CLASSEN IMMUNOTHERAPIES, INC., A MARYLAND CORPORATION, Plaintiff-Appellant,
ELAN PHARMACEUTICALS, INC., A DELAWARE CORPORATION, Defendant/Counterclaimant-Appellee JOHN BARTHELOW CLASSEN, Counterclaim Defendant
Appeal from the United States District Court for the District of Maryland in No. 1:04-cv-03521-WDQ, Judge William D. Quarles, Jr.
VACATED AND REMANDED. COSTS.
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.
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 Pharms., Inc., 466 F.Supp.2d 621 (D. Md. 2006) (granting summary
judgment); Classen Immunotherapies, Inc. v. King Pharms., 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.
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 later invalidated in light of prior art. King Pharms., 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 ...