PM(NOC)

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

January 24, 2022
Photo of a pharmacist holding out a yellow pill in one hand and a white pill in another hand. A patient reaches for the yellow pill.

Teva Blocks Competitor With Patent for 40 mg/mL Dose of Copaxone®

Outside Canada, Teva’s Copaxone® 40mg/mL dosing patents have been invalidated for obviousness, making way for generic competitors.
April 4, 2019
White and blue pharmaceutical pills scattered on a surface

Actions Under Old PM(NOC) Regime Not Automatically Applicable to the New

2018 FC 1078 - Canada's Federal Court confirms that jurisprudence under previous PM(NOC) regime is not automatically applicable to the new.
September 26, 2018

Federal Court Dismisses Motion for Early Dismissal of Action Brought Under the New PM(NOC) Regulations

2018 FC 694 – Federal Court confirms that motion for early dismissal will only be granted in the clearest of cases.
April 3, 2018

Non-Infringing Alternative Defence Denied in Omeprazole Infringement Profit Case

2017 FC 726 - The FC held that Apotex did not satisfy the factual burden required to establish a hypothetically viable non-infringing substitute during the period of infringement, which could reduce the infringement profits owed to AstraZeneca.
January 16, 2018

Federal Court Rejects Apotex’s Judicial Review Application for Apo-Omeprazole Magnesium Tablets

2017 FC 857 - The Federal Court upheld the Minister of Health’s decision to cancel reconsideration for Apo-Omeprazole Magnesium Tablets manufactured by Apotex Inc. This is yet another failed attempt by Apotex to obtain approval for the magnesium tablet form of its anti-ulcer drug.
December 19, 2017

Federal Court Upholds Pfizer’s Polymorph Patent for the Depression Drug PRISTIQ as Inventive and Useful

2017 FC 777 - The FC rejected Teva’s allegations that Pfizer's Canadian patent was obvious and lacked utility. The FC found that the POSITA would not have been able to predict the novel crystalline form taught by the patent, and that the subject-matter of the invention claimed in the patent was useful.
December 12, 2017

Federal Court shoots down an attempted revival of the promise doctrine

2017 FC 774 - The FC granted Pfizer's order pursuant to Section 6 of the PM(NOC) Regulations, prohibiting the Minister of Health from issuing a NOC to Apotex, with respect to a Canadian patent The FC found, on a balance of probabilities, that Apotex’s allegations of obviousness, inutility, non-infringement, overpromising, anticipation and double patenting were not justified.
November 14, 2017
insomnia

Federal Court finds Insomnia-treating Drug Patent neither Invalid nor Infringed

2016 FC 1362 - The formulation patent for the insomnia-treating drug zolpidem was found to be substantially valid, but not infringed by Pharmascience's generic version of zolpidem.
October 31, 2017

Federal Court Affirms Price Regulation Schemes are intra vires

2016 FC 716 - The AG was successful in bringing a motion to strike Alexion's constitutional challenge to the patented medicines price regulation scheme in the Patent Act. The motion was brought on the ground that the application was bereft of any chance in light of a line of jurisprudence, which had fully and finally determined that these sanctions are intra vires and constitutional.
October 24, 2017

Federal Court Adjourns Motion for Confidentiality Order

2017 FC 548 - In this application for judicial review over s. 5 of the PM(NOC) Regulations, the FC agreed with the AG who argued that since another innovator also had patents listed on the Patent Register pertaining to products to which Innovator Company made comparisons, the other innovator was a necessary respondent to the application.
August 22, 2017

Federal Court of Appeal remits decision based on hearsay evidence back to the Federal Court for redetermination

2016 FCA 161 - The FCA remitted a proceeding back to the FC for redetermination after agreeing with Pfizer that part of Teva’s evidence in the FC decision was based on hearsay.
July 5, 2017

FC Strikes PM(NOC) Application Due to No Chance of Success

2016 FC 525 - The Federal Court granted Celltrion’s motion to strike Janssen’s application pursuant to section 6(5)(b) of the PM(NOC) Regulations.
June 13, 2017

FC Denies Prohibition Order Request; Finds Expert Blinding Persuasive But Not Primary Interest

2016 FC 382 - The FC concluded that Apotex’s allegations of non-infringement in respect of Shire's Canadian Patent were justified and accordingly denied Shire’s requested prohibition order.
June 6, 2017

Allergan fails to demonstrate to FC that Apotex’s allegations of invalidity are not justified

2016 FC 344 - Apotex alleged in its Notice of Allegation and submissions that the ‘632 Patent was invalid because it was obvious and lacked utility. The FC found that the allegation was justified.
May 9, 2017

Apotex’s Claims for Damages for Delayed Market Entry Allowed to Proceed

2017 ONSC 224 - Apotex sought compensation from Eli Lilly for damages suffered for delayed entry to the market for its generic version of olanzapine; the ONSC ordered Eli Lilly to pay Apotex a total of $20,000.
May 2, 2017

FCA Finds Provincial Limitation Periods May Apply to Patents Subject to the Old Patent Act

2017 FCA 9 - The FCA affirmed the FC decision that AstraZeneca’s patent was valid and infringed, accepted Apotex’s appeal with respects to limitation periods, and rejected AstraZeneca’s cross-appeal regarding punitive damages.
March 14, 2017

Federal Court Grants Prohibition Order on Generic Psoriasis-treating Ointment

2015 FC 1237 - The FC heard and granted an application by Leo Pharma to prohibit Teva Canada from being issued a Notice of Compliance under the PM(NOC) Regulations.
February 7, 2017

FC Affirms Prothonotary Decision Allowing Action to Continue on Allegations of Likely Future (Quia Timet) Infringement

2016 FC 336 - The FC affirmed Prothonotary Tabib’s decision to strike some of Gilead Science's pleadings and allow the infringement action to continue on the basis of amended allegations of a likely future (quia timet) infringement.
February 3, 2017

Does the Patent Act provide a “complete code” of remedies? ONSC allows the argument to proceed that it may not

2016 ONSC 7193 - The ONSC heard pleadings by Apotex and Pfizer concerning Pfizer’s, now invalid, patent for Viagra. Apotex had previously been prevented from manufacturing its own generic because of the Viagra patent, and now claimed damages for the delay in being able to market its own variant. The appeal was dismissed and Apotex’s claim was allowed to proceed unstruck.
January 3, 2017

FC Rules PM(NOC) Prohibition Application Not An Abuse of Process

2015 FC 1016 - In this decision, the FC permitted the applicant to proceed with its prohibition application, despite a previous decision finding that the patent in question was invalid.