Category Archives: Generics / ANDA

DC denial of Takeda’s permanent injunction affirmed based on License Agreement definitions

Takeda Pharm. U.S.A., Inc. v. Mylan Pharm. Inc. Docket No. 2020-1407, -1417 PROST, NEWMAN (D), HUGHES July 31, 2020 Brief Summary: DC decisions denying Takeda a permanent injunction affirmed due to Final Court Decision regarding Licensed Patents as defined in … Continue reading

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Non-obviousness finding for Relistor® OB-listed formulation patent reversed due to structural and functional similarity to prior art compounds

Valeant Pharm. Int., Salix Pharm., Inc. et al. v. Mylan Pharm. Inc., et al., Actavis LLC Docket No. 2018-2097 LOURIE, REYNA, HUGHES April 8, 2020 Brief Summary: DC grant of SJ of non-obviousness of OB formulation patent reversed and remanded … Continue reading

Posted in Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Obviousness-Teaching Away, Summary Judgment | Leave a comment

Horizon’s petition for en banc rehearing regarding indefiniteness denied (four judges dissented regarding “consisting essentially of”))

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 (update Feb. 25, 2020) Update (2/25/20): Petition for en banc hearing denied. Judges Lourie, Newman, O’Malley and Stoll … Continue reading

Posted in comprising, consisting of, Generics / ANDA, Indefiniteness | Leave a comment

Galderma’s ivermectin claims not inherently anticipated since “claimed efficacy limitations” not disclosed by single prior art reference

Galderma Labs., L.P. et al. v. Teva Pharmaceuticals, Inc. Docket No. 2019-2396, -1213 MOORE, O’MALLEY, STOLL January 29, 2020 Non-precedential Brief Summary: DC finding of inherent anticipation reversed as it relied on a second reference to provide limitations missing from … Continue reading

Posted in Anticipation (35 USC 102), Generics / ANDA, Inherency | Leave a comment

Fed. Cir. reverses DC and finds Amneal’s Sensipar®-related product infringes Amgen ‘405 patent

Amgen Inc. v. Amneal Pharm., Pirimal, et al., Zydus Pharm., Cadila et al. Docket Nos. 2018-2414, 2019-1086 NEWMAN, LOURIE, TARANTO January 7, 2020 Brief Summary: DC claim construction reversed (“composition comprising” not closed to other components); no infringement by Amneal … Continue reading

Posted in Claim Construction, Generics / ANDA, Infringement | Leave a comment

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