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Acorda Therapeutics, Inc. v. Roxane Labs., Inc.

United States Court of Appeals for the Federal Circuit

September 10, 2018, Decided

2017-2078, 2017-2134

Opinion

 [***1004]  [*1313]   Taranto, Circuit Judge.

Before us are patents that claim the administration of a medication containing the active ingredient 4-aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Acorda Therapeutics, Inc., holds New Drug Application No. 022250, approved by the U.S. Food and Drug Administration (FDA). Pursuant to that approval, Acorda markets, under the name "Ampyra®," 10 milligram 4-AP sustained-release tablets for twice-daily oral administration. In the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, Acorda has listed, as claiming [**3]  methods of using Ampyra, four patents that Acorda owns: U.S. Patent No. 8,007,826; No. 8,663,685; No. 8,354,437; and No. 8,440,703. Those patents ("the Acorda patents") are the main patents at issue on appeal.

One additional patent is before us. Acorda holds an exclusive license to an earlier, broader patent, U.S. Patent No. 5,540,938, referred to as "the Elan patent" because it was originally assigned to Elan Corporation, plc (whose successor in interest is Alkermes Pharma Ireland Ltd.). The Elan patent, listed in the Orange Book for Ampyra along with the Acorda patents, claims methods of treating patients having certain conditions, including multiple sclerosis, by administering a drug containing a sustained-release formulation of any of certain agents, one of them 4-AP. The later Acorda patents claim species of the Elan patent's genus claims by adding further, more specific requirements to the Elan patent's claimed methods. While the Elan patent's claims broadly cover administering a sustained-release formulation of 4-AP to individuals with multiple sclerosis, the Acorda patents' claims further specify that such a drug must be administered (1) in a 10 mg dose twice a day (2) at that stable dose for the entire treatment period of [**4]  at least two weeks (3) to achieve 4-AP serum levels of 15-35 ng/ml and (4) to improve walking.

Roxane Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; and Teva Pharmaceuticals USA, Inc., have submitted Abbreviated New Drug Applications seeking FDA approval to market generic versions of Ampyra. In July 2014, Acorda and Alkermes sued those entities ("defendants") in the District of Delaware, alleging infringement of several claims in each of the Elan and Acorda patents. The defendants stipulated to infringement but challenged the validity of the asserted claims. The district court held that the asserted claims in the Acorda patents are invalid for obviousness. But the court upheld the asserted claims of the Elan patent against invalidity challenges and enjoined the defendants from activity infringing that patent until it expired on July 30, 2018.

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903 F.3d 1310 *; 2018 U.S. App. LEXIS 25536 **; 128 U.S.P.Q.2D (BNA) 1001 ***; 2018 WL 4288982

ACORDA THERAPEUTICS, INC., Plaintiff-Appellant, ALKERMES PHARMA IRELAND LIMITED, Plaintiff-Appellee v. ROXANE LABORATORIES, INC., MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA, INC., Defendants-Cross-Appellants

Subsequent History: US Supreme Court certiorari denied by Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 205 L. Ed. 2d 26, 2019 U.S. LEXIS 5890 (U.S., Oct. 7, 2019)

Prior History:  [**1] Appeals from the United States District Court for the District of Delaware in Nos. 1:14-cv-00882-LPS, 1:14-cv-00922-LPS, 1:14-cv-00935-LPS, 1:14-cv-00941-LPS, Chief Judge Leonard P. Stark.

Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 2017 U.S. Dist. LEXIS 48479 (D. Del., Mar. 31, 2017)

Disposition: AFFIRMED.

CORE TERMS

patent, dose, patients, multiple sclerosis, walking, studies, sustained-release, district court, prior art, twice, blocking, seizures, placebo, serum, skill, reasonable expectation, efficacy, measures, dosage, invention, twice-daily, pharmacokinetic, Poster, improved, levels, speed, stable, Neurology, titration, teaching

Patent Law, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, De Novo Review, Nonobviousness, Elements & Tests, Ordinary Skill Standard, Prior Art, Predictability, Infringement Actions, Exclusive Rights, Limitations, Graham Test, Secondary Considerations, Copyright Law, Copyright Infringement Actions, Digital Millennium Copyright Act, Safe Harbor Provisions