Highly-focused life sciences expertise and unique insights on client innovation
With hands-on experience as a licensed pharmacist and over 25 years of patent litigation expertise, Nancy has established a successful IP practice focused exclusively in the field of life sciences, with an emphasis on pharmaceuticals and biologics.
Nancy’s clients benefit not only from the depth and breadth of her experience but also from her unique insights on broader patenting, regulatory and business issues, helping them manage the life cycles of their products and remain competitive in an ever-changing industry.
A litigator and advisor with experience tailored to the needs of innovative life sciences clients
As a patent litigator, Nancy represents innovative life sciences companies in patent litigation, including actions under the Patented Medicines (Notice of Compliance) Regulations. She has represented clients before the Federal Court of Canada, the Federal Court of Appeal, the Supreme Court of Canada and the Ontario Superior Court of Justice. She also represents clients in judicial review applications.
In her advisory roles, Nancy provides thoughtful counsel and strategic advice regarding patents and data protection, 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), federal (AIA) and provincial (FIPPA) access to information requests, regulatory due diligence, regulatory compliance issues (under the Food and Drugs Act and associated regulations), and submissions regarding draft statutory and regulatory amendments in these areas.
Nancy has been the editor of Rx IP Update, the firm's monthly life sciences intellectual property and regulatory newsletter, since its inception in 2001 and co-editor as of 2023. Nancy currently serves on the Board of Directors of BIOTECanada.
Qualifications
- News
- Speaking
- Industry Involvement
- In the Media
- “Anticipation”, (co-presenter: Kavita Ramamoorthy), Intellectual Property Institute of Canada Patent Case Law Review Series webinar, April 11, 2023
- “Anticipation”, (co-presenter: Kavita Ramamoorthy), Intellectual Property Institute of Canada Patent Case Law Review Series webinar, March 17, 2022
- “Anticipation”, (co-presenter: Kavita Ramamoorthy), Intellectual Property Institute of Canada Patent Case Law Review Series webinar, April 13, 2021
- "Introduction to Canadian Patent-Regulatory Exclusivities" (co-speakers: Daphne Lainson and David Schwartz), Smart & Biggar webinar, July 2020
- “File Wrapper History (coming to a theatre near you: what it will mean)” (speaker), Eighth Annual University of Toronto Patent Colloquium, Toronto, ON, November 15, 2019
- "Changes to Patented Medicines Pricing in Canada," (speaker), Life Sciences Patent Network (LSPN) North America, San Francisco, CA, October 16, 2019
- "Patent Case Law Review – Remedies" (co-presenter: Paula Frederick), IPIC webinar, May 2019
- "Life Sciences Regulatory Webinar" (co-speakers: Alice Tseng and Abigail Smith), Smart & Biggar webinar, January 2019
- "CSPs: Lessons from the First Year" (co-speaker: Daphne Lainson), Smart & Biggar webinar, October 2018
- “Patent Case Law Review – Remedies" (co-presenter: Paula Frederick), IPIC webinar, May 2018
- "Pharma Patents in Canada: 2017 Year in Review," (speaker), Smart & Biggar webinar, January 2018
- "Changes to the Canadian Patent and Regulatory Landscape," (speaker) C5 Life Sciences IP Summit 2017, Munich, Germany, October 2017
- “Approval Pathway for Biosimilars in Canada,” (speaker), The Biosimilar Landscape in Canada: An Update, CBA Biotechnology Committee and OBA Information Technology & Intellectual Property Law Section, Toronto, ON, October 2016
- “Patent Listing and Data Protection: A Primer for Regulatory Affairs Professionals,” (speaker), CAPRA Dinner Meeting, Toronto, ON, January 2016
- “Pharmaceutical Brand Protection Program: Latest Trends and Legal Considerations Demystified!” The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series, July 2015
- "Patenting Drugs in Canada: Differences and Dividing Lines North and South of the Border," Fifth Annual RIPL Symposium, The John Marshall Law School, Chicago, IL, November 2013
- "Supreme Court of Canada PLAVIX Decision: The Aftermath," panel discussion at the Drug Patent and Legal Forum, Toronto, May 2009
- "Selecting the Right Expert," Advocacy Before the Federal Court in Intellectual Property Matters — Expert Witnesses, Canadian Bar Association, Ottawa, May 2008
- "The AstraZeneca Decision of the Supreme Court of Canada — Downstream Effects," Drug Patents and Legal Forum, Insight Information, Toronto, February 2008
- "Patent Time Lines: Maximizing Possibilities from Both Perspectives" (co-presenter: Angela Furlanetto, Dimock Stratton LLP), 6th Annual Forum on Pharma Patents, Canadian Institute, Toronto, October 2007
- "Changes to Patented Medicines (NOC) Regulations — Industry Perspective" (co-presenter: Gunars A. Gaikis), From Product Monograph to Promotion and Other Emerging Initiatives, Canadian Association of Professional Regulatory Affairs, Toronto, November 2007
- "Maintaining Profitability while Minimizing the Impact of Patent Expiry and Generic Entry," Drug Pricing & Reimbursement in Canada Conference, Canadian Institute, Toronto, June 2007
- "Developing and Managing Your Patent Portfolio — Maximizing Patent Life Cycles and Minimizing the Impact of Patent Expiry and Innovation Uncertainty" (co-presenter: Yoon Kang), 5th Annual Forum on Pharma Patents, Canadian Institute, Toronto, October 2006
Memberships
- Fellow, Intellectual Property Institute of Canada
- Member, The Advocates' Society
- Director, BIOTECanada
- "Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada" (co-authors: Daphne Lainson and Alice Tseng), Association of Corporate Counsel, December 2020
- "10 Things You Need to Know about Life Sciences Patent Litigation in Canada" (co-author: Sheldon Hamilton), Association of Corporate Counsel, August 2020
- "Canada’s Covid-19 response" (co-author: Daphne Lainson), Intellectual Property Magazine, May 29, 2020
- "COVID-19: The impact on IP law and practice in Canada" (co-author: David Schwartz), IP Stars, May 4, 2020
- "Compulsory licensing in Canada—revisited" (co-author: Daphne Lainson), Life Sciences IP Review, April 21, 2019
- "Canada amends Patent Act due to COVID-19" (co-author: David Schwartz), MIP IP Stars, April 23, 2020
- "Price of drug patents in Canada" (co-author: Daphne Lainson), Intellectual Property Magazine, September 30, 2019
- "Regulatory reform and impact on exclusivities" (co-author: Daphne Lainson), NOC, Summer, 2019
- "Trading up: Daphne Lainson and Nancy Pei explain why the new trade deal enhances IP-related rights for pharmaceutical innovators" (co-author: Daphne Lainson), Intellectual Property Magazine, November 5, 2018
- "The best and worst of times? Pharma forecast for 2019" (co-author: Daphne Lainson), Expert Guides, September 9, 2018
- "CETA amendments: Impact on biologics in Canada" (co-author: Daphne Lainson), BIOTECanada Insights, Spring 2018
- "Coming to Canada: Information Protocol and Regulatory Issues" (co-author: Daphne Lainson), BIOTECanada Insights, Spring 2016
- "Will the TPP top CETA for protection of new drugs and biologics in Canada?" (co-author: Daphne Lainson), Intellectual Property Magazine, February 2016
- "Enhanced IP rights in Canada" (co-author: Daphne C. Lainson), Intellectual Property Magazine, December 2013
- "Evolution of a Rare Medicines Policy in Canada" (co-author: Daphne C. Lainson), insights Magazine, Fall 2013, pp. 16-19
- "The Pharmaceutical/Biopharmaceutical Landscape—Traversing Canada's Patent and Regulatory Regimes" (co-author: Daphne C. Lainson), Biotechnology Law Report. August 2013, Vol. 32, Issue 4, pp. 252-258
- “The patent-regulatory regime in Canada” (co-author: J. Sheldon Hamilton), Pharmaceutical Patent Analyst, November 2012, Vol. 1, Issue 5
- "Canada signs up to Doha," Managing Intellectual Property, April 2004