Topic: Pharmaceuticals and life sciences

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Proposed amendments to Food and Drugs Act introduced in omnibus budget bill

By Pharma in Brief team on April 23, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The federal government has proposed changes to the Food and Drugs Act (FDA) that would allow the Minister of Health (Minister) to classify products as foods, drugs, cosmetics, devices, or “advanced therapeutic products”; require authorizations to conduct clinical trials; and modify Health Canada’s inspection powers. These changes are included in an omnibus budget bill, the … Continue reading

Regulatory changes for generics proposed to clarify ANDS pathway eligibility

By Christopher A. Guerreiro on April 1, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On March 30, 2019, the government published proposed amendments to the Food and Drug Regulations (FDR) intended to clarify whether a generic version of a drug can be approved using the abbreviated new drug submission (ANDS) pathway. These amendments affect how the FDR apply to a generic drug product if it contains a different medicinal … Continue reading

Federal Court grants application under the old PM(NOC) Regulations for a prohibition order regarding a metformin formulation

By Paul Jorgensen, Christopher A. Guerreiro and Jordana Sanft on March 25, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On March 8, 2019, the Federal Court issued a prohibition order against a generic version of GLUMETZA® (metformin hydrochloride extended-release tablets) proposed by Generic Partners Canada Inc. (Generic Partners) in an application under the pre-CETA Patented Medicines (Notice of Compliance) Regulations. GLUMETZA® is marketed in Canada by Valeant Canada LP/Valeant Canada SEC (Valeant), which asserted … Continue reading

Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions

By Morgan Westgate, Daniel Daniele and Kristin Wall on March 25, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On March 20, 2019, new amendments to both the Food and Drug Regulations (the Regulations) and the Medical Devices Regulations regarding the disclosure of clinical data were published in the Canada Gazette. These changes follow from the May 2017 release of Health Canada’s white paper – Public Release of Clinical Information in Drug Submissions and … Continue reading

Budget 2019: Federal government announces intention to implement recommendations on national pharmacare

By Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on March 20, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

As we reported the Advisory Council on the Implementation of National Pharmacare recently released an interim report calling for the creation of a national drug agency. Yesterday, the federal government announced funding to implement this recommendation. Specifically, the government intends to work with partners to implement the following: Create the Canadian Drug Agency — to … Continue reading

Competition Bureau publishes Final IP Enforcement Guidelines

By David Yi, Christopher A. Guerreiro and Brian R. Daley on March 18, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The revised IPEGs replace the earlier 2016 version. … Continue reading

Health Canada rejects product-specific suffixes for biosimilars in favour of unique brand names

By Christopher A. Guerreiro, Daniel Daniele and Pharma in Brief team on February 24, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has decided that all biologic drugs, including biosimilars, will be identified by both their unique brand name and non-proprietary (common) name — without the addition of a product-specific suffix. The ability to distinguish between biologics with the same non-proprietary name is important for pharmacovigilance and to minimize inadvertent substitution of drugs that have … Continue reading

FCA Confirms Entirety of Inventors’ Conduct is Relevant in Obviousness Analysis and Upholds Inventiveness of Crystal Form Patent

By David Yi and Allyson Whyte Nowak on February 14, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive. Obviousness The FCA began be reiterating key points of the … Continue reading

Quebec Court of Appeal overturns minister’s decision to remove Remicade from Quebec’s List of Medications

By Gregory Bordan on February 10, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Quebec Court of Appeal has declared a decision by the Minister of Health and Social Services to “delist” Remicade from Quebec’s List of Medications (Quebec’s equivalent to a formulary) to be invalid and has ordered the minister to reinstate the drug on the list. Two takeaways from this decision: the minister’s decisions to list … Continue reading

Advertising Standards Canada introduces new advertising dispute procedure for resolving disputes between competitors

By Kristin Wall and Daniel Daniele on February 4, 2019 Posted in Pharmaceuticals and life sciences

Effective February 11, 2019, Advertising Standards Canada (Ad Standards Canada) will implement a new Advertising Dispute Procedure (the Procedure) to govern complaints between competitors for alleged breaches of the Canadian Code of Advertising Standards (the Code). The new Procedure (formerly known as the Trade Disputes Procedure) is designed to further streamline the resolution process for … Continue reading

Top Headlines of 2018

By Jordana Sanft and Kristin Wall on January 14, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of … Continue reading

FCA Confirms that Non-Infringing Alternative Must be Legal and Objectively Economically Viable

By Morgan Westgate, David Yi and Allyson Whyte Nowak on December 20, 2018 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue … Continue reading

Bill C-86 receives Royal Assent, bringing amendments across Canada’s IP statutes

By Christopher A. Guerreiro, Amy Grenon and Jordana Sanft on December 14, 2018 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Canada’s core IP statutes have been amended by Bill C-86, which received Royal Assent as the Budget Implementation Act, 2018, No. 2, SC 2018, c 27 on December 14, 2018. The final version of the legislation includes amendments to the Patent Act that are substantially identical to the version that received first reading 46 days … Continue reading

Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions

By Chelsea Nimmo, Christopher A. Guerreiro and Judith Robinson on November 22, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the … Continue reading

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

By Kassandra Shortt, David Yi and Allyson Whyte Nowak on November 18, 2018 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

By Morgan Westgate, David Yi and Kristin Wall on November 18, 2018 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

By Christopher A. Guerreiro and Jordana Sanft on November 2, 2018 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)

By Christopher A. Guerreiro, Kristin Wall and Judith Robinson on October 14, 2018 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

Abbreviated New Drug Submissions will be posted on the Submissions Under Review List and other pre-market transparency initiatives

By Kristin Wall on October 14, 2018 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada recently published a notice outlining its phase III pre-market transparency initiatives for prescription drugs. Beginning October 1, 2018, Health Canada will publish a new list of abbreviated new drug submissions (ANDSs) on the Submissions Under Review (SUR) List, as well as publish Regulatory Decision Summaries (RDSs) for ANDSs, supplemental abbreviated new drug submissions … Continue reading

CETA Tracker: Update on CSPs

By Kristin Wall on September 30, 2018 Posted in 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

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians

By Kristin Wall on July 31, 2018 Posted in Pharmaceuticals and life sciences

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians The Advisory Council on the Implementation of National Pharmacare (“Council”) is consulting with Canadians on the implementation of a national program to fund prescription drugs. The consultation is open until September 28, 2018. The Council, which reports to the Minister of Health and … Continue reading

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

By Chelsea Nimmo, Paul Jorgensen, Kristin Wall and Jordana Sanft on July 30, 2018 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

Getting the Deal Through – Pharmaceutical Antitrust

By Kevin Ackhurst on July 19, 2018 Posted in Pharmaceuticals and life sciences

Norton Rose Fulbright has published a new edition of Getting the Deal Through – Pharmaceutical Antitrust. This edition is an updated, thorough overview of the application of antitrust law to the pharmaceutical sector worldwide. The pharmaceutical sector remains a priority area for antitrust enforcement in most major jurisdictions, where enforcement agencies have been increasingly prone … Continue reading

Pan-Canadian Pharmaceutical Alliance (pCPA) releases draft brand process guidelines

By Kristin Wall on June 20, 2018 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback. As part of the consultation process, pCPA is planning a webinar for innovative manufacturers on June 22, 2018. The pCPA also released a Frequently Asked Questions (FAQ) document, and a Letter of Intent (LOI) template with … Continue reading