United States District Court, D. Maryland
Richard D. Bennett United States District Judge
case is again before this court on remand from the United
States Court of Appeals for the Federal Circuit. (ECF No.
231.) Currently pending is defendant Elan
Pharmaceuticals, Inc.'s (“Elan” or
“Defendant”) Motion for Summary Judgment of
Non-Infringement (“Elan's Motion”) (ECF No.
249). Plaintiff Classen Immunotherapies, Inc.
(“Classen” or “Plaintiff”) has filed
an Opposition to Elan's Motion (“Classen's
Opposition”) (ECF No. 250), and Elan has filed a Reply
to Classen's Opposition (“Elan's Reply”)
(ECF No. 251). The Court conducted a hearing on the
parties' submissions on September 22, 2016. (ECF No.
252.) For the reasons set forth below, Elan's Motion is
AND PROCEDURAL BACKGROUND
pertinent factual and procedural history of this case was set
forth by the Federal Circuit in its decision remanding this
case to this Court. Classen Immunotherapies, Inc. v.
Elan Pharm., Inc., 786 F.3d 892, 894-95 (Fed.
“Classen owns the ‘472 patent, which is directed
to a method for accessing and analyzing data on a
commercially available drug to identify a new use of that
drug, and then commercializing that new use. Classen sued
Elan in 2004, alleging that Elan infringed the ‘472
patent when it studied the effect of food on the
bioavailability of Skelaxin, used the clinical data to
identify a new use of the drug, and commercialized the new
use. Classen, 466 F.Supp.2d at 624. Elan moved for
summary judgment of noninfringement. The district court
granted the motion in 2006, finding Elan protected by the
safe harbor provision of § 271(e)(1) because Elan
submitted its clinical data to the FDA with its citizen
petition and sNDA, and thus its activities were
“reasonably related to the submission of
information” under the Federal Food, Drug, and Cosmetic
Act (“FDCA”). Id. at 625.
“The lawsuit was then stayed pending an ex
parte reexamination of the ‘472 patent, during
which the PTO cancelled 107 of the 137 originally issued
claims. Of the remaining claims, only claims 36, 42, 48-50,
59, 73-76, 84, 131, and 135 were asserted against Elan. Prior
to issuing the reexamination certificate, the PTO Examiner
stated, as reasons for patentability, that the “prior
art of record fails to teach or fairly suggest the limitation
of ‘a manufacturer or distributor of the product must
inform consumers, users or individuals responsible for the
user, physicians or prescribers about at least one new
adverse event associated with exposure to or use of the
“After the reexamination certificate issued in 2010,
Classen filed a motion in the district court seeking to lift
the stay and to vacate the 2006 summary judgment. Classen
argued that our decision in Classen Immunotherapies, Inc.
v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) warranted
reconsideration of the summary judgment because we held in
Biogen that certain post-approval routine
submissions to the FDA are outside the safe harbor of §
271(e)(1). In response, the district court lifted the stay
but denied reconsideration of its 2006 decision. The court
concluded that Elan was protected by the safe harbor under
both Biogen and our subsequent decision in
Momenta Pharmaceuticals, Inc. v. Amphastar
Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012).
The court reasoned that unlike Biogen, where the
post-approval submissions were routine, Elan's
submissions to the FDA were “not routine” because
they were necessary to update the Skelaxin product label and
to change the FDA-approval process for generic versions of
Skelaxin. Classen, 981 F.Supp.2d at 421-22.
“On the parties' joint motion, the district court
entered final judgment of noninfringement under Rule 54(b) of
the Federal Rules of Civil Procedure.”
Classen, 786 F.3d at 895-96.
13, 2015, the Federal Circuit vacated and remanded Judge
Quarles' 2012 judgment of non-infringement in favor of
Elan. (ECF No. 232.) In its opinion remanding this case to
this Court, the Federal Circuit concluded that “the
district court correctly decided that § 271(e)(1)
exempts Elan's activities reasonably relating to
developing clinical data on its approved drug Skelaxin®
(“Skelaxin”) and submitting that information to
the Food and Drug Administration (“FDA”) in a
citizen petition and a supplemental new drug application
(“sNDA”).” Classen, 786 F.3d at
894. However, the court also found that because Judge
Quarles' opinion did not address Plaintiff's
“assert[ion] that certain activities that occurred
after the FDA submissions infringed the ‘472 patent and
that those activities are not exempt under the safe harbor of
§ 271(e)(1), ” remand was appropriate.
Id. Accordingly, the sole question now before this
court is whether Elan's “post-submission activities
constituted infringement of the ‘472 patent or whether
they were exempt under the safe harbor.” Id.
case was transferred to the undersigned on January 22, 2016
following Judge Quarles' retirement from the bench. A new
Scheduling Order (ECF No. 248) was issued, and, consistent
with that Order, Elan filed its now-pending Motion on March
31, 2016. (ECF No. 249.) The Court conducted a hearing on
September 22, 2016, and the matter is fully ripe for the
Court's resolution. (ECF No. 252.)
of the Federal Rules of Civil Procedure provides that a court
“shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.”
Fed.R.Civ.P. 56(c). A material fact is one that “might
affect the outcome of the suit under the governing
law.” Libertarian Party of Va. v. Judd, 718
F.3d 308, 313 (4th Cir. 2013) (quoting Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Thus,
summary judgment is proper “only when no
‘reasonable jury could return a verdict for the
nonmoving party.'” Monon Corp. v. Stoughton
Trailers, Inc., 239 F.3d 1253, 1257 (Fed. Cir. 2001)
(quoting Anderson, 477 U.S. at 255)). When
considering a motion for summary judgment, ...