The Federal Court has allowed Gilead’s claim to invalidate Idenix's '191 patent on the grounds of insufficient disclosure and lack of demonstrated utility/sound prediction. Idenix's counterclaim that Gilead’s '657 Patent is invalid for anticipation was dismissed.
Idenix admitted that it did not test any of the compounds falling within the scope of the claims, so utility was assessed as a sound prediction. The parties agreed that the patent contains a promise that the compounds are useful in the treatment of Flaviviridae infections, including HCV infections, in humans and other hosts. The Court held that "treatment for a host infected with Hepatitis C virus" as requiring effectiveness in combination with low toxicity as measured in accordance with the therapeutic index. However, the Court also found that the '191 Patent makes no promise of any specific result or level of treatment. Thus, Gilead needed to prove that Idenix has not soundly predicted a scintilla of utility in the compounds for the treatment of Flaviviridae.
Ultimately, the Court found that Gilead has demonstrated that Idenix could not demonstrate, nor soundly predict as an inferred fact or prima facie reasonable inference, the utility of the 2’-C-Me/F nucleoside on June 27, 2003 as an effective treatment of Hepatitis C.
The Court held that the patentee is not required to disclose the basis for its sound prediction, but it would have failed if required to do so. The reason was because the '191 Patent relates to a sound prediction of a new composition, thus there is no utility disclosure requirement. The Court assumed that this exemption from disclosure applies both to the factual basis and the line of reasoning.
As to the allegation of insufficiency, the Court held that Gilead has established that the '191 Patent as supplemented by the common general knowledge does not sufficiently disclose how to synthesize the 2'-C-Me/F compound.
The Court summarized Gilead’s novel overbreadth allegation as follows:
- At the time the patent application was filed and published, Idenix had been unsuccessful in making a compound within the scope of the claims; as they did not have a way of making the claimed compounds, they cannot be said to have completed the act of invention; and
- Not having invented the compounds, any claim to any such compounds is by definition overbroad.
In disagreeing with this novel claim of invalidity, the Court held that if the claims are soundly predicted and there has been sufficient disclosure of how to make the invention, then there can be no overbreadth of claims.
Idenix counterclaimed that Gilead's '657 Patent was anticipated by the disclosure and enablement of their subject matter by the '191 Patent. The Court found that there was disclosure of the invention, but no enabling disclosure of how to synthesize the compounds in the '191 Patent.
Idenix's infringement allegation was evaluated by the Court for the purpose of an appeal, even though the patent was found to be invalid. The Court held that Gilead’s intermediate compound falls within the scope of the '191 Patent.
Idenix had further alleged that Gilead's '657 Patent is invalid pursuant to section 53 for knowingly omitting the name of an inventor, Dr. Stuyver. The Court ultimately held that he was not a co-inventor of the compound, nor did he sign a declaration under duress acknowledging this fact in 2005.