Patent Relating to Extended Release Tablets Found to be Obvious
Biovail Corporation and Depomed, Inc. v. The Minister of Health and Apotex Inc., 2010 FC 46 (Kelen, J.)

January 20, 2010

Marguerite Ethier and Elizabeth Dipchand for the Applicants, Biovail Corporation and Depomed, Inc.
Andrew Brodkin, Dino Clarizio and Belle Van for the Respondent, Apotex Inc.
John H. Sims (Deputy Attorney General of Canada) for the Respondent, Minister of Health

This was an application commenced under the Patented Medicines (Notice of Compliance) Regulations, seeking an order of prohibition with respect to metformin extended release tablets.  Apotex alleged that Biovail’s patent was invalid for anticipation, obviousness, double patenting, and on the basis of the Gillette Defence.  The application was dismissed. 

The Court concluded that the prior art reference relied upon by Apotex for anticipation did not disclose or enable the person skilled in the art to come directly to the invention claimed in the patent at issue.  The Court also found that the patent was not invalid on the basis of double patenting and found that the Gillette Defence did not apply because the reference Apotex was relying upon with respect to this defence was not alleged to anticipate the invention.  In particular, after reviewing the jurisprudence, the Court concluded that the Gillette Defence is only ever applied in Canada when the prior art anticipates the patent.  However, the Court found that the invention claimed in the patent at issue was obvious.  In particular, the Court found that the evidence in respect of the “obvious to try” component of the test for obviousness was evenly balanced, and therefore Biovail had not met its burden to prove on a balance of probabilities that the allegation of obviousness was not justified.

By: Chantal J. Saunders, Borden Ladner Gervais LLP