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, […]
May 29, 2013

PM(NOC): s. 8 Issues Circumscribed by Antecedent s. 6 Proceeding; s. 6 Claim Construction Binding on s. 8 Proceeding in Absence of Strong Reason to the Contrary

Apotex Inc. v Pfizer Canada Inc. – 2013 FC 493 Apotex claimed damages under s. 8 of the PM(NOC) Regulations on grounds that it incurred a […]
March 26, 2013

Hughes J. Holds the Relevant Date for Assessing Sufficiency of a Canadian Patent Is the Date of Publication

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Limited, 2013 FC 283 Novartis brought two applications under the provisions of the PM(NOC) Regulations to restrain the Minister […]
March 13, 2013

Ongoing Infringement Trial Not Grounds for ex turpi causa Argument to Delay Determination of s. 8 Damages under the PM(NOC) Regulations

AstraZeneca Canada Inc. v. Apotex Inc., 2013 FCA 77 AstraZeneca appeals the trial court’s decision in a proceeding commenced by Apotex under s. 8 of the […]
March 13, 2013

FC Finds Teva’s Allegation Justified that the SEROQUEL Patent is Obvious

AstraZeneca Canada Inc. v. Teva Canada Limited, 2013 FC 245 AstraZeneca seeks an order prohibiting the Minister of Health from issuing a Notice of Compliance to […]
February 27, 2013

Ont. Div. Ct. Reinforces Unavailability of Equitable Disgorgement under S. 8 of PM(NOC) Regs

Apotex Inc. v. Eli Lilly, 2013 ONSC 1135 (Div. Ct.) Lilly sought leave to appeal from a decision of Justice J. Macdonald of the Ontario Superior […]
February 11, 2013

PM(NOC): Notice of Allegation Against the LYRICA Patent Upheld on Grounds of Insufficiency and Inutility for Lack of Sound Prediction

Pfizer Canada et al. v. Pharmascience Inc., 2013 FC 120 Pfizer brought an application under the PM(NOC) Regulations to prohibit the Minister of Health from issuing […]
January 29, 2013

PM(NOC): Application for Prohibition Is Moot after NOA Is Withdrawn

Eli Lilly Canada Inc. v. Teva Canada Limited – 2013 FC 28 This application was brought by Eli Lilly Canada under the PM(NOC) Regulations, seeking an […]
January 29, 2013

The Minister of Health May Reconsider Issuing a NOC for an Application on Patent Hold

Apotex Inc. v. Canada (Health), 2012 FCA 322 Apotex commenced an application for judicial review of the Minister of Health’s treatment of its submission for a […]
January 29, 2013

Data Protection: an Enantiomer of a Previously-Approved Racemic Mixture Is Automatically a “Variation”

Takeda Canada Inc. v. Canada (Health) – 2013 FCA 13 Takeda Canada appealed from the Federal Court’s decision dismissing Takeda's application for judicial review of a […]
January 22, 2013

No Equitable Disgorgement of a Pharma Innovator’s Profits in Ontario, Absent a Cause of Action Independent of the Operation of s. 8 of the PM(NOC) Regulations

Apotex Inc. v. Abbott Laboratories Limited, 2013 ONSC 356 In this case, Apotex claimed damages against Abbott Laboratories and Takeda Pharmaceuticals based on unjust enrichment. On […]