PATENTS - Criteria for patent protection - Non-obviousness - Inventive ingenuity - Procedure - Appeals
Thursday, May 04, 2017 @ 8:30 AM
Appeal by Bristol-Myers Squibb from a ruling finding its 736 Patent invalid on the basis of obviousness. The appellant acquired rights to the atazanavir molecule, a complex molecule used to treat the HIV virus and AIDS. The molecule was the subject of a 1997 patent application granted in 2006 under the 840 Patent to Novartis. In 1998, the appellant filed a patent application in respect of a salt of atazanavir on the basis its superior bioavailability made it useful in formulation of an oral dosage. The appellant was granted the 736 Patent in 2004. The respondent, Teva Canada, commenced proceedings under the Patented Medicines (Notice of Compliance) Regulations. The Federal Court ruled that the 736 Patent was invalid for obviousness and rejected the appellant's application for a writ of prohibition. The appellant appealed.
HELD: Appeal dismissed. The respondent's allegations of obviousness in its Notice of Allegation were justified for reasons different from those found by the Federal Court. The Federal Court correctly identified the person skilled in the art and the common general knowledge. Having identified the inventive step as comprising three elements, the Federal Court was forced to conclude that two of those elements were not inventive at all. The Federal Court did not err in the application of the obviousness test, but erred in its identification of the inventive concept. The Federal Court implicitly adopted a definition of the inventive concept which focused on the properties of atazanavir bisulfate. However, the inventive concept was not materially different from the solution taught by the patent. Had the Federal Court adopted such an approach, it would have identified the inventive concept as atazanavir bisulfate, a salt of atazanavir which is pharmaceutically acceptable because it had equal or better bioavailability than the atazanavir free base. From there, the Federal Court would have found no difference between the prior art and inventive concept without having recourse to inventiveness, as a skilled person would have regarded a salt screen as a self-evident and obvious path to a form of atazanavir with greater bioavailability.
Bristol-Myers Squibb Canada Co. v. Teva Canada Ltd., [2017] F.C.J. No. 358, Federal Court of Appeal, J.D.D. Pelletier, D.G. Near and D.J. Rennie JJ.A., April 11, 2017. Digest No. TLD-May12017010
HELD: Appeal dismissed. The respondent's allegations of obviousness in its Notice of Allegation were justified for reasons different from those found by the Federal Court. The Federal Court correctly identified the person skilled in the art and the common general knowledge. Having identified the inventive step as comprising three elements, the Federal Court was forced to conclude that two of those elements were not inventive at all. The Federal Court did not err in the application of the obviousness test, but erred in its identification of the inventive concept. The Federal Court implicitly adopted a definition of the inventive concept which focused on the properties of atazanavir bisulfate. However, the inventive concept was not materially different from the solution taught by the patent. Had the Federal Court adopted such an approach, it would have identified the inventive concept as atazanavir bisulfate, a salt of atazanavir which is pharmaceutically acceptable because it had equal or better bioavailability than the atazanavir free base. From there, the Federal Court would have found no difference between the prior art and inventive concept without having recourse to inventiveness, as a skilled person would have regarded a salt screen as a self-evident and obvious path to a form of atazanavir with greater bioavailability.
Bristol-Myers Squibb Canada Co. v. Teva Canada Ltd., [2017] F.C.J. No. 358, Federal Court of Appeal, J.D.D. Pelletier, D.G. Near and D.J. Rennie JJ.A., April 11, 2017. Digest No. TLD-May12017010
