ANDA Litigation Settlements

Summer 2017

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Case Name Drug Patent No(s). Publicly Available Terms
Kissei Pharm. Co. Ltd. v. Sandoz Inc., 13-1092 (D. Del.) Rapaflo® (silodosin capsules) 5,387,603 N/A
Shire LLC v. Amerigen Pharms. Ltd., 14-6095 (D.N.J.) Adderall® XR (amphetamine / dextroamphetamine) RE41,148 RE42,096 Defendant acknowledges that patents-in-suit are valid and enforceable; that selling a generic version of Adderall XR would infringe those patents; and until patent expiration, Defendant can only sell a generic product with Plaintiff’s permission.
PDL BioPharma Inc. v. Merck Sharp & Dohme Corp., 16-0407 (D.N.J.) Keytruda® (pembrolizumab for injection) 5,693,761 Merck will pay $19.5 million to license related patent rights and dismiss the case; and PDL agreed to not sue Merck for royalties related to Keytruda in the future.
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