Mr Brandon Heard

Brandon Heard

Updates

Healthcare & Life Sciences

Supreme Court of Canada denies Sobeys leave to appeal in loyalty rewards programme dispute
Canada | 07 November 2018

The Supreme Court of Canada recently denied Sobeys' application for leave to appeal the Alberta Court of Appeal's decision in a dispute regarding the Alberta College of Pharmacists' policy prohibiting pharmacists and pharmacies from offering loyalty rewards programmes or inducements to patients. This decision follows the court's 2016 refusal to grant Sobeys leave to appeal a decision allowing the College of Pharmacists of British Columbia to prohibit "customer incentive programmes".

Teva succeeds in Section 8 bortezomib action
Canada | 10 October 2018

The Federal Court recently granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents 2,203,936 and 2,435,146. Teva had succeeded on allegations of obviousness in both proceedings.

Shire's VYVANSE patent valid, prohibition order issued
Canada | 05 September 2018

The Federal Court has granted Shire's application under the pre-amended Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's Vyvanse) until the expiry of Canadian Patent 2,527,646. The application had been consolidated with Apotex's action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in that action.

Health Canada publishes guidance documents that address reporting of adverse reactions
Canada | 15 August 2018

Health Canada recently published the Reporting Adverse Reactions to Marketed Health Products guidance document, which provides assistance on reporting adverse reactions to marketed health products. Further, it published Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products, which addresses the format and content of annual summary reports and issue-related summary reports, as well as procedures for their submission to Health Canada.

Quebec court declines to dismiss claim under Ontario Statute of Monopolies
Canada | 01 August 2018

In an action relating to amlodipine besylate (Pfizer's Norvasc), Apotex is seeking relief in the Quebec Superior Court pursuant to the Ontario Statute of Monopolies, the UK Statute of Monopolies, the Trademarks Act and unjust enrichment. Pfizer has brought a motion to dismiss Apotex's claim. The Quebec Superior Court recently dismissed an application by Pfizer (part of the motion to dismiss) to dismiss the action, finding that the court has jurisdiction under the Ontario Statute of Monopolies.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Canada | 04 July 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

Health Canada to propose post-market amendments to Medical Devices Regulations
Canada | 27 June 2018

Health Canada recently issued a notice of intent to "propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada". Among other things, the amendments will provide the minister of health with the authority to request analytical issue reports from a manufacturer when there is a suspicion of a safety concern and require manufacturers to notify Health Canada of any significant change in the safety of a medical device.

Release of information contained in drug submissions and medical device applications
Canada | 20 June 2018

In December 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications. Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

Consultation on proposed regulations under Health Sector Payment Transparency Act 2017
Canada | 16 May 2018

The Ontario legislature recently passed the Strengthening Quality and Accountability for Patients Act 2017, which enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. When in force, the transparency act will require the disclosure of financial relationships between pharmaceutical or medical device manufacturers (among other payors) and healthcare professionals (among other recipients).

Federal Budget 2018 announces advisory council for national pharmacare programme
Canada | 02 May 2018

The federal budget was recently tabled in the House of Commons. It announced the creation of the Advisory Council on the Implementation of National Pharmacare, which will be led by former Minister of Health of Ontario Eric Hoskins and make recommendations on potential approaches to national pharmacare.

Court denies pleading amendments regarding Supreme Court decision that struck down promise doctrine
Canada | 04 April 2018

After the Federal Court found certain claims of a Canadian patent to be invalid, Apotex sought relief in the Ontario Superior Court of Justice pursuant to the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. The latter court recently dismissed motions by the defendants for leave to amend their statements of defence following the recent Supreme Court decision in AstraZeneca Canada Inc v Apotex Inc, which struck down the promise doctrine.

New guidance document on administrative processing of drug submissions and applications
Canada | 07 March 2018

Health Canada recently announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, for manufacturer and product name change applications, additional product name applications and licensing agreements between two manufacturers. The guidance will be effective from March 1 2018.

Proposed amendments to Food and Drug Regulations and Medical Devices Regulations
Canada | 07 February 2018

Among other changes, Health Canada recently released proposed amendments to the Food and Drug Regulations. Under the amendments, "clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission" would cease to be treated as confidential and would be released to the public following a final regulatory decision, with no requirement to notify the affected party of the release.

Senate reviews Cannabis Act
Canada | 31 January 2018

The so-called 'Cannabis Act', which provides a framework for restricted access to cannabis and is intended to come into force no later than July 2018, recently passed its first reading in the Senate. Concurrently, Health Canada issued a notice of intent to develop regulations under the proposed act and launched a public consultation, which was open for comments until January 20 2018.

Pfizer obtains prohibition orders for polymorphic form patent
Canada | 08 November 2017

The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.

Recent Health Canada updates
Canada | 16 August 2017

Recent Health Canada developments include new plain language labelling regulations for non-prescription drugs, proposed amendments to the Food and Drug Regulations, new regulations permitting the import of drugs to meet an urgent public health need and a consultation on changes to generic drug equivalence.

Notice of allegation is fatal defect
Canada | 23 November 2016

The Federal Court recently granted an order prohibiting the minister of health from issuing a notice of compliance to Fresenius for its moxifloxacin hydrochloride product. Fresenius alleged non-infringement in its notice of allegation (NOA). However, the court held that Fresenius's NOA failed to include a detailed statement of the legal and factual basis for the allegation of non-infringement, as required by the Patented Medicines (Notice of Compliance) Regulations.

Intellectual Property

Teva succeeds in Section 8 bortezomib action
Canada | 01 October 2018

The Federal Court recently granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents 2,203,936 and 2,435,146. Teva had succeeded on allegations of obviousness in both proceedings.

Shire's VYVANSE patent valid, prohibition order issued
Canada | 03 September 2018

The Federal Court has granted Shire's application under the pre-amended Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's Vyvanse) until the expiry of Canadian Patent 2,527,646. The application had been consolidated with Apotex's action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in that action.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Canada | 25 June 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

Federal Court declares invalid patent for medical device measuring osmolarity of tear film
Canada | 14 May 2018

The Federal Court recently found certain claims of a patent relating to a chip for measuring the osmolarity of a sample of bodily fluid, including tear film, invalid on the basis of obviousness and anticipation. The court agreed with the claim construction urged by the plaintiffs, finding that the claims encompassed both in vivo and ex vivo applications of the invention. Thus, the defendant's competing medical device – which measured osmolarity in vivo – fell within the scope of the claims.

Court denies pleading amendments regarding Supreme Court decision that struck down promise doctrine
Canada | 02 April 2018

After the Federal Court found certain claims of a Canadian patent to be invalid, Apotex sought relief in the Ontario Superior Court of Justice pursuant to the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. The latter court recently dismissed motions by the defendants for leave to amend their statements of defence following the recent Supreme Court decision in AstraZeneca Canada Inc v Apotex Inc, which struck down the promise doctrine.

Federal Court declines to assess litigation funding arrangement in patent infringement case
Canada | 08 January 2018

The plaintiff in a patent infringement action against Pfizer recently brought a motion seeking approval of a litigation funding agreement (LFA) with a third party, as required by the terms of the agreement. The prothonotary dismissed the motion on the basis that such approval is not required beyond class proceedings. Further, the Federal Court had no jurisdiction to determine the validity of the LFA.

Pfizer obtains prohibition orders for polymorphic form patent
Canada | 06 November 2017

The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.