Not a Lexis Advance subscriber? Try it out for free.

Celgene Corp. v. Peter

United States Court of Appeals for the Federal Circuit

July 30, 2019, Decided

2018-1167, 2018-1168, 2018-1169, 2018-1171

Opinion

 [*1346]  Prost, Chief Judge.

The Coalition for Affordable Drugs VI LLC ("CFAD") filed a petition for inter partes review ("IPR") challenging the validity of all of the claims of U.S. Patent No. 6,045,501 ("the '501 patent") and three petitions for [**2]  IPR challenging the validity of all of the claims of U.S. Patent No. 6,315,720 ("the '720 patent"). The Patent Trial and Appeal Board ("Board") determined that all of the claims of the '501 patent and claims 1-9 and 11-32 of the '720 patent were obvious. Celgene Corporation ("Celgene") appeals the Board's decisions.

For the reasons explained below, we affirm the Board's decisions finding the appealed claims obvious. We also hold that the retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment.

A teratogen is an agent known to disturb the development of an embryo or fetus. Teratogenic drugs can cause birth defects or other abnormalities following fetal exposure during pregnancy. One example of a teratogenic drug is thalidomide. Thalidomide, first synthesized in 1957, was originally marketed for use as a sedative in many countries, not including the United States. See '501 patent col. 1 ll. 19-22. Following reports of serious birth defects, thalidomide was withdrawn from all markets by 1962. Id. at col. 1 ll. 22-24. Despite these teratogenic effects, thalidomide has proven to be effective in treating other conditions. See id. at col. 1 ll. 24-35. The '501 patent and the '720 patent are generally directed to methods for safely distributing [**3]  teratogenic or other potentially hazardous drugs while avoiding exposure to a fetus to avoid adverse side effects of the drug.

In order to obtain FDA approval to sell and distribute thalidomide, Celgene developed a system to safely distribute thalidomide to patients, which it called the System for Thalidomide Education and Prescription Safety ("Original S.T.E.P.S."). Appeal No. 18-1171, Appellant's Br. 8-9. According to Celgene, the '501 patent is directed to its Original S.T.E.P.S. program. See id. at 10.

Read The Full CaseNot a Lexis Advance subscriber? Try it out for free.

Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.

931 F.3d 1342 *; 2019 U.S. App. LEXIS 22517 **; 2019 U.S.P.Q.2D (BNA) 281074; 2019 WL 3418549

CELGENE CORPORATION, Appellant v. LAURA A. PETER, DEPUTY UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DEPUTY DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor

Subsequent History: Petition for review granted by, 02/26/2020

Prior History:  [**1] Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2015-01096, IPR2015-01102, IPR2015-01103.

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2015-01092.

Coalition for Affordable Drugs IV v. Celgene Corp., 2016 Pat. App. LEXIS 13407 (Pat. & Trademark Office Bd. App., Oct. 26, 2016)

Disposition: AFFIRMED.

CORE TERMS

patents, written decision, reexamination, patients, medium, thalidomide, storage, readable, prior art, motivation, proceedings, drugs, male, prescription, argues, challenges, district court, inter partes, side effect, centralized, teratogenic, registered, pre-AIA, preponderance of evidence, constitutional challenge, ex parte, prescribers, pharmacies, exposure, effects

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Nonobviousness, Claims & Specifications, Claims, Claim Language, Infringement Actions, Claim Interpretation, Elements & Tests, Graham Test, Secondary Considerations, Nonobviousness, Prior Art, Administrative Law, Judicial Review, Reviewability, Preservation for Review, Constitutional Law, Bill of Rights, Fundamental Rights, Eminent Domain & Takings, Ownership, Patents as Property, Business & Corporate Compliance, US Patent & Trademark Office Proceedings, Patent Law, US Patent & Trademark Office Proceedings, Reexamination Proceedings, Defenses, Patent Invalidity, Governments, Legislation, Effect & Operation, Retrospective Operation