Canada’s Intellectual Property Law Firm

Gunars Gaikis

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Gunars Gaikis

Partner
  • Smart & Biggar LLP
Barrister and Solicitor
  • Patent and Trademark Agent
English | Latvian

Globally heralded life sciences litigator and "seasoned gladiator"

A pre-eminent and pioneering leader in life sciences intellectual property, Gunars is consistently recognized by his peers and clients for his expertise and contributions over the past 25 years in the highly specialized field of pharmaceutical patent, trademark and related litigation. Among his many accolades, Gunars has been listed as one of the top thirty patent attorneys globally and named as one of the world’s leading life sciences patent litigators. Known for his unrelenting client commitment and fierce courtroom advocacy, clients praise Gunars as an “IP star” and “seasoned gladiator.”

One of Canada’s most experienced life sciences IP litigators, Gunars has been at the forefront of the pharmaceutical patent litigation field since its emergence in the early 1990’s. In counselling clients, he strives for practical, cost-effective and creative solutions that consider client needs, financial implications and the IP rights at stake.

Ground-breaking court successes protect critical pharmaceutical innovations

A strong proponent of protecting pharmaceutical innovation, Gunars has acted as counsel in many ground-breaking court decisions on behalf of innovators seeking protection in Canada. This includes his win for AstraZeneca when the Supreme Court “wholly rejected the promise doctrine” and clarified the requirement for patent utility. He has appeared as lead counsel in numerous intellectual property cases before the Ontario, Federal and Supreme courts. His successes earned him recognition by legal publications as a “skilled fighter and life cycle strategist for original drugs companies.”

Licensed pharmacist with first-hand understanding in medical, biotech and pharmaceutical issues

As a licensed pharmacist with experience in clinical pharmacy, Gunars offers first-hand understanding of medical, biotechnology and pharmaceutical matters, including the relevant regulatory issues, in addition to his exceptional legal experience. He regularly counsels clients in pharmaceutical patent procurement, data protection, PMPRB, IP life cycle management and drug regulatory matters, and provides invaluable pre-litigation advice and due diligence. Gunars also has extensive expertise in pharmaceutical trademark and passing off cases, and has succeeded in obtaining preliminary injunctions in such trademark cases in both the Ontario Superior and Federal Courts.

Gunars joined Smart & Biggar in 1985 and was instrumental in the growth and expansion of the Toronto office.

Qualifications

  • News
  • Speaking
  • Industry Involvement
  • In the Media
  • “What Pharmacists Need to Know about Cannabis”, (co-speaker: Alice Tseng), Pharmacy Experience Pharmacie (PxP) conference, Toronto, Ontario, June 4, 2019
  • "A Focus on the Utility Doctrine" (co-presenter: Yoon Kang), The Canadian Insittue's 13th Forum on Pharma Patents, October 2016
  • "Canada: Is Case Law Moving Sidways? The Utility & the "Promise" issue" presentation at C5's Life Sciences IP Summit, October 2016
  • "Navigating Jurisdictional Challenges and Quantifying Damages in s. 8 Cases: Critical Views from Both Sides" panel discussion at the Canadian Institute's 11th Annual Forum on Pharma Patents, Toronto, October 2012
  • "Damages in Patent Infringement and Section 8 Cases: The View from Both Sides" panel discussion at the Canadian Institute's 10th Annual Forum on Pharma Patents, Toronto, October 2011
  • "Strategies in Pharma Patent Litigation," Insight Information's 9th conference on Drug Patents in Canada, Toronto, May 2010
  • "Pharma Patents Litigation: Year in Review," panel discussion at The Canadian Institute's 8th Annual Forum on Pharma Patents, Toronto, October 2009
  • "Pharma Patent Trials Within Two Years," Insight Information's Drug Patent and Legal Forum, Toronto, May 2009
  • "Year in Review – Regulatory Developments" (co-presenters: Nancy P. Pei and Daphne C. Lainson) and "Year in Review – Litigation" (co-presenters: J. Sheldon Hamilton and Yoon Kang), Smart & Biggar’s Pharma Patents 2008, Mississauga, ON, November 2008
  • "Pharma Patents and Competition Law Issues: Patentee’s Perspective," Insight Information’s Drug Patents and Legal Forum, Toronto, February 2008
  • "Successfully Maximizing Product Life Cycle: What Every Innovator Needs to Know," "The Canadian Institute's National Business and Legal Guide to Life Sciences Business and Legal, Ottawa, April 2008
  • "Pharma Patents – The Year in Review" (co-presenters: J. Sheldon Hamilton, Yoon Kang, Nancy P. Pei and Denise L. Lacombe) and "Pharmaceutical Product Life Cycle Management – Patents and the Regulatory Environment, Including Data Protection and the Patented Medicines (Notice of Compliance) Regulations" (co-presenter: Nancy P. Pei), Smart & Biggar’s Pharma Patents 2007, Mississauga, ON, November 2007
  • "Authorized Generics and Relevant Licensing Issues," The Canadian Institute's 6th Annual Forum on Pharma Patents, Toronto, October 2007
  • "Changes to Patented Medicines (NOC) Regulations — Industry Perspective" (co-presenter: Nancy P. Pei), Canadian Association of Professional Regulatory Affairs symposium From Product Monograph to Promotion and Other Emerging Initiatives, Toronto, November 2007
  • "Successfully Protecting Exclusivity in the New Regulatory Framework," The Canadian Institute's Summit on Pharmaceutical & Biotech Regulatory Compliance, Toronto, March 2007
  • "Preventing, Defending, and Financing IP Litigation," Insight/ALM conference Intellectual Property: Building, Protecting, and Profiting From Your IP Portfolio, Toronto, November 2006
  • "Pharma Patents and the Regulatory Environment" (co-presenter: Nancy P. Pei), "Litigating Pharma Patents" (co-presenters: John R. Morrissey and Steven B. Garland) and “Hot Topics and Discussion" (co-presenters: A. David Morrow and J. Sheldon Hamilton), Smart & Biggar's Pharma Patents 2006, Mississauga, ON, November 2006

Memberships

  • Fellow, Litigation Counsel of America
  • Fellow, Intellectual Property Institute of Canada
  • Member, Pharmaceutical Trade Marks Group
  • Member, American Intellectual Property Law Association
  • Past long-time Chair of the Patent Committee of the IP Section, Canadian Bar Association
  • Editorial board member of LSIPR Newsletter
  • Quoted in "Decision resurrects disputed patent principle", Law Times, November 26, 2018 
  • Process for Choosing and Vetting an Expert Witness in Patent Cases”, (co-authors Andrew Mandlsohn and Shirley Liang Komosa), Canadian Intellectual Property Review, June 2016, Volume 32
  • "Clarification of the 'promise' of utility doctrine in Canada," Expert Guides: Patent 2015, March 2015, pp. 88-89
  • "The race for market exclusivity," Life Sciences Intellectual Property Review Quarterly, Vol. 2, Issue 2 (2015)
  • "Cold Feet in Canada," Life Sciences Intellectual Property Review Quarterly, Vol. 2, Issue 1 (2015)
  • "Pharmaceutical Patent Litigation is Inevitable — Typically Overlooked Licensing Terms" (co-authors: Junyi Chen, Jeff J. Kang and Rebecca B. Rodal), presented at the Federated Press conference titled "Negotiating & Drafting Bio Pharma Contracts," June 2011
  • "The Patentability of Pharmaceutical Dosage Regimes in Canada" (co-author: David E. Schwartz), 26 Canadian Intellectual Property Review 2, December 2010
  • "Minimizing the Risk of Section 8 Damages" (co-authors: Andrew Mandlsohn, Patrick M. Roszell and Alain Laplume), presented at the 9th Annual Forum on Pharma Patents, November 2010
  • "Analyzing the Latest Developments in the Law to Identify Emerging Trends, Opportunities and Threats" (co-authors: Andrew Mandlsohn, Urszula Wojtyra and Jordan D. Scopa), presented at the 8th Annual Forum on Pharma Patents, October 2009
  • "Understanding Key Issues Impacting the Industry Today: Recent Developments in the Law of Patents" (co-authors: Andrew Mandlsohn and Jayda A. Sutton), presented at the 7th Annual Forum on Pharma Patents, October 2008
  • "Unique IP Issues in Canada's Pharmaceutical and Biotechnology Industry" (co-authors: Daphne C. Lainson and David E. Schwartz), The 2006 LEXPERT Guide to the Top 100 Industry Specialists in Canada, October 2006, pp. 125-129
  • "Proposed Amendments to the Patented Medicines (Notice of Compliance) Regulations and Data Protection Provisions of the Food and Drug Regulations" (co-author: Junyi Chen), presented at the Canadian Institute’s Pharmaceutical & Biotech Regulatory Compliance Conference, March 2006
  • "Recent Jurisprudence Under the NOC Regulations" (co-author: Junyi Chen ), presented at the Canadian Institute’s 4th Annual Forum on Pharma Patents: The Legal and Strategic Guide, October 2005
  • "Listing Patents on the Patent Register" (co-author: Junyi Chen), presented at Drug Patents: The Latest Legal, Regulatory, and Litigation Developments, March 2005
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