Canada: Pharmacapsules @ Gowlings - July 21, 2011

Edited by Jennifer Wilkie & Isabel Raasch

Federal Court Upholds Patent on Cellcept®: Found Useful, Non-obvious

Authored by Vik Haramina

On July 13, 2011, Justice O'Reilly of the Federal Court granted an application commenced by Hoffmann-La Roche under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a NOC to Apotex Inc. for its generic version of the brand drug, Cellcept® (mycophenolate mofetil ("MMF")), until the expiry of Hoffmann-La Roche's Canadian Patent 1,333, 285.

The '285 Patent includes claims to the compound MMF (a pro-drug of the previously known compound MPA), which is an immunosuppressive drug used primarily in organ transplants, and describes certain advantages of the invention. In its NOA, Apotex alleged that the '285 Patent was invalid mainly on the grounds of: (1) lack of utility – that MMF's utility was neither demonstrated nor soundly predicted, and (2) obviousness – that MMF was an obvious variant on the prior art.

The Court construed the promise of the '285 Patent to include some of the advantages stated in the patent because it is those advantages (advantageous pharmacokinetic properties) that lead to enhanced bioavailability and enhancing bioavailability was the problem that the inventors were trying to solve. The Court also construed that the invention related to use in mammals, including humans, in view of the use to which MPA had historically been put.

On the issue of demonstrated utility, the Court equated the promise of the patent with the utility of the invention. The Court then found that data disclosed in the patent was sufficient to demonstrate the stated invention as of the filing date. The Court also found that even though the patent did not disclose any human tests on MMF, the study done in monkeys demonstrated the utility of MMF as an effective prodrug of MPA. Indeed, MMF's sole mission was to deliver MPA and MPA was well-known to be useful in the treatment of conditions in humans. Thus, the utility in humans had been demonstrated at the relevant date. The Court added that even if the stated utility had not been demonstrated it was soundly predicted based on the data in the patent.

In respect of obviousness, the Court determined that MMF was not obvious to try, nor was it more or less self-evident that it would work. The Court also noted that Apotex provided no evidence about how it found the prior art it was relying on. Prior art should be discoverable on a reasonably diligent search. As such, the Court was skeptical of the value of some of the prior art references relied on by Apotex's experts.

For a copy of the decision, please see:

http://www.gowlings.com/knowledgeCentre/enewsletters/pharmacapsules/pdfs/T-1165-09.pdf

Patent Validity Attacks for Lack of "Good Faith" Ruled Out in Canada

Authored by Grant W. Lynds

In recent years, Canada's Federal Court has generated much debate with respect to whether patent applicants in Canada owe a "duty of candour" during prosecution of patent applications, especially under section 73 of Canada's Patent Act. Canada's Federal Court of Appeal has now issued a decision dated July 18, 2011 that conclusively states that section 73(1)(a) cannot be relied upon to attack the validity of a patent after it has issued.

This clarification from Canada's Federal Court of Appeal is welcome guidance to patent practitioners, as well as patent applicants and owners regarding the scope of section 73. This decision ensures that an owner of an issued patent should not be subject to a validity attack under section 73(1)(a) based on responses to requisitions from an examiner that occurred during prosecution of the underlying application.

For a more in-depth summary of the case and Court's decision, please see today's special edition IP Report.

Federal Court Remits PMPRB Matter Back for Reconsideration

Authored by Jane Clark

The Federal Court, in a July 12, 2011 decision, in the case of Sanofi Pasteur Limited v. Attorney General of Canada, declared a decision of the Patented Medicines Price Review Board ("Board") to be null and void, and required the Board to return amounts paid by Sanofi pursuant to the Board's order, and directing the matter back for reconsideration.

The Court considered a number of issues, including whether the Board had erred by imposing a "penalty" on Sanofi, or had fettered its discretion in an absolute reliance on its Guidelines. The Court answered these questions in the negative. Sanofi also claimed that the Board ignored the evidence and the particular circumstances of the case and had made findings that were based on pure speculation. The Court agreed with Sanofi and held that the Board's decision did not meet the level of transparency, intelligibility and justification required by the "reasonableness" standard and thus did not meet the reasonableness standard, was set aside, and remitted back to the Board for reconsideration.

For a more in-depth summary of the case and Court's decision, click here for the recent Drug Pricing & Reimbursement Newsletter.

Contrary Finding in an Impeachment Action for Norvasc® Does Not Lead to Setting Aside a Prior NOC Decision

Authored by Vik Haramina

The Federal Court of Appeal dismissed a motion brought by ratiopharm to set aside an order of the appellate court in Pfizer Canada Inc. v. Canada (Minister of Health), 2006 FCA 214, which had granted an order prohibiting the Minister of Health from issuing a NOC to ratiopharm for its generic version of the brand drug, Norvasc (amlodipine besylate), until the expiry of Pfizer Limited's Canadian Patent 1,321,393.

Following the issuance of the prohibition order, ratiopharm was successful in an impeachment action: ratiopharm v. Pfizer Limited, 2009 FC 711, affirmed 2010 FCA 204, which declared the '393 Patent invalid on all grounds argued at trial, i.e. obviousness, utility, sufficiency, selection patent and section 53 of the Patent Act.

ratiopharm consequently brought a motion to set aside the earlier prohibition order on two grounds: (1) by reason of a matter that was discovered subsequent to the making of the order, and (2) on the basis that the order was obtained by fraud. ratiopharm additionally sought an order dismissing the prohibition proceeding, so it could bring a claim for section 8 damages.

In respect of the first ground, the Court concluded that the issue was moot due to the prohibition order having expired with the expiry of the patent and the fact that a NOC had issued to ratiopharm and it was on the market. In any event, the Court held that a subsequent finding in an of invalidity in an impeachment proceeding did not qualify as a "new matter".

In respect of the second ground, the Court held that in order for ratiopharm to succeed in having the decision set aside for fraud, ratiopharm must establish that fraud was committed in both the NOC proceeding in the Federal Court and in the Court of Appeal and that the fraud is material, ie., but for the fraud, the Court of Appeal would not have reversed of the Federal Court's decision and granted prohibition. The Court held that ratiopharm fell short of establishing the required materiality.

Finally, the Court of Appeal made it clear that, except where an order was obtained by fraud, a subsequent decision invalidating a patent does not provide a basis upon which an earlier prohibition order should be set aside. As such, absent fraud, a generic drug manufacturer who is prohibited from being issued a NOC cannot reach back and apply the finding of invalidity in a subsequent action so as to argue it is entitled to section 8 compensation.

For a copy of the decision, please see:

http://decisions.fca-caf.gc.ca/en/2011/2011fca215/2011fca215.html

Upcoming Trials, Judicial Reviews and Appeals of Interest

Other Events

Upcoming IP seminars on Gowlings U:

The full list of events and details can be found at http://www.gowlings.com/Events/

Past Issues of Pharmacapsules are available at: http://www.gowlings.com/KnowledgeCentre/newsletters.asp?id=25