Key recent developments in the United Kingdom and Europe relating to the patents and pharmaceutical sector. One of the most significant developments in the patent law arena in recent years has been the decision of the Supreme Court in Actavis v Eli Lilly, which has changed the approach to patent infringement in the UK. The update starts by commenting on the new rules of infringement and looks at how subsequent decisions may apply this new test. The case will impact most pharmaceutical sector players, whether they are originators or generics, and may impact the strategy that patentees adopt when litigating in the UK. The update further reports on other significant developments in UK and European law, including a recent TBA decision which elevates the threshold for plausibility and recent references to the CJEU on the SPC Regulation.
Our regular patent and pharma update aims to keep you informed of recent developments in United Kingdom and European law relating to patents and the pharmaceutical industry.
A summary of the key themes are below.
A new UK approach to infringement: equivalents infringe a patent, but do not anticipate it?
The UK Supreme Court has redefined the UK approach to patent infringement, holding that the scope of protection of a patent extends to "equivalents" of the claimed invention. However, the Patents Court has since held that such equivalents, even if they pre-date the patent, do not anticipate it
Plausibility before the EPO and reliance on post-published evidence
BMS has filed a petition for review to the Enlarged Board of Appeal regarding the TBA's decision to revoke BMS's patent for the anti-cancer drug dasatinib. The Board's decision to revoke the patent suggests that the threshold for plausibility has been elevated, at least in the context of an inventive step
Further References to the CJEU on Supplementary Protection Certificates ("SPCs")
The German Federal Patent Court has referred two further issues to the CJEU regarding the interpretation of Article 2 and 3(a) of the SPC Regulation. In relation to Article 2 the Court has asked whether an SPC can be obtained for drug device combination products and, if so, in what circumstances. With regards to Article 3(a) the Court has added further detail to the questions asked by Arnold J in Teva v Gilead
New Unjustified Threats Regime in force from 1 October 2017 – encompassing unitary patents and European patents under UPC jurisdiction
The new Unjustified Threats Regime has recently come into force. This Regime is an attempt to encourage more pre-action communication by providing greater clarity on what amounts to an actionable threat
Further information ordered to be provided in an enquiry as to damages under a cross-undertaking
Birss J has provided guidance on pleadings for damages under a cross-undertaking. The High Court found the Points of Claim were fundamentally lacking critical information and Sandoz was ordered to provide further information on their substantial £100 million claim for damages, including profit margins on each type of product and profit flows between the relevant Sandoz group companies (under agreed confidentiality terms)
UK court strikes out a claim for loss suffered as a result of the tort of unlawful deceit
The High Court has struck out the NHS's claim for damages based on the tort of causing loss by unlawful means regarding misrepresentations on novelty/obviousness. Roth J's interim decision represents the latest instalment in the fall-out from Servier's actions concerning delayed entry of perindopril, and suggests that this tort should be confined within a narrow ambit
Judicial consideration of a collaboration agreement in Astex Therapeutics Limited v AstraZeneca AB  EWHC 1442 (Ch), ("Astex")
Arnold J's judgment in Astex provides insight into how the Courts will approach the interpretation of a research and collaboration agreement. Arnold J also commented on the amount of witness evidence that was put before him concerning events that had occurred between 10 to 15 years ago
Developments in Europe
A brief overview of the developments in the European arena in the past months, including an EU Commission consultation on SPCs, the new approach adopted by EPO to patentability of products obtained by essentially biological processes and how HSF can help you to successfully navigate the new data protection laws
This article provides an update on the progress of ratification of the UPCA in the UK and Germany