A vague queasiness may come over you when the envelope lands on your desk with an emphatic thump and you pull out the 100+ pages explaining why the patents on your key pharmaceutical or biologic product are under challenge. Welcome to patent actions under Canada’s Patented Medicines (Notice of Compliance) Regulations (“Regulations”). Fast-paced – 21 months to trial – and carrying significant commercial risks – loss of exclusivity, exposure to damage claims – actions under the Regulations present a significant litigation-management challenge. An understanding of the key facets of the Regulations can help you avoid pitfalls and calm your nerves. Here are ten topics that in-house counsel need to know about the Regulations:
- Service
- Use it or lost it
- Imposed confidentiality obligations
- 45 days go by fast
- Two years go by fast
- Early document production
- Waiver of the 24-month statutory stay
- Inventor (and no expert) discovery
- 10-day trial
- Expanded liability under Section 8?
The fast pace and high stakes of life sciences patent litigation in Canada can make for a stomach-churning ride. Advance planning will not slow the timetable but will smooth out bumps and potholes. Taking steps before the NOA is served to implement an
internal communication plan, collect documents, interview inventors, spot issues and identify experts will not only smooth out the ride, but also significantly enhance the chances of success.
This abbreviated article has been reproduced with permission from the original publisher Association of Corporate Counsel (ACC). If you would like to learn more, the full article is available to view online in the ACC Resource Library.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.