Eli Lilly Challenges Patent Law

Eli Lilly has filed a “Notice of Intent” to challenge the ‘promise doctrine’ in Canadian patent law through NAFTA. The focus of the statement is on the law of the ‘promise’ of a patent in determining patent validity whether it complies with Canada’s obligations under TRIPs and NAFTA.

A Notice of Intent, dated November 7, 2012 was published on the Foreign Affairs and International Trade Canada website, as noted by Jeff Gray of the Globe and Mail (via John Greiss‘s 7drams blog). According to the summary on the government website:

On November 7, 2012, Eli Lily and Company, a US-based corporation, served the Government of Canada with a Notice of Intent to Submit a Claim to Arbitration under NAFTA Chapter 11. Eli Lilly and Company is alleging that the invalidation of its Strattera pharmaceutical patent by Canada is inconsistent with Canada’s commitments under NAFTA.

As included in Eli Lilly’s Notice of Intent:

In a series of decisions issued since 2005, the Federal Court of Canada and the Federal Court of Appeal have created a new judicial doctrine whereby utility is assessed not by reference to the requirement in the Patent Act that an invention be “useful”, but rather against the “promise” that the courts derive from the patent specification. This non-statutory “promise doctrine” is not applied in any other jurisdiction in the world.

 The particular drug at issue in the Notice is the patent for Strattera (atomoxetine) and the patent for Zyprexa (olazapine) in which Eli Lilly is currently seeking leave to appeal to the Supreme Court of Canada (35067 from 2012 FCA 232 and 2011 FC 1288). Eli Lilly notes that 16 corresponding patents in other jurisdictions have been successfully defended against challenges of invalidity.

As a result Eli Lilly provides notice of expropriation, violation of minimum treatment of investments, and national treatment under NAFTA and claims $100 million in damages. Only a Notice of Intent has been published on the website so the dispute may or may not result in arbitration under Chapter 11 of NAFTA.

Foreign Affairs and International Trade Canada has a section explaining the investment chapter, Chapter 11 of NAFTA and the dispute settlement process.