Canada’s Intellectual Property Firm

Daphne Lainson

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Daphne Lainson

  • she/her/hers
Principal
  • Smart & Biggar LP
Language(s): English

A champion of innovation, protecting exclusivity in the chemical arts and life sciences

Partnering with her clients, Daphne is dedicated to helping innovators secure comprehensive patent protection for their chemical, pharmaceutical and biotechnology-related inventions.

Many of the world’s top innovators rely on Daphne’s advice and counsel. She is regarded by clients in the life sciences sector as an advisor who has “deep knowledge of the area, provides practical, well-grounded advice and is highly responsive” (IAM Patents 1000, 2018), as well as “[providing] unparalleled expertise in a thoughtful and friendly way. [She is] dedicated and knowledgeable” (Expert Guides: Women in Business Law).

With close to 25 years of experience in law and patent agency and an advanced degree in chemistry, she has been entrusted with protecting inventions across the spectrum of chemical innovation. Daphne enthusiastically champions and effectively safeguards her clients’ intellectual property rights relating to new drugs, biologics, medical devices, consumer products, agrochemicals, specialty chemicals, industrial chemical processes, oil, gas and petrochemicals.

A trusted counsellor to navigate the complex life sciences patent-regulatory landscape

Daphne provides strategic advice and counselling to clients across the life cycle of a drug, including during pre-clinical and clinical development through to marketing and loss of exclusivity. She also offers strategic advice regarding patents and data protection, including patent listing under the Patented Medicines (Notice of Compliance) Regulations, Certificates of Supplementary Protection, pricing and reimbursement including Patented Medicine Prices Review Board matters (PMPRB).

She has been recognized as an “experienced and pragmatic partner” to the world’s leading biopharmaceutical companies, and has been described as “brilliant at the intersection of IP and regulatory law” and as having “fantastic legal and business acumen, which she uses to provide thorough, best-in-class legal advice. She also has a tremendous ability to simplify and explain complex issues to non-lawyers, which helps hugely with decision-making” (IAM Patents 1000, 2019).

What sets her apart is her experience in advising clients during patent procurement on the various issues that may arise relating to patent linkage under the Patented Medicines (Notice of Compliance) Regulations, regulatory data exclusivity under the Food and Drug Regulations, supplementary protection under the Certificate of Supplementary Protection Regulations, and market access issues, including relating to pricing of patent medicines under the jurisdiction of the Patented Medicine Prices Review Board. She is proactive in her advice, and is constantly looking for practical solutions to complex problems.

A recognized leader in the patent community

Daphne is actively involved in advancing knowledge within the industry through the American Intellectual Property Law Association (AIPLA); she is an AIPLA Fellow, Chair of the Fellows Committee, and past Chair of the Food and Drug Law Committee, IP Practice in Japan Committee, Mentoring Committee and Women in Intellectual Property Law Committee. She also served as Chair of the AIPLA Mid-Winter Institutes in 2019 and 2021.

Daphne has also supported BIOTECanada in its mission to lead the advancement of a globally competitive Canadian biotechnology ecosystem.

Within Smart & Biggar, she plays a key role as a practice leader of the firm’s life sciences practice and in client relations management, particularly in key industrial markets, such as the U.S., Japan and Germany.

Her contribution to the IP community was recognized in the inaugural edition of the WIPR Influential Women in IP, where she was listed as one of 80 international female leaders in intellectual property law. She continues to be recognized in a number of other directories, including as an IP Star by Managing Intellectual Property, a World IP Review Leader in IP and a Lexpert ranked lawyer for IP and Biotechnology.

Qualifications

  • News
  • Speaking
  • Industry Involvement
  • In the Media
  • "The Evolution of Drug Pricing in Canada: How to Meet the PMPRB’s New Guidelines for the Final Regulations", (speaker), the 8th annual forum on Pathways to Access and Reimbursement, The Canadian Institute, January 20, 2023 
  • "Best Practices in Pharmaceutical Patents" (co-speakers: John Norman, Lesley Caswell), IPIC Webinar, September 21, 2022
  • “Where Patent Protection Intersects with Market Entry Decisions: How to Set Your Organizations Access Strategy Up for Success in 2022” (speaker), Pathways to Access & Reimbursement, January 2022
  • "The Future of IP in Canada –The Northern Innovation Wave in America" (co-speakers: Matthew Zischka and Mark Evans), Mondaq Webinar - Canada Future Series, May 27, 2021
  • "PMPRB Final Guidelines: An Examination of the Practical Impact on Drug Pricing in Canada" (speaker), Pathways to Access & Reimbursement, January 2021
  • "Introduction to Canadian Patent-Regulatory Exclusivities" (co-speakers: David Schwartz and Nancy Pei), Smart & Biggar webinar, July 2020
  • "Tackling the Wage Gap" (moderator), Canadian Lawyer Women in Law Summit, Toronto, ON, February 12, 2020
  • "Women in IP Law Committee Breakfast" (panelist), AIPLA Annual Meeting, Washington, DC, October 25, 2019
  • "IP Law in Mexico, Canada and the US — What Every General Counsel Needs to Know" (speaker), virtual discussion, In The House, April 25, 2019
  • "Patent Rights in Canada - an update on recent developments," (co-presenter: Yoon Kang), Life Sciences Patent Network (LSPN) North America, San Francisco, CA, October 16, 2018
  • "The increasing challenges of securing worldwide patent protection on living organisms", (speaker), AIPLA Spring Meeting, Seattle, May 15, 2018
  • "Managing Exclusivities in Canada:  The Patent-Regulatory Environment,” (co-presenter: Yoon Kang), C5 Pharma & Biotech Patent Litigation 2018, Amsterdam, The Netherlands, February 2018
  • “Post-Final Practice – Understanding Your Options at the End of the Line,” (speaker), 91st Annual Meeting, Intellectual Property Institute of Canada, October 2017
  • “Strategy Considerations for Patent Procurement Worldwide: A Panel of International Experts,” (speaker) Midwest IP Institute, September 2017
  • “Patent Protection for Pharma and Biotechnology,” (speaker) webcast hosted by The Knowledge Group, Wednesday, July 19, 2017
  • “Canadian IP Portfolio Management within the Global Context,” (speaker) LSIPR Life Sciences Patent Network North America Conference, June 1, 2017 
  • “Hatch-Waxman vs. PMNOC Regs: Claim Drafting & Other Patent-Regulatory Issues,” (speaker) AIPLA Mid-Winter Institute, February 2, 2017
  • “Patent Listing and Data Protection: A Primer for Regulatory Affairs Professionals,” (speaker), CAPRA Dinner Meeting, Dorval, QC, January 2016
  • “Biosimilars are Off and Running: A Litigation and Regulatory Update” (moderator), AIPLA Annual Meeting, 2015
  • "Subsequent Entry Biologics (SEBs) – Canada," (speaker) AIPLA Mid-Winter meeting , Las Vegas, NV, January 2012; AIPLA webinar, March 2012
  • "Making contributions visible," (speaker) 3rd Annual Women in Law conference, Calgary, AB, October 2009
  • "Partnerships: Policy and Research at the Crossroads: University-Industry Research Collaborations," (speaker) 58th Canadian Chemical Engineering Conference, Ottawa, October 2008
  • "Patenting Therapeutic/Diagnostic Delivery Devices—Maximizing Marketing Potential," (speaker) BioNorth Conference on Driving Global Innovation and Commercialization Through Partnerships, Ottawa, November 2007

Memberships

  • Member, The Canadian Association for Healthcare Reimbursement
  • Member, Canadian Association of Professionals in Regulatory Affairs
  • Member, Drug Information Association
  • Fellow, Intellectual Property Institute of Canada
  • Fellow, American Intellectual Property Law Association; Chair of the Fellows Committee, past Chair of the Food and Drug Law Committee; past co-Chair of the Japan Practice Committee; past Chair of the Mentoring Committee; and past Chair of the Women in Intellectual Property Law Committee
  • Member, Chemical Institute of Canada, Canadian Society for Chemistry
  • Member, The Women's Business Network of Ottawa
  • Member, Canadian Bar Association; member of the Patent Committee

Interviews

Publications

  • "Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada" (co-authors:  Nancy Pei and Alice Tseng), Association of Corporate Counsel, December 2020
  • "Canada’s Covid-19 response" (co-author: Nancy Pei), Intellectual Property Magazine , May 29, 2020
  • "Compulsory licensing in Canada—revisited" (co-author: Nancy Pei), Life Sciences IP Review, April 21, 2019
  • "Price of drug patents in Canada" (co-author: Nancy Pei), Intellectual Property Magazine, September 30, 2019
  • "Regulatory reform and impact on exclusivities" (co-author: Nancy Pei), NOC, Summer, 2019
  • "Supreme Court of Canada strikes down 'promise doctrine' and establishes a new test for patent 'utility'" (co-author: Kohji Suzuki), AIPPI Japan Journal, November 2018
  • "Trading up: Daphne Lainson and Nancy Pei explain why the new trade deal enhances IP-related rights for pharmaceutical innovators" (co-author: Nancy Pei), Intellectual Property Magazine, November 5, 2018
  • "The best and worst of times? Pharma forecast for 2019" (co-author: Nancy Pei), Expert Guides, September 9, 2018
  • "CETA amendments: Impact on biologics in Canada" (co-author: Nancy Pei), BIOTECanada Insights, Spring 2018
  • "Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration"(co-authors: Nancy Pei and Urszula Wojtra)  International Law Office Intellectual Property Newsletter, October 18, 2017
  • “Pharmaceutical patents in Canada: key issues for life sciences companies” (co-author: Yoon Kang), IAM Life Sciences 2017
  • "IP and trade deals: is CETA the last of its kind?" Intellectual Property Magazine, March 24, 2017
  • "CETA: are we there yet?" (co-author: Nancy Pei), Intellectual Property Magazine, December 7, 2016
  • "IP law changes coming after Europe deal", Law Times, December 5, 2016
  • "Sounding Out the Supreme Court of Canada on Utility", Best Lawyers, November 2016
  • "When it Comes to Biologics, Canada Dances to a Different Tune" (co-author: Nancy P. Pei), Expert Guides, August 26, 2016
  • "Coming to Canada: Information Protocol and Regulatory Issues" (co-author: Nancy Pei), BIOTECanada Insights, Spring 2016
  • "Will the TPP top CETA for protection of new drugs and biologics in Canada?" (co-author: Nancy Pei), Intellectual Property Magazine, February 2016
  • "Biopharmaceutical Companies Set to Benefit From International Trade Agreements" (co-author: Thuy Nguyen), Biotechnology Focus, December 2015/January 2016, p. 28
  • "Trans-Pacific Partnership has minimal IP impact, Lawyers say", Law Times, December 7, 2015
  • "CETA's patent protections", CBA/ABC National Magazine, Fall 2014
  • "Major changes to Canadian IP law" (co-author: Christian Bolduc), Intellectual Property Magazine, June 2014
  • "Enhanced IP rights in Canada" (co-author: Nancy P. Pei), Intellectual Property Magazine, December 2013
  • "Evolution of a Rare Medicines Policy in Canada" (co-author: Nancy P. Pei), insights Magazine, Fall 2013, pp. 16-19
  • "The Pharmaceutical/Biopharmaceutical Landscape—Traversing Canada's Patent and Regulatory Regimes" (co-author: Nancy P. Pei), Biotechnology Law Report, August 2013, Vol. 32, Issue 4, pp. 252-258
  • "A Bird's Eye View Of The Canadian Patent Landscape" (co-author: Sheldon Hamilton), Corporate Counsel IP Canada Report, August 2013
  • "Maximising potential – exploiting patent protection for biologics", Intellectual Property Magazine, July/August 2013
  • "Patentable subject matter" (co-authors: Steven Garland and Kevin K. Graham), Canadian Patent Law Benchbook 2012
  • "Evergreen IP", Intellectual Property Magazine, November 2012
  • "More effective protection for pharmaceuticals" (co-author: Steven Garland), Intellectual Property Magazine, July/August 2012
  • "Marketing Innovative Drugs in Canada", Corporate Livewire's Expert Guide: Intellectual Property, December 2011, pp. 72-74
  • "The utility of it all", Intellectual Property Magazine, November 2011
  • "Double Trouble: Canadian Courts Continue to Clarify the Law on Double Patenting",  Intellectual Property Magazine, May 2010
  • "Canada Paves the Way for Subsequent Entry Biologics (SEBs)" (co-author: David E. Schwartz), Pharmaceutical Law Insight, May 2009
  • "A New Line in the Sand: Supreme Court of Canada considers 'Obvious to Try' and clarifies novelty and selection inventions" (co-author: Steven B. Garland), Patent World, April 2009
  • "What Brands Need to Know: Top 10 Tips for Successfully Protecting Exclusivity in the New Regulatory Framework" (co-authors: Gunars A. Gaikis and L. Catherine Eckenswiller), paper presented at the Canadian Institute seminar Pharmaceutical & Biotech Regulatory Compliance, March 2007
  • "Biotechnology: Recent Developments of Importance" (co-author: David E. Schwartz), The 2007 LEXPERT/ALM Guide to the Leading 500 Lawyers in Canada, January 2007, pp. 164-167
  • "Patenting life forms" (co-author: Elizabeth A. Hayes), Canadian Chemical News/L’Actualité chimique canadienne, October 2006, Vol. 58, No. 9, pp. 18-19
  • "Unique IP Issues in Canada's Pharmaceutical and Biotechnology Industry" (co-authors: Gunars A. Gaikis and David E. Schwartz), The 2006 LEXPERT Guide to the Top 100 Industry Specialists in Canada, October 2006, pp. 125-129
  • "Chemical and Biomedical Patenting in Canada: From Procurement to Enforcement" presented by John Morrissey at the Royal Chemical Society symposium Creating Business Through World Patent Enforcement, March 2006
  • "New Drug Discovery — Beyond the Bench-Top", Canadian Chemical News, April 2006
  • "Biopharma Innovators Stand to Benefit from Proposed Data Protection Regulations" (co-authors: May M. Lee and Joy D. Morrow), Bio-Science Law Review, Vol. 7, Issue 2, [2004/2005] 2 BLSR 97
  • "Innovation to Commercialization — The Role Patents Play", Canadian Chemical News, June 2005
  • "Net Benefits? Internet Pharmacies in Canada", Canadian Chemical News, May 2005
  • "Balancing Act", Canadian Chemical News, October 2004
  • "Regulating Beauty", Canadian Chemical News, July/August 2004
  • "The Patented Medicines (Notice of Compliance) Regulations" (co-author: Peter R. Wilcox), 16 Canadian Intellectual Property Reports 429, 2000