Amicus Curiae Submission in NAFTA Proceedings Eli Lilly v. Canada
20 Pages Posted: 2 Mar 2016 Last revised: 11 May 2020
Date Written: February 12, 2016
This amicus brief was submitted to the NAFTA arbitral tribunal in Eli Lilly v. Canada (ICSID Case No. UNCT/14/2). The arbitration arises out of the decisions by Canadian courts to invalidate two of Eli Lilly’s pharmaceutical patents. The case involves issues of significant public interest because the tribunal’s decision is likely to impact on the legal regimes governing pharmaceutical patent protection in Canada and many other countries. Relatedly, it also bears upon international issues of access to medicines and public health. In particular, findings made in this arbitration are likely to affect, the ability and willingness of countries around the world to use the acknowledged flexibilities of the international intellectual property system, in particular under the TRIPS Agreement, for the purpose of public health and access to medicines. It will also increase the likelihood of similar investment law challenges being brought by IP owners dissatisfied by domestic courts’ decisions on the validity of their patents. This will be a new and concerning development; to date intellectual property norms have only been challenged at an international level in state-to-state proceedings.
The Brief examines, amongst other issues:
• the scope of Canada’s obligations under NAFTA Articles 1105 and its relationship with both domestic and international intellectual property laws;
• the intersection of NAFTA’s standards of protection, in particular fair and equitable treatment (FET) with Canada’s domestic patent law;
• the relationship between NAFTA Chapter 17, the TRIPs Agreement and the Patent Cooperation Treaty;
• the appropriate standard of review for judicial conduct;
• the importance of patent law flexibilities; and
• the frequency of patent invalidations.
Keywords: intellectual property rights, patents, patent invalidation, patent revocation, utility, industrial application, new medical use inventions, selection inventions, NAFTA fair and equitable treatment, FET, state responsibility for judicial conduct, legitimate expectations, TRIPs, NAFTA
JEL Classification: K11, K41, O34
Suggested Citation: Suggested Citation