Federal Court Reviews Canadian Law on Chemical Selection Patents

The Federal Court of Canada recently conducted a thorough review of the law relating to selection patents in the case of Eli Lilly Canada Inc v Apotex Inc, 2007 FC 455 (the Lilly case). An application was brought under the Patented Medicines (Notice of Compliance) Regulations to prevent the Minister from issuing a Notice of Compliance (NOC) to Apotex Inc (Apotex) for olanzapine, an antipsychotic drug marketed by Eli Lilly Canada Inc (Lilly) under the brand name ZYPREXA. In the chemical context, a selection patent is a patent that is based on the selection of a compound from a group or genus of compounds, which are generally described and claimed in an originating patent. Olanzapine is the subject of Canadian Patent 2,041,133 ("˜133 Patent), which selects olanzapine from the broad genus of compounds with central nervous system activity that are claimed in Canadian Patent 1,075,687 ("˜687 Patent). For a selection patent to be valid, the selected compound must possess some special advantage over the previously claimed general class of compounds, an advantage which could not be predicted. Apotex argued in the Lilly case that selection patents are akin to "new use" patents, in that the special advantage must be set out in a claim. The Court disagreed, holding that it is sufficient for the alleged special advantage to be disclosed within the specification. The Lilly case did not turn on the above finding because Apotex was barred from arguing that the "˜133 Patent was not a valid selection patent, since it had failed to make that allegation in its Notice of Allegation (NOA). The Court was not persuaded by Apotex's argument that despite its failure to make the allegation, it was entitled to raise such an argument. Apotex claimed that it was so entitled because Lilly raised selection as a defence in response to the allegation of double patenting in Apotex's NOA. In rejecting Apotex's assertion, the Court clearly noted that the specific grounds of invalidity must be set out in its NOA, including any allegations that a selection patent is not valid for lack of disclosure. In reaching its decision, the Court made some general comments of interest regarding NOC proceedings. After commenting on the sheer volume of evidence submitted by both parties, including much expert testimony, the Court noted that NOC proceedings have departed from their intended purpose of expediting the determination of issues relating to the validity and infringement of patents listed on the NOC register. Justice Gauthier remarked that the NOC proceedings "are not the equivalent of a civil action for patent infringement or for a declaration of invalidity nor are decisions made as a result of NOC applications binding in any subsequent action between the parties with respect to the validity of the patent under review". For the full reasons for judgment in the Lilly case, visit: http://decisions.fct-cf.gc.ca/en/2007/2007fc455/2007fc455.html Summary by: Michael Migus