Thursday, May 30, 2019

CAFC reverses DNJ in Nuvo vs. Dr. Reddy's

The outcome of Nuvo vs. Dr. Reddy's:

For the reasons stated above, we reverse the district
court’s [D NJ] determination that the asserted claims of the ’907
and ’285 patents are not invalid for lack of an adequate
written description. Those claims are invalid. We dismiss
as moot Nuvo’s cross-appeal challenging the district court’s
grant of summary judgment of noninfringement to Dr.
Reddy’s with respect to its second ANDA product and the
now-invalidated ’907 patent claims.

Of written description:

Whether a claim satisfies the written description requirement is a question of fact. Allergan, Inc. v. Sandoz
Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015). Therefore, on
appeal from a bench trial, we review a written description
determination for clear error. Id. “Under the clear error
standard, the court’s findings will not be overturned in the
absence of a ‘definite and firm conviction’ that a mistake
has been made.” Scanner Techs. Corp. v. ICOS Vision Sys.
Corp. N.V., 528 F.3d 1365, 1374 (Fed. Cir. 2008) (quoting
Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1366
(Fed. Cir. 2008)).
Our analysis begins and ends with the “efficacy” written description issue.


The Generics argue that the district court clearly erred
when it concluded that the claimed effectiveness of uncoated PPI in the ’907 and ’285 patents is supported by adequate written description. Their argument is
straightforward. The ’907 and ’285 patents claim uncoated
PPI effective to raise the gastric pH to at least 3.5, the district court found upon Nuvo’s insistence as part of its obviousness analysis that ordinarily skilled artisans would not
have expected uncoated PPIs to be effective, and nothing in
the specification would teach a person of ordinary skill in
the art otherwise.

DNJ's problem:

But its analysis does not support its conclusion. The district court, after finding that the specification
lacks “information regarding the efficacy of uncoated
PPIs,” said it was enough that the specification described
the immediate release of uncoated PPI and the potential
disadvantages of enteric-coated PPI formulations. J.A. 82–
83. But that disclosure it pointed to in no way provides
support for the claimed efficacy of uncoated PPI. Even if
the district court thought that it was enough that the patents taught how to make and use drug formulations containing uncoated PPI, it flatly rejected Nuvo’s argument
“that the efficacy of uncoated PPIs need not be described
because it is ‘necessarily inherent’ in a formulation.” J.A.
83. Nevertheless, because we review the district court’s decision for clear error, we will scour the record created below
for evidence supporting the district court’s written description finding.


In sum, the parties appear to have assumed before the
district court that the claims require a therapeutically effective amount of uncoated PPI that can raise the gastric
pH to at least 3.5. We see no reason to change course on
appeal. Because the parties’ assumption at the trial court
is a fair reading of the claim language, we will proceed as
everyone did before the district court and search the specification for written description support for the efficacy of
uncoated PPI.

Of details

We have expressly rejected the “argument that the
written description requirement . . . is necessarily met as a
matter of law because the claim language appears in ipsis
verbis in the specification.” Enzo Biochem, Inc. v. Gen–
Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). We explained that “[t]he appearance of mere indistinct words in
a specification or a claim, even an original claim, does not
necessarily satisfy” § 112, ¶ 1 because it may not both put
others on notice of the scope of the claimed invention and
demonstrate possession of that invention. Id. at 968–69.
It is true that our case law does not require experimental data demonstrating effectiveness. Allergan, 796
F.3d at 1309; see also In re ’318 Patent Infringement Litig.,
583 F.3d 1317, 1324 (Fed. Cir. 2009) (“Typically, patent applications claiming new methods of treatment are supported by test results. But it is clear that testing need not
be conducted by the inventor.”). It also does not require
theory or explanation of how or why a claimed composition
will be effective. Allergan, 796 F.3d at 1308–09. Moreover,
we have repeatedly stated that the invention does not actually have to be reduced to practice. Univ. of Rochester v.
G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004).
Nevertheless, as the Generics point out and Nuvo cannot reasonably dispute, the record evidence demonstrates
that a person of ordinary skill in the art would not have
known or understood that uncoated PPI is effective.


are not rewarded for mere searches, but are intended to
compensate their successful completion. Ariad, 598 F.3d
at 1353. That is why the written description requirement
incentivizes “actual invention,” id., and thus “[a] ‘mere
wish or plan’ for obtaining the claimed invention is not adequate written description,” Centocor, 636 F.3d at 1348
(quoting Regents of the Univ. of Cal. v. Eli Lilly & Co., 119
F.3d 1559, 1566 (Fed. Cir. 1997)).
In light of the fact that the specification provides nothing more than the mere claim that uncoated PPI might
work, even though persons of ordinary skill in the art
would not have thought it would work, the specification is
fatally flawed. It does not demonstrate that the inventor
possessed more than a mere wish or hope that uncoated
PPI would work, and thus it does not demonstrate that he
actually invented what he claimed: an amount of uncoated
PPI that is effective to raise the gastric pH to at least 3.5.
That conclusion is confirmed by the inventor’s, Dr.
Plachetka’s, own testimony at trial during which he admitted that he only had a “general concept of coordinated delivery with acid inhibition” using uncoated PPI at the time
he filed his first patent application. J.A. 9942, 10000–01.
Although Dr. Plachetka said he thought he “put a rationale
in [the specification] as to why [uncoated PPI] would work,”
he did not identify any particular part of the specification
supporting that understanding. J.A. 9997. And his only
support in the specification for “a rationale explaining why
[he] thought the uncoated PPI would be effective for
treating gastric related injury” was that, in its “entire context,” he explained “why the coordinated delivery system
would be of benefit for patients.” Id. Although inventor
testimony cannot establish written description support
where none exists in the four corners of the specification, it
illuminates the absence of critical description in this case.

Of the difference between "written description" and enablement:

Teaching how to make and use an invention does not
necessarily satisfy the written description requirement.
We have recognized that the enablement requirement,
which requires the specification to teach those skilled in
the art how to make and use the claimed invention without
undue experimentation, is separate and distinct from the
written description requirement. Ariad, 598 F.3d at 1343–
51. And the fact that an invention may be enabled does not
mean it is adequately described, and vice versa. Univ. of
Rochester, 358 F.3d at 921–22. That is because “[t]he purpose of the written description requirement is broader than
to merely explain how to ‘make and use’ [the invention].”
Id. at 920. The focus of the written description requirement is instead on whether the specification notifies the
public about the boundaries and scope of the claimed invention and shows that the inventor possessed all the aspects of the claimed invention. Id. at 926.


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