Topic: Intellectual property

Subscribe to Intellectual property RSS feed

ONCA Permits Pleading Amendments Asserting Validity of Previously Invalidated Patent following Nexium Decision

Kassandra ShorttDavid YiAllyson Whyte NowakBy Kassandra Shortt, David Yi and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences
This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug. Apotex’s claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 … Continue reading

Ontario Superior Court rejects Apotex attempts to revive the Promise Doctrine by dismissing motion for leave to amend, awards substantial indemnity costs

Morgan WestgateDavid YiKristin WallBy Morgan Westgate, David Yi and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
The Ontario Superior Court of Justice (ONSC) recently denied Apotex’s attempt to repackage the now defunct “promise of the patent” doctrine (the Promise Doctrine).  Apotex sought to amend its pleadings to reintroduce the Promise Doctrine under the guise of invalidity allegations of over-breadth, insufficiency, and willful misrepresentation pursuant to sections 27 and 53 of the … Continue reading

File-wrapper admissibility and other changes to the Patent Act are coming: what’s new for pharmaceutical patentees in Bill C-86

Christopher A. GuerreiroJordana SanftBy Christopher A. Guerreiro and Jordana Sanft on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The federal government’s recent omnibus budget bill, Bill C-86 tabled October 29th, 2018, proposes significant changes to Canada’s IP laws. Division 7 of the Bill is intended to implement many aspects of the government’s IP strategy, announced in April 2018. The Bill targets the Patent Act, the Trade-marks Act, and Copyright Act; provides for a … Continue reading

New protections for biologics and other pharmaceuticals under the United States-Mexico-Canada Agreement (USMCA)

Christopher A. GuerreiroKristin WallJudith RobinsonBy Christopher A. Guerreiro, Kristin Wall and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Canada has joined a new trilateral trade deal called the United States-Mexico-Canada Agreement (USMCA). The USMCA contains important new protections for biologic and other pharmaceutical innovation. Chief among them, Canada will introduce an extended ten-year period of data protection for biologics and patent-term restoration (PTR) for delays in the patent office. The … Continue reading

First motion for early patent dismissal fails to meet high burden under newly-amended PM(NOC) Regulations

Chelsea NimmoPaul JorgensenKristin WallJordana SanftBy Chelsea Nimmo, Paul Jorgensen, Kristin Wall and Jordana Sanft on Posted in Intellectual property, Pharmaceuticals and life sciences
On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen Canada Inc. (Amgen), was seeking an order dismissing the Plaintiffs’ action in respect of two of … Continue reading

CETA Tracker: Update on section 6 actions under the Patented Medicines (Notice of Compliance) Regulations

Christopher A. GuerreiroKristin WallJordana SanftJudith RobinsonBy Christopher A. Guerreiro, Kristin Wall, Jordana Sanft and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under the amended Regulations. New actions under the amended Regulations Nearly seven months after the amended Regulations came … Continue reading

Apotex request to re-open validity of esomeprazole patent denied

Corey McClaryKristin WallBy Corey McClary and Kristin Wall on Posted in Intellectual property
The Federal Court dismissed Apotex’s motion to re-open the validity phase of the patent infringement action relating to esomeprazole (AstraZeneca’s NEXIUM®). Apotex had moved to re-open validity to allow the Court to adjudicate the issue of “overpromising” in light of the Supreme Court of Canada’s decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC … Continue reading

ONCA upholds dismissal of summary judgment in lansoprazole s. 8 case

David YiAllyson Whyte NowakRandy SuttonBy David Yi, Allyson Whyte Nowak and Randy Sutton on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA) affirmed the lower court’s finding that a real-world notice of non-compliance – withdrawal (NON-W) issued by Health … Continue reading

Coulda, woulda, shoulda – Federal Court finds Apotex would not have used non-infringing alternatives in perindopril case

Brian John CapogrossoJoanne ChriquiJudith RobinsonBy Brian John Capogrosso, Joanne Chriqui and Judith Robinson on Posted in Intellectual property
On redetermination of an accounting of profits, the Federal Court (FC) rejected Apotex’s claim that the profits awarded to Servier due to Apotex’s manufacture and sale of infringing perindopril should be reduced based on alleged non-infringing alternatives (NIAs). Background In 2008, the FC found that Servier’s patent claiming perindopril was valid and infringed by Apotex, … Continue reading

Change in utility law not a factor in s. 8 damages

David YiLouisa PontrelliAllyson Whyte NowakBy David Yi, Louisa Pontrelli and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Appeal (FCA) has refused to apply the “special circumstances” exception to issue estoppel in view of a change in law arising from the rejection of the “promise doctrine” in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (NEXIUM, reported here). Noting any injustice to Lilly is “entirely commercial in nature” … Continue reading

CETA Tracker: Update on CSPs

Jonathan ChongKristin WallBy Jonathan Chong and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations … Continue reading

Section 8 liability offset by patent infringement in esomeprazole case

David YiBen WallworkAllyson Whyte NowakBy David Yi, Ben Wallwork and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court denied Apotex’s section 8 claim relating to esomeprazole on the basis that its product would have infringed a valid AstraZeneca patent. This aligns with a previous decision of the court that placed significant weight on patent infringement in the context of section 8 damages (reported here). There was no dispute that Apotex’s … Continue reading

FCA affirms that infringer does not have the right to elect remedy for infringement in drospirenone case

Jonathan ChongKristin WallAllyson Whyte NowakBy Jonathan Chong, Kristin Wall and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences
Following the Federal Court’s decision that Bayer’s patent relating to YAZ and YASMIN (both containing drospirenone and ethinyl estradiol) was valid and infringed by Apotex and Cobalt, Apotex argued that it, rather than Bayer, should be entitled to elect between damages and an accounting of profits. As we reported, the court disagreed, and ordered that … Continue reading

Ontario Superior Court denies pleading amendments based on Supreme Court of Canada’s rejection of promise doctrine in ramipril damages action

David YiAllyson Whyte NowakBy David Yi and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Federal Court jurisprudence is being continually reshaped by the Supreme Court’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (NEXIUM Decision). In Apotex v. Schering Corporation, 2018 ONSC 903, the Ontario Superior Court has now considered the impact of the NEXIUM Decision in the context of Apotex’s action for … Continue reading

Top Headlines of 2017

Kristin WallJordana SanftBy Kristin Wall and Jordana Sanft on Posted in Intellectual property, Pharmaceuticals and life sciences
Happy New Year from Pharma in Brief! Reflecting back on 2017, the only constant over the last year was change, with the implementation of CETA, the rejection of the Promise Doctrine and proposals for reform of various regulatory regimes. We have compiled our list of top headlines below. Major changes to regulatory framework for pharmaceutical … Continue reading

Federal Court of Appeal affirms that the Patent Act’s price control provisions over patented medicines were validly enacted

Chelsea NimmoChristopher A. GuerreiroKristin WallBy Chelsea Nimmo, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Appeal has reaffirmed the constitutionality of the excessive price provisions of the Patent Act that ground the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) over patented medicines. Background In 2015, the PMPRB commenced a proceeding against Alexion alleging that the price of Alexion’s drug SOLIRIS® (eculizumab) was excessive.  In … Continue reading

CETA tracker: First CETA PM(NOC) action has been commenced in Federal Court

Jordana SanftKristin WallJudith RobinsonBy Jordana Sanft, Kristin Wall and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
The first court action under the newly amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) was commenced on December 11, 2017.  Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc. (T-1921-17) addresses allegations of infringement with respect to Canadian Patent Nos. 2,376,596; 2,596,133; 2,407,556 and 2,540,547 and a biosimilar new drug submission for … Continue reading

PMPRB responds to proposed amendments to the Patented Medicines Regulations with Guidelines Scoping Paper

Christopher A. GuerreiroKristin WallBy Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
On Monday, December 11, 2017, the Patented Medicine Prices Review Board (PMPRB) released a scoping paper providing a high-level overview of how a new, risk-based approach to its mandate could function under revised Guidelines following forthcoming amendments to the Patented Medicines Regulations. This previews an official consultation on a revised set of proposed Guidelines that … Continue reading

Federal Court of Appeal Provides Further Guidance on Inventive Concept

Corey McClaryBrian R. DaleyBy Corey McClary and Brian R. Daley on Posted in Intellectual property
The Federal Court of Appeal has provided additional guidance on the framework for analyzing obviousness. In dismissing an appeal from the Federal Court, the Court of Appeal identified the search for an inventive concept as an “unnecessary satellite debate” and held that a more useful approach would be to construe the claims. Case:  CIBA Specialty … Continue reading

Amendments to the Patented Medicines Regulations are coming: Health Canada proposes new powers for the PMPRB to lower prices of patented medicines in Canada

Christopher A. GuerreiroKristin WallBy Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
On Friday, December 1, 2017, the government revealed proposed amendments to the Patented Medicines Regulations (the Regulations) conferring new powers on the Patented Medicine Prices Review Board (PMPRB) and setting the stage for revised Guidelines from the Board. Interested stakeholders have until February 14, 2018 to provide comments to the government. A definitive version of … Continue reading

PMPRB update: new developments in eculizumab and adapalene cases

Christopher A. GuerreiroKristin WallBy Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
We provide an update of developments in recent PMPRB cases below. Notably, the PMPRB has ordered Alexion Pharmaceuticals Inc. to pay $4,245,329.60 in excess revenues earned on sales of SOLIRIS (eculizumab) to Her Majesty in right of Canada and has also appealed the Federal Court’s judgment against it in the Galderma case regarding DIFFERIN. Updates … Continue reading

Federal Court finds that the PMPRB incorrectly applied patent-pertaining analysis in Galderma judicial review

Christopher A. GuerreiroKristin WallBy Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court found that the PMPRB wrongly asserted jurisdiction over Differin® pricing based on an incorrect application of the patent-pertaining analysis. The Court allowed an application for judicial review by Galderma Canada Inc. (Galderma) from the PMPRB’s failure-to-file decision, holding that the PMPRB had failed to consider the entirety of Galderma’s patent when determining … Continue reading

Patented Medicine Prices Review Board releases its 2016 Annual Report

Christopher A. GuerreiroKristin WallBy Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
In its 2016 Annual Report, the Patented Medicine Prices Review Board (PMPRB) provides  a detailed summary and analysis of its findings concerning the 1,435 patented drug products under its jurisdiction. These products represent $15.5 billion in sales and account for 60.8% of all drug sales in Canada. The 2016 Annual Report reflects the current climate … Continue reading

FCA Limits Scope of Dutch Industries and Declines to Invalidate Patent on the Basis of Administrative Non-Compliance with Patent Act in latanoprost s. 8 case

David YiJordana SanftBy David Yi and Jordana Sanft on Posted in Intellectual property
Pfizer Canada Inc. successfully resisted Apotex’s appeal of the Federal Court’s dismissal of Apotex’s motion for summary judgment for invalidity based on a failure to pay the correct “final fee” owing prior to patent grant. The Federal Court of Appeal upheld the lower court’s decision and held that alleged infringers of a patent cannot rely … Continue reading
LexBlog