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Warner-Lambert Company LLC v (1) Generics (UK) Limited (trading as Mylan), (2) Actavis Group PTC EHF, (3) Actavis UK Limited and (4) Caduceus Pharma Limited, England and Wales Court of Appeal (Floyd, Pattern and Kitchin LJJ), London UK, 13 October 2016, Neutral Citation Number: [2016] EWCA Civ 1006

The Court of Appeal dismissed Warner-Lambert’s appeal against the decision of Arnold J that: (i) certain claims of European patent (UK) 0 934 061 (the “Patent”) were invalid for insufficiency; and (ii) that Warner-Lambert’s application to amend claim 3 after the first instance judgment on invalidity had been handed down, was an abuse of process.  The Court also considered (obiter) whether Arnold J’s finding of non-infringement of Swiss-form claims was correct.

The pertinent claims of the Patent related to the use of pregabalin for the treatment of “pain” (claim 1) and “neuropathic pain” (claim 3).  The key issues on sufficiency were: (i) how those terms should be construed; and (ii) whether the data in the Patent made treatment of those conditions plausible.

Warner-Lambert sought to have the construction of claim 1 limited to pain having a central sensitisation component, and claim 3 limited to exclude central neuropathic pain.  The Judge dismissed these constructions, instead upholding Arnold J’s construction that “pain” would have been given its ordinary, broad meaning, and “neuropathic pain” would include both central and peripheral neuropathic pain.

On plausibility, Floyd LJ confirmed that the test is a “low, threshold test”, designed to prohibit speculative claiming.  A patent which predicts that an invention will work based only on the slimmest of evidence may still be plausible, similarly a patent which includes a reasonably credible theory as to why the invention will or might work, or where the data in a patent encourages the reader to try the invention, will not be speculative.

Floyd LJ held that, in accordance with the skilled person’s common general knowledge, neuropathic pain can be fairly divided into central and peripheral neuropathic pain. As such, whilst there may be cases in which an insufficiency attack focuses on a contrived or artificial part of the claim, such that the attack does not undermine the validity, this case is far from such an example. Whilst the data in the Patent may have encouraged the skilled person to test the effectiveness of pregabalin in the treatment of peripheral neuropathic pain (rendering that invention plausible), the same was not true of central neuropathic pain, and therefore not of neuropathic pain as a whole.  As such, both claims were insufficient.

In his judgment at first instance, Arnold J suggested that had claim 3 been limited to peripheral neuropathic pain it would have been inventive and sufficient.  In an application made following the judgment, Warner-Lambert sought to amend its Patent to include a claim limited to peripheral neuropathic pain, but this was refused by Arnold J as an abuse of process, following a line of authority that a patentee should not be permitted to have a second bite at the cherry.

Floyd LJ agreed  with Arnold J on this issue, holding that Warner-Lambert should have raised the issue no later than the first day of trial so that the trial Judge could case manage the issue.  It was too late to wait until the decision and then seek to amend.

Of particular interest are Floyd LJ’s comments on infringement.  As the Patent was held invalid, his comments are strictly obiter, but are likely to be followed in any subsequent UK proceedings.

In relation to the construction of Swiss-type claims, Floyd LJ confirmed that the appropriate interpretation of the word “for” is the objective one that he previously formulated during the preliminary injunction appeal relating to the same Patent, namely that, “the skilled person was using the word “for” in the claim to require that that the manufacturer knows (and for this purpose constructive knowledge is enough) or can reasonably foresee the ultimate intentional use for pain”.  On direct infringement, Floyd LJ went on to note that some acts will be sufficient to “negative” that intention.  Specifically, he suggested that whilst carving out alone would not be sufficient to avoid infringement, “where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring” the manufacturer may not be liable.  Of course, the question remains what “all reasonable steps” may comprise.

Floyd LJ also stated that for indirect infringement, the process of the invention could be put into effect by the subsequent ascription of purpose by, for example, a pharmacist.  Floyd LJ was careful to note that this is not to be translated into a requirement for a “downstream act of manufacture”, but that what is required is that means are provided which are for putting the invention into effect.  The invention could be put into effect by the acts of a pharmacist writing an express statement on a label (as in this case), or alternatively, could include the pharmacist preparing the composition for administration, but in both cases, only if done with the necessary intention.  He made it clear that these are not limiting examples.

In conclusion, the Court of Appeal agreed with the findings of Arnold J on validity and dismissed the appeal, but also provided useful commentary on the direct and indirect infringement of Swiss-form claims

A copy of the judgment can be found here.

Headnote by Claire Phipps-Jones, Bristows LLP