Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

In this edition we cover landmark judgments from the UK and German Supreme Courts, on sufficiency in the UK and FRAND obligations in Germany. We also cover a significant decision of the CJEU in relation to SPCs in the Santen case, as well as a decision concerning the provision of sample medicine to pharmacists and the Advocate General’s Opinion regarding an appeal from a fine imposed for anticompetitive agreements and we report on an important decision of the European Patent Office regarding the patentability of plant and animal products. This edition also includes our analysis of a number of noteworthy UK High Court and Court of Appeal decisions on issues including injunctions, attempted strike-out of an infringement claim and the law on obviousness. Finally, we report on UK’s formal withdrawal from the Unified Patent Court Agreement.

1. UK Supreme Court in Regeneron v Kymab: technical contribution critical to determining sufficiency

We cover the recent UK Supreme Court decision addressing the requirements for patent sufficiency under UK law.

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2. The CJEU’s decision in Santen

We update on the CJEU’s decision in Santen concerning the interpretation of Articles 1(b) and 3(d) of the SPC regulation. In this decision the CJEU considered the definition of ‘product’ under Article 1(b) and what constitutes a ‘first authorisation’ under Article 3(d).

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3. German Federal Court of Justice provides reasons for Judgement in the Sisvel v Haier case

We consider key guidance issued by the German Supreme Court on the requirements for a patentee to be awarded an injunction in relation to a standard essential patent. In particular, the burden placed on the implementer to declare its willingness to accept a FRAND licence, failing which an injunction can be awarded.

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4. Advocate General Kokott’s Opinion in Lundbeck v Commission

The Advocate General has proposed that the European Commission’s fine on Lundbeck for anticompetitive agreements aimed at delaying the marketing of generic versions of citalopram be upheld. We provide our analysis of the key points in that Opinion.

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5. Pepper trumps Broccoli: EPO finds products produced by essentially biological processes are not patentable

Responding to a question referred to it by the European Patent Office’s President, the Enlarged Board of Appeal of the European Patent Office has held that plants and animal products produced by essentially biological (natural) processes are not patentable. We set out the key points to take from that decision.

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6. CJEU rules that providing free samples of non-prescription drugs to pharmacists is permitted

We cover a recent decision of the CJEU in which it held that free samples of non-prescription drugs may be supplied by pharmaceutical companies to pharmacists.

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7. Recent injunction decisions in the courts of England & Wales

We cover the recent first instance and subsequent appeal decision in the Neurim case in which the Court refused to grant an interim injunction for a pharmaceutical patent. We also cover the Evalve v Edwards case in which the Court considered whether to grant a stay of a final injunction.

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8. Unsuccessful strike-out of a quia timet infringement counterclaim

We provide our analysis of the Teva v Chiesi Pharmaceutici case in which the Court refused to strike-out a counterclaim for infringement and rejected competition law and abuse of process arguments advanced by Teva.

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9. Obvious in light of the obscure – UK Court of Appeal upholds High Court’s findings on obviousness over “paper proposal” prior art

In a split decision, the Court of Appeal refused to overturn a finding of obviousness over an obscure US patent application from a different field. We consider the UK courts’ approach to obviousness through Arnold LJ’s leading judgment and Floyd LJ’s dissenting opinion.

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10. UK’s exit from the UPC now final

We report on the UK’s official withdrawal of its ratification of the Unified Patent Court Agreement.

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11. Table of recent patent decisions relating to validity and/or infringement

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12. Table of other recent decisions

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Jonathan Turnbull

Jonathan Turnbull
Partner, London
+44 20 7466 2174

David Webb

David Webb
Associate, London
+44 20 7466 2629

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

Monika Klajn

Monika Klajn
Senior Associate, London
+44 20 7466 7604