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Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was … Continue reading

Federal Court finds generic would induce infringement of combination therapy patent

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on 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

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Brian R. Daley and Pharma in Brief team on 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

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on 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

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Brian R. Daley and Pharma in Brief team on 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

Photo of Kristin WallPhoto of Pharma in Brief teamBy Kristin Wall and Pharma in Brief team on 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

CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

Photo of Kristin WallPhoto of Pharma in Brief teamBy Kristin Wall and Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the … Continue reading

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

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

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

Photo of David YiPhoto of Kristin WallPhoto of Pharma in Brief teamBy David Yi, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Intellectual property
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

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

Photo of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy Christopher A. Guerreiro and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Pharma in Brief: The 2020 Year in Review

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on 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

Canada amends CSP Regulations, adding UK to list of “timely submission requirement” countries

Photo of Kristin WallPhoto of Pharma in Brief teamBy Kristin Wall and Pharma in Brief team on Posted in Uncategorized
Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection (CSP). The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility … Continue reading

Divided success in PM(NOC) actions regarding glatiramer acetate

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy Sarah Pennington, Christopher A. Guerreiro and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon “speculative” prior art and rejected an argument that there was insufficient disclosure to satisfy the test for sound prediction. However, the Court found one of … Continue reading

Prosecution history cannot be invoked against patent licensees

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Brian R. Daley and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court has found that prosecution history evidence is inadmissible to rebut representations made by a patent licensee (as opposed to the patentee) on claims construction. The Court also considered the issues of “essential elements”, infringement, and obviousness in the context of a formulation patent. Background The Court’s decision concerns Canadian Patent No. 2,507,002 … Continue reading

NOC issued after Federal Court overturns Minister’s decision on effective date of consent letter under the PM(NOC) Regulations

Photo of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy Christopher A. Guerreiro and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to … Continue reading

Finality, finally:  Adir and Servier Canada Inc. confirm their perindopril win

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “Servier”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “Apotex”). The end was marked by the Supreme Court of Canada’s dismissal of Apotex’s application for leave to appeal a decision requiring it to disgorge its profits associated … Continue reading

Federal Court finds Minister’s CSP decision unreasonable on patent eligibility for fixed-dose combination drug product

Photo of Kristin WallPhoto of Pharma in Brief teamBy Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) … Continue reading

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

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on 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

Federal Court determines that infringement action under PM(NOC) Regulations is not moot where trial proceeds after patent expiry

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent. Background … Continue reading

Federal Court supports virtual trials for intellectual property actions

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Canada has embraced virtual hearings as the best solution to the prolonged Covid-19 shutdown. While acknowledging some litigants’ concerns pertaining to procedural fairness and information security in recent rulings, the Court is more concerned that justice delayed can become justice denied. Videoconferencing will not impede the Court’s ability to assess the … Continue reading
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