Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc.

United States Court of Appeals
for the Federal Circuit
______________________

CLASSEN IMMUNOTHERAPIES, INC.,
A MARYLAND CORPORATION,
Plaintiff-Appellant

JOHN BARTHELOW CLASSEN,
Counterclaim Defendant

v.

ELAN PHARMACEUTICALS, INC.,
A DELAWARE CORPORATION,
Defendant/Counterclaimant-Appellee
______________________

2014-1671
______________________

Appeal from the United States District Court for the
District of Maryland in No. 1:04-cv-03521-WDQ, Judge
William D. Quarles, Jr.
______________________

Decided: May 13, 2015
______________________

JOSEPH J. ZITO, DNL ZITO, Washington, DC, argued
for plaintiff-appellant.

JAMES B. MONROE, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, Washington, DC, argued for
defendant/counterclaimant-appellee. Also represented by
PAUL WILLIAM BROWNING.
2 CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC.

______________________

Before PROST, Chief Judge, LOURIE, Circuit Judge, and
GILSTRAP, District Judge. *
LOURIE, Circuit Judge.
Classen Immunotherapies, Inc. (“Classen”) appeals
from the decision of the United States District Court for
the District of Maryland granting summary judgment
that Elan Pharmaceuticals, Inc. (“Elan”) did not infringe
U.S. Patent 6,584,472 (“the ’472 patent”) based on the
safe harbor provision of 35 U.S.C. § 271(e)(1). See Classen
Immunotherapies, Inc. v. King Pharm., Inc., 466 F. Supp.
2d 621 (D. Md. 2006) (granting summary judgment);
Classen Immunotherapies, Inc. v. King Pharm., Inc., 981
F. Supp. 2d 415 (D. Md. 2013) (denying reconsideration).
We conclude 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 also asserts that certain activities that oc-
curred after the FDA submissions infringed the ’472
patent and that those activities are not exempt under the
safe harbor of § 271(e)(1). Because the district court did
not determine whether those activities constituted in-
fringement or whether they were exempt from liability
under the safe harbor, we vacate the judgment of nonin-
fringement and remand.

* Honorable Rodney Gilstrap, District Judge, Unit-
ed States District Court for the Eastern District of Texas,
sitting by designation.
CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 3

BACKGROUND
Elan has marketed and sold metaxalone, a muscle re-
laxant, under the brand-name Skelaxin, and was the
owner of an approved new drug application (“NDA”). In
early 2001, years after the initial approval of Skelaxin,
Elan learned that another company conducted in vivo
bioequivalence fasting studies and in vitro dissolution
tests on metaxalone and that, based on the results of
those studies, the FDA proposed to change the designa-
tion of metaxalone tablets from “non bioproblem” to
“bioproblem.” J.A. 1531–32.
In July 2001, Elan initiated its own clinical study on
Skelaxin administered with and without food in humans
and observed a significant effect of food on the drug’s
bioavailability. In October 2001, Elan submitted a citizen
petition to the FDA, requesting that the FDA require both
fed and fasting bioavailability data from an applicant of
an abbreviated new drug application (“ANDA”) for a
generic version of Skelaxin. Concurrently, Elan also
submitted an sNDA, viz., a labeling supplement to the
Skelaxin NDA, to revise its product label. See 21 C.F.R.
§ 314.70. Elan included its clinical study report with
those FDA submissions and explained to the FDA that
the results of its clinical study showed that “the bioavail-
ability [of Skelaxin] was significantly increased when
Skelaxin was administered with food in that both the rate
. . . and extent of absorption . . . were increased.” J.A.
1532. The FDA subsequently granted Elan’s citizen
petition and approved its sNDA.
In December 2001 and March 2002, Elan filed two pa-
tent applications in the United States Patent and Trade-
mark Office (“PTO”) based on its clinical bioavailability
data. The second application is a continuation of the first
and shares the same specification. Those applications
issued as U.S. Patents 6,407,128 and 6,683,102 (“the Elan
patents”). However, all claims of the Elan patents were
4 CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC.

later invalidated in light of prior art. King Pharm., Inc. v.
Eon Labs, Inc., 616 F.3d 1267, 1283 (Fed. Cir. 2010).
Classen owns the ’472 patent, which is directed to a
method for accessing and analyzing data on a commercial-
ly 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 Skelax-
in, 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 nonin-
fringement. 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 product.’”
J.A. 1484.
Claim 36 is representative of the asserted method
claims and depends from cancelled claim 33; both are
reproduced below:
33. [(cancelled during reexamination)] A method
for creating and using data associated with a
CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 5

commercially available product, wherein the
method comprises the steps of:
accessing at least one data source, comprising
together or separately, adverse event data as-
sociated with exposure to or use of the product
and commercial data regarding marketing,
sales, profitability or related information per-
taining to the product;
analyzing the accessed data to identify (i) at
least one new adverse event associated with ex-
posure to or use of the product, (ii) at least one
new use for the product responsive to identifica-
tion of the at least one new adverse event, and
(iii) the potential commercial value of the at
least one new use for the product; and
commercializing the newly identified product
information based upon the analyzed data.
36. The method of claim 33, wherein the commer-
cializing step comprises formatting the data relat-
ing to at least one new adverse event associated
with exposure to, or use of the product, or docu-
menting same, such that a manufacturer or dis-
tributor of the product must inform consumers,
users or individuals responsible for the user, phy-
sicians or prescribers about at least one new ad-
verse event associated with exposure to or use of
the product.
’472 patent col. 26 ll. 38–53, 60–67 (emphases added).
The asserted kit claims depend from the method claims.
Claim 59 is representative and reads as follows:
59. A proprietary kit comprising (i) product and
(ii) documentation notifying a user of the product
of at least one new adverse event relating to the
product, wherein determination of the new ad-
6 CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC.

verse event is based upon the data provided by the
method of claim 36.
’472 patent reexamination certificate col. 2 ll. 5–9 (em-
phases added).
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 Immunother-
apies, 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 Pharma-
ceuticals, 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. Clas-
sen, 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. Elan’s invalidity coun-
terclaim is still pending at the district court. Classen
appealed from the judgment of noninfringement, and we
have jurisdiction under 28 U.S.C. § 1295(a)(1). 1

1 Because issues of validity are not before us in this
appeal, we express no opinion as to whether the asserted
claims cover patent ineligible subject matter in light of
CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 7

DISCUSSION
We review the grant of summary judgment under the
law of the regional circuit in which the district court sits,
here, the Fourth Circuit. Teva Pharm. Indus. Ltd. v.
AstraZeneca Pharm. LP, 661 F.3d 1378, 1381 (Fed. Cir.
2001). Applying the law of the Fourth Circuit, we review
the district court’s grant of summary judgment de novo.
Gallagher v. Reliance Standard Life Ins. Co., 305 F.3d
264, 268 (4th Cir. 2002). Summary judgment is appropri-
ate when, drawing all justifiable inferences in the non-
movant’s favor, “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(a); Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 255 (1986).
Section 271(a) of the patent statute provides that
“[e]xcept as otherwise provided in this title, whoever
without authority makes, uses, offers to sell, or sells any
patented invention, within the United States or imports
into the United States any patented invention during the
term of the patent therefor, infringes the patent.” 35
U.S.C. § 271(a). In 1984, as part of the Drug Price Com-
petition and Patent Term Restoration Act of 1984 (Hatch-
Waxman Act), Congress created an exemption from the
general rule of infringement for certain uses of a patented
invention in the federal regulatory process. Pub. L. No.
98-417, § 202, 98 Stat. 1585, 1603 (1984) (codified as
amended at 35 U.S.C. § 271(e)(1)). The safe harbor provi-
sion of § 271(e)(1) provides in relevant part that:
It shall not be an act of infringement to make, use,
offer to sell, or sell within the United States or
import into the United States a patented inven-
tion . . . solely for uses reasonably related to the

the Supreme Court’s decision in Alice Corp. v. CLS Bank
International, 573 U.S. __, 134 S. Ct. 2347 (2014).
8 CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC.

development and submission of information under
a Federal law which regulates the manufacture,
use, or sale of drugs . . . .
35 U.S.C. § 271(e)(1) (emphasis added).
In the district court, Classen alleged that Elan in-
fringed the ’472 patent by conducting a clinical study on
the bioavailability of Skelaxin and submitting the results
to the FDA to revise the Skelaxin product label, among
other accused activities. Classen, 466 F. Supp. 2d at 624;
see also Classen Immunotherapies, Inc. v. King Pharm.,
Inc., No. 04-3521, ECF No. 123-8 (D. Md. Dec. 23, 2005).
On appeal, Classen no longer asserts that Elan’s clinical
study and FDA submissions are infringing, Appellant’s
Br. 7, 20–27, 29, 40, 43, 45, 46–47, 50, but it nevertheless
argues that the district court erred in finding those activi-
ties exempt under the safe harbor because, according to
Classen, those activities are merely routine post-approval
reporting to the FDA, id. at 4 & n.2, 29.
Under § 271(e)(1), the exemption from infringement
“extends to all uses of patented inventions that are rea-
sonably related to the development and submission of any
information under the FDCA.” Merck KGaA v. Integra
Lifesciences I, Ltd., 545 U.S. 193, 202 (2005) (emphasis in
original). The statute does not exclude “certain infor-
mation from the exemption on the basis of the phase of
research in which it is developed or the particular sub-
mission in which it could be included.” Id. Nor does the
statute limit the safe harbor only to those activities
necessary for seeking approval of a generic version of a
brand-name drug product. Id. at 206.
Although in the post-approval context it may be less
straightforward to determine whether an accused infring-
er’s use of a patented invention was “solely for uses rea-
sonably related to the development and submission of
information” under the FDCA, 35 U.S.C. § 271(e)(1)
(emphasis added), the statutory language does not cate-
CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 9

gorically exclude post-approval activities from the ambit
of the safe harbor, Momenta, 686 F.3d at 1359. Indeed,
under the FDCA, drug manufacturers may voluntarily, or
sometimes may be required to, conduct post-approval
studies on their products for purposes of developing and
submitting information to the FDA. See 21 U.S.C.
§ 355(e), (o); id. § 356(c)(2)(A); 21 C.F.R. § 314.70.
In some circumstances, drug manufacturers voluntar-
ily conduct post-approval scientific studies and clinical
trials to support “supplemental” new drug applications,
seeking the FDA’s approval to revise the label of their
products. See 21 C.F.R. § 314.70. Just like NDA or
ANDA applicants, sNDA applicants must submit relevant
data to the FDA to support their applications. Id.
§ 314.70(b)(3). Thus, after the initial approval of a drug,
its manufacturer may perform additional research to
further characterize the drug and submit that information
to the FDA for a labeling change. Such post-approval
studies serve similar purposes as pre-approval studies in
ensuring the safety and efficacy of approved drugs. As an
integral part of the regulatory approval process, those
activities are “reasonably related to the development and
submission of information” under the FDCA, 35 U.S.C.
§ 271(e)(1), and are therefore exempt from infringement
liability.
Here, Elan’s clinical study and its FDA submissions
clearly fall within the scope of the safe harbor. After
learning that the FDA proposed to change the designation
of metaxalone tablets, Elan initiated its own clinical trial
to characterize the effect of food on the absorption of
Skelaxin and observed a significant increase in bioavaila-
bility when Skelaxin was administered with food. Elan
submitted that information to the FDA to revise the
Skelaxin product label and to propose changes to the
approval requirements for generic versions of Skelaxin.
Those activities were anything but “routine” post-
approval reporting, Biogen, 659 F.3d at 1070; rather, they
10 CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC.

were “necessary” to the approval of both the brand-name
and generic versions of Skelaxin, Momenta, 686 F.3d at
1358. The district court therefore did not err in holding
that Elan’s clinical activities and FDA submissions are
exempt from infringement under the safe harbor provi-
sion.
Classen also argues that after Elan generated and
submitted the clinical data to the FDA, its subsequent
actions of reanalyzing the clinical data to identify patent-
able information and filing patent applications are com-
mercial activities outside the scope of the safe harbor.
Classen also argues that Elan infringed the kit claims by
making and selling Skelaxin with the revised label that
contained the information derived from the clinical study.
Classen contends that the safe harbor does not protect
those post-submission commercial uses of information
derived from the clinical study.
Elan responds that it generated the clinical data on
Skelaxin mainly for submission to the FDA and that it did
not reanalyze the data when filing the patent applica-
tions. Elan contends that subsequent uses of clinical data
generated for the FDA in other contexts do not result in
the removal of the safe harbor protection. Elan also
responds that because each of the kit claims depends from
a method claim that Elan did not infringe, Elan’s making
and selling of Skelaxin with the revised label is likewise
not infringing.
As indicated, we have concluded that Elan’s clinical
study and its FDA submissions are exempt under the safe
harbor provision. We have also held that the subsequent
disclosure or use of information obtained from an exempt
clinical study, even for purposes other than regulatory
approval, does not repeal that exemption of the clinical
study, provided that the subsequent disclosure or use is
itself not an act of infringement of the asserted claims.
CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 11

Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520,
1523–24 (Fed. Cir. 1992).
In Telectronics, the patentee conceded that the dis-
semination of information derived from an exempt clinical
study, including the activities of “presenting clinical trial
data at a cardiology conference, reporting clinical trial
progress to investors, analysts and journalists, and de-
scribing clinical trial results in a private fund-raising
memorandum,” did not, in and of itself, constitute an act
of infringement in that case. Id. We held that the patent
statute does not identify the mere dissemination of data
as a potentially infringing activity and that, when enact-
ing § 271(e)(1), Congress did not intend to prevent com-
petitors “from using, in an admittedly non-infringing
manner, the derived test data for fund raising and other
business purposes.” Id. at 1524–25.
Here, unlike in Telectronics, Classen alleges that
Elan’s post-submission activities using the clinical data
for non-regulatory purposes infringed the claims of Clas-
sen’s ’472 patent. Specifically, Classen asserts that Elan’s
filing of patent applications based on the clinical data
infringed the method claims and that Elan’s sale of
Skelaxin with the revised label containing information
derived from the clinical trial infringed the kit claims. As
indicated, when granting summary judgment of nonin-
fringement, the district court did not determine whether
those post-submission activities constituted infringement
of the ’472 patent or whether they were exempt under the
safe harbor. Rather than deciding those issues in the first
instance on appeal, we vacate the judgment of nonin-
fringement and remand the case to the district court for
further proceedings on the parties’ pending claims and
counterclaims, including issues of validity, enforceability,
and infringement of the asserted patent.
To assist the district court in its analysis of infringe-
ment, if the court reaches that issue on remand, we make
12 CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC.

the following observations of the record. Filing a patent
application is generally not an infringement of a patent.
It is not the making, using, offering to sell, selling, or
importing of an invention. It is the act of approaching an
agency of the government in order to obtain a limited
privilege and to fulfill a public goal of making knowledge
of an invention available to the public. It is not commer-
cializing an invention, which requires introducing an
invention into commerce, or making preparations to do so.
Moreover, infringing a multi-step method claim requires
carrying out all the steps of the claim. As filing a patent
application is not commercializing an invention, a method
claim requiring commercialization, as claim 36 does, is
likely not infringed by Elan’s actions here.
In addition, placing the information submitted to the
FDA on the product label after sNDA approval generally
cannot be an infringement. Information obtained from
exempt activities does not cease to be exempt once the
sNDA is approved. It is a requirement of law that a drug
product contains the labeling approved by the FDA. This
is not to say that a pharmaceutical patent claiming a
method of treatment, a method of preparation, or a com-
position of matter cannot be infringed by the subsequent
actions of making, using, offering to sell, selling, or im-
porting of a drug covered by that patent based on infor-
mation derived from exempt activities. But that is not the
case here.
Having stated the above, we leave it to the district
court to deal with any infringement or other issues as it
deems appropriate.
CONCLUSION
We have considered Classen’s remaining arguments
but find them unpersuasive. For the foregoing reasons,
we vacate the district court’s judgment of noninfringe-
ment and remand.
CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 13

VACATED AND REMANDED
COSTS
Costs to Elan.