Case information

Intellectual property — Patents — Validity — Hearsay — Presumption of validity — Sufficiency — Anticipation — Enablement test — How does the principled approach to hearsay apply to admissions — What is the proper approach for giving effect to the presumption of validity set out in the Patent Act — Whether the enablement test for anticipation should be harmonized with the sufficiency test — If so, whether this is an appropriate case to address harmonization of the tests.

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The two patents at issue here claimed compounds that act against the virus family which includes Hepatitis C. The specific claimed compound is a modified nucleoside (a building block of ribonucleic and deoxyribonucleic acids). In 2002, Idenix filed two U.S. patent applications for certain nucleoside structures and their derivatives, including the claimed compound. As none of them had been synthesized, Idenix set out to synthesize some of them, including the claimed compound. Idenix’s U.S. patent applications established priority for Canadian Patent No. 2,049,191 (the “191 Patent”). Idenix filed a Patent Cooperation Treaty Patent Application for the Canadian patent in June 2003.

In May 2003, a chemist at Pharmasset, now Gilead, synthesized the claimed compound. His provisional U.S. patent application in 2004 was the foundation for Gilead’s Canadian Patent No. 2,527,657 (the “657 Patent”), filed in April 2004. It discloses the step-by-step synthesis of the claimed compound and its antiviral activity against Hepatitis C in some detail. The 657 Patent was issued in June 2011. In May 2013, Gilead filed a New Drug Submission for sofosbuvir, an oral treatment for Hepatitis C.

Gilead alleged that the 191 Patent was invalid due to insufficient disclosure, lack of demonstrated utility or sound prediction, and overbreadth. By counterclaim, Idenix sought a declaration that Gilead’s subsequent 657 Patent for infringement, lack of novelty, and wilful misleading. The trial judge found the 191 Patent to be invalid and dismissed Idenix’s counterclaim. The Court of Appeal dismissed Gilead’s appeal.