Ms Katie Lee

Katie Lee

Updates

Healthcare & Life Sciences

Health Canada publishes revisions to guidance document on notifying Health Canada of foreign actions
Canada | 23 January 2019

Health Canada recently updated its Notifying Health Canada of Foreign Actions – Guidance Document for Industry, including by providing a link to an online reporting form. This update comes after the foreign risk reporting requirement provisions of the Food and Drug Regulations came into force in October 2018.

Interim order permits import of FDA-approved drug to address Canadian shortage of EpiPens
Canada | 14 November 2018

The minister of health recently made an order permitting the immediate import and sale of epinephrine auto-injectors for use in emergency treatment of life-threatening allergic reactions to address the shortage of EpiPen products. This is the first time that an interim order under Section 30.1(2)(a) of the Food and Drugs Act has been used to address the shortage of an approved product.

Amended PMNOC Regulations: first anniversary update
Canada | 31 October 2018

The amended Patented Medicines (Notice of Compliance) Regulations came into force on 21 September 2017, heralding significant changes to the regulatory landscape for pharmaceutical companies in Canada. Following the first anniversary of the amendments, it is timely to examine the status of actions under the amended regulations, as well as the new procedural rules and guidelines which were introduced in conjunction therewith.

Apotex's appeal in judicial review of decision seeking further information from India facilities dismissed
Canada | 10 October 2018

In 2017 the Federal Court dismissed Apotex's application for judicial review of the Therapeutic Products Directorate decision which continued to require Apotex to submit additional information with respect to products manufactured or tested in its facilities in India. The Federal Court of Appeal recently dismissed Apotex's appeal of the Federal Court's decision.

Eli Lilly's Effient combination use patent found obvious
Canada | 03 October 2018

The Federal Court recently dismissed Eli Lilly's application for a prohibition order, finding that Apotex's allegation of obviousness of Patent 2,432,644 (the '644 Patent) was justified. The '644 Patent covered the use of prasugrel (Eli Lilly's Effient) in combination with aspirin for diseases caused by thrombus or embolus. Apotex made a number of attacks on the patent's validity, specifically with regard to patentable subject matter, obviousness and sufficiency and overbreadth.

Health Canada news: September 2018
Canada | 26 September 2018

There have been a number of recent Health Canada developments. For example, in June 2018 the Advisory Council on the Implementation of National Pharmacare was launched, together with the release of a discussion paper and the opening of a public consultation. In addition, Health Canada recently published notice of revised guidance documents on post-notice of compliance changes and its Drug and Medical Device Highlights 2017 report.

New regulations governing powers to require assessments, tests and studies
Canada | 11 July 2018

The sections of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) that grant the minister of health powers to require assessments, tests and studies and create appropriate regulations recently came into force. Among other things, the amendments support post-market safety by imposing notification requirements for foreign incidents and eliminate the requirement for filing clinical case reports in a filed submission or supplement.

Update on Vanessa's Law
Canada | 11 July 2018

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), approved in 2014, amended the Food and Drugs Act and granted new powers to the minister of health directed at post-marketing oversight of therapeutic products (ie, drugs, medical devices and drug-device combinations). There have been many developments since 2014, including the passage of certain associated regulations and the release of Health Canada guidance.

First CSPs issued and application fee increased
Canada | 20 June 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Teva seeks leave in levofloxacin damages assessment
Canada | 13 June 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

Supreme Court denies leave regarding natural health product licence
Canada | 13 June 2018

The Supreme Court recently dismissed The Winning Combination's leave to appeal. The Federal Court of Appeal had previously set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination for its natural health product, Resolve.

New use patent valid and infringed by biosimilar
Canada | 02 May 2018

The Federal Court recently upheld the validity of Kennedy Trust's patent covering a use of infliximab (Janssen's Remicade) and granted Kennedy's counterclaim that Hospira's biosimilar Inflectra had infringed the patent. This is the third patent infringement action decision relating to a biologic and the second on the merits relating to a biosimilar.

CADTH outlines revisions to biosimilar and pharmaceutical review programmes
Canada | 04 April 2018

In its Common Drug Review Update – Issue 133, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process. Among other things, the update created a streamlined approach for biosimilar reviews, made application fees applicable to all Common Drug Review submissions and resubmissions and introduced new fee guidance for pharmaceutical review programmes.

Health Canada implements mandatory use of eCTD format
Canada | 14 March 2018

Health Canada previously announced January 1 2018 as the proposed date for mandatory filing of specified regulatory activity. As such, all new drug submission, supplementary new drug submission, abbreviated new drug submission and supplemental abbreviated new drug submission regulatory activities for human drugs – as well as additional information and subsequent regulatory activities and transactions – must be filed in Electronic Common Technical Document format as of this date.

Decision striking out challenge to constitutionality of PMPRB regime upheld
Canada | 17 January 2018

The Federal Court of Appeal recently upheld the decision striking out Alexion's pleadings challenging the constitutionality of the Patented Medicine Prices Review Board (PMPRB) regime. The Federal Court of Appeal upheld the decision on the basis of, among other things, the fact that Alexion had not been entitled to bring the constitutional issue before the Federal Court, as it had not raised the issue before the PMPRB.

PMPRB releases scoping paper concerning proposed amended regulations
Canada | 17 January 2018

The Patented Medicine Prices Review Board recently released a high-level overview of the potential new framework proposed by the Regulations Amending the Patented Medicines Regulations. The overview aims to provide a non-binding outline of preliminary thoughts on how best to implement the proposed changes and should be read in conjunction with the proposed amendments and the regulatory impact analysis statement.

Health Canada publishes final guidance documents on quality requirements for regulatory filings
Canada | 03 January 2018

Health Canada recently published the final version of a number of guidance documents and templates which implement new requirements for new drug submissions and abbreviated new drug submissions. The changes will be implemented by way of a phased-in approach, with the general quality guidance requirements being implemented in January 2018 and the new stability requirements and requirements for commercial and pilot scale batches being implemented in October 2019.

Court rejects Apotex's application for judicial review of omeprazole magnesium tablet submission
Canada | 29 November 2017

The Federal Court recently rejected Apotex's application for judicial review regarding Health Canada's review of its omeprazole magnesium tablet regulatory submission. Apotex had applied for reconsideration, which was cancelled due to disagreement on an eligible question to pose to the reconsideration panel. Apotex had focused the question solely on safety and efficacy, while the minister of health had required that the question consider bioequivalence.

Ontario bill proposes mandatory disclosure of financial relationships
Canada | 22 November 2017

The Ontario legislature recently introduced Bill 160, which – if passed – will enact the Health Sector Payment Transparency Act 2017. The act will require the disclosure of financial relationships between healthcare professionals and pharmaceutical or medical device manufacturers and the reporting of various information. More details, such as the manner and frequency of reporting, will be prescribed by regulation.

Supreme Court leave sought for decision refusing natural health product licence
Canada | 18 October 2017

In May 2017 the Federal Court of Appeal set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination Inc for its natural health product, Resolve, and remitted the matter back to the minister for redetermination. The Winning Combination recently applied to the Supreme Court for leave.

Intellectual Property

Eli Lilly's Effient combination use patent found obvious
Canada | 24 September 2018

The Federal Court recently dismissed Eli Lilly's application for a prohibition order, finding that Apotex's allegation of obviousness of Patent 2,432,644 (the '644 Patent) was justified. The '644 Patent covered the use of prasugrel (Eli Lilly's Effient) in combination with aspirin for diseases caused by thrombus or embolus. Apotex made a number of attacks on the patent's validity, specifically with regard to patentable subject matter, obviousness and sufficiency and overbreadth.

First CSPs issued and application fee increased
Canada | 04 June 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Teva seeks leave in levofloxacin damages assessment
Canada | 04 June 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

New use patent valid and infringed by biosimilar
Canada | 07 May 2018

The Federal Court recently upheld the validity of Kennedy Trust's patent covering a use of infliximab (Janssen's Remicade) and granted Kennedy's counterclaim that Hospira's biosimilar Inflectra had infringed the patent. This is the third patent infringement action decision relating to a biologic and the second on the merits relating to a biosimilar.

Government announces suspension of IP provisions under CPTPP
Canada | 02 April 2018

The government recently published the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP) - Backgrounder. According to the backgrounder, Canada and other signatories have agreed to suspend certain IP, patent and pharmaceutical obligations under the Trans-Pacific Partnership, including with respect to patent term adjustments to compensate for unreasonable patent office delays and marketing authorisation delays.

Idenix seeks leave to appeal from Supreme Court in SOVALDI dispute
Canada | 13 November 2017

The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents concerning Gilead's SOVALDI (sofosbuvir). The Court of Appeal upheld the validity of Gilead's Patent 2,527,657 and declared Idenix's Patent 2,490,191 invalid on the basis of insufficiency of disclosure and inutility. Idenix has applied to the Supreme Court for leave to appeal.