Pharmaceutical Patent

Pharmaceutical inventions have been the subject of special provisions in the past, the likes of which have not been applied to other inventions. Furthermore, pharmaceuticals are the subject of much government regulation outside of the patent system.

October 11, 2018

What Pharma Patentees Need to Know About Canada’s CSP Regime

Canada’s Certificate of Supplementary Protection Regime – an overview a year into its introduction
June 27, 2018
accounting

Defendants Are Not Entitled to Elect Accounting of Profits

2018 FCA 32 - The FCA dismissed Apotex’s appeal challenging the remedial decision, regarding Bayer's Canadian Patent No. 2,382,426, holding that subsection 57(1) of the Patent Act did not grant a defendant in a patent infringement suit the right to choose an accounting of profits over damages to be paid to the patentee.
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.
January 2, 2018

Federal Court of Appeal Confirms Issued Patents cannot be Invalidated by Underpayment of an Administrative Fee

2017 FCA 201 - The FCA upheld the FC’s ruling against Apotex, that Pfizer's failure to pay the proper final fee for the issuance of a Canadian patent will not invalidate the patent.
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.
December 5, 2017

Federal Court Declines Jurisdiction to Approve Third-Party Funding Agreements in the Private Litigation Context

2017 FC 826 - The FC declined to approve, or disapprove, Seedlings' litigation funding agreement with Bentham, where Bentham would fund Seedlings' patent litigation against Pfizer. The FC found that it lacked jurisdiction, as contractual matters are generally provincial in nature, and that only agreements related to class action proceedings would require the approval of the FC.
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.
November 7, 2017
tadalafil

Apotex Fails to Change FCA’s Opinion in Tadalafil Case

2016 FCA 267 - Apotex unsuccessfully sought to show that the FCA had erred in another decision by not following the SCC's decision in Whirlpool. Apotex also unsuccessfully argued that the FC had erred by finding the tadalafil patent to have sufficient disclosure.
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 10, 2017
insufficient disclosure

Federal Court of Appeal Upholds Finding of Insufficient Disclosure

2017 FCA 161 - The FCA dismissed Idenix's appeal to a FC decision in which Idenix's Canadian patent was found invalid for insufficient disclosure and its counterclaim against Gilead was dismissed.
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 18, 2017

Federal Court of Canada Dismisses Motion for Interlocutory Injunction and Orders Security for Costs

2016 FC 606 - The FC dismissed TearLab’s application for an interlocutory injunction preventing I-MED from selling its i-Pen System, and ordered TearLab to pay security for costs.
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 27, 2017

ICSID Tribunal dismisses Eli Lilly’s NAFTA claim against Canada

Case No. UNCT/14/2 - An ICSID Tribunal dismissed Eli Lilly’s claim against Canada, which was brought in relation to two Canadian patents owned by Eli Lilly that had been invalidated for failing to provide the utility they promised.
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 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.
April 25, 2017

Federal Court finds foreign, non-exclusive licensee entitled to damages

2016 FC 593 - The FC awarded Janssen Canada and Janssen US almost $19 million in total damages for Teva's infringement of a Japanese entity's patent, for which Janssen US had never even exercised its licence in Canada.
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.