Professionals

Nancy Pei
Partner, Toronto
Barrister and Solicitor,
Patent and Trademark Agent

 

CONTACT
Phone: 416.593.5514
Fax: 416.591.1690
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YEAR OF CALL
Ontario Bar 1997
QUALIFICATIONS
  • University of Toronto B.Sc. (Pharmacy) 1991
  • University of Toronto LL.B. 1995
  • Registered Trademark Agent 1998
  • Registered Patent Agent 2004
  • Registered Pharmacist (Ontario College of Pharmacists)(Part B)
 

Nancy Pei practises exclusively in the field of life sciences (pharmaceuticals, biologics, medical devices, natural health products). She has over fifteen years of experience with pharmaceutical patent and related litigation and in providing regulatory advice to clients operating in the life sciences industry.

Nancy represents innovative life sciences companies in litigation relating to the Patented Medicines (Notice of Compliance) Regulations and in patent infringement actions. She has represented clients before the Federal Court of Canada, the Federal Court of Appeal, the Supreme Court of Canada, the Ontario Superior Court of Justice and in opposition proceedings before the Canadian Intellectual Property Office. Most recently, Nancy was a member of the Smart & Biggar team that successfully represented AstraZeneca in its patent infringement action against Apotex: AstraZeneca Canada Inc. v Apotex Inc., 2015 FC 322 (LOSEC, omeprazole).

She also provides advice and assistance on matters relating to life cycle management (including strategic advice regarding patents and data protection), patent listing under the Patented Medicines (Notice of Compliance) Regulations, pricing and reimbursement (including Patented Medicine Prices Review Board matters), 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. She has also represented clients in related judicial review applications.

Nancy’s hands-on experience as a pharmacist coupled with the expertise gained through her highly focussed yet diverse practice afford her a unique position in examining broader patenting and regulatory issues of importance to innovative life sciences clients.

Nancy has been the editor of Rx IP Update, the firm's monthly pharmaceutical intellectual property and regulatory newsletter, since its inception in 2001. She is also an editor of IP Update — Canada, the firm's intellectual property law bulletin.


Rankings and recognition

  • Recognized in the 2016 edition of Managing Intellectual Property – IP STARS list, as one of the Top 250 Women in IP
  • Nominated for Intellectual Property Litigator of the Year, Benchmark Canada 2016
  • Recognized in the 2015 edition of Euromoney's Expert Guides: Women in Business law as a top female legal practitioner in the area of trademarks
  • Recognized annually in The Best Lawyers in Canada under Intellectual Property Law since 2015
  • Recognized annually as an 'IP Star' since the inaugural edition in 2014 of Managing Intellectual Property’s IP Stars Handbook: Patents
  • Recognized annually since the inaugural Canada Chapter in 2013 of LMG Life Sciences as a 'Life Science Star' under Intellectual Property
  • Listed in the The Canadian Legal Lexpert® Directory as repeatedly recommended in the areas of intellectual property (since 2012), biotechnology (since 2014) and Intellectual Property Litigation (since 2015)
PRACTICE AREAS
Pharmaceutical
Litigation
Chemical & Industrial Biotechnology
Life Sciences
Life Sciences — Regulatory & Compliance
Cleantech
 

Selected Cases:

AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322 (appeal pending)

Photocure ASA v Canada (Health), 2015 FC 959

Apotex Inc v AstraZeneca Canada Inc, 2012 FC 559, aff’d 2013 FCA 77

Bayer Inc v Canada (Health), 2009 FC 1171, aff’d 2010 FCA 161, leave to appeal denied

Apotex Inc v Canada (Health), 2009 FC 721

Apotex Inc v Syntex Pharmaceuticals International Limited, 2009 FC 494, aff’d 2010 FCA 155

Apotex Inc v AstraZeneca Canada Inc, 2009 FC 120

Immunex Corporation v Canada (Health), 2008 FC 1409

Sanofi-Aventis Canada Inc v Canada (Health), 2008 FC 1062, aff’d 2009 FCA 169

Bayer Inc v Canada (Health), 2008 FC 857, aff’d 2009 FCA 133

Sanofi-Aventis Canada Inc v Canada (Health), 2007 FC 1156, rev’d 2008 FC 129

Ferring Inc v Canada (Health), 2007 FC 300, aff’d 2007 FCA 276

Apotex Inc v Sanofi-Aventis Canada Inc, 2007 FCA 7

Apotex Inc v Merck & Co Inc, 2006 FCA 198

Merck & Co Inc v Apotex Inc, 2006 FC 524, aff’d 2006 FCA 323

Merck & Co Inc v Apotex Inc, 2005 FC 1560

Apotex Inc v Syntex Pharmaceuticals International Ltd, 2005 FC 1310, aff’d 2006 FCA 60

Merck & Co Inc v Apotex Inc, 2005 FC 1251

AstraZeneca Canada Inc v Canada (Minister of Health), 2005 FCA 189, rev’d [2006] 2 SCR 560

AstraZeneca Canada Inc v Canada (Minister of Health), 2005 FCA175, aff’g 2004 FC 736

AstraZeneca Canada Inc v Canada (Minister of Health), 2005 FCA 58, aff’g 2004 FC 1278

Apotex Inc v Syntex Pharmaceuticals International Ltd, 2005 FC 121, aff’d 2005 FC 480, aff’d 2005 FCA 424

Hoffman-La Roche Ltd v Canada (Minister of Health), 2004 FC 1547, aff’d 2005 FCA 140

AstraZeneca Canada Inc v Apotex Inc, 2004 FC 1075, aff’d 2005 FCA 216, leave to appeal to appeal denied

AB Hassle v Genpharm Inc, 2004 FC 892, aff’d 2004 FCA 413, leave to appeal denied

Apotex Inc v Syntex Pharmaceuticals International Ltd, 2004 FC 383

Merck & Co Inc v Apotex Inc, 2003 FCA 488, rev’g in part 2003 FCT 159, aff’g 2002 FCT 509

Apotex Inc v Merck & Co, 2003 FCA 438, rev’g 2003 FCT 160

Novopharm Ltd v AstraZeneca AB, 2003 FC 1212

AstraZeneca AB v Novopharm Ltd, 2003 FCA 57, aff’g 2001 FCT 1171

Glaxo Group Limited v Canada (Minister of National Health and Welfare), 1997 CanLII 5591

 

Memberships

  • Fellow, Intellectual Property Institute of Canada


Speaking engagements

  • “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

Publications

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