1. Patent Law Update Trevor Cook LES Britain & Ireland Conference 25 March 2015

2. WilmerHale Patent Law Update  The New Patent Package (2016 or 2017)  Unified Patent Court …  European Patent with Unitary Effect …  Patents in the English courts in 2014 …  5 sections of the Intellectual Property Act 2014  15 Infringement: marking product with internet link  16 Opinions service  17 Unified Patent Court  18 Sharing information with overseas patent offices  19 Minor amendments to the Patents Act 1977  Coming CJEU patent attractions … 2

3. WilmerHale Unified Patent Court  Infringement and revocation proceedings of classical European “bundle” patents can be brought in either UPC or national court  For first 7 years, may be extended up to 14 years  UPC presents risk for patentees and licensees of classical European “bundle” patents:  Centralised –Revocation proceedings –Declarations of non-infringement  Patents the subject of, or that have survived, opposition, may be the most at risk of centralised revocation  Opt out from UPC available for classical European “bundle” patents if not already the subject of UPC proceedings  ‘Sunshine’ period before entry into force  Scope to opt back in  Fees for both opting out and opting in 3

4. WilmerHale European Patent with Unitary Effect  Designation as such will be available on grant for European applications pending on entry into force  Geographical scope of unitary effect will depend on how many countries have ratified at time of designation  Some Pros and Cons  Broad geographical scope  Unified Patent Court obligatory  Property right under German law, unless first named applicant is based elsewhere in the EU  Renewal fees not fixed as yet –Current proposal is for equivalent fees for top 4 or 5 countries after year 10, with transition from EPO renewal fee to then  No scope to reduce fees over time by dropping designations 4

5. WilmerHale Licensing Considerations  Proprietor lodges opt-out applications.  Agreements should provide who decides as between Licensor and Licensee whether  to seek unitary effect and  whether to opt out Classical European patents and opt back in  Priorities may be different  Exclusive licensee determines?  Unanimous decision required?  Consultation provisions?  For co-owned patents (including where ownership of different designations is split) all proprietors must apply to opt out so licences and collaboration agreements should provide mechanism for deciding 5

6. WilmerHale Licensing Considerations  National law governing unitary patent as an object of property is that of  Member State where applicant has residence or principal place of business,  or else any place of business,  otherwise German law  For joint applicants,  Order of applicants determines governing national law  National law relating to rights of patent co-owners differs subtly around the EU  Agreements should provide for order of listing or include provisions regarding disposal and exploitation  But better never to have joint applicants! 6

7. WilmerHale The last year or so in the English courts  Statistics for 2014  First instance –23 final hearings concerning 31 patents –15 infringed, 6 not, others not in issue or conceded –10 valid, 17 not, others not in issue  Appeal –7 appeals from final hearings concerning 8 patents –First instance upheld as to 5 patents –First instance on 2 patents on infringement –First instance on 1 patent on validity  Breakdown at First Instance  7 Pharma & Biotech …  6 ICT …  1 Chemical process  1 Medical device  8 Miscellaneous mechanical or electrical 7

8. WilmerHale Pharma & Biotech sector cases in 2014  Hospira v Genentech  1 dosage regime and 1 composition patent invalid  Actavis v Eli Lilly  1 salt patent not infringed  Generics (UK) v Gedeon Richter  1 dosage regime patent invalid  Teva v AstraZeneca  1 medical use of combination patent invalid  Teva v Leo  2 medical use of combination patents invalid  Hospira v Genentech  2 formulation patents invalid  Idenix Pharmaceutical v Gilead Sciences  NCE patent invalid 8

9. WilmerHale ICT sector cases in 2014  Starsight Telecast v Virgin Media  2 invalid  Rovi Solutions v Virgin Media  1 invalid  Koninklijke Philips Electronics v Nintendo of Europe  2 valid and infringed, 1 invalid  Rovi Solutions v Virgin Media  1 invalid  Vringo Infrastructure v ZTE (UK)  1 valid and infringed  Adaptive Spectrum and Signal Alignment v British Telecommunications  1 infringed 9

10. WilmerHale The last year or so in the English courts  Construction  Product by process claims –Hospira UK v Genentech  Infringement  The return of the Improver test? –Actavis v Eli Lilly  When can ‘skinny labelled’ pharmaceuticals infringe medical use patents to the excluded use? –Warner Lambert v Actavis  Validity  Assignments of priority –Idenix Pharmaceutical v Gilead Sciences  Lack of inventive step and insufficiency –Idenix Pharmaceutical v Gilead Sciences 10

11. WilmerHale The last year or so in the English courts  Procedural Issues  Pan European declaration of non-infringement –Where validity not in issue – Actavis v Eli Lilly  Infringement may be appropriate for summary judgment –Nampack Plastics Europe v Alpla UK  Can one reopen a case after judgment? –Vringo Infrastructure v ZTE(UK)  Staying English revocation proceedings pending the outcome of an EPO Opposition –Actavis v Pharmacia  Identifying the skilled addressee early in IPEC –Environmental Defence Systems v Synergy Health 11

12. WilmerHale Actavis v Lilly [2014] EWHC 1511 (15 May 2014)  English court assumes jurisdiction for Declarations of Non-infringement in relation to France, Italy and Spain  Where there is no challenge in any of those jurisdictions to validity  Where jurisdiction over the patentee has been established  English court must therefore, under Brussels I Regulation, consider infringement not only under English law but also under that of France, Italy and Spain  But locus to bring DNI proceedings is a matter of English law under Rome II Regulation as it is procedural  Provides interesting comparative law insight into issues of –Equivalents –“File Wrapper Estoppel” (or at least using the file wrapper as an aid to construction) 12

13. WilmerHale Actavis v Lilly [2014] EWHC 1511 (15 May 2014)  Claims 1, 2, 12 of EP 0 432 677 B  1) Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof …  2) Use according to claim 1 wherein said medicament is administered in combination with vitamin B12 or a pharmaceutical derivative thereof … and a folic binding protein binding agent …  12) A product containing pemetrexed disodium, vitamin B12 or a pharmaceutical derivative thereof … and, optionally, a folic binding protein binding agent …  Where claims as initially filed had not referred to “pemetrexed disodium” but to “an antifolate” and then to “pemetrexed”  Issue: Does a medicine containing pemetrexed diacid, pemetrexed dipotassium or pemetrexed dinitromethane infringe any claim? 13

14. WilmerHale Actavis v Lilly [2014] EWHC 1511 (15 May 2014)  “Improver” questions for the UK  Improver Question 1 –ie, does it work in the same way? –Yes (conceded by Actavis)  Improver Question 2 –ie, is it obvious to skilled person that it works in the same way? –No  Improver Question 3 (Obiter) –ie, would skilled person consider that patentee intended that strict compliance with the primary meaning was essential? –Yes –Taking into account, inter alia, the prosecution history as an aid to construction 14

15. WilmerHale Coming CJEU Patent Attractions  C-170/13 - Huawei Technologies Co. Ltd v ZTE Corp., ZTE Deutschland GmbH  Article 102 TFEU and standards essential patents  Advocate General’s opinion delivered  C-567/14 - Genentech Inc. v Hoechst GmbH, formerly Hoechst AG, Sanofi-Aventis Deutschland GmbH  “Must the provisions of Article 101 TFEU be interpreted as precluding effect being given, where patents are revoked, to a licence agreement which requires the licensee to pay royalties for the sole use of the rights attached to the licensed patent?”  Pending reference from Dusseldorf OLG as to Article 13 of Directive 2004/48/EC (damages and licence fee uplifts)  Pending reference from Antwerp Court of Appeal as to Article 14 of Directive 2004/48/EC (costs shifting ceilings) 15

16. WilmerHale Thank you  Trevor Cook (Legal Consultant, New York; Solicitor, England and Wales), is a partner in the Litigation/Controversy Department and a member of the Intellectual Property Litigation Practice at WilmerHale.  Mr. Cook has more than 35 years of experience in global patent litigation, particularly in Europe and Asia. He has acted in many of the leading patent infringement cases that have come before the English courts, most of which have concerned pharmaceuticals and biotechnology, and also in many of the leading cases regarding data exclusivity.  He joined WilmerHale in their New York office at the start of 2014 from Bird & Bird LLP in London.  trevor.cook@wilmerhale.com trevor.cook@wilmerhale.com