PM(NOC)

The Patented Medicines (Notice of Compliance) Regulations regulations link the patent system to the regulatory regime for food and drugs in Canada.

March 10, 2014

Federal Court of Appeal Upholds Disqualification, But Refuses to Invalidate Cobalt’s Notice of Allegation

Valeant Canada LP v Canada (Health), 2014 FCA 50 - The Court dismissed an appeal from the Federal Court’s decision to grant Valeant’s motion to disqualify Cobalt’s in-house lawyer from any further involvement in the application before the Court on the ground that he could be presumed to have Valeant’s confidential information.
January 23, 2014

Human Antibody Patent Upheld at FC

AbbVie Corporation v Janssen Inc. [2014 FC 55]   Background The action is in respect of a patent directed to human antibodies capable of binding a […]
January 7, 2014

Alcon’s Opthalmic Solution Patent Ruled Invalid in NOC Proceeding

Alcon Canada Inc. v Apotex Inc. [2012 FC 410]   Background The patent at issue is Canadian Patent 2,195,094. The patent is for a topical ophthalmic […]
January 7, 2014

FC Allows Application in Part – Prevents NOC from Issuing

Gilead Sciences Inc. v Canada (Health) [2013 FC 1270] Bristol-Myers Squibb v Canada(Health) [2013 FC 1271] Gilead Sciences Inc. v Canada(Health) [2013 FC 1272]   Background […]
December 23, 2013

FC Changes Approach to Double Ramp Up

Apotex Inc. v Takeda Canada Inc. 2013 FC 1237   Background This is an application under section 8 of the PM(NOC) process dealing with lost revenue […]
October 24, 2013

FC and FCA Clarify Issues with Respect to Cost Awards

Mylan Pharmaceuticals ULC v Bristol-Myers Squibb Canada Co. [2013 FCA 231] Background This is an appeal of a cost award from a Judgment of Justice Barnes […]
September 16, 2013

Apotex’s Unjust Enrichment Claim Fails Based Upon Operation of the PM(NOC) Regulatory Regime

Apotex Inc. v Abbot Laboratories Ltd. Takeda Pharmaceuticals Company Ltd. And Takeda Pharmaceuticals America Inc.  2013 ONCA 555   Apotex appealed the dismissal of its unjust […]
August 14, 2013

FC Holds the Liability Phase of a Bifurcated Trial Is Concluded Even If Judge Defers Deciding Some Liability Issues to the Quantification Phase

Eli Lilly Canada Inc. v. Novopharm Limited – 2013 FC 677 Per Prothonotary Tabib: In this motion Teva sought to amend its Statement of Defence and […]
July 24, 2013

FC Dismisses Roche’s Prohibition Application, Holds Apotex’s Allegations Are Justified that Patent Covering VALCYTE Is Anticipated and Obvious

Hoffman-La Roche Limited v. Apotex Inc., 2013 FC 718 In this application brought under the PM(NOC) Regulations Roche sought to prohibit the Minister of Health from […]
June 7, 2013

FC Clarifies Purposive Construction of Product-by-Process Claims

Bayer Inc. v. Cobalt Pharmaceuticals, 2013 FC 573 Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Cobalt, […]