1. meyerlustenberger Rechtsanwälte − Attorneys at Lawwww.meyerlustenberger.ch European Patent Law and Litigation Guest Lecture, Health and Intellectual Property Law in a Global Environment 4 August 2010 | Geneva | Mark Schweizer

2. European Patent Law and Litigation2 Overview 1.Briefest introduction to the European Patent Convention (EPC) 2.Patentable subject matter: second and further medical use, or Swiss type claims no more 3.Litigation in Europe: of Italian torpedos, the spider in the web, and what‘s left of them 4.Outlook: European and European Union Patents Court (EEUPC)

3. European Patent Law and Litigation3 European Patent Convention Centralized grant, decentralized enforcement

4. European Patent Law and Litigation4 European Patent Convention

5. European Patent Law and Litigation5 European Patent Convention 1.Filing with the European Patent Office (EPO) 2.Examination at EPO and grant if the application complies with the European Patent Convention, namely »Patentable subject matter (veery basically: technology) »Industrial application, novelty, and inventiveness 3.But: after grant, independent right in each jurisdiction 4.Even during opposition before EPO

6. European Patent Law and Litigation6 European Patent Convention: Opposition

7. European Patent Law and Litigation7 European Patent Convention: Validation Validation in each jurisdiction where protection is sought, namely by »filing of a translation into the official language of that state »paying of patent annuities for that state

8. European Patent Law and Litigation8 European Patent Convention: Cost

9. European Patent Law and Litigation9 European Patent Convention: London Agreement

10. European Patent Law and Litigation10 European Patent Convention: Summary „European“ Patent is a bundle of national patents: centrally examined and granted, but after grant and validation, each national part of the European Patent (EP) is independent »national courts are competent to decide on validity and infringement »one national part may be annulled, another part (of the same EP) may be upheld

11. European Patent Law and Litigation11 Patentable Subject Matter Any technology – but what is technology?

12. European Patent Law and Litigation12 Patentable Subject Matter: Methods of treatment any invention, in all fields of technology Methods for treatment of the human […] body by […] therapy […] shall not be regarded as inventions which are susceptible of industrial application […]. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

13. European Patent Law and Litigation13 Patentable Subject Matter: Methods of treatment

14. European Patent Law and Litigation14 Novelty of first medical use The fact that a substance as such is known (not novel, part of the state of the art) does not exclude that its use in a method of treatment can be patented, provided that its use for this method is not comprised in the state of the art

15. European Patent Law and Litigation15 Patentable Subject Matter: Second medical use „Substance X for the treatment of disease y“ „Use of substance X for the manufacture of a medicament for the treatment of disease y“

16. European Patent Law and Litigation16 Patentable Subject Matter: Second medical use Expansion of „new use“ by case law to »use of known substance for treatment of known disease in new subjects; »use of known substance for treatment of known disease with new way of administration; »use of known substance for treatment of known disease with new dosage regime?

17. European Patent Law and Litigation17 Novelty of further medical use: „Dosage regime“ „Use of nicotinic acid […] for the manufacture of a sustained release medicament for use in the treatment by oral adminstration once per day prior to sleep, of hyperlipidemia, […]“

18. European Patent Law and Litigation18 Novelty of further medical use: „Dosage regime“ The fact that a substance is known for (at least one) medical use does not exclude the patentability of this substance for any specific use in a method of treatment, provided that such use is not comprised in the state of the art. Art. 54(5) EPC 2000

19. European Patent Law and Litigation19 Novelty of further medical use: Conclusion EPC 2000 allows „use type claims“ for further medical uses of substances with known therapeutic effects, such uses are not restricted to the treatment of a different disease »Swiss-type claims no longer required (and no longer permitted)

20. European Patent Law and Litigation20 Patentable subject matter: methods of treatment?

21. European Patent Law and Litigation21 Cross-border litigation or rather: same dispute, different courts, sometimes different outcomes

22. European Patent Law and Litigation22 Cross-border litigation: Brussels Regime 1.Persons should be sued at their domicile (art. 2(1) Brussels I Regulation) 2.A person may be sued in matters relating to tort, delict or quasi- delict, in the courts for the place where the harmful event occurred or may occur (art. 5(3) Brussels I Regulation) 3.If a person is one of a number of defendants, he may be sued in the courts for the place where any one of them is domiciled, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings (art. 6(1) Brussels I Regulation) 4.However, in proceedings concerned with the registration or validity of patents the courts of the Member State in which the registration has been applied for have exclusive jurisdiction (art. 22(4) Brussels I Regulation)

23. Cross-border litigation: practicalities European Patent Law and Litigation23

24. Cross-border litigation: the torpedo Where proceedings involving the same cause of action and between the same parties are brought in the courts of different Member States, any court other than the court first seised shall of its own motion stay its proceedings until such time as the jurisdiction of the court first seised is established (art. 27(1) Brussels I Regulation) European Patent Law and Litigation24

25. Cross-border litigation: the torpedo European Patent Law and Litigation25

26. Cross-border litigation: GAT v. LuK (C-4/03) European Patent Law and Litigation26

27. Cross-border litigation: Roche v. Primus (C-593/03) European Patent Law and Litigation27

28. Litigation in the pharma sector: some figures European Patent Law and Litigation28

29. Litigation in the pharma sector: some figures European Patent Law and Litigation29

30. Litigation in the pharma sector: some figures European Patent Law and Litigation30

31. Litigation in the pharma sector: some figures European Patent Law and Litigation31

32. European Patent Law and Litigation32 European and EU Patents Court (EEUPC) the way forward?

33. European and EU Patents Court (EEUPC) European Patent Law and Litigation33 One court (with several first instance divisions) with exclusive jurisdiction in respect of civil litigation related to the infringement and validity of EU patents and European patents

34. European Union (EU) Patent European Patent Law and Litigation34

35. European and EU Patents Court (EEUPC) European Patent Law and Litigation35

36. European Patent Law and Litigation36 Thank you for your attention. Questions? Mark Schweizer m.schweizer@meyerlustenberger.ch meyerlustenberger Forchstrasse 452 Postfach 1432 8032 Zürich www.meyerlustenberger.ch