HOT TOPIC For reprint orders, please contact [email protected]

Extension of the Bolar exemption law: what will this mean for UK drug research?

Stephen Bennett*,1 & Ian Moss1

1 Hogan Lovells International LLP, Atlantic House, Holborn Viaduct, London, EC1A 2FG *Author for correspondence: [email protected]

The Bolar Exemption The term ‘Bolar Exemption’ refers to a variety of national and supranational laws in force across the world aimed at exempting from patent infringement studies and trials seeking regulatory approval for generic medicines. The first ‘Bolar’ Exemption was introduced in 1984 in the USA by the ‘Hatch–Waxman’ Act [1] . Hatch–Waxman overturned the Court of Appeals for the Federal Circuit’s judgment in Roche Products v Bolar Pharmaceutical [2] , which found that Bolar’s use of a patented Roche product in trials aimed at securing regulatory approval for its own generic product constituted patent infringement. The Bolar Exemption was specifically designed to address this situation by providing a safe harbor. The Bolar Exemption was introduced into European law by Article 10 of Directive 2004/27/EC (amending Directive 2001/83/EC) (Article 10) and subsequently transposed into the national law of the EU member states. The language of Article 10(6) exempts from patent infringement “conducting the necessary studies and trials with a view to paragraphs 1 to 4 (concerning marketing approval of generic medicinal products and biosimilars via the abridged procedure) and the consequential practical requirements.” The aim of Article 10 was to harmonize the law across the European Union and encourage the development of the generic medicines industry. In practice, the Directive established a minimum requirement but

10.4155/PPA.15.5 © 2015 Future Science Ltd

Pharm. Pat. Anal. (2015) 4(3), 123–125

harmonization has proved elusive. Instead, member states have fallen into two groups with divergent approaches to implementation. The first group, which includes Ireland and the Netherlands, implemented the Bolar Exemption narrowly, in line with Article 10’s language. Thus, only trials of medicines carried out in relation to European regulatory approvals for generic medicines and biosimilars were covered. The second group, the majority including Germany, France and Italy, implemented a wider Bolar Exemption extending to trials of innovative as well as generic medicines carried out for the purpose of seeking regulatory approval anywhere in the world. Bolar in the UK The UK’s Bolar Exemption was originally set out in s.60(5)(i) Patents Act 1977 which states that an act is not patent infringement if “it consists of (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 4 of article 10…or (ii) any other act which is required for the purpose of the application of those paragraphs.” The corresponding German provision by contrast states that “the effects of the patent shall not extend to studies and trials and the resulting practical requirements necessary for obtaining a marketing authorization 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

ISSN 2046-8954

123

Hot Topic  Bennett & Moss or in third countries” and therefore covers innovative products and trials worldwide. Concerns that the UK’s implementation of the Bolar Exemption was damaging the UK’s viability as a base for pharmaceutical research led to several Government consultations, resulting in a 2013 Impact Assessment [3] . According to the Impact Assessment, consultation respondents reported that the uncertainty and narrow nature of the UK provisions resulted in additional costs of up to GB £135,000 per study for work such as freedom to operate searches or the even greater expense of full patent revocation actions. The narrow UK implementation coincided with an observed reduction in the UK’s leading position as a site for clinical trials between 2002 and 2007; states with wide Bolar Exemptions (including France, Denmark and Germany) saw more significant increases in the number of clinical trials carried out than the UK (especially Germany where trials numbers rose tenfold) [4] . The UK Government has now sought to improve matters via the Legislative Reform (Patents) Order 2014 which came into force on 1 October 2014. The Order inserts new sections 60(6D) – (6G) into the Patents Act 1977 which add to the existing s.60(5)(i) provision. The new extended Bolar Exemption works by reference back to the so called ‘experimental use’ exception already present in the Patents Act and defines as experimental (and therefore noninfringing) use “anything done in or for the purposes of a medicinal product assessment.” Medicinal product assessments include “any testing, course of testing or other activity undertaken with a view to providing data for” obtaining regulatory authorizations for a ‘medicinal product’ (which includes innovative as well as generic medicines), complying with regulatory requirements in relation to those authorizations and enabling a government or public authority to assess the medicinal product’s suitability for human use, in each case for the UK or anywhere else in the world. The last component of the definition makes clear that Health Impact Assessments (required for the NHS to begin using a new medicine) are within the scope of the exemption. The Intellectual Property Office has included guidance as to what it considers to fall within the new Bolar Exemption in its announcement of the new Bolar Exemption which should act as a useful guide for industry [5] . International context The changes to UK law bring it into line with the European majority. As such, the UK will not gain any advantage over its main competitors but has removed a significant disadvantage. Unsurprisingly, other states are also keen to maximize their attractiveness to the pharmaceu-

124

Pharm. Pat. Anal. (2015) 4(3)

tical industry. Ireland for example initially implemented a provision in very similar terms to the UK and is also now making changes. In Ireland’s case the new provisions refer specifically to the pre-existing Bolar Exemption provision and not the experimental use exemption as in the UK. Ireland’s new provisions exempt “acts done in conducting studies, tests, experiments and trials (including clinical trials and field trials) with a view to satisfying the application requirements for a marketing authorisation or similar instrument (howsoever described) required by the law of [Ireland] or any other state in order to sell or supply a medicinal product”. Spain is also implementing changes to its Bolar Exemption to clarify that it is separate to the experimental use exemption and to confirm its scope extends to innovative medicines. The new provisions exempt “acts conducted with experimental purposes which refer to the subject-matter of the patented invention” and “the studies and tests that are required to obtain the marketing authorization of drugs, including the preparation, production and use of the active principle for those purposes.” Remaining issues In the European Union, Bolar Exemptions must still be interpreted in line with Article 10 and a number of issues remain as concerns for industry. One such concern is the status of third party suppliers of active pharmaceutical ingredients (APIs) and whether they are able to benefit from the safe harbor. The issue was recently considered in Poland and Germany in the Astellas Pharma v Ropharma SA multijurisdiction litigation. The Polish Supreme Court [6] concluded that the Bolar Exemption should be interpreted narrowly and as such found that third party API suppliers do not benefit from the exemption unless they also carry out the relevant trials themselves. This interpretation is perhaps even more restrictive than it first appears because generics companies generally are not capable of manufacturing APIs in the quantities required for trials. By contrast, the Dusseldorf Court of Appeal chose to refer the issue to the CJEU for guidance [7] , while making clear its view that in certain circumstances third party suppliers could be protected. The Court’s reasoning included consideration of the specific legislative purpose of facilitating the generic medicines industry and suggested that contractual provisions aimed at controlling the use to which the supplied APIs are put could in certain (context dependent) circumstances be sufficient. Unfortunately the CJEU will not now consider the issue following withdrawal of the Dusseldorf proceedings. For its part, the UK IPO guidance states that “the new provisions do not extend to commercial activities such as sale, commercial supply, or manufacture in preparation for supply” but does not

future science group

Extension of the Bolar exemption law: what will this mean for UK drug research? 

address the question of supply for use in experimental trials, as such. Future developments The Unitary Patent system, currently slated to commence in 2017, may significantly impact Bolar Exemptions across Europe. Article 27(d) of the UPC Agreement incorporates the existing EU Bolar regime by direct reference to Article 10. As explained, Article 10 sets out a minimum standard that the majority of EU states have now gone beyond. Quite how the UPC will interpret this provision, in light of the current national provisions remains to be seen. The effect may be to ‘reset’ Bolar to the narrow interpretation. However, the Judges of the new UPC will be drawn from existing patent courts and may well impose a broad reading. References 1

21 U.S.C. § 355(j).

2

Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir.) (1984).

3

Experimental use and Bolar Exception, Impact Assessment No: BIS0402. www.parliament.uk

4

The Review and Refresh of Bioscience 2015: a report to government by the bioscience innovation and growth team. http://webarchive.nationalarchives.gov.uk

future science group

Hot Topic

Conclusion The new Bolar Exemption brings the UK into line with Germany and other states with wide implementations. Hopefully the result will be an improved industry perception of the UK’s attractiveness as a destination for clinical trials, complementing the existing industry and encouraging investment, growth and skill retention, as well as earlier access to new medicines for patients. Financial & competing interests disclosure The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. 5

Changes to patents legislation made by the Legislative Reform (Patents) Order 2014 from 1 October 2014, UKIPO. www.gov.uk

6

Astellas Pharma Inc. v. Polpharma SA Pharmaceutical Works., Docket Number IV CSK 92/13 (2013).

7

Astellas Pharma Inc. v. Polpharma SA Pharmaceutical Works., Case C-661/13 (2014).

www.future-science.com

125

Extension of Bolar exemption law: what will this mean for UK drug research?

Extension of Bolar exemption law: what will this mean for UK drug research? - PDF Download Free
979KB Sizes 3 Downloads 11 Views