In the battles between generic and brand-name pharmaceutical companies, this decision can be considered a major clarification of the law.

Last week the Supreme Court of Canada (SCC) released its decision in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61. This patent litigation case centres around so-called “selection patents”. Selection patents claim “an advantage for a compound within a previously disclosed class of compounds which has not been disclosed in the prior patent”, as described by the court. Unlike originating or genus patents, which cover an originating invention involving a new reaction or a new compound, selection patents build on previously disclosed classes of compounds but identify a new use or benefit of the compound undisclosed in the originating patent. In this particular circumstance, Apotex (the generic manufacturer) claimed that one of Sanofi’s selection patents was invalid because it was covered within one of Sanofi’s earlier originating patents. The court disagreed with Apotex and upheld Sanofi’s selection patent. The win is significant for Sanofi since it covers the drug company’s second-best-selling drug, and the patent does not expire until 2012, giving the company 4 more years of monopoly over generic manufacturers.

As for the complaint from generics that big pharma is engaging in “evergreening” to continue their monopolies long past the time intended by the Patent Act, the court stated: “Strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act, depending on the circumstances, but a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents. A selection patent may be sought by a party other than the inventor or owner of the original genus patent so that evergreening does not arise. In addition, selection patents encourage improvements over the subject matter of the original genus patent because that selection does something better than or different from what was claimed in the genus patent.”
Related Reading: Pharma Patent Decision Released

Calgary – 17:45 MST