Ms Daphne Lainson

Daphne Lainson

Updates

Healthcare & Life Sciences

Certificate of supplementary protection regime: first anniversary update
Canada | 31 October 2018

The certificate of supplementary protection (CSP) regime, which recently celebrated its first anniversary, was a long-awaited complement to the existing forms of protection for pharmaceutical products in Canada. As the regime is still new, companies are reminded to consider applying for a potential CSP for any planned new product in Canada early in the lifecycle planning.

Canada releases proposed amendments to patented medicines pricing regulations
Canada | 10 January 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration
Canada | 18 October 2017

The government recently published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement. Health Canada has since published guidance regarding the application process under the new regulations. In addition, the Federal Court has published a practice notice regarding actions brought under the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations 2017.

Publication of final regulations on patent linkage and term restoration relating to CETA
Canada | 27 September 2017

The government recently published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement. According to an order in council, the new regulations will come into force on September 21 2017. The amended regulations mark a significant change to the environment for pharmaceutical companies in Canada, with long-lasting consequences for innovators in terms of exclusivity and drug product lifecycle management.

CADTH consultation regarding proposal to allow revisions to CDEC recommendations
Canada | 16 August 2017

The Canadian Agency for Drugs and Technologies in Health recently sought feedback on a proposal to permit revisions to existing Canadian Drug Expert Committee recommendations made through the common drug review process during the therapeutic review process, eliminating the need to update recommendations through the request for advice process. A formal reconsideration process will not be available, but manufacturers' input will be considered before finalising the revised recommendations.

CETA draft regulations on patent linkage and term restoration published for public comment
Canada | 02 August 2017

The government recently published the long-anticipated draft regulations regarding changes to the Patented Medicines (Notice of Compliance) Regulations and proposed Regulations to Implement Certificates of Supplementary Protection to compensate innovators for lost patent term due to regulatory delays. The proposed changes will herald a new environment for pharmaceutical companies, with long-lasting impact.

Latest Health Canada updates
Canada | 26 July 2017

Recent Health Canada updates include proposed amendments to the Food and Drug Regulations, further amendments to Vanessa's Law, updated guidance on data protection, the proposed release of clinical data after regulatory review, changes to the location of summary basis and regulation decisions, confirmation of the date for the introduction of the Electronic Common Technical Document format and changes to IP hold submissions.

Patented Medicines Prices Review Board update
Canada | 19 July 2017

The Minister of Health recently announced a consultation regarding proposed amendments to the Patented Medicines Regulations that would significantly affect the Patented Medicines Prices Review Board's (PMPRB's) approach to drug price evaluation. The PMPRB also published a new annual publication providing information on recently launched drugs in Canada and select international markets as well as its annual report on the drivers of drug expenditures in select Canadian public drug plans.

Life sciences IP update: 2016 highlights
Canada | 25 January 2017

There were many significant developments in Canadian life sciences IP and regulatory law in 2016, including AstraZeneca's appeal to the Supreme Court regarding the utility promise doctrine and its patent relating to esomeprazole (Nexium). Also pending is a decision of the arbitration tribunal regarding the damages claim made by Eli Lilly under the North American Free Trade Agreement.

Bill C-30 to implement CETA: implications for pharmaceuticals
Canada | 07 December 2016

Following the recent signing of the Comprehensive Economic Trade Agreement (CETA), the minister of international trade tabled Bill C-30. One of the main provisions of the bill specifically relevant to pharmaceuticals is the proposal to amend the Patent Act by adding core certificate of supplementary protection provisions. Although CETA still requires a positive vote in the European Parliament before it can be provisionally applied, the bill could become law as quickly as the end of 2016.

Intellectual Property

Certificate of supplementary protection regime: first anniversary update
Canada | 29 October 2018

The first anniversary of the certificate of supplementary protection (CSP) regime was 21 September 2018. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in researching and obtaining regulatory approval in Canada. This article looks back on the previous year, recaps how the regime works and provides an update on the CSPs granted and rejected to date.

Canada releases proposed amendments to patented medicines pricing regulations
Canada | 15 January 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

CETA draft regulations on patent linkage and term restoration published for public comment
Canada | 07 August 2017

The government recently published the long-anticipated draft regulations regarding changes to the Patented Medicines (Notice of Compliance) Regulations and proposed Regulations to Implement Certificates of Supplementary Protection to compensate innovators for lost patent term due to regulatory delays. The proposed changes will herald a new environment for pharmaceutical companies, with long-lasting impact.

Patented Medicines Prices Review Board update
Canada | 24 July 2017

The Minister of Health recently announced a consultation regarding proposed amendments to the Patented Medicines Regulations that would significantly affect the Patented Medicines Prices Review Board's (PMPRB's) approach to drug price evaluation. The PMPRB also published a new annual publication providing information on recently launched drugs in Canada and select international markets as well as its annual report on the drivers of drug expenditures in select Canadian public drug plans.

Bill C-30 receives royal assent
Canada | 26 June 2017

Bill C-30 was passed by the Senate in May 2017. It implements the Canada-EU Comprehensive Economic and Trade Agreement. The bill recently received royal assent and became an act. However, apart from certain coordinating amendments, the act will not come into force until there is an order in council.

Bill C-30 ushers in changes to Canadian pharma patent regulations
Canada | 12 June 2017

The Senate recently passed Bill C-30 without amendment. The bill will implement the Canada-EU Comprehensive Economic and Trade Agreement and includes a number of IP law provisions – the most notable relating to the protection of pharmaceuticals. The provisions will come into force only once changes to the related regulations are registered.

Life sciences IP update: 2016 highlights
Canada | 30 January 2017

There were many significant developments in Canadian life sciences IP and regulatory law in 2016, including AstraZeneca's appeal to the Supreme Court regarding the utility promise doctrine and its patent relating to esomeprazole (Nexium). Also pending is a decision of the arbitration tribunal on the damages claim made by Eli Lilly under the North American Free Trade Agreement regarding patents pertaining to Strattera (atomoxetine) and Zyprexa (olanzapine).

Bill C-30 to implement CETA: implications for pharmaceuticals
Canada | 28 November 2016

Following the recent signing of the Comprehensive Economic Trade Agreement (CETA), the minister of international trade tabled Bill C-30. One of the main provisions of the bill specifically relevant to pharmaceuticals is the proposal to amend the Patent Act by adding core certificate of supplementary protection provisions. Although CETA still requires a positive vote in the European Parliament before it can be provisionally applied, the bill could become law as quickly as the end of 2016.

Canada concludes TPP negotiations – IP aspects
Canada | 07 December 2015

The text of the Trans-Pacific Partnership (TPP) Agreement – which sets common standards on a variety of issues relating to trade, including intellectual property – was recently released. While much of Canada's legislation is already compliant, a number of specific changes will be required. The reform process will likely not begin until the TPP is ratified; thus it may be some years before these changes are implemented.

Patent term restoration for pharmaceutical and biologic patents
Canada | 17 November 2014

The text of CETA was recently released. Chapter 22 in particular includes provisions specifically affecting pharmaceuticals and biologics in three areas: patent term restoration, innovator's right of appeal under the Patented Medicines (Notice of Compliance) Regulations and data protection.

Text of CETA released
Canada | 03 November 2014

The text of the Comprehensive Economic and Trade Agreement (CETA) between Canada and Europe was recently released. Chapter 22 addresses intellectual property, stating that CETA's objectives are to facilitate the production and commercialisation of innovative and creative products and the provision of services, and to achieve an adequate and effective level of protection and enforcement of IP rights.

Text of CETA finalised – finally!
Canada | 26 August 2014

The Canadian government has announced that the text of the Comprehensive Economic and Trade Agreement between Canada and Europe has been finalised after many months of silence on the historic trade deal. Significant changes are expected to IP protection, including for geographical indications, pharmaceuticals and biologics.

CETA between Canada and Europe: a new age of IP reform?
Canada | 02 December 2013

The Canadian government recently tabled a report with further details concerning the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union. CETA's provisions relating to intellectual property will, among other things, affect an innovator's right of appeal and extend the protection available to pharmaceutical products protected by eligible patents.

Green light for green patenting
Canada | 15 July 2013

The race to patent 'green' inventions in Canada is in full swing. Demand for patents relating to environmentally friendly and energy-conserving technologies is expected to increase rapidly over the next few years due to the growing market and competitive atmosphere. Recognising the importance of protecting green inventions, the government has introduced a means for applicants to speed up the patent application process.

Amended rules and practice bring opportunities for expedited patent examination
Canada | 19 December 2011

A backlog of patent applications at the Canadian Intellectual Property Office (CIPO) has prompted recent amendments to the Canadian Patent Rules and changes to CIPO practice which provide patent applicants with greater opportunities for expediting patent examination.

Patent Listing Timing Requirements Remain Unchanged
Canada | 14 May 2007

Sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations came into force last year. However, the amendments did not affect the patent listing timing requirements. Therefore, a patent is still eligible for filing only if its Canadian filing date precedes the filing date of the related regulatory submission.

Jurisdiction of the Patented Medicines Prices Review Board
Canada | 02 October 2006

The Patented Medicines Prices Review Board has jurisdiction to control pricing of patented medicines. A key issue is whether the board has jurisdiction to control the pricing of a medicine back to the date on which the patent application was laid open.

Strategic Considerations for Patenting Pharmaceuticals
Canada | 04 September 2006

The Patented Medicines (Notice of Compliance) Regulations link drug regulatory approval to patent protection. Under the regulations, a pharmaceutical patentee may delay regulatory approval for a second party (usually a generic manufacturer) to sell the patentee's medicine. In order to benefit from the regulations, a patent must be listed on the Patent Register maintained by the minister of health.