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Court applies a practical approach to the law of utility and affirms Gleevec patent

Feb. 22, 2013
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On Feb. 19, 2013 the Federal Court released an important decision on Teva Canada Limited and Apotex Inc. v. Novartis AG 2013 FC 142, which offers a refreshing and practical approach by the Court regarding utility and the promise of pharmaceutical patents.

Justice Snider dismissed two impeachment actions brought by Teva and Apotex against Novartis relating to the compound patent for Novartis’ breakthrough cancer drug, Gleevec® (imatinib mesylate). In dismissing the actions, Justice Snider tempered the approach taken in some recent cases that imposed very high standards of proof and knowledge to establish a demonstration and sound prediction of utility, including the disclosure requirement. This decision is also important in that it is the first to comment on the effect of the recent Supreme Court of Canada (SCC) Viagra decision.

The patent being attacked had a number of genus and species claims to novel compounds and also included some claims to the use of certain compounds, including imatinib, for chemotherapy of tumours.

The overriding point of contention between the parties was whether the promise of the patent (and therefore the analysis on utility) varied depending upon whether one was looking at the compound claims or the use claims. In this regard, the Court agreed with Novartis’ position that the promise of the patent must be analyzed by focusing on the claims. Thus, the Court rejected the Plaintiffs’ approach that all claims have the same utility and that the entire patent should be treated as a use patent. On the contrary, the Court found that the patent makes it very clear that the compound claims are “the most important aspect of the patent, with the use claims, the process claims and the medicinal composition claims arising from the properties of the compounds.” Consequently, different “promises” applied to the different types of claims. The Court found that the narrower genus claims, the species claims, the process claims and the use claims were valid.

Counsel for Novartis were Gowlings lawyers: Tony Creber, John Norman, Jennifer Wilkie, Isabel Raasch and Marc Richard.

For further analysis on this decision, click here.

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