Schering Corp. v. Geneva Pharmaceuticals, Inc.

339 F.3d 1373
CourtCourt of Appeals for the Federal Circuit
DecidedAugust 1, 2003
DocketNos. 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
StatusPublished
Cited by47 cases

This text of 339 F.3d 1373 (Schering Corp. v. Geneva Pharmaceuticals, 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
Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2003).

Opinion

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., No. 98-1259, 2002 WL 2001552 (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]*1375I.

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™. Unlike conventional antihistamines when CLARITIN™ 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 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:

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Claim 1 of the '716 patent covers DCL (for X = Cl), its fluorine analog, and their salts; claim 3 covers only DCL and its salts:

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1. A compound of the formula or a pharmaceutically acceptable salt thereof, wherein X represents Cl or F.
3. A compound having the structural formula
[1376]*1376[[Image here]]
or a pharmaceutically acceptable salt thereof.

The '233 patent issued on August 4, 1981, over one year before the earliest priority date of the '716 patent, February 15,1984. The '233 patent is thus prior art to the '716 patent. See 35 U.S.C. § 102(b) (2000) (“A person shall be entitled to a patent unless ... the invention was patented ... in this or a foreign country ... more than one year prior to the date of the application for patent in the United States.”). The '233 patent discloses a class of compounds including loratadine (disclosed in Example IB). '233 patent, col. 3, 11. 5-12. The '233 patent claims loratadine in claim 7. Id., col. 6, 11. 38-40. The '233 patent claims four other compounds in claims 8-11. Examples 6-7 are prophetic1 examples of pharmaceutical compositions (a syrup and a tablet), each containing an unidentified “active compound.” The '233 patent does not expressly disclose DCL and does not refer to metabolites of loratadine.

The numerous defendants-appellees sought to market generic versions of lora-tadine once the '233 patent expired. Seeking regulatory approval, each appellee submitted an application to the Food and Drug Administration (FDA). See 21 U.S.C. § 355(b), (j) (2000). Because Sehering included the '716 patent in the Orange Book listing for loratadine, the applications also contained a certification that the '716 patent was invalid. See id. § 355(b)(2)(A), 355(j)(2)(A)(vii). The ap-pellees notified Sehering of the FDA filings. See id. § 355(b)(3)(B), 365(j)(2)(B)(ii).

After receiving notice of the FDA filings, Sehering filed suit for infringement. See 35 U.S.C. § 271(e)(2)(A) (2000). After discovery, the parties filed cross motions for summary judgment on the validity issue. The district court construed claims 1 and 3 of the '716 patent to cover DCL in all its forms, including “metabolized within the human body” and “synthetically produced in a purified and isolated form.” The parties agreed to that construction. Applying that claim construction, the district court found that the '233 patent did not expressly disclose DCL. Nonetheless, the district court also found that DCL was necessarily formed as a metabolite by carrying out the process disclosed in the '233 patent. The district court concluded that the '233 patent anticipated claims 1 and 3 of the '716 patent under 35 U.S.C. § 102(b). The district court therefore granted the appellees’ motions for summary judgment of invalidity. Sehering timely appealed to this court under 28 U.S.C. § 1295(a)(1) (2000).

II.

This court reviews a grant of summary judgment without deference. Telemac Cellular Corp. v. Topp Telecom, Inc., [1377]*1377247 F.3d 1316, 1323 (Fed.Cir.2001). In reviewing a summary judgment determination, this court draws all reasonable inferences in favor of the non-movant. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

A.

A patent is invalid for anticipation if a single prior art reference discloses each and every limitation of the claimed invention. Lewmar Marine, Inc. v. Barient, Inc., 827 F.2d 744, 747 (Fed.Cir.1987). Moreover, a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference. Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.Cir.1991).

At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art. Schering relies on Elan Pharmaceuticals, Inc. v. Mayo Foundation for Medical Education & Research, 304 F.3d 1221 (Fed.Cir.2002) for that proposition. This court has since vacated Elan. See 304 F.3d 1221 (Fed.Cir.2002). Other precedents of this court have held that inherent anticipation does not require that a person of ordinary skill in the art at the time would have recognized the inherent disclosure.

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Bluebook (online)
339 F.3d 1373, Counsel Stack Legal Research, https://law.counselstack.com/opinion/schering-corp-v-geneva-pharmaceuticals-inc-cafc-2003.