The UK Supreme Court has handed down its judgment in the Warner-Lambert v Generics (UK) (Mylan) case concerning the validity and infringement of a patent claiming the use of pregabalin for the treatment of neuropathic pain: the patent is held invalid. If the patent had been valid it would not have been infringed.
The key issues the Court had to resolve were the tests for infringement of a second medical use claim and the test for plausibility of a claim such that it is sufficient:
- On infringement of second medical use claims, Lords Hodge and Briggs consider it necessary to show the intention of the manufacturer to infringe, Lords Sumption and Reed consider that the intention of the infringer is irrelevant and that the sole criteria of infringement is whether the product as it emerges from the manufacturing process, including any labelling or accompanying leaflet, is presented as suitable for the uses which enjoy patent protection. Lord Mance followed the latter view, with some qualifications. According to both tests, Lecaent did not infringe the patent.
- On plausibility Lord Sumption (giving the leading majority judgment) states that "the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. Plausibility is not a distinct condition of validity with a life of its own, but a standard against which that must be demonstrated. Its adoption is a mitigation of the principle in favour of patentability. It reflects the practical difficulty of demonstrating therapeutic efficacy to any higher standard at the stage when the patent application must in practice be made. The test is relatively undemanding." Lords Hodge and Mance, dissenting, thought the standard was lower and were in agreement with the lower courts. On the facts, the Court upheld the lower courts' decision that the patent did not plausibly support the treatment of central neuropathic pain and, by majority, that it also did not plausibly support peripheral neuropathic pain, therefore allowing Mylan and Actavis's cross-appeal.
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