• About
  • Offices
  • Careers
  • News
  • Students
  • Alumni
  • Payments
  • FR
Background Image
Bennett Jones Logo
  • People
  • Expertise
  • Knowledge
  • Search
  • FR Menu
  • Search Mobile
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
View all
Practices
Corporate Litigation Regulatory Tax View all
Industries
Capital Projects Energy Funds & Finance Mining View all
Advisory
Crisis & Risk Management ESG Strategy and Solutions Governmental Affairs & Public Policy
View Client Work
International Experience
Insights News Events
New Energy Economy Series Business Law Talks Podcast Economic Outlook
ESG & the CIO Subscribe
People
Practices
Industries
Advisory Services
Client Work
About
Offices
News
Careers
Insights
Law Students
Events
Search
Alumni
Payments
Subscribe

Stay informed on the latest business and legal insights and events.

LinkedIn LinkedIn Twitter Twitter Vimeo Vimeo
 
Blog

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

September 14, 2017

Written By Dominique T. Hussey, Jeilah Y. Chan and Emily P. Kettel

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the Minister for International Trade, announced that proposed amendments to the Patented Medicines (Notice of Compliance) Regulations will be proclaimed into law on September 21, 2017. The regulations govern patent infringement and invalidity disputes involving patented medicines between "first" and "second" persons (i.e., brand v. generic and biologic v. biosimilar products). These amendments affect Canadian pharmaceutical patent holders, pharmaceutical manufacturers and potential generic/biosimilar pharmaceutical manufacturers. We previously reported on draft amendments published in July 2017, which are the same as the amendments that will come into force on September 21.

The full text of the finalized amendments is available online.

IP Type

Patents

Summary

The amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) will change how pharmaceutical patent holders approach litigation in Canada. Previously, a patent holder could assert a patent against a generic or biosimilar through the PM(NOC) application proceeding and also in a subsequent infringement action.

Now, a patent holder must decide whether to commence an action against a generic or biosimilar shortly after Notice of Allegation service, or not at all. The patent holder should consider whether to commence an action on additional, non-Patent Register patents at the same time. The patent holder must also weigh whether to allow the generic or biosimilar on the market during the infringement action suit to avoid paying “Section 8” damages (the generic or biosimilar’s damages due to being kept off the Canadian market during PM(NOC) litigation).

The generic or biosimilar also faces new decision points: whether to preemptively address additional patents not listed on the Patent Register to minimize later litigation and whether to launch “at-risk” if the patent holder waives the 24-month statutory stay.

Certificates of Supplementary Protection (CSP) Regulations

The Canadian government also announced that the Certificates of Supplementary Protection Regulations would come into force on September 21, 2017. CSPs provide a form of “patent term extension” meant to compensate patent owners for time spent in research and while seeking marketing authorization. CSPs have terms of a maximum of two years. CSPs can be added to the Patent Register and litigated like Register patents, and will be a valuable tool for patent holders.

The full text of the CSP Regulations is available online.


For further information on how to protect and enforce your intellectual property rights, contact Dominique Hussey, Jeilah Chan, or another member of the Intellectual Property Litigation team.


Equip is our platform for curated, key intellectual property cases.  Delivered weekly, Equip distills the current substantive and procedural issues in Canadian IP litigation, equipping you with the key points for your business.

Download PDF

Authors

  • Dominique T. Hussey Dominique T. Hussey, Vice Chair and Toronto Managing Partner
  • Jeilah Y. Chan Jeilah Y. Chan, Partner, Trademark Agent
  • Emily P. Kettel Emily P. Kettel, Partner

Our Managing Partners on Workplaces Where Women Thrive

Related Links

  • Insights
  • Media
  • Subscribe

Recent Posts

Blog

Canada's Underused Housing Tax: What You Need to Know Before May 1, 2023

March 23, 2023
       

Blog

Canadian Securities Regulators Announce Increased [...]

March 23, 2023
       

Blog

Unpaid Municipal Taxes Will Impact New AER Licences and Licence Transfers

March 22, 2023
       

Blog

Application of Statutory Bar to Workplace Bullying and Harassment Claims

March 20, 2023
       

Blog

The Current State of Canada's ZEV Market

March 20, 2023
       
Bennett Jones Centennial Footer
Bennett Jones Centennial Footer
About
  • Leadership
  • Diversity
  • Community
  • Innovation
  • Security
  • History
Offices
  • Calgary
  • Edmonton
  • Montréal
  • Ottawa
  • Toronto
  • Vancouver
  • New York
Connect
  • Insights
  • News
  • Events
  • Careers
  • Students
  • Alumni
Subscribe

Stay informed on the latest business and legal insights and events.

LinkedIn LinkedIn Twitter Twitter Vimeo Vimeo
© Bennett Jones LLP 2023. All rights reserved.
  • Privacy Policy
  • Disclaimer
  • Terms of Use
Logo Bennett Jones