Schering Corporation 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.

Citations: 348 F.3d 992; 68 U.S.P.Q. 2d (BNA) 1760; 2003 U.S. App. LEXIS 22046Docket: 02-1545

Court: Court of Appeals for the Federal Circuit; October 27, 2003; Federal Appellate Court

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The United States Court of Appeals for the Federal Circuit issued a decision on October 28, 2003, regarding the case Schering Corporation v. Geneva Pharmaceuticals, among numerous defendants, stemming from the United States District Court for the District of New Jersey. Schering Corporation, the plaintiff-appellant, filed a combined petition for panel rehearing and rehearing en banc, represented by a team from Kirkland & Ellis LLP and Schering Corporation. The defendants-appellees included multiple pharmaceutical companies, with various legal representatives from different firms responding to the petition. The court invited and received responses from the appellees before referring the petitions to the original panel and then to circuit judges for consideration of en banc rehearing. Ultimately, the court denied both the petition for panel rehearing and the petition for rehearing en banc. Circuit Judge Pauline Newman dissented from the denial of the rehearing en banc.

Circuit Judge Lourie dissents from the denial of rehearing en banc, expressing concern over the panel's ruling regarding the patentability of descarbethoxyloratidine (DCL), a novel chemical compound discovered as a degradation product of loratidine. Lourie argues that the panel's classification of DCL as "inherently anticipated" contradicts established law, which states that a product is not considered anticipated if it is new. While acknowledging that a new product may be unpatentable due to obviousness, he emphasizes that it cannot be deemed unpatentable for lack of novelty if it was previously unknown and not part of the prior art.

Lourie critiques the panel's reasoning, noting that it incorrectly conflates validity with infringement, and insists that the law allows for the discovery of products that may have existed but were unknown. He highlights the implications of the panel's ruling for biological product discoveries and warns that the decision does not align with the patent statute or the objectives of the patent system. He clarifies that precedent has consistently maintained that novel subject matter can be patentable if it meets the criteria of non-obviousness, while non-novel subject matter cannot be patented. The discussion includes examples from precedent, illustrating how anticipation and obviousness are evaluated based on prior art.

In MEHL/Biophile International Corp. v. Milgraum, the court determined that a prior art reference disclosed all steps of a process involving laser irradiation of hair follicles, though it did not explicitly mention hair removal. The court ruled this effect was inherent in the process, and the same steps could not be claimed, as the claim did not restrict applicability to human skin. In Titanium Metals Corp. v. Banner, the court found that discovering a known alloy's corrosion resistance did not confer patentability since this property was inherent to the alloy.

For claims to be anticipated, they must be disclosed in a single prior art reference. If elements are missing, the law dictates that these elements were known to be present in the referenced subject matter. Despite a panel's attempt to disavow this precedent, any change in law necessitates en banc court action. The precedent established in Continental Can Co. USA v. Monsanto Co. illustrates that inherent anticipation can fill gaps in references with extrinsic evidence, provided that such evidence clarifies that the missing characteristic is necessarily present and recognized by skilled individuals in the field.

The analysis of inherency allows for the determination of whether unmentioned subject matter was known in the relevant field, as acknowledged in EMI Group North America, Inc. v. Cypress Semiconductor Corp. This requirement emphasizes that those skilled in the art must recognize inherent characteristics present in prior art. The dissent argues against the panel's rejection of this precedent, especially concerning the claimed compound descarbethoxyloratidine, which was neither shown in any reference nor recognized as formed in vivo from loratidine ingestion.

The dissenting judge expresses concern that the panel's decision could bar patentability for human drug metabolites, warranting en banc review due to the significant implications of this ruling on patent law.

An issued patent for a pharmaceutical product provides an enabling disclosure for all metabolites formed in the body upon ingestion of that product simply by stating that the product can be administered to humans. This ruling, upheld by the full court, establishes that such a patent serves as prior art against any subsequent patent applications for those metabolites. While it is acknowledged that metabolites in public use prior to a patent application are unpatentable, the court's decision extends further, asserting that merely issuing the patent inherently anticipates claims to the metabolites, assuming their formation is a natural consequence of administering the drug.

Specifically, the court critiques U.S. Patent 4,282,233, which included only minimal disclosures regarding the use of the compounds as antihistamines, lacking detailed guidance on metabolite formation. The patent did not identify or mention any metabolites, yet the court held that it anticipates those metabolites. The implications of this ruling raise questions about the necessity of a separate patent for a metabolite if a product patent exists, especially since another entity could independently patent the metabolite before the product's public use. Ultimately, the ruling emphasizes that the patent law issue at hand is whether the minimal disclosure of administering a product can inherently cover its metabolites, which the author contends is incorrect.