Topic: Life sciences and healthcare

Subscribe to Life sciences and healthcare RSS feed

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

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

On March 13, 2019, the Competition Bureau (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 … Continue reading

Interim Report on Implementation of National Pharmacare calls for creation of a National Drug Agency

The Advisory Council on the Implementation of National Pharmacare (“Council”) presented an interim report following consultation with Canadians.  The report outlines work done to date by the Council, core principles the Council believes should underpin national pharmacare, and initial foundational recommendations. As we reported, the Council consulted with Canadians on the implementation of a national … Continue reading

Ontario Introduces Legislation to Change Healthcare Administration

This week the Ontario government announced legislation that will overhaul the administration of healthcare delivery in Ontario. Bill 74 was introduced in the Ontario Legislature on February 26, 2019, and passed first reading.  The bill creates the Connecting Care Act (the “Act”). The province’s 14 existing Local Health Integration Networks (LHINs) and six other agencies … Continue reading

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

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

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

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

Top Headlines of 2018

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

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

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

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

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

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

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

Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity

The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal Court (FC) properly considered the evidence and that it did not err in finding that the decision … Continue reading

Health Canada Releases Updated Guidance on Amended PM(NOC) Regulations

As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations on September 21, 2017. Health Canada has now issued an updated guidance document on the administration of the Regulations in light of these amendments. The update also reflects administrative practices. The guidance document is effective as of May 11, 2018 … Continue reading

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

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

Ontario delays implementation of regulations under the Health Sector Payment Transparency Act

Although there has been no public announcement, we understand that the Ontario government has indicated it will not be proceeding with the final approval of regulations developed under the Health Sector Payment Transparency Act (“HSPTA”) before the upcoming election.  Rather, these regulations will be revisited in the fall of 2018. As we reported, Ontario passed … Continue reading

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

Health Canada to advance self-care products framework under existing regulations

As we reported, Health Canada is proposing to change the way it regulates non-prescription drugs, natural health products and cosmetics, which will now be referred to collectively as “self-care products.” Under the new proposed regime, a product will be regulated by Health Canada based on the risk posed to consumers. Products will be classified as … Continue reading

Ontario Health Sector Payment Transparency Act, 2017 – Draft Regulation Published for Consultation

As we reported, Ontario passed the Health Sector Payment Transparency Act, 2017 (Bill 160) in December 2017, which will require those defined as “payors” – such as pharmaceutical and medical device manufacturers, wholesalers and distributors – to disclose financial relationships with healthcare professionals and organizations to the government. On February 21, 2018, the Ontario Government … 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

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

Federal Court upholds cancellation of reconsideration of Apotex’s ANDS for Apo-omeprazole

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence. Health Canada also rejected Apotex’s request for reconsideration. The court found Apotex did not have legitimate expectations … 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

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
LexBlog