Colin Hyslop

Federal Court finds generic would induce infringement of combination therapy patent

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product. Background Janssen Inc. markets OPSUMIT® (macitentan) to treat patients … Continue reading

Federal Court finds a combination therapy patent valid and infringed

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on June 14, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations that the asserted patent claims were invalid for obviousness, lack of utility, overbreadth, and insufficiency of disclosure. Background Janssen Inc. (Janssen) markets OPSUMIT® in Canada for the treatment of pulmonary arterial … Continue reading

Federal Court finds salt patent valid in a PM(NOC) action regarding sitagliptin

By Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on April 19, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of obviousness and insufficiency, and it found the asserted claims to be valid and infringed. In reaching its decision, the Court provided substantive guidance on hearsay evidence in infringement … Continue reading

Federal Court sends NOC dispute concerning data protection provisions back to the Minister for a second redetermination

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on March 23, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court (FC) has granted an application for judicial review involving the data protection provisions in section C.08.004.1 of the Food and Drug Regulations in a case involving new drug submissions (NDSs) for two different amifampridine products. This is the second time that the FC has set aside a decision to issue a notice … Continue reading

Federal Court rejects motion for summary judgment in Canadian patent infringement case following voluntary dismissal of parallel US litigation

By Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on March 17, 2022 Posted in Intellectual property

In a recently released decision, the Federal Court (FC) considered what happens when a patent infringement plaintiff agrees to resolve a dispute in a foreign jurisdiction, but continues to press parallel litigation against the same defendant in Canada. In this case, the defendant sought summary judgment based on the terms of a voluntary dismissal between the … Continue reading

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

By Kristin Wall, Corey McClary and Colin Hyslop on October 20, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences, Uncategorized

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

Amendments to the Federal Courts Rules

By Colin Hyslop, David Yi and Kristin Wall on July 7, 2021 Posted in Uncategorized

On June 17, 2021, a series of amendments to the Federal Courts Rules (the Amended Rules), were registered and came into force. On July 7, 2021, the Amended Rules were officially published in the Canada Gazette Part II. Key Changes and Additions: The Amended Rules include the following key changes and additions: The monetary relief … Continue reading

Pharma in Brief: The 2020 Year in Review

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on January 24, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

PMPRB takes jurisdiction over medicine (again) following Federal Court of Appeal remand

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on July 7, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB or Board) has found that a patent can pertain to a medicine based on clinical similarities to the invention—even if the patent does not actually encompass the medicine. Background This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat … Continue reading

Dosing regimen patent found valid and infringed in the second decision under the new PM(NOC) Regulations

By Shantelle LaFayette, Colin Hyslop and Brian R. Daley on May 27, 2020 Posted in Intellectual property, Pharmaceuticals and life sciences

In the second trial judgment under the new Patented Medicine (Notice of Compliance) Regulations, the Federal Court (FC) found for the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V., and enjoined Teva Canada Limited (Teva) from making, constructing, using or selling paliperidone palmitate (paliperidone) in accordance with its abbreviated new drug submission. The Court rejected Teva’s … Continue reading

Governmental Use of Patented Inventions during a Pandemic: A Global Survey

By Chelsea Nimmo and Colin Hyslop on April 22, 2020 Posted in Intellectual property

Key Contacts: Jeffrey Lewis (New York), Jenny Shum (New York), Clemens Rubel (Munich), Seiko Hidaka (London), Justin Davidson (Hong Kong SAR), Jackie O’Brien (Sydney) Around the globe, pharmaceutical and medical device companies are helping in the fight of the COVID-19 pandemic. Many of these companies may have patents pertaining to technology that could be used … Continue reading

Patent owner files its own pleading in a PM(NOC) action

By Colin Hyslop, Daniel Daniele and Brian R. Daley on January 29, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, … Continue reading

Pharma in Brief: The 2019 Year in Review

By Kristin Wall, Christopher A. Guerreiro and Colin Hyslop on January 19, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

In this article, the Pharma in Brief team curated the most significant topics we covered during 2019. The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national … Continue reading

Federal Court reinstates damages decision concerning prejudgment interest

By Colin Hyslop, David Yi and Allyson Whyte Nowak on January 15, 2020 Posted in Damages

The Federal Court has vindicated Lilly, reinstating a patent infringement damages decision that awarded Lilly prejudgment interest equal to its average annual rate of return during the interest earning period, on a compound basis. It found that Lilly’s real-world rate of return was convincing evidence of both what could have and what would have occurred … Continue reading

Federal Court dismisses motion for determination of an issue of law under the new PM(NOC) Regulations

By Colin Hyslop and Judith Robinson on November 29, 2019 Posted in Pharmaceuticals and life sciences

The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court … Continue reading

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

By Colin Hyslop on November 25, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

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

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on November 7, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

By Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on October 6, 2019 Posted in Intellectual property

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