Topic: Intellectual property

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Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

SUMMARY The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug BELSOMRA (suvorexant). BACKGROUND A CSP provides patent-like rights and is intended to compensate patentees for … Continue reading

Canada seeks leave to appeal to the Supreme Court in PMPRB excessive-pricing case

The Attorney General of Canada has sought leave to appeal to the Supreme Court in an excessive-pricing case regarding the drug SOLIRIS. As we reported, Alexion Pharmaceuticals Inc. was successful before the Federal Court of Appeal in an application for judicial review of a 2017 PMPRB decision finding that Alexion had sold SOLIRIS at an … Continue reading

ONSC dismisses Apotex’s second monopolies action

The Ontario Superior Court of Justice has released the second decision in a series of summary judgment motions relating to Apotex’s claims against innovative drug companies under various causes of action pursued above and beyond the section 8 damages regime in the Patented Medicines (Notice of Compliance) Regulations. In Apotex Inc. v. Pfizer Ireland Pharmaceuticals, … Continue reading

PMPRB excessive price decision quashed by Federal Court of Appeal

The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination. Procedural background The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive … Continue reading

PMPRB Guidelines update: consultation on changes re delayed implementation

The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines. The PMPRB has indicated that these changes are intended to account for … Continue reading

Consultation on proposed amendments to Patent Rules

The Government of Canada has proposed a series of amendments to the Patent Rules intended to keep Canada compliant with its obligations under the Canada-United States-Mexico Agreement (CUSMA) and the Patent Cooperation Treaty (PCT). As part of the proposal, the Canada Gazette published a Regulatory Impact Analysis Statement on July 3, 2021, summarizing the changes and their anticipated impact. Interested persons have … Continue reading

PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which are scheduled to come into force at the same time as the amendments. The amendments contain a number of … Continue reading

Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation

The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the “second person” (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation (NOA). While new allegations may not be … Continue reading

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees. Regulations amending the Regulations, which will … Continue reading

Federal Court of Appeal Gradually Phases Out Suspension Period

The Federal Court of Appeal (FCA) has begun to gradually restore filing deadlines in appeals before the Court that were subject to the Court’s Suspension Period. Under the Suspension Period system, the progress of individual appeals has been managed by “selecting” and “deselecting” them from a Selected Files list. As we previously reported, the FCA … Continue reading

Federal Court quashes NOC in dispute over Data Protection Provisions

The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process … Continue reading

Federal Court Issues Consolidated IP Guidelines

On May 18, 2021, the Federal Court (FC) issued amended Case and Trial Management Guidelines for Complex Proceedings (the Updated FC Guidelines). As we previously reported, the FC first issued the FC Guidelines to consolidate and address topics in earlier FC Notices to the Profession. Notable amendments: The Updated FC Guidelines include the following notable … Continue reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading

New Proposed Amendments to the Federal Courts Rules: Proportionality, Abuse of Process, and Motions Before the Federal Court of Appeal

On April 10, 2021, the Rules Committee of the Federal Court of Appeal and the Federal Court (the Rules Committee) launched a consultation on amendments to the Federal Courts Rules (the Rules) on proportionality, abuse of process, and Federal Court of Appeal motions. In the Regulatory Impact Analysis Statement (RIAS), the Committee has stated these … Continue reading

PMPRB Update: New periods for compliance with the new Guidelines

The PMPRB has confirmed that patentees of “Grandfathered” and “Gap” medicines will have two reporting periods to comply with new price ceilings to be set under its new Guidelines, replacing previous guidance that only one reporting period would be permitted. Updates to the Guidelines As we reported, the Guidelines were released by the PMPRB on … Continue reading

Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on … Continue reading

Federal Court of Appeal provides guidance on the “inventive concept”

The Federal Court of Appeal (FCA) has held that the “inventive concept” can go beyond the essential elements of the claim and may include advantageous properties stated in the patent’s description. The FCA confirmed that the inventive concept is the end-point in the obviousness analysis: for a claimed invention to be obvious, the gap between … Continue reading

Ontario Superior Court summarily dismisses Apotex’s novel monetary claims under Statutes of Monopolies, Trademarks Act, and at common law

On March 8, 2021, the Ontario Superior Court granted summary judgment dismissing novel claims by Apotex under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law. It is the first decision on the merits of Apotex’s novel claims and arises in the context of litigation relating to Eli Lilly’s patented … Continue reading

Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the … Continue reading

Federal Court finds 45-day limitation period does not apply to s 8.2 PM(NOC) related rights of action for unlisted patents

Summary The Federal Court has held that the “related right of action” for infringement of unlisted patents under section 8.2 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) is not subject to the 45-day limitation period familiar to patentees asserting infringement of listed patents under subsection 6(1). Background Merck Canada Inc. and Merck Sharp … Continue reading

Federal Court upholds patent validity and issues declarations of infringement against two generic apixaban tablets

In one of its first patent decisions of 2021, the Federal Court tackled arguments regarding the relevant date for insufficiency allegations and the level of disclosure required for demonstrated utility. The Court resolved these and other issues in the patentees’ favour, granting declarations of infringement against two proposed apixaban generics. Background ELIQUISTM (an blood thinner) … Continue reading

PM(NOC) Regulations do not preclude defendants from amending the statement of defence

A defendant in a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations was allowed to amend its defence to include invalidity allegations not found in the Notice of Allegation. Background In an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) concerning three patents, the … Continue reading

Pharma in Brief: The 2020 Year in Review

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2020. Introduction The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. The industry was among the heroes of 2020, developing, commercializing … Continue reading

Federal Court updates guidance on COVID-19

On January 18, 2021, the Federal Court (FC) issued its latest COVID-19 Practice Direction, which supersedes all its prior COVID-19 practice directions. The FC’s facilities in Ontario and Quebec have been closed in light of the recent public health measures to combat the pandemic. The FC will continue its operations remotely in these two provinces … Continue reading
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