Teva Canada Limited v. Pfizer Canada Inc., et al.

(Federal) (Civil) (By Leave)

(Sealing order)




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Patents — Medicines — Construction of patents — Disclosure — Sufficiency of disclosure — Whether guidance is needed on the law of sufficiency of disclosure — Whether an allegation of insufficiency is at the “heart of the patent system” or a “technical attack” — Whether the Federal Court of Appeal has confused the Consolboard questions — Whether the Federal Court of Appeal condones the imposition of a research project — Whether the Federal Court of Appeal’s “claim based” approach rewrites the law of sufficiency of disclosure — Whether the Federal Court of Appeal confuses disclosure of invention with “best mode” — Whether the Federal Court of Appeal imposes a crippling “wait and see” regime on generic manufacturers.

In 1994, Pfizer applied for a patent for a range of compounds, of which it claimed that one compound was effective for the oral treatment of erectile dysfunction. It received Patent 2,163,446 on July 7, 1998. Patent ’446 expires in 2014.

The disclosure explains that the invention concerns the use of a compound of formula (I) or a salt thereof as a medicament for the treatment of erectile dysfunction. Claim 1 sets out formula (I), which produces 260 quintillion possible compounds. Claims 2 5 are for successively smaller ranges of compounds of formula (I), with Claim 5 being narrowed to a range of nine compounds. Claims 6 and 7 refer to one compound each. Neither the disclosure nor the claims disclose that Claim 7 contains the effective compound, that sildenafil is that compound, or that it is the only active compound sold commercially under the trade name Viagra. Nor does it disclose that the remaining compounds in the patent had not been found to treat erectile dysfunction.

Novopharm, now Teva, applied for a Notice of Compliance to produce a generic version of Viagra, alleging that the patent was invalid for obviousness, lack of utility, and insufficient disclosure. The Federal Court judge found that the patent was not obvious, had utility, and did not fail to adequately disclose the invention. He prohibited the Minister from issuing the requested Notice of Compliance. The Federal Court of Appeal dismissed an appeal.

Lower Court Rulings

June 18, 2009
Federal Court

T-1566-07, 2009 FC 638
Appliction allowed; Minister of Health prohibited from issuing Notice of Complicance for a generic version of Viagra until patent 2, 163,446 expires
September 24, 2010
Federal Court of Appeal

A-292-09, 2010 FCA 242
Appeal dismissed with costs