Abbott Laboratories v. TorPharm, Inc.

503 F.3d 1372, 84 U.S.P.Q. 2d (BNA) 1829, 2007 U.S. App. LEXIS 23803, 2007 WL 2948555
CourtCourt of Appeals for the Federal Circuit
DecidedOctober 11, 2007
Docket2007-1019
StatusPublished
Cited by26 cases

This text of 503 F.3d 1372 (Abbott Laboratories v. TorPharm, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Abbott Laboratories v. TorPharm, Inc., 503 F.3d 1372, 84 U.S.P.Q. 2d (BNA) 1829, 2007 U.S. App. LEXIS 23803, 2007 WL 2948555 (Fed. Cir. 2007).

Opinions

Opinion for the court filed by MICHEL, Chief Judge. Opinion concurring-in-part and dissenting-in-part filed by DYK, Circuit Judge.

MICHEL, Chief Judge.

This appeal involves the parties’ ongoing dispute over the efforts of TorPharm, Inc., Apotex, Inc., and Apotex Corporation (collectively, “Apotex”) to market a generic version of Depakote®, an anti-seizure medication containing divalproex sodium patented, produced, and sold by Abbott Laboratories (“Abbott”). Apotex now appeals from a final judgment of the United States District Court for the Northern District of Illinois holding Apotex in contempt for violating an injunction barring it from commercially manufacturing, using, selling, offering to sell, or importing into the United States generic divalproex sodium infringing Abbott’s U.S. Patent Nos. 4,988,731 and 5,212,326 until their expiration. Abbott Labs. v. Apotex, Inc., 455 F.Supp.2d 831, 840 (N.D.Ill.2006) (“Abbott V”). The charged conduct was the filing of a repetitive Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration (“FDA”). We uphold the district court’s decision to entertain a contempt proceeding as well within its discretionary authority. However, because [1376]*1376the district court erred in finding Apotex in contempt when the conduct at issue was not within the express terms of the injunction, we reverse the district court’s judgment of contempt.

I.

This is the third time the parties are before us, and a brief history of the facts is warranted. In 1997, Apotex1 filed ANDA No. 75-112 (“the Apotex ANDA”) under the provisions of The Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355 and 35 U.S.C. § 271) (the “Hatch-Waxman Act”), seeking FDA approval to manufacture and sell a generic version of Depa-kote®. The active ingredient of Depa-kote® is divalproex sodium. Abbott owns two patents directed to divalproex sodium: U.S. Patent Nos. 4,988,731 and 5,212,326 (collectively, the “Abbott patents”). The claims of the Abbott patents recite an oli-gomer containing about 4 to 6 repeating units of divalproex sodium. In its ANDA, Apotex certified under 21 U.S.C. § 355(j) (2)(A) (vii) (IV) (“paragraph TV certification”) that the Abbott patents are invalid.

Abbott responded by filing suit against Apotex for patent infringement under 35 U.S.C. § 271(e)(2)(A). The district court granted summary judgment in favor of Abbott on both validity and infringement. Abbott Labs. v. Torpharm, Inc., 156 F.Supp.2d 738 (N.D.Ill.2001) (“Abbott /”). On appeal, this court affirmed the ruling on validity but remanded for a trial on infringement. Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367 (Fed.Cir.2002) (“Abbott II ”). We held that, when making all reasonable inferences in favor of Apotex, a genuine issue of material fact was raised by the evidence as to whether Apotex’s product was an oligomer having about 4 to 6 repeating units as required by Abbott’s claims. Id at 1376-77.

On remand, Judge Posner of the United States Court of Appeals for the Seventh Circuit, sitting by designation in the United States District Court for the Northern District of Illinois, conducted a bench trial, then concluded that Apotex’s filing of the Apotex ANDA infringed the claims of the Abbott patents because Abbott’s claims read on the product that was the subject of the Apotex ANDA. Abbott Labs. v. TorPharm, Inc., 309 F.Supp.2d 1043 (N.D.Ill.2004) (“Abbott III”). In that case, the district court found that “Abbott proved by a preponderance of the evidence that Apo-tex’s product is an oligomer of 4 to 7[sie] units of divalproex sodium and therefore infringes Abbott’s patent.” Id at 1054. Accordingly, the district court entered the following injunction:

TorPharm, Inc., Apotex, Inc., Apotex Corp., and their respective affiliates, successors in interest, and assigns are enjoined from commercially manufacturing, using, selling, or offering to sell generic divalproex sodium which the Court has found to be infringing within the United States, or from importing such product into the United States, until Abbott’s U.S. Patent Nos. 4,988,731 and 5,212,326 expire and defendants have received final approval from FDA to market generic divalproex sodium.
The effective date of any approval by FDA of ANDA No. 75-112, or any other [1377]*1377application concerning defendants’ generic divalproex sodium which the Court has found to be infringing, shall be no earlier than January 29, 2008, the date of expiration of Abbott’s U.S. Patent Nos. 4,988,731 and 5,212,326.

Abbott Labs. v. Torpharm, Inc., No. 97 C 7515, Injunction Order (N.D.Ill. Apr. 1, 2004).

Apotex appealed the district court’s judgment of infringement and the injunction, which this court affirmed without opinion following oral argument. Abbott Labs. v. Torpharm, Inc., 122 Fed.Appx. 511 (Fed.Cir.2005) (‘Abbott IV”).

Apotex, according to its evidence, then attempted to design around Abbott’s patent claims and allegedly developed dival-proex sodium in the form of a polymer which differs from an oligomer in that the polymer is made up of much more than about 4 to 6 repeating units of divalproex sodium. Rather than file a new ANDA itself, however, Apotex entered into an informal agreement with Nu-Pharm, Inc. (“Nu-Pharm”) whereby Apotex would pay for costs associated with preparation of a new ANDA filing but NuPharm would take on what Apotex characterizes as the “litigation risks” arising from such a filing.2

On March 7, 2005, Nu-Pharm filed ANDA No. 77-615 (“the Nu-Pharm ANDA”) under 21 U.S.C. § 3550) seeking FDA approval to manufacture and sell a 500 mg divalproex sodium product. Nu-Pharm made a paragraph IV certification that its product did not infringe the claims of the Abbott patents. Abbott filed a complaint for patent infringement under 35 U.S.C. § 271(e)(2)(A) against Nu-Pharm in the Northern District of Illinois on June 24, 2005, alleging that the Nu-Pharm ANDA also infringed the Abbott patent claims. The case was routinely assigned to District Judge Pallmeyer. In March 2006, Nu-Pharm filed an amended ANDA seeking FDA approval of 125 mg and 250 mg divalproex sodium products. Shortly thereafter, on May 3, 2006, Abbott filed a second section 271(e)(2)(A) action for patent infringement, this time against both Nu-Pharm and Apotex, who Abbott apparently had just learned were acting in concert. In its complaint, Abbott alleged that Apotex was the true party in interest behind the Nu-Pharm ANDA and the product described therein. The case, also filed in the Northern District of Illinois, was assigned in the normal course to District Judge Guzman.

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503 F.3d 1372, 84 U.S.P.Q. 2d (BNA) 1829, 2007 U.S. App. LEXIS 23803, 2007 WL 2948555, Counsel Stack Legal Research, https://law.counselstack.com/opinion/abbott-laboratories-v-torpharm-inc-cafc-2007.