Category Archives: Generics / ANDA

Federal Circuit reverses DC and finds Horizon’s ‘907 and ‘285 Vimovo® Orange Book patents invalid for lack of written description

Nuvo Pharmaceuticals, Horizon Medicines LLC v. Dr. Reddy’s Labs. et al. Docket No. 2017-2473, -2481, -2484, -2486, -2489, -2491-93 PROST, CLEVENGER, WALLACH May 15, 2019 Brief summary: DC reversed as FC panel found found Nuvo/Horizon’s ‘907 and ‘285 claims to … Continue reading

Posted in Generics / ANDA, Inherency, Written description | Leave a comment

Novartis Pharmaceuticals Corp. et al. v. West-Ward Pharmaceuticals Int. Ltd.

Docket No. 2018-1434 STOLL, PLAGER, CLEVENGER May 13, 2019 Brief summary: DC’s “ultimate determination that the challenged claims would not have been obvious” due to no reasonable expectation of success affirmed. Summary: WW (which filed ANDA 207486 for generic Afinitor®) … Continue reading

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Amgen, Inc. et al. v. Sandoz Inc. et al.

Docket Nos. 2018-1551 and -1552 LOURIE, O’MALLEY, REYNA May 8, 2019 Brief summary: DC claim construction findings and grant of SJ of non-infringement to Sandoz regarding its Neupogen® and Neulasta® biosimilars affirmed. Summary: Amgen appealed two DC decisions finding Sandoz’s … Continue reading

Posted in Biosimilars, Claim Construction, Collateral estoppel, Doctrine of equivalents, Generics / ANDA, Infringement | Leave a comment

Endo Pharm. Inc., Mallinckrodt LLC v. Actavis LLC et al.

Docket No. 2018-1054 WALLACH, CLEVENGER, STOLL May 3, 2019 Brief summary: DC holding that Endo’s claims to low “ABUK” oxymorphone were not shown to be invalid for obviousness affirmed. Summary: Actavis appealed DC holding that claims 1-6 of Endo’s US … Continue reading

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Endo Pharm. Inc., Mallinckrodt LLC v. Actavis LLC et al.

Docket No. 2018-1054 WALLACH, CLEVENGER, STOLL May 3, 2019 Brief summary: DC holding that Endo’s claims to low “ABUK” oxymorphone were not shown to be invalid for obviousness affirmed. Summary: Actavis appealed DC holding that claims 1-6 of Endo’s US … Continue reading

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Grunenthal Gmbh et al. v. Alkem Labs. Ltd., Hikma Pharm., Actavis et al.

Docket No. 2017-1153, -2048-50 REYNA, TARANTO, CHEN March 28, 2019 Brief summary: DC decisions of nonobviousness of Grunenthal’s polymorph claims, no induced or contributory infringement due to section viii carve-out, and specific utility of the claimed polymorph affirmed. Summary: Alkem … Continue reading

Posted in Anticipation (35 USC 102), Contributory Infringement, Generics / ANDA, Inducement to Infringe, Inherency, Obviousness, Utility | Leave a comment

Brigham & Women’s Hospital, et al. v. Perrigo Company et al.

Docket No. 2017-1950, -2021, -2555, 2018-1243 LOURIE, O’MALLEY, STOLL February 28, 2019 Non-precedential Brief summary: DC grant of JMOL of noninfringement affirmed. Summary: Perrigo appealed DC denial of judgment as a matter of law (JMOL) that Brigham’s (Johnson & Johnson … Continue reading

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