Wednesday, October 30, 2019

Judge Newman in dissent in Idenix: "The jury verdict of validity under section 112 is in accordance with law and supported by substantial evidence. "

The outcome of Idenix v. Gilead:

Idenix Pharmaceuticals LLC and Universita Degli
Studi Di Cagliari (collectively, “Idenix”) appeal from the
decision of the U.S. District Court for the District of
Delaware granting judgment as a matter of law (“JMOL”)
against Idenix and finding that U.S. Patent No. 7,608,597
is invalid for lack of enablement. Idenix Pharm. LLC v.
Gilead Scis., Inc., 2018 WL 922125, at *25 (D. Del. Feb. 16,
2018) (“JMOL Opinion”). Gilead Sciences Inc., (“Gilead”)
argues that the patent is also invalid for failure to meet the
written description requirement, and that the district court
erred by failing to grant JMOL on that ground as well. We
affirm as to non-enablement and hold that the patent is
also invalid for lack of written description.

Judge Newman dissented:

I respectfully dissent. The court errs in holding that
the specific narrow claims of the ’597 patent are invalid.
The large number of unclaimed chemical variants in the
specification are not described, not synthesized, and not
tested for antiviral activity. It is incorrect to include these
variants in the claims and then to invalidate the claims because
these variants are not described and not enabled.


reasonable jury could have understood the claims as directed to the nucleosides that are specifically described and
that are shown to have the claimed antiviral activity. A
reasonable jury could have credited the evidence that the
’597 claims are for these specific compounds, not the “billions and billions” of unsynthesized and
unevaluated variants in the specification. It is not disputed that the specific
claimed compounds meet the requirements of 35 U.S.C.
§ 112. The jury verdict of validity must be viewed in light
of the evidence and argument before the jury.
The majority’s holding that validity under section 112
is determined based on whether unclaimed subject matter
is described and enabled, provides a new path of uncertainty and unreliability of the patent grant. I respectfully

The claims define the scope of the invention.
Judge Newman wrote:

My colleagues err in ruling that the claims cover “billions” of variants. The ’597 specification recites a very
large number of substituents for nucleosides that are not
synthesized, not characterized, not evaluated, and not included in the claims. Some of these variants have been
claimed in other patents and applications.1 However, they
are not claimed in the ’597 patent.
My colleagues err in
holding that because other substituents and modifications


The panel majority now discards the jury verdict, stating “the jury was not free to adopt a number lower than the
many, many thousands of configurations identified as
‘principal embodiment[s]’ in the patent itself.” Maj. Op.
at 12 (alteration in original). However, the jury was not
free to adopt an incorrect view of the patent, for almost all
of the embodiments that the specification calls “principal
embodiments” are for Formulas for which no synthesis and
no evaluation data are provided in the ’597 specification.


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