On February 16th, the District of Delaware granted a motion for judgment as a matter of law filed by Foster City, CA-based pharmaceutical giant Gilead Sciences (NASDAQ:GILD) to invalidate a patent owned by Idenix, a subsidiary of Kenilworth, NJ-based pharma firm Merck & Co. (NYSE:MRK). In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case ever handed out. After a two-week trial in December 2016, the jury had awarded Index $2.64 billion in damages, which was based on finding Gilead infringed the Idenix patent – U.S. Patent No. 7,608,597 — by selling the hepatitis C virus (HCV) treatments Harvoni and Sovaldi.
The opinion penned by Delaware’s Chief Judge Leonard Stark dismissed a motion filed by Gilead to reduce the $2.54 billion damages award handed out by the jury, and also dismissed a motion on invalidity of Idenix’s patent for failure to meet written description requirements mandated by 35 U.S.C. § 112. Chief Judge Stark did, however, find that Idenix’s U.S. Patent No. 7608597, titled Methods and Compositions for Treating Hepatitis C Virus, was invalid under Section 112 for lack of enablement.
“[W]hile judgment as a matter of law is improper on damages and written description, the ‘597 patent is invalid for lack of enablement,” Stark wrote.
Gilead had argued that the ‘597 was invalid for written description because a list of substituents disclosed in the specification failed to describe the full scope of the claims. Idenix pointed to expert testimony which established that the specification included clear indications that the HCV polymerase should be targeted in identifying effective compounds, thus limiting the scope of the claims by the functional limitation and guidance in the patent with respect to the polymerase target. The court found that substantial evidence supported the jury’s implicit finding that there was no lack of written description in the ‘597 patent.
In finding in favor of Gilead’s motion for invalidity based on enablement, the court noted two limitations outlined in claim 1 of the ‘597 patent: a structural limitation regarding the chemical makeup of the claimed nucleoside; and a functional limitation regarding the effective amount of the nucleoside used to treat HCV. Further, the court noted that the use of the nucleoside to target the NS5B polymerase, which Idenix contended was key to a compound demonstrating effectiveness in treating HCV, was not an explicit claim limitation. “The patent claims are not limited to compounds that are effective in treating HCV due to their acting on the NS5B polymerase,” the court’s opinion reads.
“In the Court’s view, it is undisputed that the Structural Limitations of the claims are satisfied by billions of compounds,” Chief Judge Stark wrote, noting that the claims allow for an indeterminate number of combinations. Idenix contended that a person skilled in the art would not fill in each compound variable with any element meeting the literal terms of the structural limitations. For example, given that the patent is directed at compounds effective as medicines for human beings, a person of ordinary skill would not place radioactive plutonium in the compound as that could kill a person. However, the court found that this explanation, at best, only reduced the scope of the structural limitations to “many, many thousands,” requiring that a person skilled in the art would still require a great deal of time and effort to synthesize every compound that met the structural limitations of the claims, even when refined by the functional limitations.
An appeal seems virtually certain with so much at stake.