The Court of Appeal handed down a judgment in Mexichem UK Ltd v Honeywell International Inc  EWCA Civ 473 upholding the decision of Hacon J refusing to strike out Arrow declarations in a claim relating to a revocation of a number of Honeywell’s patents. The decision confirms that there is no threshold or level of particularity at which an Arrow declaration ought to be formulated. The Court also recognised that, although the question of obviousness cannot be sliced up into a number of individual steps, there may be instances where such step-by-step analysis was appropriate, following the Supreme Court judgment in Actavis v ICOS. Continue reading
This week the Supreme Court is hearing an appeal in Warner-Lambert v Generics (UK) Ltd (Mylan) and others (UKSC 2016/0197) which will consider the following questions relating to the role of plausibility in UK patent law:
- “Whether (and what) role plausibility should play in the statutory test for sufficiency, and whether a patent should be held insufficient for lack of plausibility even though it is in fact enabled across the full scope of the claim.”
- “If a plausibility test is appropriate, provided there is basis to support the claim across part of its scope, whether later evidence can be used to fill the gap.”
“Plausibility” has been an increasingly hot topic in patent litigation in recent years, particularly in cases relating to pharmaceuticals, and its rise has not been without controversy amongst patent lawyers. It has most frequently been associated with inventive step and insufficiency, but it has also come up in relation to industrial applicability, priority and novelty and it is now a firmly established concept for any lawyer considering the validity of a patent.
What is required for something to be “made plausible” has been considered by the Supreme Court before (HGS v Lilly (2011), in which it was found to be a low, threshold test) but that was in the context of industrial applicability. This appeal to the Supreme Court asks the fundamental question of whether (and what) role plausibility should play in the statutory test for sufficiency. The Court of Appeal has accepted that plausibility plays a role in sufficiency (and inventive step), based on EPO Technical Board of Appeal case law relating to both inventive step and insufficiency, combining it with English law relating to principles of general application. It will be particularly interesting to see how the Supreme Court approaches this question, given the firmly established case law in the EPO on this issue.
Fundamentally, this is a question about what is required of a patentee at the time they file a patent application – is it enough for them to speculate in the specification on a possible use for the claimed compounds, in the hope that that speculation will later turn out in fact to be true (if it is not, the claim will be insufficient anyway), or should public policy require that the patentee at least provides some real reason for believing that the proposed use is true at the time of filing, to prevent patentees from excluding others from large areas of research in the hope that active compounds turn up one day? The answer to that question has potentially significant ramifications for patentees, both in terms of what they need to be including in future patent applications by way of reasoning and/or data (which may affect the stage of the R&D process at which they are able to file them) and in considering the validity of their existing patents. It is interesting that the UK BioIndustry Association has intervened in the case – more details on their position can be found here.
It’s worth noting that as well as the plausibility questions being considered, the Supreme Court will also hear argument on questions regarding expert evidence on claim construction and abuse of process in relation to late claim amendments, the answers to which may have effects on routine practice in the Patents Court.
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.
1. 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 Read more
2. 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 Read more
3. 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 Read more
4. 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 Read more
5. 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) Read more
6. 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 Read more
7. 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 Read more
8. 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 Read more
9. UPC Update
This article provides an update on the progress of ratification of the UPCA in the UK and Germany Read more
See our previous Patent and Pharma Updates on our IP Blog here:
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.