068.154e-gmo fall 2012

VIAGRA®'S PATENT INVALIDATED BY THE SUPREME COURT OF CANADA
ROBIC, LLP

The patent that covers the use of the active molecule of Viagra®, sildenafil was the
subject of a unanimous decision by seven judges of the Supreme Court of Canada
on November 8th, 2012 [Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60]. It
considered that the Canadian Patent 2,163,446 was invalid, reversing the decisions
of the Federal Court and Federal Court of Appeal, on the grounds that the description
of the invention was insufficient at the date of patent filing, and therefore not in
compliance with Section 27 (3) of the Patent Act, which reads :
The specification of an invention must(a) correctly and fully describe the invention and its operation or use as contemplated by the inventor. The expiration of the patent was expected in May 2014, 20 years after the date of filing of the patent application, but this decision will allow the generic drug company, Teva Pharmaceutical Industries (formerly Novopharm Limited), to obtain a notice of compliance of the Ministry of health and to enter the market now4. Pfizer's patent discloses and claims the use of a family of compounds for the treatment of male impotence. In the short description of 12 pages, it is only mentioned that "one of the especially preferred compounds induces penile erection in impotent males", without specifying the exact structure of the compound having this property. Then, in the claims written in "cascade", the compound is first claimed by a generic chemical formula "for 260 quintillion possible compounds." The claims end with claims 6 and 7, added after the filing of the application, each covering a single compound. Claim 7 covers the active drug in Viagra™ (sildenafil), but nothing in the patent indicates that it is the molecule claimed in claim 7, which is sildenafil. Citing the AZT [AZT is the common name of the Supreme Court Judgement Apotex Inc. C. Wellcome Foundation Ltd., 2002 SCC 77] decision and incorporating Article 27 (3) of the Patent Act, the Supreme Court held that the patentee had not fulfilled its obligations under the quid pro quo contract that applies according to the Patent Act: the Canadian government provides a monopoly on an invention for 20 years on condition that the invention is novel, inventive, useful, but also fully disclosed at the
CIPS, 2012.
*From ROBIC, LLP, a multidisciplinary firm of Lawyers, and Patent and Trade-mark Agents. Published
in the Fall 2012 (Vol. 16, no. 3) Newsletter of the firm. Publication 068.154E.
ROBIC, LLP
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Source: http://www.robic.ca/admin/pdf/1071/068.154F-GMO-Fall-2012.pdf