United States District Court, D. Massachusetts
MOMENTA PHARMACEUTICALS, INC. and SANDOZ INC., Plaintiffs,
AMPHASTAR PHARMACEUTICALS, INC. and INTERNATIONAL MEDICATION SYSTEMS, LTD., Defendants.
MEMORANDUM & ORDER
Nathaniel M. Gorton United States District Judge
a patent infringement case in which plaintiffs, Momenta
Pharmaceuticals, Inc. and Sandoz Inc. (collectively,
“Momenta” or “plaintiffs”), claim
that defendants, Amphastar Pharmaceuticals, Inc. and
International Medication Systems, Ltd., (collectively,
“Amphastar” or “defendants”),
infringed their ‘886 patent during the course of
defendants' manufacture and sale of generic enoxaparin
before the Court is Momenta's motion for judgment as a
matter of law under Fed.R.Civ.P. 50(a) on Amphastar's
affirmative defenses. Pursuant to Fed.R.Civ.P. 50(a) judgment
as a matter of law is warranted when
a party has been fully heard on an issue during a jury trial
and the court finds that a reasonable jury would not have a
legally sufficient evidentiary basis to find for the party on
Fed. R. Civ. P. 50. Because the only reasonable conclusion as
to the defenses of 1) patent eligible subject matter and 2)
indefiniteness is that they are inapplicable, with respect to
those two defenses, the motion will be allowed.
two-step framework for patentable subject matter is described
in Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 132 S.Ct. 1289, 1293 (2012). First, the Court must
determine whether the patent claims are
“directed” to a patent-ineligible concept, such
as a natural law, natural phenomenon or abstract idea.
Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827
F.3d 1042, 1047 (Fed. Cir. 2016) (quoting Mayo, 132
S.Ct. at 1296-97). If the claims are not so directed, they
are patentable. Id. If the claims are directed to an
ineligible concept, then the Court determines whether the
elements of the invention “transform” the claims
into an application eligible for a patent. Id.
Patent eligibility is a question of law. Id.
the ‘886 patent “[is] directed to a new and
useful method” of ensuring the quality of enoxaparin
and involves a series of laboratory steps rather than a law
of nature or abstract idea, this Court concludes that the
asserted claims involve patentable subject matter. See
CellzDirect, 827 F.3d at 1048. Therefore, with respect
to the affirmative defense that the asserted claims do not
involve patent eligible subject matter, Momenta's motion
will be allowed.
respect to the indefiniteness defense, a patent's
specification must be sufficiently “definite” so
as to include at least one claim that “particularly
point[s] out and distinctly claim[s] the subject matter which
the applicant regards as [the] invention.” 35 U.S.C.
§ 112 (2002). Pursuant to Nautilus, Inc. v. Biosig
Instruments, Inc., 134 S.Ct. 2120, 2124 (2014),
[a] patent is invalid for indefiniteness if its claims, read
in light of the specification delineating the patent, and the
prosecution history, fail to inform, with reasonable
certainty, those skilled in the art about the scope of the
“[s]ome modicum of uncertainty” is permissible,
the “patent must be precise enough to afford clear
notice of what is claimed.” Trusted Knight Corp. v.
Int'l Bus. Machines Corp., No. 2016-1510, 2017 WL
899890, at *3 (Fed. Cir. Mar. 7, 2017) (quoting
Nautilus, 134 S.Ct. at 2128-29).
Court evaluates indefiniteness by examining intrinsic
evidence, such as the claims and specifications in the
patent, indefiniteness is a question of law. Biosig
Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1378
(Fed. Cir.), cert. denied, 136 S.Ct. 569 (2015).
contends that all of the claims are indefinite because they
are limited to “the non naturally occurring sugar
associated with peak 9 of FIG. 1” and there is no
specific “FIG. 1” in the ‘886 patent. Based
on the intrinsic evidence, however, the “Figure
1” in the patent is composed of Fig.
1A and Fig. 1B. The only
figure in the patent with peak 9 is FIG. 1A.
Moreover, the claims of the patent involve enoxaparin and the
Fig. 1A is titled “Lovenox”
which is the brand name for enoxaparin. Furthermore, the
“Brief Description of the Drawings” in the patent
clarifies that FIG. 1A is a
“[c]apillary electrophoresis (CE) profile of enoxaparin
(LovenoxTM)”. Therefore, this Court
concludes that the patent “afford[s] clear notice of
what is claimed.” Trusted Knight Corp., 2017
WL 899890, at *3 (quoting Nautilus, 134 S.Ct. at
2128-29) and, with respect to the infiniteness defense, the
motion for judgment as a matter of law with be allowed.
accordance with the foregoing, plaintiffs' motion for
judgment as a matter of law (Docket No. 1069) is, with
respect to the defenses based upon patent eligible subject
matter and ...