What has been your most memorable case to date, and why?
It is difficult to identify just one case! My practice focuses on supporting innovative pharmaceutical companies navigate the complex patent-regulatory landscape in Canada. On so many occasions I have been privileged to assist organisations as they launch their products in Canada, but the cases that stand out most in my mind are those where I have supported companies in bringing their life-changing drugs to paediatric populations. There is no better feeling than being part of something (even if only a very small part) that gives children and parents hope.
As principal of Smart & Biggar's Ottawa office, what does effective leadership look like to you?
If the whole is better than the individual parts, then that is a sign of effective leadership. When we are working together in synergy, the results are palpable. Our people are happy and engaged and focused on our clients and each other.
What recent decisions or legislative developments are having the biggest impact on your clients' IP strategies in Canada right now?
For pharmaceutical companies, uncertainty relating to the pricing of patented medicines remains one of the biggest issues. The Patented Medicine Prices Review Board has jurisdiction over the maximum non-excessive price of patented drugs. While amendments to the governing regulations were adopted on 1 July 2022, we are still awaiting guidelines that operationalise the amended rules. This pricing uncertainty creates uncertainty for business and for patients.
By 1 January 2025, Canada will be adopting patent-term adjustment to address delays before the Canadian Patent Office. This has moved the office to adopt practices to facilitate a more compact prosecution, including excess claims fees. These changes have resulted in an earlier focus on the claims to be pursued in Canada, made more complicated by the fact that there is no continuation practice and divisional applications are generally only filed further to a unity objection in view of our double patenting laws.
What changes would you like to see in the Canadian life sciences IP landscape, and do you think these are likely to happen?
Double patenting remains an issue under Canadian law, with no relief in sight. Canada has same invention and obviousness double patenting without the benefit of a terminal disclaimer. Ideally, the Patent Act would be amended to allow patentees to be able to address double patenting issues post-grant.
Also, Canada has no orphan drug exclusivity. While the federal government has announced measures in support of a national strategy for drugs for rare diseases, it has been silent on this issue.
You play a key role in client relations management, particularly in key industrial markets such as the United States, Japan and Europe. What are the key differences when it comes to protecting life sciences inventions in these jurisdictions?
The fundamentals of patenting are similar across each jurisdiction. The most significant differences for life sciences companies are found at the patent-regulatory interface (ie, patent linkage, supplementary protection and data protection).
Canada is similar to the United States when it comes to patent linkage, and similar to Europe insofar as supplementary protection is concerned.
A key difference between Canada’s linkage laws and those of the United States is that the same regulations apply to both small molecules and human biologics. There are also other differences between how patent listing works in Canada compared to the United States (Health Canada will actively review any patent lists submitted), including the types of patents that are listable (patents claiming the approved medicinal ingredient, formulation, dosage form or use may be listed) and the mechanics of linkage litigation.
A key difference between certificates of supplementary protection (CSPs) and European supplementary protection certificates (SPCs) is the term. The CSP term is capped at a maximum of two years, while the SPC cap is five years and is subject to a paediatric extension, which is not available in Canada.
Regulatory data exclusivity is different in Canada than the other jurisdictions. If a drug is an innovative drug (ie, small molecule or human biologic), then it is entitled to eight years of market exclusivity (eight-and-a-half with a paediatric extension) and a subsequent entrant (generic or biosimilar) cannot file its submission with Health Canada for six years, with these terms measured from the first marketing authorisation for the innovative drug.
It is critical for innovators to understand these various distinctions so that they can better plan for loss of exclusivity within each market.
Daphne Lainson is a principal and leader of the life sciences practice group in Smart & Biggar's Ottawa office. She has over her 25 years of practice in IP law, along with an advanced degree in chemistry. Many of the world’s top innovators rely on Ms Lainson’s advice and counsel. Partnering with her clients, she is dedicated to helping innovators secure comprehensive patent protection for their chemical, pharmaceutical and biotechnology-related inventions.