Rx IP Update


February 2011

In this issue:

SCC finds PMPRB has jurisdiction over U.S.-based Special Access Programme sales »

Supreme Court of Canada news »

PMPRB news »

Other news »

Recent Court decisions »

Janssen's appeal of denial of Order of prohibition for galantamine (method of medical treatment) dismissed as moot »

Teva permitted to continue separate NOC proceedings inherited from Novopharm and ratiopharm »

Court of Appeal allows CPGA and Rx&D’s motions to intervene in EpiCept’s appeal of data protection denial for CEPLENE »

Issuance of Letters of Request granted regarding Apotex's Indian supplier for citalopram »

Ontario regulations effectively prohibiting sales of private label generic drugs found invalid »

New Court proceedings »

SCC finds PMPRB has jurisdiction over U.S.-based Special Access Programme sales

In its first decision relating to the Patented Medicine Prices Review Board ("PMPRB"), the Supreme Court of Canada held that the PMPRB has jurisdiction over Celgene's U.S.-based sales of Thalomid to Canadians pursuant to Health Canada's Special Access Programme ("SAP"): Celgene Corp. v. Canada (Attorney General), 2011 SCC 1. The PMPRB and Celgene agreed that based on common law commercial principles, the sales of the drug took place in New Jersey. On this basis, Celgene submitted that the sales were therefore outside the bounds of section 80(1)(b) of the Patent Act, which pertains to medicines that are "sold in any market in Canada." Celgene was successful in the Federal Court (2009 FC 271), however the PMPRB's jurisdiction was affirmed by the Court of Appeal (2009 FCA 378), as reported in the January 2010 issue of Rx IP Update, and again by the Supreme Court.

Read More »

Supreme Court of Canada news

SCC dismisses Bayer's application for leave to appeal Minister's decision not to list formulation patent against YAZ. As reported in the October 2010 edition of Rx IP Update, Bayer applied for leave to appeal the Federal Court of Appeal's decision relating to the eligibility for listing a formulation patent against the new drug submission ("NDS") for YAZ (ethinyl estradiol/drospirenone). The patent claims a formulation explicitly referring to one medicinal ingredient, and YAZ is a combination product containing two medicinal ingredients. While there was no dispute that YAZ falls within the scope of the claims, the Minister found that the relevance requirement had not been met. The Federal Court determined that the Minister's interpretation was correct and the Court of Appeal affirmed. On January 20, 2011, the Supreme Court dismissed Bayer's application for leave to appeal.

Bayer Inc. v. Canada (Minister of Health) et al., June 15, 2010.
SCC Case No – 33845.
Court of Appeal decision – 2010 FCA 161.
Federal Court decision – 2009 FC 1171.

GSK applies for leave to appeal striking of colour mark applied to ADVAIR DISKUS inhaler as non-distinctive. As reported in the December 2010 edition of Rx IP Update, the Federal Court of Appeal upheld a decision of the Federal Court striking GlaxoSmithKline's ("GSK") registration consisting of dark and light purple applied to its ADVAIR DISKUS inhaler from the Register of Trademarks. The Federal Court found, among other things, that consumers did not associate the colour and shape of the GSK mark with a single source. The Federal Court of Appeal found that the Judge had turned his mind to the proper burden of proof, and in any event, the presumption of validity simply requires that an examination of all the evidence establish that the trademark was not registrable at the relevant time, that the Judge applied the correct test for distinctiveness, and that GSK had not established any palpable and overriding error in the Judge's application of the law to the facts in the case. On December 1, 2010, GSK applied for leave to appeal to the Supreme Court.

Glaxo Group Limited v. Apotex Inc., June 15, 2010.
SCC Case No – 34006.
Federal Court of Appeal decision – 2010 FCA 313.
Federal Court decision – 2010 FC 291.

Mylan, Apotex and Cobalt apply for leave to appeal prohibition Orders regarding escitalopram. As reported in the December 2010 edition of Rx IP Update, the Federal Court of Appeal dismissed appeals by Genpharm (now Mylan), Apotex and Cobalt from the decisions of Justice Harrington granting Lundbeck prohibition Orders relating to escitalopram (Lundbeck's CIPRALEX), an antidepressant. The appeals were dismissed on all grounds: invalid selection patent, anticipation, obviousness, lack of sound prediction and inutility, ambiguity and insufficiency of disclosure, and procedural fairness and inadequacy of reasons. On January 24, 2011, Mylan, Apotex and Cobalt applied for leave to appeal the decision to the Supreme Court.

Apotex Inc. v. Lundbeck Canada Inc., November 25, 2010.
SCC Case No – 34068.
Federal Court of Appeal decision – 2010 FCA 320.
Federal Court decision – 2009 FC 146.

PMPRB news

New NEWSletter released. The PMPRB has released its January 2011 NEWSletter, which reports on voluntary compliance undertakings regarding MIOCHOL-E and TASIGNA. (NEWSletter.)

Board finds PENLAC priced excessively. On January 31, 2011, the PMPRB issued a decision on the merits regarding PENLAC, sanofi-aventis's treatment for a fungal nail infection. The PMPRB found that PENLAC is not clinically equivalent to two other treatments for the same condition, and therefore does not belong in the same therapeutic class. The PMPRB concluded that PENLAC was excessively priced and ordered repayment to offset excess revenues.

Full decision — PMPRB-07-D2-PENLAC. Order.

Other news

Canadian Intellectual Property Council releases report urging Canada to close IP gap in the pharmaceutical sector. On January 19, 2011, the Canadian Intellectual Property Council ("CIPC"), backed by the Canadian Chamber of Commerce, released a report urging greater protection of intellectual property and improvements to regulations and legislation affecting the pharmaceutical industry: "Innovation for a Better Tomorrow: Closing Canada's Intellectual Property Gap in the Pharmaceutical Sector." The report urges Canada to implement the following three recommendations in order to protect and create highly skilled jobs, foster investment and establish a globally competitive climate in the pharmaceutical field:

  1. Grant research-based companies an effective right to appeal an adverse court decision under the Patented Medicines (Notice of Compliance) Regulations.
  2. Implement additional data protection equivalent in both scope and duration to that provided by Canada's key trading partners and competitors.
  3. Implement a five-year patent term restoration ("PTR") system to offset regulatory delays in the approval of a medicine.

Recent Court decisions

Patented Medicines (Notice of Compliance) Regulations

Janssen's appeal of denial of Order of prohibition for galantamine (method of medical treatment) dismissed as moot. As reported in the December 2010 edition of Rx IP Update, Justice Barnes dismissed Janssen's application for an Order of prohibition against Mylan regarding galantamine (Janssen's REMINYL), finding that the relevant patent claims for a dosing regime of galantamine with a titration schedule to treat Alzheimer's disease cover a method of medical treatment that cannot be monopolized. Janssen appealed; however, before the appeal was heard, Mylan obtained a notice of compliance from the Minister. The Court of Appeal dismissed Janssen's appeal, declining to exercise its discretion to hear the moot appeal, stating that the Court was "of the view that the question of patent law raised in this case is best determined in the context of an action for infringement of the patent in issue."

Janssen v. Mylan, January 17, 2011.
Federal Court of Appeal decision – 2011 FCA 16.
Federal Court decision – 2010 FC 1123.

Teva permitted to continue separate NOC proceedings inherited from Novopharm and ratiopharm. Ratiopharm Inc. ("ratiopharm") and Novopharm Inc. ("Novopharm") filed separate abbreviated new drug submissions based on different formulations for pregabalin products, and each served a notice of allegation ("NOA") on Pfizer. Pfizer, which markets pregabalin as LYRICA, commenced applications against ratiopharm and subsequently Novopharm. Novopharm changed its name to Teva Canada Limited ("Teva"), and Teva subsequently amalgamated with ratiopharm and now operates as Teva. Pfizer brought a motion to stay what was the ratiopharm proceeding on the basis that it was an abuse of process for Teva to continue with two proceedings that contained similar allegations with respect to the same drug. Pfizer submitted that because Novopharm amalgamated with Teva before the ratiopharm amalgamation, the Novopharm proceeding was the first proceeding.

The Court dismissed the motion, finding that although multiple NOAs from the same generic manufacturer will generally not be permitted, there was no abuse of process on these unique facts, as the NOAs are separate and distinct, and rely on different formulations, excipients and evidence. The Court also questioned whether it had the jurisdiction to stay the proceeding indefinitely as the statutory stay may be extended in only two circumstances (consent and failure to reasonably co-operate in expediting the proceeding), neither of which were applicable.

Pfizer Canada Inc. v. ratiopharm Inc., January 20, 2011.
Federal Court decision – 2011 FC 74.

Other decisions

Court of Appeal allows CPGA and Rx&D’s motions to intervene in EpiCept's appeal of data protection denial for CEPLENE. As reported in the October 2010 edition of Rx IP Update, the Office of Patented Medicines and Liaison ("OPML") denied data protection for CEPLENE (EpiCept's histamine dihydrochloride). EpiCept sought judicial review of the Minister's decision, and the Federal Court dismissed the application. EpiCept has appealed the Federal Court decision. The Canadian Generic Pharmaceutical Association ("CGPA") and Canada's Research-Based Pharmaceutical Companies ("Rx&D") have both been granted leave to intervene in the appeal.

EpiCept Corporation v. Canada (Health), September 24, 2010.
Federal Court of Appeal Case No. A-397-10.
Federal Court decision – 2010 FC 956.

Issuance of Letters of Request granted regarding Apotex’s Indian supplier for citalopram. Motions were brought in the context of a section 8 action by Apotex against Lundbeck, seeking damages for alleged delay in issuing a notice of compliance for citalopram. Lundbeck counterclaimed for infringement of several patents. Apotex appears to have imported citalopram from Matrix Laboratories in India during the alleged period of delay, defending on the basis of non-infringement, among other grounds. Lundbeck sought and was granted issuance of Letters Rogatory for discovery of a representative of Matrix. However, Apotex’s request that a witness’s (Dr. Adlington, a chemistry professor at Oxford University) evidence be taken out of court and that it be compelled through Letters Rogatory addressed to the English Court was denied. Dr. Adlington had produced reports regarding the nature of the Matrix process in the context of European proceedings instituted by Lundbeck against Lagap Pharmaceuticals. Apotex has appealed.

Apotex v. Lundbeck, January 26, 2011.
Federal Court decision – 2011 FC 88.

Ontario regulations effectively prohibiting sales of private label generic drugs found invalid. The Shoppers Drug Mart group of companies (including Sanis Health Inc., which provides generic drugs under its own label to Shoppers Drug Mart pharmacies) and the Katz group of companies (which operates Rexall) challenged the validity of certain provisions of the Regulations made under the Ontario Drug Benefit Act ("ODBA," Ontario Regulation 201/96), and the Drug Interchangeability and Dispensing Fee Act ("DIDFA," Ontario Regulation 935). The provisions deal with private label products, essentially those that are non-arms length from pharmacies. Section 12.0.2(1) of the ODBA Regulations provides that a private label product "shall not be designated as a listed drug product" and section 9(1) of the DIDFA Regulations provides that a private label drug "shall not be designated as interchangeable." The result of these provisions was that Sanis label generic drugs could not be sold in the public or private market in Ontario. The Ontario Divisional Court held that these provisions are of no force and effect, including as they are beyond the scope of the regulation-making authority in the parent statute.

Shoppers Drug Mart v. Ontario, February 3, 2011.
Decision – 2011 ONSC 615.

New Court proceedings

Other proceedings


methylphenidate ER-C (CONCERTA)


Teva Canada Limited


Janssen-Ortho Inc and Alza Corporation

Date Commenced:

December 14, 2010

Court File No.:



Action for section 8 damages. Teva also seeks damages "for making false and misleading statements" regarding the safety and effectiveness of Teva’s methylphenidate product contrary to section 7(a) of the Trademarks Act, and damages pursuant to section 52 of the Competition Act as a result of "representations to the public that were false or misleading in material respects."

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

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