Federal appeals court upholds validity of glatiramer acetate patent

The Federal Court of Appeal has dismissed an appeal by Pharmascience from a decision of the Federal Court that found   Canadian patent No 2,760,802 (the 802 patent) valid and infringed by Pharmascience's proposed glatiramer acetate product, a generic of Teva Pharmaceutical Industries’ (NYSE: TEVA) blockbuster multiple sclerosis drug Copaxone and Pharmascience's Glatect.

According to patent lawyer Andrea Berenbaum of Smart & Biggar writing on ILO Healthcare & Life Sciences, a second patent, Canadian patent no 2,702,437, which was found invalid for obviousness by the Federal Court, was not at issue n the appeal.

Canada-based Pharmascience argued that the trial judge had erred regarding the disclosure requirement for sound prediction because she had not acknowledged the requirement to describe the factual basis and line of reasoning supporting the prediction of utility. The parties did not disagree on whether a "heightened" disclosure requirement for sound prediction exists, and the Federal Court of Appeal, therefore, noted that it was not necessary to comment on that question. The Federal Court of Appeal disagreed with Pharmascience's argument, holding that the trial judge had not misunderstood the disclosure requirement under the sound prediction doctrine.