IN THIS ISSUE:

VIAGRA litigation: an update »

Federal Court of Appeal provides further clarity on approach to inventive concept »

Supreme Court of Canada news »

Quebec announces elimination of "15-year rule" for reimbursement »

Private member's bill to amend Canada's Access to Medicines Regime (CAMR) defeated »

Health Canada approves generic versions of OXYCONTIN »

New Court proceedings »

VIAGRA litigation: an update

The recent decision by the Supreme Court of Canada in Teva Canada Limited v Pfizer Canada Inc, 2012 SCC 60 (sildenafil, VIAGRA), continues to reverberate through the patent world. In particular, the finding that the ’446 patent is "void" has generated a flurry of activity in the Supreme Court and Federal Court.

Read more »

 

Federal Court of Appeal provides further clarity on approach to inventive concept

On November 23, 2012, the Federal Court of Appeal dismissed Apotex's appeal of the Federal Court decision granting an Order prohibiting the Minister from issuing a notice of compliance (NOC) to Apotex for its ophthalmic drug combining brimonidine and timolol (Allergan's COMBIGAN). In so doing, the Court of Appeal re-analyzed Apotex's allegation of obviousness and commented on the doctrine of judicial comity.

The appeal arose in an unusual way. As explained in the July 2012 issue of Rx IP Update, the Federal Court had found that Apotex's allegation of obviousness was justified (2012 FC 767). Despite this finding, the Federal Court issued the prohibition Order specifically to allow the Court of Appeal to address apparent "serious issues raised as to comity," which arose because of a prior decision of the Federal Court holding that Sandoz's allegation of obviousness was not justified (Allergan Inc v Minister (Health) and Sandoz Inc, 2011 FC 1316, "Sandoz decision").

The Court of Appeal held that by issuing a formal judgment that was contrary to the conclusion that he reached on the merits, the Federal Court judge had "failed in his task." The Court of Appeal did not agree that there were any serious issues of comity raised in the Apotex proceeding. The Court explained that the doctrine of comity promotes certainty in the law and seeks to prevent the same legal issue from being decided differently by members of the same Court. Judicial comity only applies to determinations of law as, in theory, there can only be one correct answer to a question of law. A departure is authorized where a judge is convinced that the prior decision is wrong and the departure is necessary, and where cogent reasons can be articulated for doing so.

The Court of Appeal held that construing a patent to identify the inventive concept when it is not readily discernible from the claim itself requires looking at the whole of the patent and gives rise to a question of law. In the Court of Appeal's view, the Federal Court judge was wrong to have construed the inventive concept differently from what had been found in the Sandoz decision as the Federal Court judge had not identified any error in the prior construction, nor did he rely on distinct evidence to explain why he chose to construe the patent differently.

Faced with two conflicting and equally authoritative decisions on the construction of the patent, the Court of Appeal undertook the task of determining which construction was the correct one. The Court agreed with Allergan and the Federal Court's Sandoz decision that the inventive concept, on the basis of the whole of the patent disclosure including the clinical study disclosed in Example II, included an improved safety profile associated with the drug combination. In so doing, the Court of Appeal held that the Federal Court judge had taken too narrow a view of the inventive concept when he restricted it to what was stated in one paragraph of the patent in isolation of the rest of the disclosure. The Court reiterated that claim construction must be conducted in light of the patent as a whole.

The Court of Appeal then proceeded with the remaining steps of the obviousness analysis rather than remitting the matter back to the Federal Court judge. The Court found that the difference between the state of the art and the inventive concept of the patent, in particular the improved safety profile of the drug combination, would not have been obvious to a skilled person. As such, the Court of Appeal dismissed the appeal and stated that "although the prohibition order was issued by the Federal Court for the wrong reason, it was nevertheless properly issued."

Urszula Wojtyra, Toronto

Apotex Inc v Allergan Inc and Minister (Health), November 23, 2012.
Federal Court decision — 2012 FC 767.
Federal Court of Appeal decision — 2012 FCA 308.

 

Supreme Court of Canada news

Supreme Court finds VIAGRA patent "void" for insufficient disclosure. As reported in an IP Update on November 8, 2012 (with continued reporting above), the Supreme Court unanimously held that Canadian Patent No. 2,163,446, covering the use of sildenafil (Pfizer's VIAGRA) for the treatment of erectile dysfunction, failed to satisfy the disclosure requirements of section 27(3) of the Patent Act. The Court also commented on utility. The lower Court decisions were previously reported in the July 2009 and October 2010 issues of Rx IP Update. Pfizer has brought a motion for a rehearing of the appeal and/or amendment of the judgment (SCC Case No. 33951).

Teva Canada Limited v Pfizer Canada Inc, November 8, 2012.
Supreme Court of Canada decision — 2012 SCC 60.
Federal Court of Appeal decision — 2010 FCA 242.
Federal Court decision — 2009 FC 638.

Wyeth denied leave to appeal decision determining that Teva is not precluded from pursuing ratiopharm's section 8 claim regarding venlafaxine. On November 26, 2012, the Supreme Court denied Wyeth leave to appeal a Federal Court of Appeal decision (reported in the July 2012 issue of Rx IP Update) that reversed Justice Hughes's finding that the equitable doctrine of election barred Teva from pursuing a section 8 claim initiated by ratiopharm against Wyeth regarding venlafaxine (Wyeth's EFFEXOR XR) and his subsequent dismissal of Teva's action. The Court of Appeal held that the equitable doctrine of election does not apply and allowed Teva's appeals.

Wyeth LLC et al v Teva Canada Limited (SCC Case No. 34918).
Federal Court of Appeal decision — 2012 FCA 141.
Federal Court decisions — 2011 FC 1169 and 2011 FC 1442.

Eli Lilly seeks leave to appeal decision upholding the invalidity of olanzapine selection patent. As reported in the October 2012 issue of Rx IP Update, the Federal Court of Appeal upheld the decision of Justice O'Reilly of the Federal Court invalidating Eli Lilly's selection patent for the compound olanzapine (ZYPREXA). Justice O'Reilly had found that the utility promised by the patent had not been demonstrated and could not have been soundly predicted. Eli Lilly has sought leave to appeal.

Eli Lilly Canada Inc et al v Novopharm Limited November 8, 2012 (SCC Case No. 35067).
Federal Court of Appeal decision — 2012 FCA 232.
Federal Court decision — 2011 FC 1288.

 

Quebec announces elimination of "15-year rule" for reimbursement

On November 20, 2012, the Minister of Finance and the Economy for Quebec tabled the 2013-2014 Quebec budget. The budget contained measures expected to impact the pharmaceutical industry in the province, including eliminating the 15-year rule, which was introduced in 1994. As stated by the Minister, under the rule, "innovative drugs are reimbursed within 15 years following their entry on the list of medications, even if the patent has expired and a less-expensive generic drug is also available." The Minister noted that "in recent years, the business model of the industry has undergone a sea change" and the rule "no longer meets its objective, namely, to foster research in Quebec."

To continue to encourage research and development in Quebec, the Minister also announced an increase in tax credits for certain research and development activities and a plan to provide matching funding for private-public research partnerships.

Budget plan. Budget speech.

 

Private member's bill to amend Canada's Access to Medicines Regime (CAMR) defeated

Bill C-398, An Act to amend the Patent Act (drugs for international humanitarian purposes), was defeated in the House of Commons on the Second Reading on November 28, 2012. The Bill sought to amend the Patent Act to make it easier to manufacture and export pharmaceutical products to developing and least-developed countries.

Bill C-398.

 

Health Canada approves generic versions of OXYCONTIN

On November 26, 2012, Health Canada granted NOCs to seven generic manufacturers for oxycodone hydrochloride, generic versions of Purdue Pharma's OXYCONTIN, despite requests by the provincial health ministers to delay such approvals in view of concerns regarding potential misuse of the products.

Health Canada provided a Statement on the authorization of generic OXYCONTIN explaining the rationale for the decisions and referring to the new Guidelines to the New Licence Conditions Regarding Controlled Release Formulations of Oxycodone Products.

Statement. Guidelines.

 

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

 

 

 

 

 

 

 

 

 

 

Other proceedings

 

 

 
To check the status of Federal Court cases, please click here.