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Schering Corp. v. Geneva Pharms., Inc.

United States Court of Appeals for the Federal Circuit

August 1, 2003, Decided

02-1540, 02-1541, 02-1542, 02-1543, 02-1544, 02-1545, 02-1546, 02-1547, 02-1548, 02-1549, 03-1021, 03-1022, 03-1023, 03-1025, 03-1027

Opinion

 [***1665]   [*1374]  RADER, Circuit Judge.

On summary judgment, the United States District Court for the District of New Jersey determined that claims 1 and 3 of  U.S. Patent No. 4,659,716 (the '716 patent) are invalid.  Schering Corp. v. Geneva Pharm., Inc., 275 F. Supp. 2d 534, 2002 U.S. Dist. LEXIS 14587, No. 98-1259 (D.N.J. Aug. 8, 2002). Because the district court correctly found that  U.S. Patent No. 4,282,233 (the '233 patent) inherently anticipates claims 1 and 3 of the '716 patent, this court affirms.  

 [*1375]  I.

Schering Corporation (Schering) owns the '233 and '716 patents on antihistamines. Antihistamines inhibit the histamines that cause allergic symptoms.

The prior art '233 patent covers the antihistamine loratadine, the active component of a pharmaceutical that Schering markets as CLARITIN TM. Unlike conventional antihistamines when CLARITIN TM was launched, loratadine does not cause drowsiness.

The more recent '716 patent at issue in this case covers a metabolite of loratadine called descarboethoxyloratadine (DCL). A metabolite is the compound formed in the [**4]  patient's body upon ingestion of a pharmaceutical. The ingested pharmaceutical undergoes a chemical conversion in the digestion process to form a new metabolite compound. The metabolite DCL is also a non-drowsy antihistamine. The '716 patent issued in April 1987 and will expire in April 2004 (the '233 patent issued in 1981 and has since expired). See 35 U.S.C. § 154(c)(1) (2000) (defining the term of a patent in force before June 8, 1995, as the greater of twenty years from the earliest U.S. priority date or seventeen years from grant).

Structurally, loratadine and its metabolite DCL differ only in that loratadine has a carboethoxy group (i.e., -COOEt) on a ring nitrogen, while DCL has a hydrogen atom on that ring nitrogen: [***1666]  

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339 F.3d 1373 *; 2003 U.S. App. LEXIS 15496 **; 67 U.S.P.Q.2D (BNA) 1664 ***

SCHERING CORPORATION, Plaintiff-Appellant, v. GENEVA PHARMACEUTICALS, INC. and NOVARTIS CORPORATION, and TEVA PHARMACEUTICALS USA, INC., and ANDRX CORPORATION, ANDRX PHARMACEUTICALS LLC, and ANDRX PHARMACEUTICALS, INC., and MYLAN PHARMACEUTICALS, INC., and WYETH, ESI-LEDERLE, WYETH PHARMACEUTICALS, and WYETH CONSUMER HEALTHCARE (formerly American Home Products Corporation, Wyeth-Ayerst Laboratories, and Whitehall Robbins Healthcare), and IMPAX LABORATORIES, INC., APOTEX, INC. and NOVEX PHARMA, COPLEY PHARMACEUTICAL, INC., and GENPHARM, INC., Defendants-Appellees.

Subsequent History: Rehearing denied by, Rehearing, en banc, denied by Schering Corp. v. Geneva Pharms., Inc., 348 F.3d 992, 2003 U.S. App. LEXIS 22046 (Fed. Cir., Oct. 28, 2003)

Prior History:  [**1]  Appealed from: United States District Court for the District of New Jersey. Chief Judge John W. Bissell.

Schering Corp. v. Geneva Pharms., Inc., 275 F. Supp. 2d 534, 2002 U.S. Dist. LEXIS 14587 (D.N.J., 2002)

Disposition: Affirmed.

CORE TERMS

patent, prior art, anticipation, loratadine, compound, metabolite, subject matter, discloses, district court, disclosure, invention, ingestion, patient, pharmaceutical, skill, summary judgment, critical date, administering, metabolizes, covering, invalid, antihistamine, composition, enabling, infringe, genuine, missing, ribs, ordinary person, plastic bottle

Patent Law, Anticipation & Novelty, Elements, General Overview, Invention Date & Priority, Statutory Bars, Civil Procedure, Summary Judgment, Entitlement as Matter of Law, Appeals, Summary Judgment Review, Accidental Anticipation & Inherency, Specifications, Enablement Requirement, Defenses, Inequitable Conduct, Claims & Specifications, Invention Theory, Governments, Courts, Judicial Precedent, Preliminary Considerations, Venue, Utility Patents, Process Patents, Computer Software & Mental Steps, Infringement Actions, Infringing Acts, Standards & Tests, Reduction to Practice, Description Requirement, Product Patents, US Patent & Trademark Office Proceedings, Reissue Proceedings, Judgments, Evidentiary Considerations, Materiality of Facts