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

The Supreme Court has handed down today its judgment in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, allowing Kymab’s appeal and holding Regeneron’s patents invalid for insufficiency by a majority of 4:1.

The judgment emphasises the fundamental principle of the patent bargain, which envisages that the patentee makes full disclosure of the invention in return for a time-limited monopoly. Sufficiency is, amongst other tools like novelty, inventive step and industrial application, one of the ways to ensure such patent bargain is struck in the right place, such that the protection afforded by the claim is commensurate with the technical contribution to the art made by the disclosure of the invention in the patent. Whilst the Lords and Lady of the Supreme Court were of the view that their judgment does not change the existing, fundamental legal principles of sufficiency contained in the well-established authorities in the UK and of the Technical Board of Appeal of the European Patent Office, this case illustrates the importance of, and difficulty in, identifying a patent’s technical contribution and the significant consequences which follow. Continue reading

Supreme Court hears Kymab’s appeal against the sufficiency findings of the Court of Appeal

On 11 and 12 February the UK Supreme Court heard the appeal brought by Kymab against the judgment of the Court of Appeal which  found Regeneron’s European Patents (UK) No 1 360 287 and its divisional EP (UK) No 2 264 163 valid and infringed, reversing the invalidity finding of the first instance court (see our analysis of the first instance judgment here). The Supreme Court hearing can be viewed here.

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Patent and Pharma Update, February 2020

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

In this issue we report on the Supreme Court decision of Shanks v Unilever on employee inventor compensation. We update on two CJEU decisions relation to public access to documents submitted to the EMA and a key competition decision on “pay-for-delay” agreements. We cover a string of patent-related UK Court of Appeal cases, including Ablynx v VHSquared on jurisdiction, Anan Kasei v Neo on insufficiency and joint tortfeasorship and L’Oreal v Liqwd on claim amendments and admission of late evidence. We provide brief updates from the EPO on the recent CRISPR priority decision, as well as its AI inventorship decision. We have bumper SPC and FRAND updates covering key Court of Appeal and CJEU decisions in respect of SPCs and a string of interesting interim decisions in the UK in the case of FRAND. We round off the issue with a link to our new IP podcast series and updates on Brexit and the UPC. Continue reading

Patent and Pharma Update – December 2018

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

This issue reports on several ground-breaking decisions from the UK courts on second medical use patents and skinny labels, infringement by equivalents and the possibility of global FRAND licences for standard essential patents (SEPs).  We also look at some significant decisions from the CJEU on SPCs and reimbursements in relation to medicinal products and a few developments at the European Patent Office. Finally, we provide our usual round-up of the latest UPC developments (this time from Italy) and Brexit-related developments relevant to the pharma sector. Continue reading

UK SUPREME COURT RAISES SUFFICIENCY STANDARD FOR SWISS-FORM CLAIMS AND LIMITS THE ABILITY TO ASSERT THEM AGAINST “SKINNY LABEL” PRODUCTS

Commercial impact

Yesterday’s Supreme Court decision in Warner-Lambert v Mylan is disappointing news for patentees who may have made significant investment in R&D to develop new uses for known medicines. The full judgment and press release can be found here.

The Supreme Court recognised the value of such second (and further) medical uses and the importance of their patent protection so as to reward and incentivise the patentee. In spite of this, the Supreme Court:

  1. raised the standard of sufficiency of disclosure, with the result that existing Swiss-form claims may be more vulnerable to attack and future medical use claims may be more difficult to obtain; and
  2. limited the protective effect of Swiss-form claims.

Whilst its decision concerns Swiss-form claims, the Supreme Court recognised that although EPC 2000 claims (which have superseded Swiss-form claims) may be drafted differently, they give rise to similar difficulties as those discussed in the decision. As a consequence, yesterday’s decision will have long-felt ramifications for patentees both in terms of litigation and prosecution strategy, as well as being influential in the courts of other jurisdictions.

Comment

The Supreme Court has adopted a higher standard for the assessment of the plausibility of Swiss-form claims than previously used. In doing so, the Supreme Court appears to increase the amount of information required to be disclosed in a patent’s description as well as the specificity required in claims where there are sub-categories of related indications. This may narrow the window that innovative companies have to file patent applications in advance of clinical trials and may necessitate the need for additional dependent claims covering the separate, related indications rather than relying on a category claim. The decision was by a majority view (Lord Sumption, Lord Reed and Lord Briggs).

Although obiter, the Supreme Court prefers an approach to the infringement of Swiss-form claims (which are purpose-limited process claims) in which:

  1. the ability to assert indirect infringement ends at the manufacturer’s gate; and
  2. an objective approach is taken to direct infringement by the sale of the product of the infringing process (under section 60(1)(c) of the Patents Act 1977). Under this objective approach, “skinny labels” carving out the patented indication will often be effective in avoiding infringement.

This approach to direct infringement appears to have taken its lead from the approach in Germany. However, as highlighted by Lord Briggs, the Supreme Court was not provided with any information about the particular features of the German system for prescribing and dispensing medicines or about the market conditions within which a fair balance has to be struck, all of which could have a significant impact on this balance. This would particularly be the case if, for instance, it was not possible to obtain reimbursement in Germany for the off-label prescription, but reimbursement was possible in the UK.

On the facts of the case before it, the Supreme Court held that the claims of Warner-Lambert’s patent relating to neuropathic pain were invalid for insufficiency in their entirety, and that there would have been no infringement by Actavis had the claims been held to be valid.

Contacts

Jonathan Turnbull
Jonathan Turnbull
Partner
+44 20 7466 2174
Alex Freelove
Alex Freelove
Senior Associate
+44 20 7466 7452

Supreme Court considers the role of plausibility in UK patent law

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.

Authors

Andrew Wells
Andrew Wells
Senior Associate
+44 20 7466 2929

Trunki’s claim over Kiddee Case design fails to appeal to Supreme Court

The UK Supreme Court today handed down its first decision on design rights, in the Trunki case (PMS International (Respondent) v Magmatic (Appellant) [2016] UKSC 12). The Supreme Court upheld the decision of the Court of Appeal to the effect that there was no infringement of the Community registered design for Magamatic's Trunki suitcase by PMS's "Kiddee" suitcase, which copied the idea but not the design as registered.

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