 of the European Parliament and the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection.

9 ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 9 Conclusions The application and development of the experimental use exemption and then Bolar in national law has been a fairly haphazard affair. The experimental use exemption is applied differently in different courts, as exemplified by the German and UK approaches, and Bolar despite being intended to harmonise protection from patent infringement of certain work conducted in the pharmaceutical field has brought anything but a harmonised approach across Europe. The United Kingdom has only now responded to this divergence by amending its Patent Act to provide an exemption to infringement for clinical studies and related work conducted for the purpose of a wide-ranging class of medicinal product assessments. In doing so, it has consciously followed Germany as the gold standard. However, just as a large part of Europe is consolidating around such broad exemptions, the drafting of Article 27(d) UPC Agreement suggests that the interpretation of Bolar will come full circle to again be limited to the original wording in Article 10(6) of the Directive. This would apply to all European patents litigated in the UPC and all Unitary Patents. However, given that national laws will continue to apply to those European patents litigated in the national courts (either during the transitional period or because they have opted-out of the UPC), the complexity of the legal landscape on Bolar will increase. In the circumstances, a more consistent exemption might be secured across Europe if Article 10(6) of the Directive were to be broadened by amendment or if Article 27(d) UPC Agreement itself were similarly re-drafted. Alternatively, alleged infringers before the UPC who wish to seek the benefit of an exemption for conducting clinical trial activities may have to fall back on arguing that the UPC should prefer the approach of the German courts to the experimental use exemption Clinical Trials I, Clinical Trials II and Polpharma over those of contracting Member States to the UPC with narrower interpretations.