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
Outside Canada, Teva’s Copaxone® 40mg/mL dosing patents have been invalidated for obviousness, making way for generic competitors.
April 4, 2019
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
2018 FC 694 – Federal Court confirms that motion for early dismissal will only be granted in the clearest of cases.
April 3, 2018
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
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
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
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
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
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
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
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.