Gilead Sciences, Inc. et al v Idenix Pharmaceuticals, Inc. et al, 2015 FC 1156
For tech companies worried about possibly infringing a patent, this Federal Court (“FC”) case illustrates one pro-active strategy worth considering. This decision dealt with the validity of two patents related to Sovaldi, the brand name for the antiviral drug sofosbuvir used to treat Hepatitis C virus (“HCV”) sold by the plaintiffs (collectively “Gilead”). Gilead brought their application as interested persons under section 60 (1) of the Patent Act, RSC 1985, c P-4, as a proactive step to protect Sovaldi from a patent owned by the defendants (collectively “Idenix”).
Background
Gilead brought an application for a declaration that Idenix’s patent, Canadian Patent No. 2,490,191 (the “’191 Patent”), was invalid on the grounds of insufficient disclosure, lack of demonstrated utility and sound prediction, and overbreadth. [7] In response, Idenix brought a counterclaim alleging that a compound in Gilead’s own patent, Canadian Patent No. 2,527,657 (the “’657 Patent”) was anticipated by the ‘191 Patent, and sought a declaration of invalidity.
Ultimately, Gilead’s application was allowed and the FC dismissed the counterclaim. The FC found that Idenix’s patent was invalid for a lack of utility, demonstrated or soundly predicted, and for insufficient disclosure.
The ‘657 Patent
The ’657 Patent includes claims to a new compound, sofobuvir, used to treat Hepatitis C infections. After being issued a Notice of Compliance for sofobuvir, Gilead sold it under the brand name Sovaldi. The FC described Sovaldi as a revolutionary drug, as it represented a significant breakthrough in the treatment of HCV, which over 2.2% of the world’s population is said to be infected by. [6] Idenix alleged that the ‘657 Patent was invalid on the grounds of anticipation based on the ‘191 Patent or in the alternative, under section 53 of the Patent Act for willful misrepresentation by knowingly omitting naming Lieven Stuyver as an inventor. [12]
Anticipation
The FC rejected Idenix’s claim of anticipation based on the ‘191 Patent. The FC found that although the same invention of the ‘657 Patent was disclosed in the ‘191 Patent, there was no enabling disclosure of how to synthesize the compounds in the ‘191 Patent. [810]
Patent Act, s 53
The FC dismissed Idenix’s allegation that the ‘657 Patent was invalid under section 53 of the Patent Act. The FC held that Stuyver was not a co-inventor of the compound and noted that when Stuyver signed a declaration acknowledging this fact in 2005, it was not under duress. [904, 914] The FC went on to comment that Idenix nevertheless failed to establish how failure to name a co-inventor was a “material” untrue allegation. [928]
The ‘191 Patent
While developing new compounds for the treatment of HCV, Idenix discovered that some known nucleoside analogues had activity in in vitro assays against a family of viruses including HCV, which became the foundation of the ‘191 Patent. [27]
Utility
The parties agreed that the ‘191 Patent promised that its claimed compounds were useful in the treatments of Flaviviridae infections, including HCV, in humans and other hosts. [232, 235] However, the FC found that the ‘191 Patent did not promise any specific result or level of treatment and that Gilead therefore had to prove that Idenix failed to demonstrate or soundly predict a scintilla of utility in the claimed compounds for the treatment of Flaviviridae infections. [241] Utility was assessed on the basis of sound prediction because Idenix admitted that they had not synthesized any compound falling within the scope of the claims of the ‘191 Patent until after the date of filing. [221] The FC held that the ‘191 Patent lacked sound prediction, finding that Idenix failed to establish that a person skilled in the art could have soundly predicted the utility in the claimed compounds for the treatment of Flaviviridae. [255]
The FC went on to discuss the utility disclosure requirement. The FC adopted the reasoning from Astrazeneca Canada Inc v Apotex Inc, 2014 FC 638, which states that the disclosure requirement of soundly predicted utility only applies to “new use” inventions. [378] Since the ‘191 Patent relates to a sound prediction of a new composition, the FC held that no utility disclosure was required. [380] Noting that the law on the disclosure requirement of soundly predicted utility is contentious, the FC went on to assess the sufficiency of the disclosure should the law change in the future. [381] The FC held that the ‘191 Patent did not sufficiently disclose how to synthesize the nucleoside compound. [412]
Disclosure
The FC held that the ‘191 Patent did not sufficiently disclose how to synthesize the claimed compounds and was therefore invalid. Idenix sought to rely on common general knowledge and permissible experimentation to meet the burden of disclosure. The FC rejected Idenix’s argument noting that in order for a published statement to be common general knowledge in relation to the synthesis of a compound it, “must possess some fore-ordained degree of near-certainty, to be confirmed, not proven, by routine experimentation.” [536]
Overbreadth
The FC found that the claims of the ‘191 Patent were not overbroad.
Commentary
This case illustrates a successful example of a patentee proactively bringing an action against a patent that it foresees may threaten or be asserted against their own. In his first patent decision, Annis J. took care to highlight areas of law that he suggests may be subject to change. Annis J. noted that while the current law states that the disclosure requirement of soundly predicted utility only applies to “new use” inventions, it is contentious and undertook further analysis should the law surrounding utility disclosure requirement change. Annis J. also questioned how the failure to name a co-inventor qualified as a “material” untrue allegation, leaving room for the issue to be reexamined.