Topic: Pharmaceuticals and life sciences

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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

Supreme Court dismisses leave to appeal on damages against Health Canada for Apo-Trazodone

On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions. Case: Apotex Inc v Canada (Minister of Health) (SCC Docket: 37593) Drug: Apo-Trazodone Nature of case: Application for leave to appeal … 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

Ontario legislation requiring disclosure of payments to physicians receives Royal Assent

On December 12, 2017, Bill 160 passed third reading and received Royal Assent.  Included in Bill 160 is the Health Sector Payment Transparency Act (the “Act”). This Act will come into force at a later date to be determined by the government. The stated purpose of the Act is to require the reporting of information … 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

PAAB Announces New Code of Advertising Acceptance

The Pharmaceutical Advertising Advisory Board (PAAB) has announced an updated Code of Advertising Acceptance (Code).  The new Code will be implemented beginning on January 1, 2018. The primary change is to the Code’s format.  It will only be available online and will allow keyword searching and filtering code provisions by core principle.  Other changes include … 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

Bill 148 : A Bill to limit generic medication procurement by owner pharmacists

Bill 148, An Act to regulate generic medication procurement by owner pharmacists and to amend various legislative provisions, was tabled in the National Assembly on October 5. It will amend An Act respecting Prescription Drug Insurance, introducing the Regulation to govern generic medication procurement by owner pharmacists. The new Regulation will provide, subject to certain exceptions, … 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

Ontario health sector disclosure legislation referred to committee

As we reported, Ontario has introduced legislation that will require pharmaceutical and medical device manufacturers to disclose financial relationships with healthcare professionals and organizations to the government. The legislation has passed second reading and has been referred to committee.  The Standing Committee on General Government will hold public hearings on November 15, 16, 20, and … 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

Ontario introduces legislation requiring disclosure of payments to physicians

Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations. The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers to periodically disclose details about … 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

Health Canada consultation on draft guidance documents implementing Vanessa’s Law

As we reported, the Government of Canada recently published draft regulations under Vanessa’s Law that set out additional reporting requirements for manufacturers, based on the actions of foreign regulators, and provide details regarding the Minister of Health’s powers to require tests, assessments and studies of a post-market drug authorization. Health Canada has now published two … Continue reading

Ontario considers requiring disclosure of drug company payments to healthcare providers

The Government of Ontario has announced it is consulting with patients, healthcare providers, and the pharmaceutical and medical devices industries about current regulations and guidelines that govern the disclosure of payments from the private sector to healthcare professionals. Although some innovative pharmaceutical companies already voluntarily disclose payments to healthcare providers, Ontario is assessing what additional … 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

Apotex continues battle to prevent release of ANDS information: FCA upholds decision that Commissioner of Information is a proper respondent to Apotex’s judicial review

As we reported, Apotex Inc. applied for judicial review of the Minister’s decisions to disclose information from Apotex’s abbreviated new drug submission in response to an access to information request. The Federal Court of Appeal upheld an order adding the Commissioner of Information as a respondent, holding that the test was whether the Commissioner’s participation … Continue reading