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Warner-Lambert Company LLC v Sandoz GmbH, UK, High Court (Chancery Division), Mr Justice Arnold, 21 December 2016

These proceedings concerned an application by Sandoz to vary an interim injunction restraining Sandoz from supplying or offering to supply full label generic pregablin granted by Mr Justice Arnold the previous month (“the 17 November Order”).

Patent protection for pregablin itself expired in 2013; however, Warner-Lambert had a second medical use patent (the Patent), with claims 1 and 3 in the Swiss form relating to use for the treatment of pain:
1. Use of [pregablin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.
3. Use according to claim 1 wherein the pain is neuropathic pain.

Sandoz had obtained both full label and skinny label marketing authorisations for pregablin, and there was no dispute that Sandoz intended (whether acting by themselves or via agents) to package, label and market the Sandoz full label product. In the earlier decision, Arnold J had concluded that granting the relief sought by Warner-Lambert would create a lesser risk of irremediable harm than refusing it and would preserve the status quo, namely the absence in the market of full label generic pregablin products.

Subsequent to the issuance of the 17 November Order, Warner-Lambert had stated that it would not seek an injunction to restrict generic companies from marketing pregablin under intermediate labels which extended to central neuropathic pain. In the opinion of Arnold J, this was a material change of circumstances; therefore, Sandoz passed the test to have the injunction re-assessed.

The validity of the Patent was the subject of other proceedings which were the subject of an appeal with the Court of Appeal having recently held claims 1, 3, 4, 6, 13 and 14 of the Patent to be invalid. Warner Lambert were in the process of seeking permission to appeal that decision. It was common ground that a Supreme Court decision on whether or not permission to appeal would be granted would be unlikely before mid-January 2017. The respondents in the appeal proceedings had filed statements of objection and had requested that if Warner Lambert we given permission to appeal, they should be granted permission to cross-appeal the finding that claims 10, 11, and 12 of the Patent were valid.

Arnold J concluded that Warner-Lambert had “not merely an arguable, but a strong case” that the Sandoz full label product would infringe claims 10, 11 and 12 of the Patent, for essentially the same reasons he had previously stated in his earlier judgement. Since he had concluded that Warner-Lambert was on the face of it entitled, assuming that its claim for infringement succeeded, to use that monopoly to protect the full label market for pregablin (as distinct from the skinny label and intermediate label markets), Sandoz’s application was dismissed.

The judgment can be found here.

Headnote: Nicholas Fox, Simmons & Simmons LLP