Federal Court of Appeal Dismisses Appeal to Have Formulation Patent Listed on the Patent Register

On March 13, 2006, in Biovail Corporation v Canada (Minister of National Health and Welfare) 2006 FCA 105, the Federal Court of Appeal affirmed a decision of the Federal Court dismissing an application by Biovail Corporation (Biovail) for judicial review of the Minister of Health's (Minister) refusal to list a patent on the Patent Register. To be eligible for listing on the Patent Register under Section 4 of the Patented Medicines (Notice of Compliance) Regulations, a patent must contain a claim for the "medicine" itself or a claim for the "use of the medicine" in respect of the drug for which the patent is to be listed. Once a patent is listed on the Patent Register in respect of a drug, the Minister may not issue a Notice of Compliance for a generic drug that is comparable in specified respects to that drug for which the patent was listed, unless this patent is addressed by the generic drug manufacturer and the provisions under the Regulations are satisfied. Biovail's patent claimed a controlled release composition and contained a claim which explicitly mentioned buproprion and diltiazem hydrochloride, the "medicines" at issue. However, the Federal Court held that the patent related to a drug delivery system that can be used for many different medicines and not to a particular "medicine" or "use of a medicine". Furthermore, it was held that the patent's paramount purpose was to "protect the delivery system, not the payload". On this basis, the Federal Court concluded that the Minister was correct not to list the patent on the Patent Register. The Federal Court of Appeal agreed. It held that when construed in the context of the patent as a whole, the claim in question was for the use of the polymers to achieve the slow release of six of the 40 or so active ingredients mentioned in the patent. Accordingly, the Court of Appeal held that the claimed invention does not relate not to the "medicine" itself and should not to be listed on the Patent Register For a copy of the Federal Court's decision, visit: http://decisions.fct-cf.gc.ca/fct/2005/2005fc1135.shtml The decision of the Federal Court of Appeal, when it becomes available online, will be found by searching for the case name alphabetically at: http://decisions.fca-caf.gc.ca/fca/2006/01.shtml Summary by: Nick Wong