When is Simply Having a Good Idea Insufficient?
Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories Inc.
The written description requirement of 35 U.S.C. § 112
is generally considered a distinct criterion of patentability, separate from
the enablement requirement. Less than a
decade ago, the U.S. Court of Appeals for the Federal Circuit affirmed that
this was so, pointing to a long legal pedigree.
Ariad Pharmaceuticals, Inc. v. Eli
Lilly and Co., 598 F3d 1336 (Fed. Cir. 2010) (en banc). The contours of the written description
requirement continue to be shaped, especially in the context of
pharmaceuticals. One new contour was
carved in the Federal Circuit’s May 15 opinion in Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy’s
Laboratories Inc., Case 2017-2473 (Fed. Cir. 2019).
Nuvo held patents to solid drug formulations that
comprise an encapsulated non-steroidal anti-inflammatory drug (NSAID) and an
acid inhibitor, at least a portion of the latter not being encapsulated. The encapsulation of the NSAID prevents the
release of the NSAID from the solid formulation until the acid inhibitor
counteracts the acid in the stomach and upper small intestine, causing the pH to
rise to at least 3.5. When the NSAID is released in the less acidic
environment, theory suggests that the NSAID will cause fewer damaging side
effects to the upper gastrointestinal tract.
A technical wrinkle in the scheme to achieve
sequential release of the acid inhibitor and the NSAID is that the proton pump
inhibitors (PPIs), a type of acid inhibitor, are sensitive to degradation by
the acidic environment of the upper gastrointestinal tract. Thus, the invention’s use of at least some
acid inhibitor that is not encapsulated ran contrary to the notions in the art
at the time.
The defendant-appellants (generic drug companies) had
filed for U.S. Food and Drug Administration approval of their generic versions
of Nuvo’s solid drug formulation using the Abbreviated New Drug Application
(ANDA) procedure, piggy-backing on the prior approval of the branded
drug/patent holder. The generic drug
companies contended at trial that the patents were invalid for lack of
enablement, lack of adequate written description, and for obviousness. The U.S. District Court of New Jersey upheld
the patents with regard to each of these criteria of patentability. However, the appellate panel disagreed with
the trial court’s conclusion of adequate written description. The panel — in an opinion penned by Judge Raymond
C. Clevenger III on behalf of Chief Judge Sharon Prost, Judge Evan J. Wallach,
and himself — found that not only was the district court’s conclusion
unsupported by its analysis, but also the panel’s own review of the record
failed to find support for the conclusion.
The key factors supporting the appellate panel’s
decision overturning the district court’s holding of adequate written
description were: (a) the failure of the specification to provide any data
showing efficacy; (b) the failure of the specification to provide any
explanation of the purported efficacy; and (c) patent owner Nuvo’s persuasive
showing at trial (in rebutting the defendant’s assertion of obviousness) that
those of skill in the art would not have expected efficacy. The appellate panel justified its conclusion with
an orderly progression of legal principles.
First, the panel stated that merely having the words of the claim in the
specification is not always sufficient because the words “may not both put
others on notice of the scope of the claimed invention and demonstrate
possession of that invention.”[1] Second, the panel reiterated the established
principles from case law that, on their own, might have led to a favorable
disposition: (a) data demonstrating
effectiveness is not required; (b) a theory or explanation of efficacy is not
required; and (c) reduction to practice is not required. Although these three elements are generally
not required, the panel concluded that in this case, where a person of skill in
the art would not have had a reasonable expectation of efficacy, that person
would not have understood that the invention is effective from such a bare-bones
specification. The person of skill in
the art would not have understood that the inventor was in possession of the
invention at the time of filing.
The panel was careful to qualify its holding as fact-specific. It justified the outcome by pointing to three
specific factors in this case: the
claims recite a result (therapeutic efficacy), the specification fails to
provide any data, and the specification fails to provide any explanation why
the invention would work. One can expect
creative litigants to challenge the adequacy of a patent’s written description
in other situations where they can argue that the specification did not put
others on notice of the scope of the claimed invention or demonstrate possession
of the invention.
Practice Notes
Did the plaintiff patentee make a strategic error in
advancing two inconsistent arguments with regard to written description and
obviousness? Previously, these two
issues may not have seemed to be in opposition.
If drafting an application for an invention whose non-obviousness may
rely on “no reasonable expectation of success” in the art, this case counsels toward
inclusion of data and/or explanations that could overcome any negative
expectation.
On appeal, the panel rejected Nuvo’s five claim
construction arguments because Nuvo had not raised them at trial. By restating each argument separately and
finding each argument waived or forfeited, the court seemed to telegraph to
future appellants and appellees its pique that it had to address improperly
raised issues. The opinion is a reminder
not to use an appeal as a second bite at a trial strategy.
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[1]
The panel cited Enzo Biochem. v.
Gen-Probe, Inc., 323 F.3d 956,968-969 (Fed. Cir. 2002).