Federal Court Considers Enforcement of Drug Patent for Unapproved Uses

In Pfizer Canada Inc v The Minister of Health and Apotex, 2007 FC 642, the Federal Court of Canada considered whether a patent holder, Pfizer Canada Inc (Pfizer), could prohibit a generic manufacturer from obtaining regulatory approval to market a generic drug despite the failure of the patent owner to obtain authority to sell its own drug for the use protected by the patent. Pfizer had brought an application under the Patented Medicines (Notice of Compliance) Regulations to prevent the Minister of Health (Minister) from issuing a Notice of Compliance (NOC) to Apotex Inc (Apotex) for the drug quinapril (intending to market it under the name Apo-Quinapril) until the expiry of Canadian Patent 2,023,089 ("˜089 Patent). Quinapril is approved in Canada and marketed by Pfizer for the treatment of hypertension and congestive heart failure under the brand name Accupril. The "˜089 Patent claims the treatment of cardiac and vascular hypertrophy and hyperplasia by administration of angiotensin converting enzyme inhibitors (Patented Use). However, the Patented Use had not been approved by Health Canada, and, as a result, even Pfizer was not yet able to sell Accupril for the treatment of these conditions. Apotex alleged in its NOA that it would not infringe the "˜089 Patent because it would not make, use or sell Apo-Quinapril for the Patented Use. Apotex also provided an Undertaking in the NOA that it would make, use or sell Apo-Quinapril only for the treatment of hypertension. However, Apotex's draft product monograph, draft labels and the Abbreviated New Drug Submission (ANDS) for this product all referred to the intended use for hypertension and congestive heart failure, in an apparent inconsistency with Apotex's Undertaking. On the issue of infringement, Justice Phelan held that if Apotex's sale of Apo-Quinapril was only for hypertension, there is no basis for infringement. However, the contentious area was in the treatment of congestive heart failure and the incidental use that may be made of Apo-Quinapril. Pfizer argued that because Apotex's draft product monograph included an indication for "congestive heart failure" and those with congestive heart failure may suffer from hypertrophy, use for congestive heart failure would infringe the "˜089 Patent. The law seems well established that incidental treatment of a patented use through administration of medicine to treat a non-patented use is not grounds, on its own, to prohibit the Minister issuing an NOC to a generic manufacturer. In order to succeed, Pfizer must show that Apotex did "something more", such as inducing physicians and patients to use the drug for the Patented Use. However, the Court found that Apotex's Undertaking was a complete answer to the allegation and could be incorporated into any NOC issued to Apotex. Apotex would also have to modify the draft product monograph and draft labels to be in accordance with its Undertaking. Thus, the Court found no evidence that Apotex would actively induce physicians to prescribe quinapril pills to treat hypertrophy. Finally, the Court noted that the Patented Use covered in the "˜089 Patent had not been approved by Health Canada for quinapril, and Pfizer was attempting to use the "˜089 Patent to prevent Apotex's drug from coming to the market despite Pfizer's failure, to date, to obtain regulatory approval to sell its own drug for the Patented Use. Such a result, said the Court, would allow a non-using monopoly holder to prevent a lower cost drug from entering the market and that: "This was never the intention of the legislation." As a result, the Court dismissed Pfizer's application and ordered that any NOC to be issued to Apotex contain a condition that is consistent with Apotex's Undertaking. For the full reasons for judgment, visit: http://decisions.fct-cf.gc.ca/en/2007/2007fc642/2007fc642.html Summary by: Nicholas Wong