Category Archives: Generics / ANDA

Board decision invalidating Sanofi’s Lantus®-related claims for obviousness affirmed

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. Docket Nos. 2019-1368, -1369 (IPR2017-01526, -01528) NEWMAN, TARANTO, CHEN November 19, 2019 Nonprecedential Brief Summary: Board IPR decision invalidating Sanofi’s Lantus®-related claims for obviousness affirmed. Summary: Sanofi appealed USPTO (“Board”) IPR decision finding … Continue reading

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

Horizon’s OB ‘913 claim 12 survives obviousness challenge (Pennsaid® for osteoarthritis)

HZNP Medicines LLC et al. v. Actavis Laboratories UT, Inc. Docket No. 2017-2149, -2152-53, -2202-3, -2206 PROST, NEWMAN, REYNA October 10, 2019 Brief Summary: DC findings of indefiniteness, no induced infringement, and no invalidity for obviousness regarding Horizon’s OB patents … Continue reading

Posted in Claim Construction, Generics / ANDA, Indefiniteness, Inducement to Infringe, Infringement, Obviousness, Uncategorized | Leave a comment

PTAB IPR decision finding OSI’s Tarceva® patent obvious reversed (e.g., “unpredictability in cancer treatment generally”, reasonable expectation of success only with hindsight)

OSI Pharmaceuticals, LLC v. Apotex Inc. et al. Docket No. 2018-1925 (IPR2016-01284) NEWMAN, TARANTO, STOLL October 4, 2019 Brief Summary: PTAB’s IPR decision holding OSI’s OB ‘221 patent obvious reversed (e.g., the PTAB “misinterpreted the asserted references”, “NSCLC treatment was … Continue reading

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

Nalpropion’s naltrexone/bupropion claims found by FC panel not to lack written description (affirming DC) but invalid for obviousness (reversing DC)

Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. Docket No. 2018-1221 PROST, LOURIE, WALLACH August 15, 2019 Brief Summary: DC decision of no invalidity for lack of WD affirmed, but decision of no obviousness reversed. Summary: Actavis appealed DC judgment … Continue reading

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

Lilly’s Orange Book ‘209 patent regarding administration of pemetrexed not literally infringed, but infringed under DOE

Eli Lilly and Company v. Hospira, Inc., Dr. Reddy’s Laboratories Docket No. 2018-2126, -2127, -2128 LOURIE, MOORE, TARANTO August 9, 2019 Brief Summary: DC literal infringement decision reversed, but infringement under DOE affirmed. Summary: Hospira and Dr. Reddy’s (DRL) appealed … Continue reading

Posted in Claim Construction, Doctrine of equivalents, Generics / ANDA, Infringement, Method claims, Prosecution History Estoppel, Uncategorized | Leave a comment

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