Gunars Gaikis is one of Canada's premier and most experienced life sciences Intellectual Property litigators. He is a partner in Smart & Biggar/Fetherstonhaugh's Toronto office, and has more than 30 years of experience in the highly specialized field of pharmaceutical patent, trademark and related litigation.
Gunars has been described as "one of the best patent litigators since the industry began". He has been recognized as one of the world's leading life sciences patent litigators, an outstanding biotechnology lawyer and in the world's top 30 patent attorneys. He has appeared as lead counsel in numerous IP cases before the Ontario and Federal Courts and the Supreme Court. His work includes protection of IP assets relating to esomeprazole, omeprazole, ramipril, lisinopril, trastuzumab, ciprofloxacin, ranitidine, naproxen and doxorubicin, to name a few.
He has also shaped the law through his trial and appellate work in pharmaceutical patent litigation. In 1993 Gunars was counsel in the first litigation ever commenced under the Patented Medicines (Notice of Compliance) Regulations, and has continued to represent innovators in precedent setting decisions in PMNOC litigation.
In 2017, Gunars was lead counsel on the Smart & Biggar team which successfully represented AstraZeneca in a landmark pharma patent case in which the Supreme Court of Canada on June 30, 2017 struck down the utility "promise doctrine" and upheld AstraZeneca's NEXIUM patent as useful.
In addition, Gunars has also assisted pharmaceutical innovators in:
- Patent listing under the PMNOC Regulations,
- Data protection matters under the Food and Drug Regulations,
- Pricing before the Patented Medicine Prices Review Board, and
- Trademark procurement and enforcement.
He also regularly counsels clients in patent procurement and IP life-cycle management, and provides invaluable pre-litigation advice and due diligence.
As a licensed pharmacist and having completed a residency program in clinical pharmacy, Gunars is very familiar with medical and pharmaceutical matters, including the relevant regulatory issues. This background coupled with his in-depth expertise in complex pharmaceutical and biotechnology patent litigation make Gunars an invaluable asset to clients operating in these fields.
Among his many accolades, Gunars has been recognized annually as a "life Science Star" in the Canada Chapter of LMG Life Sciences since 2013 and identified as a World IP Review Leader since 2016. He was named as one of the World's Leading Patent Professionals in the 2017 edition of IAM Patent 1000, an IP leader in the 2018 edition of Chambers Global – The World's Leading Lawyers for Business, and named MIP 2018 Outstanding IP Practitioner of the Year in Canada. In 2015 Gunars was selected as Canadian Patent Litigation Attorney of the Year by LMG Life Sciences, and has been recognized as one of the top thirty patent lawyers in the world in Euromoney's Expert Guides, since 2014.
In a decision dated October 30 2014, the Federal Court of Appeal provided some clarification on the utility requirements for patentability in Canada, and in particular the nature and application of the "promise" of utility. This doctrine has recently been extensively relied on by generic companies...