Momenta Pharmaceuticals, Inc. et al v. Amphastar Pharmaceuticals, Inc. et al

Filing 1079

Judge Nathaniel M. Gorton: ENDORSED ORDER entered. MEMORANDUM AND ORDERIn 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 indefiniteness, ALLOWED but otherwise DENIED without prejudice. So ordered.(Caruso, Stephanie)

United States District Court
District of Massachusetts
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Plaintiffs,
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v.
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AMPHASTAR PHARMACEUTICALS, INC. )
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and INTERNATIONAL MEDICATION
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SYSTEMS, LTD.,
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Defendants.
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MOMENTA PHARMACEUTICALS, INC.
and SANDOZ INC.,

Civil Action No.
11-11681-NMG

MEMORANDUM & ORDER
GORTON, J.
This is 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 products.
Pending 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

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have a legally sufficient evidentiary basis to find for the
party on that issue[.]
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.
The 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 patentineligible 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.

Because 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

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the asserted claims do not involve patent eligible subject
matter, Momenta’s motion will be allowed.
With 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 invention.
Although “[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).
When a 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).
Amphastar contends that all of the claims are indefinite
because they are limited to “the non naturally occurring sugar
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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.
ORDER
In 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
indefiniteness, ALLOWED but otherwise DENIED without prejudice.

So ordered.

/s/ Nathaniel M. Gorton______
Nathaniel M. Gorton
United States District Judge
Dated July 21, 2017
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