Schering Corporation v. Geneva Pharmaceuticals, Inc.

339 F.3d 1373 (2003)

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Nature of the Case

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Facts

P owns the '233 and '716 patents on antihistamines. The prior art '233 patent covers the antihistamine loratadine, the active component of a pharmaceutical that P markets as CLARITIN. Loratadine does not cause drowsiness. The more recent '716 patent covers a metabolite of loratadine called descarboethoxyloratadine (DCL). A metabolite is a 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). Loratadine and its metabolite DCL differ only in that loratadine has a carboethoxy group on a ring nitrogen, while DCL has a hydrogen atom on that ring nitrogen. The '233 patent is prior art to the '716 patent. The '233 patent discloses a class of compounds including loratadine. The '233 patent does not expressly disclose DCL and does not refer to metabolites of loratadine. Ds sought to market generic versions of loratadine once the '233 patent expired. Ds notified P of the FDA filings. P filed suit for infringement. Ds 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 district court found that the '233 patent did not expressly disclose DCL. The district court 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 §102(b). P appealed from a grant of summary judgment to Ds.