Friday, November 6, 2015

Inventorship Not Material for Purposes of S 53

Gilead Sciences, Inc v Idenix Pharmaceuticals, Inc 2015 FC 1156 Annis J
            2,490,191 2,527,657 / sofosbuvir / SOVALDI

Previous posts have discussed Gildead’s utility and sufficiency attacks on Idenix’ 191 patent. This post deals primarily with Idenix’ s 53 attack on Gilead’s 657 patent. Section 53 provides that a patent is void if “any material allegation” in the application is untrue and wilfully misleading. Annis J’s decision adds to the growing body of case law holding that an error in inventorship is not a “material” allegation giving rise to invalidity under s 53. While we are still not at the point of a per se rule that errors in inventorship can never be material, we are getting close.

Idenix argued that the ‘657 Patent was invalid under s 53 for knowingly omitting naming Dr Lieven Stuyver as inventor [877]. The first question was whether he was an inventor at all. The argument failed on the facts on this point, as Annis J held that it had not been established that Dr Stuyver contributed to the inventive concept [904], [916]. 

Annis J nonetheless went on to consider whether the omission would have been material if Dr Stuyver had been an inventor. He noted that “a fair reading of Corlac [blogged here] indicates that the Court very much minimized the impact of improperly omitting a co-inventor on the determination of materiality in section 53(1)” [919] He also pointed out that the FCA in both Corlac and in Wellcome /AZT [2001] 1 FC 495, had noted that it would illogical to hold a patent invalid for failure to name an inventor, because that would deprive that inventor of any effective remedy [921], [922]. Annis J summarized the FC and FCA decisions in Corlac as being to the effect that failure to name an inventor will only be material for the purposes of s 53 if that failure affects “the term, substance or ownership of the ‘657 Patent, or the public’s ability to use the invention” [923] (and there was no such detriment in this case). That is, there must be some detriment to the public to warrant invalidating the patent. That strikes me as a sound view of this provision.

No comments:

Post a Comment