Topic: Intellectual property

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Amended CUSMA no longer extends data protection for biologics

On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years … Continue reading

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020. Background As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and … Continue reading

Federal Court refuses to allow fifth generic to join common trial on validity

The Federal Court has denied a motion by Dr. Reddy’s Laboratories’ (Dr. Reddy’s) seeking to participate in a common validity issues trial in actions concerning four other generic versions of the same drug under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). Background As we reported, the Federal Court has made a number of … Continue reading

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines. Background As we reported, the Government released final amendments to the Patented Medicines … Continue reading

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s … Continue reading

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

The Federal Court of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal concluded that when viewed as a whole, there was no reviewable error in the judgment … Continue reading

Federal Court rejects the concept of “first mover advantage” for generics in PM(NOC) infringement actions

The Federal Court has ordered that two additional generic defendants (Taro Pharmaceuticals Inc., Sandoz Canada Inc.) be added to a trial of common issues currently set for Bayer Inc.’s claims against Teva Canada Limited and Apotex Inc. concerning generic versions of XARELTO® (rivaroxaban) under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). All four … Continue reading

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

The Federal Court has found that it is reasonably arguable that a claim for “a composition for use in the treatment of a disorder” may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished these claims from pure “use of a composition for a treatment” claims, which can only … Continue reading

Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations

On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect … Continue reading

Federal Court relies on foreign prosecution history in first application of file wrapper estoppel

In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time. While CanMar is not a life sciences case, the application of Canada’s new file wrapper estoppel provision has implications for patentees generally. In CanMar, … Continue reading

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into … Continue reading

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the … Continue reading

Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in … Continue reading

Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed … Continue reading

CUSMA Implementation Bill Introduced

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty. CUSMA provides more protections for biologic and innovative pharmaceuticals … Continue reading

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole. Background As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to … Continue reading

Regulatory changes for generics proposed to clarify ANDS pathway eligibility

On March 30, 2019, the government published proposed amendments to the Food and Drug Regulations (FDR) intended to clarify whether a generic version of a drug can be approved using the abbreviated new drug submission (ANDS) pathway. These amendments affect how the FDR apply to a generic drug product if it contains a different medicinal … Continue reading

Federal Court grants application under the old PM(NOC) Regulations for a prohibition order regarding a metformin formulation

On March 8, 2019, the Federal Court issued a prohibition order against a generic version of GLUMETZA® (metformin hydrochloride extended-release tablets) proposed by Generic Partners Canada Inc. (Generic Partners) in an application under the pre-CETA Patented Medicines (Notice of Compliance) Regulations. GLUMETZA® is marketed in Canada by Valeant Canada LP/Valeant Canada SEC (Valeant), which asserted … Continue reading

Competition Bureau publishes Final IP Enforcement Guidelines

On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The revised IPEGs replace the earlier 2016 version. … Continue reading

FCA Confirms Entirety of Inventors’ Conduct is Relevant in Obviousness Analysis and Upholds Inventiveness of Crystal Form Patent

The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive. Obviousness The FCA began be reiterating key points of the … Continue reading

Top Headlines of 2018

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of … Continue reading

FCA Confirms that Non-Infringing Alternative Must be Legal and Objectively Economically Viable

The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue … Continue reading

Bill C-86 receives Royal Assent, bringing amendments across Canada’s IP statutes

Canada’s core IP statutes have been amended by Bill C-86, which received Royal Assent as the Budget Implementation Act, 2018, No. 2, SC 2018, c 27 on December 14, 2018. The final version of the legislation includes amendments to the Patent Act that are substantially identical to the version that received first reading 46 days … Continue reading

Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions

The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the … Continue reading
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