Case information

Intellectual property — Patents — Medicines — Applicants’ patents for pharmaceutical compound invalidated for obviousness — Should the extra statutory “selection patent” doctrine be eliminated? — What is the correct way to approach the analysis of inventiveness/obviousness in the context of a small selection from a very broad genus, in context of the Patent Act, R.S.C. 1985, c. P 4? — Should there be a different standard for obviousness in relation to a selection patent that deviates from that found in s. 28.3 of the Patent Act? — Can a claimed drug molecule be compared against other molecules also made by the inventors, and disclosed only in the patent in suit, instead of to the prior art? — Can a few non-selected members with a similar special advantage, from a genus of millions, invalidate a selection patent and thus make the selection “obvious”? — Can overwhelming commercial success simply be ignored as an indicia of patent inventiveness?

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Teva Canada Limited (“Teva”) brought an action against Janssen Inc. and Millenium Pharmaceuticals, Inc. (collectively, “Millenium”) for compensation under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93¬133, for losses suffered during the time that Teva was kept off the market for its generic version of the drug, bortezomib, used for treating certain blood cancers. Prior to this action, Millenium had commenced two applications under the Regulations against Teva seeking orders prohibiting the issuance of a notice of compliance to Teva until after the expiry of Patents 936 and 146. Those applications were both dismissed on the grounds that the 936 and 146 Patents were invalid for obviousness. Teva then obtained its notice of compliance and subsequently brought its action for s. 8 damages. Millenium defended on the grounds that Teva was not entitled to compensation because its generic product infringed the 936, 146 and 706 Patents. Teva denied infringement and alleged that the three patents were invalid. The parties agreed on the amount of damages.The trial judge concluded that the patents in suit were invalid for obviousness. This decision was upheld on appeal.