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.
There have been a number of major highlights in Canadian life sciences law over the past six months, including the consultation on the proposed Regulations Amending the Patented Medicines Regulations. Among other developments, eight certificates of supplementary protection were issued and a number of new biosimilars were approved. Further, the creation of an Advisory Council on the Implementation of National Pharmacare was announced in February 2018.
Health Canada recently announced the publication of proposed Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals). Pursuant to the proposed amendments, all hospitals must provide the specified information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident.
Health Canada recently issued updated guidance on the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Revisions include the introduction of directions on how to provide litigation information to Health Canada so that it is aware of barriers to the issuance of a second person's notice of compliance and the provision of example scenarios outlining when certificates of supplementary protection will be eligible for inclusion on the Patent Register.
There were a number of biosimilars developments in the first half of 2018, including with regard to approvals and patent litigation. In addition, the Canadian Agency for Drugs and Technologies in Health published its environmental scan on biosimilars and Health Canada issued its Notice to industry: Aligned reviews between Health Canada and health technology assessment organisations.
The government recently published the new Industrial Design Regulations in the Canada Gazette and set 5 November 2018 as the date on which the amendments to the Industrial Design Act and the regulations will come into force. The amendments will allow applicants to file international design applications designating Canada under the Hague Agreement and will be the first of several major changes to Canada's IP regime expected to take effect over the next year.
In most jurisdictions, copyright owners face numerous challenges when seeking to enforce their rights against media pirates, including with regard to ongoing harm pending judgment, proving damages and unscrupulous defendants destroying evidence or failing to comply with court orders. However, in a series of recent decisions, the Federal Court granted various extraordinary remedies against media pirates, making Canada an attractive forum for copyright owners to litigate such cases.
In early 2018 the Federal Court of Appeal dismissed Eli Lilly Canada's appeal of a trial decision awarding more than C$70 million to Teva Canada under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Federal Court of Appeal recently granted Teva's cross-appeal seeking to add to its recovery lost pipe fill sales and an adjustment to account for underreporting of sales in the data relied on by both parties' experts. Eli Lilly has since applied to the Supreme Court for leave to appeal.
The Patented Medicine Prices Review Board (PMPRB) recently announced that the next step in its guideline reform will be the inception of a multi-stakeholder working group intended to gather stakeholder input on key technical aspects of the new regime. The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation.
The Supreme Court recently dismissed Idenix's application for leave to appeal the decision of the Federal Court of Appeal affirming the trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). The Federal Court of Appeal upheld the validity of Gilead's patent and declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility.