Category Archives: Generics / ANDA

DC grant of SJ of infringement to Lilly under DOE affirmed

Eli Lilly And Company v. Apotex, Inc. Docket No. 2020-1328 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1328.OPINION.12-21-2020_1705369.pdf) PROST, BRYSON, STOLL December 21, 2020 Non-precedential Brief Summary:  DC grant of SJ of infringement under DOE affirmed. Summary:  Apotex appealed DC grant of Lilly’s motion for summary judgment … Continue reading

Posted in Doctrine of equivalents, Generics / ANDA, Indefiniteness, Prosecution History Estoppel | Leave a comment

FC panel affirmed DC claim construction based in part on Maia’s stipulation to infringement

Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. Docket No. 2020-1387 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1387.OPINION.12-17-2020_1703604.pdf) NEWMAN, O’MALLEY, TARANTO December 17, 2020 Non-precedential Brief Summary:  DC decision affirmed based on claim construction and Maia’s stipulation to infringement (e.g., technical construction errors “harmless”). Summary:  Maia appealed … Continue reading

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

Infringement by Hospira’s ANDA of Par’s epinephrin injection-related claims affirmed

Par Pharmaceutical, Inc. et al. v. Hospira, Inc. Docket No. 2020-1273 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1273.OPINION.11-23-2020_1689851.pdf) DYK, TARANTO, STOLL November 23, 2020 Non-precedential Brief Summary:  DC finding that Hospira’s ANDA infringed Par’s claims affirmed (e.g., “[w]hat a generic asks for an receives approval to … Continue reading

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

Teva’s ANDA carve-out does not save it from induced infringement (“when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met”)

GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals USA, Inc. Docket No. 2018-1976, -2023 PROST, NEWMAN, MOORE October 2, 2020 Brief Summary:  GSK appealed DC judgment of a matter of law (JMOL) finding no induced infringement of RE40,000 by Teva’s Coreg® … Continue reading

Posted in Damages, Generics / ANDA, Inducement to Infringe, Willfullness | Leave a comment

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

Posted in Generics / ANDA, Licensing | Leave a comment

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