Topic: Pharmaceuticals and life sciences

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CADTH releases updated guidelines for biosimilars

The CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (Non-Cancer) and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars (Cancer) provide an overview of the Common Drug Review procedures and guidance to applicants for biosimilar submissions. The new guidelines are effective as of February 13, 2018. CADTH reports the following key … Continue reading

Federal Budget 2018 – the foundation for a national pharmacare program?

The Federal government tabled the 2018-2019 budget on February 27, 2018, which included an announcement of steps toward the creation of a national pharmacare program to cover the reimbursement of certain prescription medications. The government will create an Advisory Council on the Implementation of National Pharmacare, with the goal of starting a national dialogue on … Continue reading

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

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

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

Health Canada consultation on the naming of biologics including biosimilars

On January 18, 2018, Health Canada and the Institute for Safe Medication Practices Canada opened a consultation on the naming of biologic drugs (including biosimilars) in Canada. As we reported, the US Food and Drug Administration began affixing a four-letter suffix to the generic name of biosimilar drugs, which is intended to facilitate pharmacovigilance and … Continue reading

Lower prices announced for commonly prescribed generic drugs

On January 29, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association issued a joint statement announcing that effective April 1, 2018, 20 commonly prescribed generic drugs will be further reduced to 10% of the cost of the reference brand product.  The list of drugs reimbursed at 18% has also grown and … Continue reading

Top Headlines of 2017

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

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