1. 1 Bolar Provisions in Europe Robert Watson Chartered Patent Attorney European Patent Attorney AIPLA, February 2006

2. 2 Overview The EU New Pharma legislation Existing Exemption from Infringement Focus on Countries Summary

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4. 4 The EU 25 countries Population:455 million (US:293 million) GDP: $11,000 billion (~ same as US) EU accounts for 20% of exports from and imports to US

5. 5 New EU Pharma Legislation EU Directive (2004/27/EC) amends rules relating to approval of medicines Only has the force of law in member states when it is enacted in their legislation (no later than October 30, 2005)

6. 6 New EU Pharma Legislation Introduces sweeping amendments to the rules on generic products Harmonises the term of data protection for innovative medicinal products Broadens the abridged process for relying on dossier of reference products Introduces Bolar provision

7. 7 Briefly … Applicants for generic product authorisations under ‘abridged’ or ‘hybrid abridged’ procedures may rely on an dossier for a reference product once the reference product has been on the market for 8 years But, cannot be put generic on the market until 10 years

8. 8 New ‘Bolar’ Provisions Article 10(6) of the Directive reads: “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.”

9. 9 New ‘Bolar’ Provisions Article 10(1) is the ‘abridged’ procedure Article 10(3)(4) are the ‘hybrid abridged’ procedures where some extra pre-clinical and/or clinical data is required Not clear whether such extra tests are covered by exemption

10. 10 Experimental Use Old EU states infringement law derived from Community Patent Convention Article 31(b) CPC (1975) exempted: “acts done for experimental purposes relating to the subject-matter of the patented invention” Construed differently across EU

11. 11 UK Position Directive enacted in identical wording – though by Regulatory Authority to cover both ‘abridged’ and ‘hybrid’ abridged procedures Experimental Use exemption construed narrowly

12. 12 UK Position Monsanto v Stauffer (1985, Ct of Appeal) Field trials of herbicides Experimental purposes may have a commercial end in view Following can be fairly regarded as experiments: trials carried out (i) in order to discover something unknown, or (ii) to test an hypothesis, or

13. 13 UK Position (iii) to find out whether something which is known to work in specific conditions will work in different conditions, or (perhaps) (iv) to find out whether the experimenter could manufacture commercially in accordance with the patent. Trials carried out to demonstrate to a third party (e.g. a regulatory body) that a product works as its maker claims are not for experimental purposes.

14. 14 German Position Bolar provision enacted more broadly Covers all studies and trials necessary to obtain authorisations of a medicinal product in EU, or elsewhere Research exemption construed more broadly than in UK

15. 15 French Position Bolar provision enacted more broadly Covers all studies and trials necessary to obtain authorisations of a medicinal product in EU, but not elsewhere Research exemption construed more broadly than in UK

16. 16 Dutch Position Clinical Trials have been held ineligible for the research exemption unless aimed at researching a further medical indication of the patented product. As no plans to introduce a Bolar provision into patent law, the research exemption will likely now be construed to cover the necessary trials!

17. 17 Swedish Position Plans to enact Bolar provision as in the UK No established case law on research exemption, but clinical trials probably non-exempted acts

18. 18 ‘New’ EU states Hungary: Article 19(6) of 1995 Patents Act exempts “acts done for experimental purposes relating to the subject matter of the invention, including experiments and tests necessary for the registration of a medicine” Poland: Article 69 of 2000 IP Law similar in effect to above

19. 19 Summary There is now a minimum standard for exemption of work relating to generic medical approval … but a great deal of variation in the breadth of exemptions The minimum standard will only be clarified by case law

20. 20 Bolar Provisions in Europe Robert Watson robert.watson@mewburn.com Mewburn Ellis LLP York House, 23 Kingsway, London WC2B 6HP