Apotex wins at CAFC in case related to pegfilgrastim (Neulasta®) and filgrastim (Neupogen®).

The two suits were consolidated. The district court
held a bench trial in July 2016, and it issued findings of
fact and conclusions of law on September 6, 2016. The
court found that Amgen had failed to prove that Apotex’s
proposed commercial marketing of the two products,
pursuant to Apotex’s applications, would infringe the ’138
patent, either literally or under the doctrine of equivalents.

Amgen appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(1). We affirm.



Of evidentiary issues:


We do not question the general legal principle that
Amgen asserts: we agree that a district court cannot
ignore letters sent during the BPCIA’s information exchange
if properly offered into evidence. Indeed, the prelitigation
information exchange is part of the BPCIA’s
“carefully calibrated scheme for preparing to adjudicate,
and then adjudicating, claims of infringement.” Sandoz
Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017). The
purpose of the exchange is “to identify relevant patents
and to flesh out the legal arguments that the[] [parties]
might raise in future litigation.” Id. at 1671. Through
the information exchange, the BPCIA seeks to facilitate
the efficient resolution of patent disputes. The statements
in the pre-litigation letters are party admissions
and therefore have some probative weight. The district
court’s statement that the letters “are not probative on
the issue of protein concentration,” J.A. 24 ¶ 39, is therefore
an overstatement to the extent it suggests that the
letters lack probative value as a matter of law.
We read the district court’s statement in context,
however, to mean only that the letters are not sufficiently
probative to outweigh other evidence presented at trial
indicating that the information in the letters was inaccurate.
Indeed, the district court did not ignore the prelitigation
letters. Rather, it first concluded that the
letters were not binding on Apotex, a conclusion that
Amgen does not dispute, and it then found that the letters
lacked probative value in light of the other evidence
presented at trial. Thus, the court gave the letters their
evidentiary due. We do not believe that the court’s phrasing
reflects an error in the approach it actually took to
reach its findings or calls the court’s ultimate conclusion
into question.
The letters do not render the finding of fact regarding
the protein concentration clearly erroneous. The district
court found that the letters were “not probative on the
issue of protein concentration” because they were “factually
incorrect,” J.A. 24, and it had a sufficient basis in the
evidence to make that finding.



The Sunovion case is discussed:




Amgen argues that the district court’s noninfringement
finding rests on too restrictive a view of
Apotex’s FDA applications. It challenges that view as
contrary to this court’s decision in a Hatch-Waxman Act
case, Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc.,
731 F.3d 1271 (Fed. Cir. 2013), under which, Amgen
argues, the district court here was required to assess
infringement based on the full range of processes that
would be consistent with Apotex’s applications. Apotex
does not challenge the importation of Sunovion’s analysis
into the BPCIA context, but it does dispute Sunovion’s
applicability to the facts of this case. We agree with
Apotex.
Sunovion involved an abbreviated new drug application
that, on its face, authorized the applicant to engage
in actions that would, in fact, infringe the patent in
question. Sunovion, 731 F.3d at 1274–75. The district
court had granted summary judgment of noninfringement
because the defendant had “certified” that it
did not actually intend to run its process in an infringing
manner and presented evidence of internal manufacturing
guidelines showing non-infringement. Id. This court
reversed, reasoning that internal guidelines and a certification
were insufficient to avoid a finding of infringement
when the application itself authorized the activity that
would infringe. Id. at 1280.

Here, in contrast, the district court had a sufficient
basis for reading Apotex’s applications as not authorizing
processes that infringe, indeed, as constraining the processes
to non-infringing levels. The district court credited
the testimony of Dr. Dowd, based on the numbers in the
applications, that the maximum protein concentration
possible in the refold mixtures of Apotex’s applications is
0.708 g/L. J.A. 3618–20. Dr. Dowd arrived at this calculation
using the high-end of the “key process parameter”
range for solubilized inclusion bodies, 11.8 mg/mL, and
the minimum 75 percent purity of the target protein (i.e.,
filgrastim or pegfilgrastim) specified by the applications.
Amgen argues that the key process parameters do not
prevent Apotex from infringing the ’138 patent because
they are not absolute limits. But the applications indicate
that close adherence to the key process parameters is
critical to the function of the process. J.A. 6725 (noting
that key process parameters must be “carefully controlled
within a narrow range and are essential for process
performance”); J.A. 6728 (identifying the 11.8 mg/ml
figure as a “qualified upper limit”). Consistent with this
description, Dr. Dowd testified at trial that Apotex needs
to maintain its process within the key process parameters
in order “for the batch to be acceptable,” and that, if those
ranges are exceeded, “the batch would be thrown out.”
J.A. 3622–23. The district court found this testimony
credible. J.A. 26. In light of the evidence, we see no basis
for deeming the district court’s finding as to the constraints
in Apotex’s applications to be clearly erroneous.