Schering Corp. v. Geneva Pharmaceuticals, 02-1540.

• Decision Date: 01 August 2003
• Docket Number: No. 02-1541.,No. 03-1021.,No. 02-1545.,No. 02-1544.,No. 02-1542.,No. 03-1022.,No. 02-1548.,No. 02-1540.,No. 02-1549.,No. 03-1025.,No. 02-1546.,No. 03-1027.,No. 02-1543.,No. 02-1547.,No. 03-1023.,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.
• Parties: 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.
• Court: U.S. Court of Appeals — Federal Circuit

339 F.3d 1373

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.

No. 02-1540.

No. 02-1541.

No. 02-1542.

No. 02-1543.

No. 02-1544.

No. 02-1545.

No. 02-1546.

No. 02-1547.

No. 02-1548.

No. 02-1549.

No. 03-1021.

No. 03-1022.

No. 03-1023.

No. 03-1025.

No. 03-1027.

United States Court of Appeals, Federal Circuit.

August 1, 2003.

Robert G. Krupka, Kirkland & Ellis, of Los Angeles CA, argued for plaintiff-appellant. Of counsel on the brief were David P. Swenson, Kirkland & Ellis, of Washington, DC; John M. Desmarais, Sandra A. Bresnick, Peter J. Armenio, Maxine Y. Graham, Monica V. Bhattacharyya, and Young J. Park, Kirkland & Ellis, of New York, NY. Of counsel were John F. Hoffman and Arthur Mann, Schering Corporation, of Kenilworth, NJ.

Robert D. Bajefsky, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for defendants-appellees Wyeth, ESI-Lederle, Wyeth Pharmaceuticals and Wyeth Consumer Healthcare (formerly American Home Products Corporation, Wyeth-Ayerst Laboratories, and Whitehall Robbins Healthcare). With him on the brief were Barbara R. Rudolph and Matthew J. Mason. Of counsel on the brief were David A. Manspeizer and Lawrence Alaburda, Wyeth, of Madison, NJ. On the brief was Julie A. Petruzzelli, Venable, Baetjer, Howard, & Civiletti, LLP, of Washington, DC, for defendant-appellee Impax Laboratories, Inc. Of counsel were Peter J. Curtin and James E. Gray. Also on the brief were Edgar H. Haug, Daniel G. Brown, and Porter F. Fleming, Frommer Lawrence & Haug LLP, of New York, NY; for defendant-appellee Genpharm Inc.; Colin A. Underwood, Soloman, Zauderer, Ellenhorn, Frischer & Sharp, of New York, NY, for defendants-appellees Andrx Corporation, Andrx Pharmaceuticals LLC, and Andrx Pharmaceuticals, Inc.; E. Anthony Figg, Joseph A. Hynds, Rothwell, Figg, Ernst & Manbeck, of Washington, DC, for defendant-appellee Mylan Pharmaceuticals, Inc.

Robert S. Silver and William J. Castillo, Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd., of Philadelphia, PA, for defendants-appellees Apotex, Inc. and Novex Pharma.

Thomas L. Creel, Goodwin Procter, LLP, of New York, NY, for defendants-appellees Teva Pharmaceuticals USA, Inc. and Copely Pharmaceutical, Inc. With him on the brief were Frederick H. Rein and Keith A. Zullow.

Douglass C. Hochstetler, Schiff, Hardin & Waite, of Chicago, IL, argued for defendants-appellees Geneva Pharmaceuticals, Inc. and Novartis Corporation. With him on the brief were Patricia J. Thompson and Jo-Anne M. Kokoski. Of counsel on the brief was Kevin M. Flowers, Ph.D., Marshall Gerstein & Borun, of Chicago, IL.

Before RADER, Circuit Judge, PLAGER, Senior Circuit Judge, and BRYSON, Circuit Judge.

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.

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 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:

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

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:

1. A compound of the formula

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

or a pharmaceutically acceptable salt thereof, wherein X represents Cl or F.

3. A compound having the structural formula

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

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 1B). '233 patent, col. 3, ll. 5-12. The '233 patent claims loratadine in claim 7. Id., col. 6, ll. 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 loratadine 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 Schering 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 appellees notified Schering of the FDA filings. See id. § 355(b)(3)(B), 355(j)(2)(B)(ii).

After receiving notice of the FDA filings, Schering 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. Schering 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., 247 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. E.g., In re Cruciferous Sprout Litig., 301 F.3d 1343, 1351 (Fed.Cir.2002); MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed.Cir.1999) ("Where ... the result is a necessary consequence of what was deliberately intended, it is of no import that the article's authors did not appreciate the results."); Atlas Powder, 190 F.3d at 1348-49 ("Because `sufficient aeration' was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."). Thus, recognition by a person of ordinary skill...