Topic: Intellectual property

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

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

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

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

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

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

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

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

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

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

Federal Court confirms innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to another innovator company, confirming that the second innovator has a legal interest in the determination of … Continue reading

PMPRB applies unknown test against patentee to make excessive-pricing order outside of the Guidelines

The Patented Medicine Prices Review Board (PMPRB) has issued an excessive-pricing order against Alexion Pharmaceuticals Inc. (Alexion) in respect of SOLIRIS (eculizumab) based on the application of a Lowest International Price Comparison (LIPC) test. In public reasons issued September 27, 2017, the PMPRB ordered Alexion to (i) repay excess revenues to the Crown from the … Continue reading

Federal Court releases new guidelines for prohibition actions under the amended Patented Medicines (Notice of Compliance) Regulations

As we reported, amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) took effect on September 21, 2017, as part of the broader roll-out of measures implementing the Comprehensive Economic and Trade Agreement (CETA) with the European Union. The amendments introduce significant changes to proceedings under the Regulations, which will now proceed by … Continue reading

Update on utility and the impact of the SCC decision in NEXIUM case

The impact of the Supreme Court’s landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM decision) rejecting the “Promise Doctrine” is taking shape in the Federal Court. As we reported, the SCC held that the level of utility required of a Canadian patent is driven by the claims of the patent … Continue reading

CETA tracker: CETA implemented September 21

Final CETA regulations impacting pharmaceuticals come into force Canadian and European Union leaders signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. As we reported, the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Act) and accompanying regulations provide key reforms to the Patent Act affecting the pharmaceutical industry, including … Continue reading

Apotex disentitled to section 8 recovery on the basis of patent infringement in omeprazole case

For the first time, the Federal Court has disentitled compensation pursuant to section 8 of the Regulations on the basis of infringement of a patent. This holding was also based on the court’s finding that Apotex would not have had an available non-infringing alternative (NIA) at any point during the period of infringement (September 5, … Continue reading

CETA tracker: Final Regulations released

Final CETA regulations impacting pharmaceuticals published but not yet in force As we reported, in July the Canadian government released draft versions of the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30. On September 7, the government released the final versions … Continue reading

FCA upholds Gilead victory invalidating Idenix patent relating to anti-HCV compounds

In a brief decision, the Federal Court of Appeal dismissed Idenix’s appeal of a Federal Court decision which found that a patent owned by Idenix and purporting to claim anti-HCV compounds was invalid for: (i) failing to sufficiently disclose a synthetic method by which the claimed compounds could be made; and (ii) for lack of … Continue reading

Mid-year roundup – 2017

Hard to believe, but we are halfway through 2017 already! It has been a busy six months, with major developments, including Canada preparing to implement CETA and the Supreme Court of Canada abolishing the “Promise Doctrine.” Below, Pharma in Brief has compiled the top headlines so far this year. The Big Three: Utility and the … Continue reading

Updated statistics on protection of patented and innovative drugs released in the Therapeutic Products Directorate Statistical Report for PM(NOC) Regulations and Data Protection

  Innovators’ growing use of the Patent Register is highlighted in the annual statistical report on the Patented Medicines (Notice of Compliance) Regulations and Data Protection issued by the Therapeutic Products Directorate (TPD) on July 14, 2017. This report includes data up to the end of fiscal year (FY) 2016/2017, which ended March 31, 2017. … Continue reading

CETA tracker: CETA Upends the Once-Delicate Balance

New CETA regulations impacting pharmaceuticals published but not yet in force The Canadian government has published the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30.  A 15-day consultation is open for interested parties to make submissions. Since their first enactment, the … Continue reading

Innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review application regarding the Minister of Health’s determination that it compared its product to a product with listed patents and was therefore required to address the listed patents. The Federal Court determined that the third-party innovator of the product with listed patents is a person “directly affected” by the application … Continue reading

CETA Tracker: Pharmaceutical patent reform to be provisionally implemented in September 2017

As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions.  The reforms were originally scheduled to come into force on July 1, 2017; however, the … Continue reading

“Promise Doctrine” rejected as a basis for invalidating patents for lack of utility in landmark Supreme Court of Canada ruling

The “Promise Doctrine” has been conclusively rejected by Canada’s highest court as a basis for invalidating a Canadian patent. In a judgment that reverses years of jurisprudence in the lower courts, the Supreme Court of Canada today held that the level of utility required of a Canadian patent must not be measured by statements in … Continue reading

CETA Tracker: Delays for the implementation of pharmaceutical patent reform

As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions.  The reforms were expected to come into force on July 1, 2017; however, media sources … Continue reading
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