Patent Law Update

Trevor Cook

LES Britain & Ireland Conference

25 March 2015

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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 …

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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

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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

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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

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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!

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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

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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

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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

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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

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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

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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)

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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?

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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

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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)

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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