Canada: Pharmacapsules @ Gowlings: April 3, 2012 - Volume 11, Number 4

Edited by Jennifer L. Wilkie and Isabel Raasch

Mylan Pharmaceuticals ULC v. Pfizer Canada Inc., 2012 FCA 103 - Aricept (donepezil), appeal of NOC case

The Court of Appeal upheld on Order prohibiting the Minister of Health from issuing a NOC to Mylan for donepezil, a drug for the treatment of Alzheimer's type dementia, until expiry of Pfizer's '808 Patent. Mylan had alleged that the patent was invalid due to an unsound prediction of the promised utility, but the trial judge found that this allegation was not justified. 

On appeal, Mylan argued that the trial judge erred in failing to find that the '808 Patent promised that donepezil would have acceptable toxicity and be safer and longer acting than prior compounds. The Court of Appeal reviewed the judge's findings on construction and the promise of the patent. The promise of the '808 Patent was found to be a "a new class of compounds has been discovered (donepezil being one) which, having regard to the cholinergic function theory of AChE inhibition, is effective for the treatment of Alzheimer's". 

Lack of toxicity in humans at effective doses was not found to be part of the promise and as such was not a necessary requirement to demonstrate utility. In this regard, the Court noted that patentees are not required to perform clinical trials to determine toxicity and other factors prior to filing, as that is a part of the regulatory process.  Patent law looks at utility in the context of inventiveness, and the doctrine of sound prediction presupposes that future work remains to be done.  In addition, the Court agreed that a person of skill in the art would construe the statements in the patent to potential toxicity and efficacy to be potential advantages as opposed to promises.  Since therapeutic use is only a predicted use and a skilled person knows years of testing will follow attributes that will be determined by that testing cannot be read into the patent.  The Court of Appeal rejected Mylan's argument that the Court of Appeal Latanoprost decision applied and that the promise of the patent ought to include the statements as to improved side effects because in Latanoprost the statements about improved side effects appeared in the claims whereas the claims in this case did not mention improved side effects.

The decision may be found at:

Gilead Sciences Canada, Inc. v. Canada (Minister of Health), 2012 FC 2, Complera (tenofovir, emtricitabine and rilpivirine), patent listing decision

In this case the Court accepted the Minister's position that a patent with combination patent claims and formulation claims to a triple medicinal ingredient product was not eligible for listing. 

The claims of interest referred to 2 of the 3 medicinal ingredients explicitly:  tenofovir disoproxil fumarate and emtricitabine.  The third medicinal ingredient as claimed in  both  formulation and combination compound claims was referred to as an "anti-viral agent"; an anti-viral agent selected from  either an HIV protease inhibitor, an HIV nucleoside reverse transcriptase inhibitor, an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) or an HIV integrase inhibitor; or, more specifically, an antiviral agent which was an NNRTI. It was acknowledged by the parties and found as a fact that rilpivirine is an NNRTI.

Counsel for Gilead argued that the Minister was incorrect in not listing the patent under s. 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") (which deals with claims to a formulation).  Further, the patent was, in any event, eligible under s. 4(2)(a)  (which deals with claims to a medicinal ingredient) on the basis that the product falls within the combination compound claims. 

The Minister's position was that the relevant claims had to be considered under s. 4(2)(b) as formulations rather than as combinations under s. 4(2)(a), since the NDS was for the approval of a formulation of three active medicinal ingredients in a tablet. 

The judge acknowledged that there were formulation and compound claims that made reference to a third antiviral agent.  The Judge also  accepted that different types of claims are to be construed differently and that the test for listing of claims to compounds under s. 4(2)(a) was not as restrictive as the test for listing formulation claims under s. 4(2)(b), referring to the decision in Bayer Inc. v Canada (Minister of Health), 2009 FC 1171, aff'd 2010 FCA 161. However, the Court went on to accept the Minister's position that the patent was properly considered for listing under s. 4(2)(b). Applying the Court of Appeal decisions in Bayer and Purdue Pharma v Canada (Attorney General), 2011 FCA 132, the Court found that the failure to explicitly mention rilpivirine in the claim meant that the patent was not eligible for listing under s. 4(2)(b).

The analysis under s. 4(2)(b) alone arguably extends the doctrine of specificity beyond the Bayer and Purdue Court of Appeal decisions. In those decisions, the claims at issue did not even refer to a second medicinal ingredient at all and thus were not listable.  The additional language in the claims in this case could have been the basis for a different conclusion by the Court. 

A copy of this decision is attached: Reasons and Judgment.pdf

Apotex Inc. v. Merck & Co. Inc., 2011 FCA 363 – lovastatin; appeal from patent infringement case

In a decision is dated December 19, 2011 (but not released until recently) the Court of Appeal has upheld the trial judge's finding that Apotex infringed Merck's patent for lovastatin.  In reaching its decision, the Court of Appeal noted that the appeal was generally seeking to overturn the earlier factual findings and that the Court of Appeal was loath to do so in this case as the trial judge had a firm grasp of the evidence presented over a 35-day trial.

 As a point of law, the Court of Appeal reiterated that for an appellant to succeed in an attack challenging a finding of fact, the appellant must establish that the errors being raised constitute not only a clear and obvious error (palpable) but more importantly, one that is overriding

Finally, although the trial judge's decision was upheld, the Court of Appeal expressly stated that it was not endorsing her interpretation of section 55.1 of the Patent Act (s. 39(2) of the old Patent Act) because it was done without the benefit of a complete record including reference to subsection 1709(11) of NAFTA and section 3 of the NAFTA Implementation Act). Apotex has sought leave to appeal to the Supreme Court of Canada.

The decision may be found at:

Apotex Inc. v. Merck & Co. Inc., 2011 FCA 364 – lovastatin; appeal from s.8 case

In a decision is dated December 20, 2011 (but not released until recently), the Court of Appeal has overturned the Court's finding that s. 8 of the 1993 NOC Regulations and found that the underlying NOC Regulation proceeding was "pending" at the time of the amendment of the NOC Regulations in 1998 as an appeal had been heard by the Supreme Court at that time and a decision was under reserve.  Thus, the amended section 8 applied. 

The Court of Appeal went on to note that the trial judge had not thus applied the amended s. 8 to determine if there was liability under this section.  The Court of Appeal rejected Merck's argument that the section did not apply on the basis that Apotex's actions in coming to market and selling lovastatin after the NOC proceeding were subsequently found to be infringing.  The Court indicated that this argument could not be used to preclude liability but very well may be relevant to the application of s. 8(5) of the NOC Regulations which confers a broad discretion on the court in assessing the amount of compensation to the second person.

On the final issue, the Court of Appeal found that the remaining legal and factual issues concerning the amount of compensation (if any) payable to Apotex under the NOC Regulations should be determined by the trial judge and not the Court of Appeal. Such issues include the basis on which the loss should be determined, the extent to which the ex turpi causa principle should be applied on the facts, if at all and the starting date of the period during which the loss must have occurred. Thus this matter was remitted to the trial judge. Merck has sought leave to appeal to the Supreme Court of Canada.

The decision may be found at:

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