Richards Layton & Finger
 

Chief Judge Stark Finds Patent Not Enabled on Renewed Motion for Judgment as a Matter of Law

April 3, 2018

In Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc., No. 14-846-LPS (D. Del. Feb. 16, 2018), Chief Judge Stark granted the defendant’s motion for judgment as a matter of law that the asserted patent was not enabled. The plaintiffs, Idenix Pharmaceuticals LLC and Universita Degli Studi di Cagliari (together, “Idenix”), sued the defendant, Gilead Sciences, Inc., for infringement of a patent covering a treatment for Hepatitis C. During litigation, Gilead stipulated that the accused product infringed the asserted claims. A jury returned a verdict that the patent was not invalid and awarded Idenix $2.54 billion in damages. In its renewed motion for judgment as a matter of law, Gilead argued that the asserted claims were invalid for failure to satisfy the written description and enablement requirements, and challenged the damages award as unsupported by the evidence.

Chief Judge Stark stated that Gilead made “powerful factual attacks” against the comparability of the licenses used by Idenix’s expert to establish a reasonable royalty, but that as a matter of law the jury was free to accept the expert’s conclusion. The Court also found that, contrary to Idenix’s argument, substantial evidence supported the finding that the patent covered the entire accused product, and thus the entire market value rule was not implicated. Noting that the Court had twice denied motions for summary judgment on the “identical dispute,” Chief Judge Stark further found that substantial evidence supported the jury’s finding that the asserted patent was not invalid for inadequate written description.

But Chief Judge Stark concluded that the patent was not enabled. In an extensive analysis, the Court reviewed the record to determine which facts were not genuinely disputed. Applying the Wands factors, Chief Judge Stark found that it would have required undue experimentation of one of ordinary skill to make use of the full scope of the claimed invention. Identifying suitable compounds, according to the Court, would have been challenging, requiring synthesis and screening of at least thousands of candidates that could take years; the Court pointed to repeated failures at Idenix to synthesize the compound of the accused product over a period of years as illustrative. The field of the art, although established, was found to be unpredictable in its application to compounds for the treatment of Hepatitis C. The Court characterized the testing that would have been required as “exploratory rather than confirmatory,” and stated that only experimentation, not prediction, could determine whether any given compound would satisfy the limitations at issue. For these reasons, Chief Judge Stark granted Gilead’s renewed motion for judgment as a matter of law that the patent was invalid for lack of enablement.

Key Point: The Court held that Gilead’s addressing of willfulness in a footnote, in which it incorporated by reference prior briefing on this issue, did not suffice to renew the motion Gilead made at trial for judgment as a matter of law of no willfulness. As a result, Chief Judge Stark refused to address the issue of willfulness.