Dev. Inc. v. Eon Labs Inc.

• Decision Date: 14 October 2010
• Docket Number: Nos. 2009-1437, 2009-1438.,s. 2009-1437, 2009-1438.
• Citation: 616 F.3d 1267
• Parties: KING PHARMACEUTICALS, INC., and King Pharmaceuticals Research and Development, Inc, Plaintiffs-Appellants, v. EON LABS, INC., Defendant-Appellee, v. Elan Pharmaceuticals, Inc., Counterclaim Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

616 F.3d 1267

KING PHARMACEUTICALS, INC., and King Pharmaceuticals Research and Development, Inc, Plaintiffs-Appellants,

v.EON LABS, INC., Defendant-Appellee,

v.Elan Pharmaceuticals, Inc., Counterclaim Defendant-Appellant.

Nos. 2009-1437, 2009-1438.

United States Court of Appeals,Federal Circuit.

Aug. 2, 2010.

Rehearing and Rehearing En Banc Denied Oct. 14, 2010.

COPYRIGHT MATERIAL OMITTED.

Gregory A. Castanias, Jones Day, of Washington, DC, argued for plaintiffs-appellants. With him on the brief were F. Dominic Cerrito, Daniel L. Malone and Eric C. Stops, of New York, NY. Of counsel was Evangeline Shih.

Martin B. Pavane, Cohen Pontani Lieberman & Pavane LLP, of New York, NY, argued for defendant-appellee. With him on the brief were Alfred H. Hemingway, Jr. and Marilyn Neiman.

James B. Monroe, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Washington, DC, argued for counterclaim defendant-appellant. With him on the brief were Paul W. Browning and Kakoli Caprihan. Of counsel were Justin J. Hasford and Lawrence L. Ilag.

Before BRYSON, GAJARSA, and PROST, Circuit Judges.

GAJARSA, Circuit Judge.

King Pharmaceuticals, Inc. and King Pharmaceuticals Research and Development, Inc. (“King”) appeal the U.S. District Court for the Eastern District of New York's grant of Eon Labs, Inc.'s (“Eon”) motion for summary judgment that all claims of U.S. Patent Nos. 6,407,128 (the “ '128 patent”) and 6,683,102 (the “ '102 patent”) are invalid. See King Pharms., Inc. v. Eon Labs, Inc., 593 F.Supp.2d 501 (E.D.N.Y.2009). In granting Eon's motion, the district court held four claims invalid under 35 U.S.C. § 101, three claims invalid under 35 U.S.C. § 103, and the remaining claims invalid under 35 U.S.C. § 102. See id. at 506-15.

Following the summary judgment order, the district court entered a final judgment against both King and Elan Pharmaceuticals, Inc. (“Elan”), a prior owner of one of the asserted patents and a third-party, counterclaim defendant. Elan filed a “cautionary” notice of appeal on July 2, 2009 contending that the district court lacked jurisdiction to enter a final judgment against it. Elan then moved to be dismissed as a party from this appeal for lack of subject matter jurisdiction and to vacate the district court's judgment as to Elan. A Federal Circuit motions panel denied the motion because the jurisdictional facts went to the merits of the case. Elan reasserts its jurisdictional arguments in the present appeal.

For the reasons stated below, we affirm the district court's grant of summary judgment of invalidity. We vacate the district court's invalidity order against Elan because the district court lacked subject matter jurisdiction to adjudicate the invalidity counterclaim.

Background

King markets and sells a name brand version of metaxalone called Skelaxin. Metaxalone is a muscle relaxant that is used to treat “discomforts associated with acute, painful musculosketal conditions.” '128 patent col.1 ll.21-23. Metaxalone was first discovered in the 1960s, and the first patent claiming the method of producing the compound, U.S. Patent No. 3,062,827, issued in 1962 to A.H. Robins Company, Inc. A.H. Robins began selling metaxalone under the brand name Skelaxin in 1962. Elan eventually acquired the rights to Skelaxin and sold those rights in 2003 to King, which now markets and sells Skelaxin.

On August 31, 2004, Eon filed an Abbreviated New Drug Application (“ANDA”) for a generic 800 mg metaxalone tablet. Eon filed with the ANDA a patent certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”), which alleged that none of the claims of the '128 patent would be infringed by the manufacture, use, or sale of Eon's generic 800 mg metaxalone tablet, and that all the claims of the '128 patent are invalid. In response to the ANDA and Paragraph IV Certification, King filed suit against Eon under the Hatch-Waxman Act (the “800 mg Action”). The complaint accused Eon of infringing the '128 and '102 patents. King's action was consolidated with an earlier, related action, Elan Pharmaceuticals, Inc. v. Eon Labs, Inc., No. 03-0006 (E.D.N.Y.) (the “ 400 mg Action”), that Elan filed in 2001 against Eon after Eon filed an ANDA for a generic 400 mg metaxalone tablet. Elan asserted the '128 patent in the 400 mg Action, but the case was dismissed after Eon withdrew its 400 mg ANDA. The district court then severed Eon's claims for attorneys fees against King and Elan and consolidated those claims with the 800 mg Action.

The '128 patent, titled “Method for Increasing the Bioavailability of Metaxalone,” issued on June 18, 2002 and was initially assigned to Elan. Elan subsequently assigned the '128 patent to King in 2003. The patent discloses a method of “increasing the bioavailability of metaxalone by administration of an oral dosage form with food.” '128 patent [Abstract]. The claimed invention is the result of “the unexpected finding that administration of metaxalone with food increases both the rate and extent of absorption via the oral dosage form in human subjects.” Id. at col.2 ll.6-9.

The '128 patent has three independent claims, claims 1, 9, and 17. Claim 1 claims “a method of increasing the oral bioavailability of metaxalone” by “administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.” Claim 9 claims a method for increasing “the rate and extent of absorption ... of metaxalone ... in the blood stream” by “administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.” Claim 17 claims a method similar to claim 1, but limits the effective amount of metaxalone to between 400 and 800 mg and defines an increase in bioavailability as “an increase in the maximal plasma concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone compared to administration without food.”

Dependent claims 2, 3, 10, and 11 specify that the “therapeutically effective amount” of metaxalone is “200 mg to 900 mg” (claims 2 and 10) or “400 mg to 800 mg” (claims 3 and 11). Dependent claims 4-6, 12-14, and 18-20 specify specific times for administering the metaxalone relative to the consumption of food, either thirty minutes prior to two hours after consumption of food (claims 4, 12 and 18), “substantially at the same time” as consumption of food (claims 5, 13 and 19), or up to one hour after consumption of food (claims 6, 14 and 20). Dependent claims 7 and 15 limit the dosage to a tablet form, and dependent claims 8 and 16 limit the dosage to a “unit dosage form.” Dependent claim 21 claims the method of claim 1 with the additional limitation of “informing” the patient that taking metaxalone with food will increase the drug's bioavailability, and dependent claim 22 claims the method of claim 1 with the additional limitation that “the metaxalone is from a container with printed labeling advising” that taking metaxalone with food will increase the drug's bioavailability.

The '102 patent issued on January 27, 2004 and is titled “Methods of Using Metaxalone in the Treatment of Musculoskeletal Conditions.” Elan assigned the application that resulted in the '102 patent to King in 2003. Like the ' 128 patent, the '102 patent discloses a method of “increasing the bioavailability of metaxalone by administration of an oral dosage form with food.” '102 patent [Abstract]. Independent claim 1 claims a method for using metaxalone in the treatment of musculosketal conditions comprising both “providing” a patient with a “therapeutically effective amount of metaxalone” and “informing” the patient that taking metaxalone with food increases the bioavailability of the drug. Claims 2 through 5 depend from claim 1 and either specify the “therapeutically effective amount” as 200 mg to 900 mg (claim 2) or 400 mg to 800 mg (claim 3), or limit the dosage to a tablet form (claim 4) or a “unit dosage form” (claim 5).

Independent claim 6 claims a “method of using metaxalone in the treatment of musculosketal conditions” consisting of “informing a patient” that taking metaxalone with food increases the bioavailability of the drug compared to taking metaxalone without food. Independent claim 7 claims a “method of using metaxalone in the treatment of musculosketal conditions” by “obtaining metaxalone from a container providing information that administration of metaxalone with food” increases the drug's bioavailability and “ingesting the metaxalone with food.”

Independent claim 8 claims a “method of using metaxalone in the treatment of musculosketal conditions” comprising both administering metaxalone with food and informing the patient that such administration increases the bioavailability of the drug. Dependent claims 9 through 11 limit claim 8 to metaxalone from a container with printed information concerning the increased bioavailability of the drug (claim 9), metaxalone in a tablet form (claim 10), and 400 mg of metaxalone (claim 11). Claims 12, 13, and 14 depend from claim 9 and limit the printed label to stating certain percentage increases in the bioavailability of metaxalone. Finally, claim 15 depends from claim 8 and limits the metaxalone to a 400 mg tablet with a printed label that states certain percentage increases in the bioavailability of the metaxalone.

Before the district court, Eon presented six prior art references it contended invalidated the '128 and '102 patents. See King Pharms., Inc., 593 F.Supp.2d at 504-06. In granting Eon's motion for summary judgment, the district court relied only upon three references: Kazem Fathie, Musculoskeletal Disorders and Their Management with a New Relaxant, Clinical Medicine 678 (April 1965) (“Fathie II”); Joseph A. Albanese, Nurses' Drug Reference 427 (2 ed. 1982) (“Albanese”); and Anne C. Abrams, Clinical Drug Therapy 145 (1995) (“Abrams”). See id. at 506-15.

Fathie II describes a clinical study in which patients were given 800 mg of...