EPLAW Patent Blog

BE - Novartis v. Mylan / Fluvastatin

Novartis v. Mylan, Brussels court of appeal, Belgium, 26 October 2010, Docket number A.R. 2010/KR/175, with thanks to Philippe de Jong, Altius, for sending in the case and translation

The Brussels court of appeal has reversed a decision from the Brussels commercial court which had rejected Novartis’ claim for a preliminary injunction against Mylan’s intended commercialisation of a generic sustained release formulation of fluvastatin. In doing so, the Brussels court of appeal upheld the established approach applied by the Belgian courts that a granted (European) patent is presumed to be valid for the purpose of obtaining an interim injunction. According to the court, upon a proprer application of Article 106(1) EPC, it is irrelevant that the EPO Opposition Division revoked the patent, even in its entirety, since the appeal against that decision before the EPO Technical Board of Appeal has suspensive effect.

Read the decision (in Dutch) here.

Read the decision (in English) here.

Head note: Philippe de Jong


UK - Actavis UK Limited v Novartis AG

Actavis UK Limited v Novartis AG, High court of Justice, Court of Appeal (Civil Division), London, UK, 17 February 2010, [2010] EWCA Civ 82

The Court of Appeal has dismissed Novartis's appeal against the High Court's decision that its European Patent EP0948320, claiming a sustained release formulation of fluvastatin, a drug used to treat high cholesterol, was invalid for obviousness. In its appeal, Novartis submitted that a reformulation of the problem identified in their patent, would have resulted in the skilled person viewing the basis of the invention as a problem. The evidence however, showed that fluvastatin was itself widely known before the patent application, and that a number of standard production methods for a sustained release formulation would work.

Favouring the multifactorial approach for assessing Art 56 EPC obviousness laid down in Pozzoli, Jacob LJ dismissed the appeal, finding the patent invalid for lack of inventive step. He disagreed with Warren J that the case was finely balanced, stating that, "once the basis of the patent was proved illusory there was nothing left to save it." Jacob LJ favoured English jurisprudence over the "two-bite" approach allowing for consideration of obviousness under the EPO problem/solution approach. In Jacob LJ's opinion, the problem/solution approach does not adequately deal with cases where the invention involves perceiving that there is a problem.

Read the judgment (in English) here.