Category Archives: Generics / ANDA

DC decision that Invidior’s Suboxone® sublingual film patents are infringed by certain parties and not invalid for obviousness affirmed

Invidior Inc. et al. v. Dr. Reddy’s Labs. (DRL), Actavis/Watson, Teva, Par, Intelgenx, Alvogen Pine Brook, LLC Docket Nos. 2017-2587, 2018-1010, -1058, -1062, -1114, -1115, -1176, -1177 Newman, Mayer (D), Lourie July 12, 2019 Brief Summary: DC findings that Invidior … Continue reading

Posted in Claim Construction, Doctrine of equivalents, Generics / ANDA, Obviousness, Written description | Leave a comment

DC findings of infringement and validity of one UCB rotigotine patent and invalidity of another as anticipated by use in a single patient in a clinical trial affirmed

UCB, Inc. et al. v. Watson Laboratories, Inc. et al. Docket No. 2018-1397, -1453 TARANTO, SCHALL, CHEN June 24, 2019 Brief summary: DC decisions finding that UCB’s ‘434 patent was infringed under DOE and not invalid and UCB’s ‘414 patent … Continue reading

Posted in Anticipation (35 USC 102), Generics / ANDA, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

IPR decision finding mesalamine method claims obvious affirmed, Salix’s appeal of DC non-infringment holding dismissed

Dr. Falk Pharma GmbH v. Generico, LLC et al., Salix Pharm. v. Mylan Pharm. Docket 2017-2312 (IPR2016-00297, -01386, -01409); 2017-2636, 2018-1320 LOURIE, LINN, WALLACH June 12, 2019 Non-precedential Brief summary: Board’s IPR obviousness determination affirmed and Salix’s appeal of DC … Continue reading

Posted in Claim Construction, Generics / ANDA, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Recent Pharma-Related Federal Circuit Opinions regarding DC and USPTO IPR Obviousness Decisions

BTG Int. Ltd. and Jannsen Biotech, Inc. et al. v. Amneal Pharmaceuticals LLC, et al. May 14, 2019 Obviousness affirmed PTAB IPR decision finding BTGs’s ZYTIGA® (abiratone) Orange Book ‘438 method of treatment patent invalid for obviousness affirmed (e.g., the … Continue reading

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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