Topic: Intellectual property

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

Photo of Fortunat Nadima NadimaPhoto of Christopher A. GuerreiroPhoto of Amy GrenonBy Fortunat Nadima Nadima, Christopher A. Guerreiro and Amy Grenon 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

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

Photo of Shantelle LaFayettePhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyBy Shantelle LaFayette, Christopher A. Guerreiro and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Colin Hyslop, Christopher A. Guerreiro and Kristin Wall 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

Federal Court updates guidance on COVID-19

Photo of Caroline HenriePhoto of Brian R. DaleyBy Caroline Henrie and Brian R. Daley on Posted in Intellectual property
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

Divided success in PM(NOC) actions regarding glatiramer acetate

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Amy GrenonBy Sarah Pennington, Christopher A. Guerreiro and Amy Grenon 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 Fortunat Nadima NadimaPhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyBy Fortunat Nadima Nadima, Christopher A. Guerreiro and Brian R. Daley 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

Federal Court of Appeal Upholds First Trial Judgment under New PM(NOC) Regulations

Photo of Orestes PasparakisPhoto of Mark DavisPhoto of Daniel DanielePhoto of Paul JorgensenPhoto of Kassandra ShorttBy Orestes Pasparakis, Mark Davis, Daniel Daniele, Paul Jorgensen and Kassandra Shortt on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The … Continue reading

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

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroBy Kassandra Shortt and Christopher A. Guerreiro 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 Judith RobinsonPhoto of Joanne ChriquiBy Judith Robinson and Joanne Chriqui 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 issues new consolidated guidelines on complex proceedings

Photo of Caroline HenriePhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Caroline Henrie, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property
On October 22, 2020, the Federal Court (FC) issued new Case and Trial Management Guidelines for Complex Proceedings (the FC Guidelines). These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015); … Continue reading

PMPRB Update: Final Guidelines Released

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Kristin WallBy Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On Friday, October 23, the Patented Medicine Prices Review Board (PMPRB) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments). According to the PMPRB: The Guidelines provide information on the PMPRB’s general approach to the price review … Continue reading

Overview of IP Law In Canada – The Intellectual Property Review, 9th Edition

Photo of Caroline HenriePhoto of Adam HallerPhoto of Kristin WallBy Caroline Henrie, Adam Haller and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The recently published Ninth Edition of the Intellectual Property Review (the Review) includes a chapter detailing the various forms of IP protection available in Canada, and highlights important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team. The chapter also provides an overview … Continue reading

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

Photo of Morgan WestgatePhoto of Kristin WallBy Morgan Westgate and Kristin Wall 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 Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Colin Hyslop, Christopher A. Guerreiro and Kristin Wall 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 lifts Suspension Period

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on Posted in Intellectual property
On June 25, 2020, the Federal Court (FC) issued its latest Practice Direction and Order (FC Update) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations … Continue reading

PMPRB launches consultation on revised Draft Guidelines

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Brian R. DaleyBy Christopher A. Guerreiro, Kristin Wall and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public … Continue reading

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

Photo of Morgan WestgatePhoto of David YiPhoto of Amy GrenonBy Morgan Westgate, David Yi and Amy Grenon 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

PMPRB update: Amendments delayed, new Guidelines consultation announced, and judicial review heard

Photo of Christopher A. GuerreiroPhoto of Kristin WallBy Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review … Continue reading

Two PM(NOC) Actions Dismissed After Common Trial on Validity of Treatment Regimen Patent

Photo of Paul JorgensenPhoto of David YiPhoto of Daniel DanieleBy Paul Jorgensen, David Yi and Daniel Daniele on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were … Continue reading

Federal Court supports virtual trials for intellectual property actions

Photo of Bianca PietracupaPhoto of Brian R. DaleyBy Bianca Pietracupa and Brian R. Daley 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

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

Photo of Shantelle LaFayettePhoto of Colin HyslopPhoto of Brian R. DaleyBy Shantelle LaFayette, Colin Hyslop and Brian R. Daley on 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

FCA gives guidance for common PM(NOC) trials involving multiple actions

Photo of Fortunat Nadima NadimaPhoto of Christopher A. GuerreiroPhoto of Judith RobinsonBy Fortunat Nadima Nadima, Christopher A. Guerreiro and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Appeal has reversed the Federal Court’s decision to add two additional generic defendants (Taro Pharmaceuticals Inc. and Sandoz Canada Inc.) to an upcoming common trial under the Patented Medicines (Notice of Compliance) Regulations. The common trial will determine patent validity issues in Bayer Inc.’s actions against Teva Canada limited and Apotex … Continue reading

Suspension Periods extended at the FCA and CIPO

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on Posted in Intellectual property
This week, the Federal Court of Appeal (FCA) extended its Suspension Period and the Canadian Intellectual Property Office (CIPO) extended its deadlines, both until the end of May. Federal Court of Appeal As we reported, the FCA has issued a number of Notices to the Parties and the Profession concerning the conduct of litigation during … Continue reading

Federal Court extends Suspension Period and expands use of virtual hearings

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on Posted in Intellectual property
On April 29, 2020, the Federal Court (FC) published a Practice Direction and Order (FC Update) extending its Suspension Period until May 29, 2020 and adjourning hearings until June 29, 2020—subject to certain exceptions. During this time, the Court has made provisions to hold certain hearings by phone or Zoom videoconference. The FC Update is … Continue reading
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