Friday, May 08, 2020

CAFC reviews "disclosed, not claimed, dedicated" in Eagle Pharmaceuticals; D. Delaware affirmed

The outcome was that appellant lost:

Eagle Pharmaceuticals appeals a district court judgment of non-infringement on the pleadings. Eagle sued
Slayback Pharma LLC for infringing four patents covering
Eagle’s brand name bendamustine pharmaceutical product. Eagle argues that the district court committed two errors when it concluded that the dedication-disclosure
doctrine barred Eagle’s claim of infringement under the
doctrine of equivalents. First, Eagle contends that the district court erred when it concluded that the asserted patents disclose, but do not claim, ethanol—and therefore
dedicated ethanol to the public. Second, Eagle contends
that the district court improperly applied the dedicationdisclosure doctrine at the pleadings stage, in the presence
of factual disputes and without drawing all inferences in
Eagle’s favor. Because we find no error in the district
court’s judgment on the pleadings, we affirm.

Of the relevant law of the Third Circuit:

We review the district court’s judgment on the pleadings under the law of the regional circuit, which in this case
is the Third Circuit. Data Engine Techs. LLC v. Google
LLC, 906 F.3d 999, 1007 (Fed. Cir. 2018). The Third Circuit reviews the grant of judgment on the pleadings de
novo, “accept[ing] all of the allegations in the pleadings of
the party against whom the motion is addressed as true
and draw[ing] all reasonable inferences in favor of the nonmoving party.” Id. (quoting Allstate Prop. & Cas. Ins. Co.
v. Squires, 667 F.3d 388, 390 (3d Cir. 2012)). In doing so,
we “disregard rote recitals of the elements of a cause of action, legal conclusions, and mere conclusory statements.”
James v. City of Wilkes-Barre, 700 F.3d 675, 679 (3d Cir.
2012). Rule 12(c) judgment is appropriate when the moving party clearly establishes that there are “no material
issues of fact, and that he or she is entitled to judgment as
a matter of law.” DiCarlo v. St. Mary Hospital, 530 F.3d
255, 259 (3d Cir. 2008); see FED. R. CIV. P. 12(c).

Johnson & Johnston is cited as to the concept of disclosure without claiming creating dedication to
the public:

The disclosure-dedication doctrine bars application of
the doctrine of equivalents. Johnson & Johnston Assoc. v.
R.E. Servs., 285 F.3d 1046, 1054 (Fed. Cir. 2002) (en banc).
It states that “when a patent drafter discloses but declines
to claim subject matter, . . . this action dedicates the unclaimed subject matter to the public.” Id. By preventing a
patentee from recapturing unclaimed subject matter, the
disclosure-dedication doctrine reinforces “the primacy of
the claims in defining the scope of the patentee’s exclusive
right.” Id. To determine whether the disclosure-dedication
doctrine applies in a given case, we ask whether the specification discloses unclaimed subject matter with “such
specificity that one of ordinary skill in the art could identify
the subject matter that had been disclosed and not
claimed.” PSC Comput. Prods., Inc. v. Foxconn Int’l, Inc.,
355 F.3d 1353, 1360 (Fed. Cir. 2004). If the court concludes
that the inventor dedicated an alleged equivalent to the
public, the patent owner cannot prevail on its doctrine of
equivalents infringement claim based on that equivalent.
Maxwell v. J. Baker, Inc., 86 F.3d 1098, 1108 (Fed. Cir.

This appeal centers on Eagle’s challenge to the merits
and procedural aspects of the district court’s application of
the disclosure-dedication doctrine.

Of the first of the contested points:

Instead, we have held that the disclosurededication doctrine requires only that the specification disclose the unclaimed matter “as an alternative to the relevant claim limitation.” Pfizer, Inc. v. Teva Pharm. USA,
Inc., 429 F.3d 1364, 1378 (Fed. Cir. 2005).
We conclude that the asserted patents disclose ethanol
as an alternative to PG in the “pharmaceutically acceptable fluid” claim limitation. The specification repeatedly
identifies—without qualification—ethanol as an alternative pharmaceutically acceptable fluid.

Of the second:

Eagle also challenges the district court’s judgment on
procedural grounds. Eagle asserts that, at the time the district court entered judgment of non-infringement on the
pleadings, a factual dispute existed: whether a skilled artisan would understand the specification to disclose ethanol as an alternative to PG in the claimed invention. Eagle
argues that the district court erred by resolving that factual dispute at the pleadings stage without drawing all reasonable inferences in Eagle’s favor. Appellant Br. 46
(citing Nalco Co. v. Chem-Mod, LLC, 883 F.3d 1337, 1349
(Fed. Cir. 2018)). Specifically, Eagle argues that the district court was required to infer that a “skilled artisan
would not have understood that ethanol was an alternative
to PG in the claimed ‘PEG/PG/Antioxidant’ category of formulations.” Id. at 44.


As a preliminary matter, when ruling on a Rule 12(c)
motion, district courts have discretion to consider evidence
outside the complaint for purposes of deciding whether to
accept that evidence and convert the motion into one for
summary judgment. Kulwicki v. Dawson, 969 F.2d 1454,
1462 (3d Cir. 1992); see also 5C WRIGHT & MILLER, FED.
PRAC. & PROC. CIV. § 1371 (3d ed.) (“As is true of practice
under Rule 12(b)(6), it is well-settled that it is within the
district court’s discretion whether to accept extra-pleading
matter on a motion for judgment on the pleadings and treat
it as one for summary judgment or to reject it and maintain
the character of the motion as one under Rule 12(c).”). We
conclude that the district court did not abuse its discretion
when it set aside Dr. Amiji’s declaration. The district court
reviewed Dr. Amiji’s declaration and determined that it
was merely an “attempt[] to manufacture a factual dispute.” Eagle, 382 F. Supp. 3d at 346. The district court
also found that the patents themselves provided “sufficient
context to decide” the legal issue at hand. Id. Eagle has
not persuaded us otherwise. In opposing Slayback’s motion
to dismiss, Eagle conceded that the district court’s “reliance
on expert testimony would be improper at this preliminary
[pleadings] stage.” J.A. 233.

We find no error in the district court’s decision to grant
judgment of non-infringement on the pleadings. The application of the disclosure-dedication doctrine is a question of
law. Pfizer, 429 F.3d at 1378. Here the district court concluded that the patents themselves provided “sufficient
context to decide a question of law, i.e., that the disclosurededication doctrine applies to bar Eagle’s claims for infringement under the doctrine of equivalents.” Eagle, 382
F. Supp. 3d at 346.


in Amgen Inc. v. Coherus
BioSciences Inc., we held that expert testimony was not
necessary to understand whether a patent owner “clearly
and unmistakably surrendered unclaimed [disclosure] during prosecution.” 931 F.3d 1154, 1160 (Fed. Cir. 2019) (affirming judgment of non-infringement on the pleadings
because prosecution history precluded Amgen’s infringement allegations based on the doctrine of equivalents). We
explained that “Amgen’s statements during prosecution,”
on their face, showed that “a competitor would reasonably
believe that Amgen surrendered unclaimed salt combinations” as a matter of law. Id. (internal quotations omitted).
Here, we conclude that the only reasonable inference
that can be made from the patent disclosures is that a
skilled artisan would understand the patents to disclose
ethanol as an alternative to the claimed PG. Nothing in
the record permits us to infer that a skilled artisan “would
have understood that the patent specification describes distinct categories of formulations that contain different ingredients and work in different ways.” Appellant Br. 44.
As a result, even when viewing the pleadings in the light
most favorable to Eagle, we conclude there is no material
issue of fact to resolve and Slayback is entitled to judgment
in its favor as a matter of law.


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