EPLAW PATENT BLOG

UK – Idenix v. Gilead

Posted: January 5th, 2015

Idenix Phamaceuticals, Inc v Gilead Sciences, Inc and Gilead Sciences Ltd and Centre National de la Recherche Scientifique and Universita Degli Studi de Cagliari and L’Universite Montpellier II, Patents Court, Neutral Citation Number: [2014] EWHC 3916 (Pat)

The UK Patents Court has held, in a judgment handed down on 1 December 2014, that European Patent (UK) No. 1 523 489, which concerned certain compounds for the treatment of Flaviviridae including Hepatitis C, was invalid on the grounds of lack of novelty, obviousness, insufficiency and (for some claims only) added matter.

Idenix contended that the sale by Gilead of Solvaldi (sofosbuvir) infringed the patent.  Gilead counterclaimed for invalidity, including lack of novelty over their earlier International Patent Application.  This claim required the judge (Arnold J) to consider the legal claim to priority of that application.  This raised issues of fact and US law.  Together with the other invalidity issues raised the judgment stretches to 621 paragraphs.

The case is interesting for a number of reasons but of particular interest is the part of the judgment that considers the application of the EPO case law in the context of obviousness. This judgment is the first time that a UK judge has considered the EPO Board of Appeal decision AgrEvo (T 939/92) in the context of obviousness.  Previously the AgrEvo type analysis has been rolled up into insufficiency (see e.g. Regeneron v Genentech).  Idenix suggests an approach to obviousness more aligned with that of the EPO.

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AgrEvo obviousness arises where the alleged technical contribution is not plausible for substantially everything covered by the claim, with the result that the alleged technical contribution cannot be included within the technical problem against which obviousness is judged.  The patent claim is then likely to be found to be obvious and invalid.

The Judge accepted that, for both the granted and proposed to be amended claims, it was not plausible that substantially all the compounds covered would be effective against Flaviviridae.  He cited eleven reasons for this finding including: that the patent contains no experimental data and no rationale for the assertion of activity for the claimed compounds, that it adds nothing to the CGK of the skilled team regarding the types of compounds claimed, that Idenix’s defence relied upon raising the level of CGK but that this was unsuccessful and that Idenix’s counsel in cross examination sought to support plausibility “in the sense of worth testing” when in the empirical field of the alleged invention this was the case for all compounds related to the class claimed.

The judge therefore held that all the claims asserted to be independently valid lacked an inventive step because the claimed inventions do not make any technical contribution to the art.  The same was true of the claims as proposed to be amended. A further point worthy of brief mention is that this case is the second in the UK to consider the prosecution history as an aid to construction.  In this case the judge explained that in his view the prosecution history was not of use in this case and noted that limitations to avoid a lack of clarity objection are less likely to be of assistance (compared to a limitation to avoid a lack of support as in Actavis v Lilly).

Read the entire decision here.

Headnote: Ian Turner and Graham Burnett-Hall, Marks&Clerk Solicitors

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