Shire LLC v. Amneal Pharma., LLC, No. 14-1736 (Fed. Cir. 2015)
Annotate this CaseShire’s patents are directed to derivatives of amphetamines, used to treat various disorders, including attention deficit hyperactivity disorder. A drawback to the use of amphetamines is their potential for abuse. The patents describe modifying amphetamine to decrease its activity when administered in high doses—as when the drug is being abused—but to maintain activity similar to that of unmodified amphetamine when delivered at lower doses. Shire’s FDA-approved capsules are distributed under the brand name Vyvanse®. The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists all the Vyvanse® patents. Defendants filed Abbreviated New Drug Applications (ANDAs) for generic versions of Vyvanse® before expiration of the patents The ANDAs included Paragraph IV certifications, 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patent claims are invalid or not infringed. Shire sued under 35 U.S.C. 271(e). The court found certain claims not invalid, denied defendants’ motion to amend their invalidity contentions to include an on-sale bar claim, and found that Johnson induced infringement by providing the active pharmaceutical ingredient to the ANDA defendants. The Federal Circuit affirmed in part, finding that defendants failed to raise a genuine issue of material fact that the asserted claims are obvious and that court did not abuse its discretion in denying the motion to amend. In the circumstances of this case Johnson cannot be liable for induced infringement before FDA approval of the ANDA application.
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