In Novo Nordisk Canada Inc. v. Cobalt Pharmaceuticals Inc., 2010 FC 746., Justice Mactavish dismissed an application by Novo Nordisk Canada Inc. (“Novo Nordisk”) under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Inc. (“Cobalt”) for its generic version of repaglinide, a drug used in the treatment of Type 2 diabetes.
Cobalt asserted that Canadian Patent No. 2,111,851 (the “851 Patent”) was invalid on various grounds, including anticipation and obviousness. Ultimately, Justice Mactavish found Cobalt’s allegation of obviousness to be justified.
Interestingly, Cobalt also put forward the allegation that the 851 Patent was void pursuant to section 53(1) of the Patent Act, which provides that a patent is void if it contains, for example, any material allegation in the petition of the patent that is untrue, or the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made. Furthermore, section 53(1) requires that the omission or addition is wilfully made for the purpose of misleading. Section 53(1) is the only provision in the Patent Act that is directed to issues of fraud.
The Court noted that because an allegation under this provision “implicates the notion of fraud,” it should not be made recklessly or on the basis of mere speculation. Furthermore, wilfulness must be established for omissions or additions. Untrue statements in a patent, if material, will void the patent even if there was no intent to mislead.
For a patent to be void under section 53(1), there are three elements that must be met: (i) the allegation must be contained in the petition; (ii) the allegation must be material; and (iii) the allegation must be untrue.
Cobalt alleged that there were a number of misleading statements and omissions in the 851 Patent which, when taken together, supported a finding that the 851 Patent was void. The Court rejected this argument, finding that none of the alleged omissions were material. Each asserted omission or misstatement failed on the second arm of the three-part test, since they were not material. The Court’s findings on the asserted omissions and misstatements were as follows:
- The fact that a sentence explaining two figures included in the 851 patent was missing from the second page was found to be inadvertent, with the omission giving the inventors no advantage.
- The fact that the 851 patent did not indicate that the basis for the assertion of “the surprisingly quick onset of the lowering of blood sugar by (repaglinide) compared with the (racemate)” was obtained from testing on a single healthy volunteer – one of the inventors – was not an omission.
- The fact that the studies mentioned in the disclosure were carried out on healthy volunteers, as opposed to Type 2 diabetics, was also found not to amount to an omission.
As such, satisfying the threshold for the materiality of an untrue allegation appears to be the challenge for invalidating a patent under section 53(1) of the Patent Act.R