In Ratiopharm Inc. v. Pfizer Limited (2009 FC 711), the Federal Court of Canada (FC) granted a declaration that Canadian Patent 1,321,393 (‘393 Patent) is invalid pursuant to s.60(1) of the Patent Act. The Court accepted all five grounds of invalidity put forward by the generic challenger. In invalidating the ‘393 Patent, the FC reviewed evidence beyond the patent specification to assess the level of utility specifically promised in the disclosure. The FC also indicated that “wilfully mislead”, under s.53 of the Patent Act, could be established by inference. Ratiopharm brought this action after the Federal Court of Appeal (FCA) (2006 FCA 214) rejected similar challenges in litigation under the Patented Medicines (Notice of Compliance) Regulations.

Deception by Inference

Unlike in most patent related actions, the parties placed extensive evidence pertaining to the development of pharmaceuticals in the 1980s, the development and patenting of the invention in question, the invention specifically promised by the inventor and subsequent developments which put into that promise.

The FC began by noting that Canada does not have an explicit statutory provision directed to issues of fraud, but that s.53 of the Patent Act comes close. This provision renders a patent void where omissions or additions to the specification and drawings are “wilfully made for the purpose of misleading.” Citing G.D. Searle & Co. v. Novopharm Ltd., 2007 FC 81, rev’d on other grounds in 2007 FCA 173 without discussion of this issue, the FC held that “proper disclosure is essential and that intent to mislead can be inferred.” The FC then inferred the requisite intent from the evidence, including the plaintiff’s failure to call the junior patent agent who drafted the patent and the mindset of corporate executives surmised from their actions. The FC then held that the ‘393 Patent was therefore invalid.

Assessing Utility Beyond the Patent

The FC then turned to utility, noting that s.2 of the Patent Act requires that a patented invention be “useful”. Although the ‘393 Patent was held to be useful in Pfizer Canada Inc. v. Canada (Minister of Health), 2008 FC 500, “based on the patent alone”, “evidence beyond the patent” was available in this case. After quoting from Pfizer Canada Inc., the FC held that this evidence established that the disclosed invention patent was not a “unique” combination of features making it “outstandingly suitable” for certain pharmaceutical formulations, as specified in the patent disclosure. Therefore, on the basis of this external evidence, the Court invalidated the ‘393 Patent because the promise of the invention as unique and outstanding as compared to other similar pharmaceutical compounds was not fulfilled.

Other Grounds

The FC also held the patent to be invalid on three other grounds. First, thepatent was obvious because, to a person skilled in the art, it would have been obvious to try testing certain other salts, and in particular the claimed salt which had already been shown to offer advantages over other salts in terms of stability. Second, the patent was not a valid selection patent because the evidence did not establish that the claimed salt possessed any special advantage. Finally, the specification was insufficient because, lookingto the significant amount of evidence from the inventors themselves, the ‘393 Patent did not disclose the invention as contemplated by the inventors.