Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01671/USCOURTS-ca13-14-01671-0/pdf.json

Parties Involved:
John Barthelow Classen
Not party
Classen Immunotherapies, Inc.
Appellant
Elan Pharmaceuticals, Inc.
Appellee

Document Text:

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. 

Case: 14-1671 Document: 52-2 Page: 1 Filed: 05/13/2015
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 occurred 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 infringement or whether they were exempt from liability 

under the safe harbor, we vacate the judgment of noninfringement and remand. 

* Honorable Rodney Gilstrap, District Judge, United States District Court for the Eastern District of Texas, 

sitting by designation.

 

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CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 3

BACKGROUND

Elan has marketed and sold metaxalone, a muscle relaxant, 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 designation 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 bioavailability [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 patent applications in the United States Patent and Trademark 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 

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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 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 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 

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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 associated with exposure to or use of the product 

and commercial data regarding marketing, 

sales, profitability or related information pertaining to the product; 

analyzing the accessed data to identify (i) at 

least one new adverse event associated with exposure to or use of the product, (ii) at least one 

new use for the product responsive to identification 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 commercializing step comprises formatting the data relating to at least one new adverse event associated 

with exposure to, or use of the product, or documenting same, such that 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. 

’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 adCase: 14-1671 Document: 52-2 Page: 5 Filed: 05/13/2015
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 (emphases 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 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 FDAapproval 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. Elan’s invalidity counterclaim 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 

 

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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 appropriate when, drawing all justifiable inferences in the nonmovant’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 Competition and Patent Term Restoration Act of 1984 (HatchWaxman 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 provision 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 invention . . . 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).

 

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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 infringed 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 activities 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 reasonably 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 information from the exemption on the basis of the phase of 

research in which it is developed or the particular submission 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 infringer’s use of a patented invention was “solely for uses reasonably 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 cateCase: 14-1671 Document: 52-2 Page: 8 Filed: 05/13/2015
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 voluntarily 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 bioavailability 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” postapproval reporting, Biogen, 659 F.3d at 1070; rather, they

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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 provision. 

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 patentable information and filing patent applications are commercial 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 applications. 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. 

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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 dissemination 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 describing 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 enacting § 271(e)(1), Congress did not intend to prevent competitors “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 Classen’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 noninfringement, 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 noninfringement 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 infringement, if the court reaches that issue on remand, we make 

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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 commercializing 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 composition of matter cannot be infringed by the subsequent 

actions of making, using, offering to sell, selling, or importing of a drug covered by that patent based on information 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 noninfringement and remand. 

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CLASSEN IMMUNOTHERAPIES, INC. v. ELAN PHARM., INC. 13

VACATED AND REMANDED

COSTS

Costs to Elan.

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