Category Archives: Generics / ANDA

Biogen’s petition for rehearing en banc denied, panel decision affirmed DC decision that single mention of dose at lower end of range is insufficient written description

Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc. Docket No. 2020-1933 (https://cafc.uscourts.gov/opinions-orders/20-1933.OPINION.11-30-2021_1871902.pdf) O’MALLEY (dissent), REYNA, HUGHES November 30, 2021 (update March 16, 2022) Update (March 16, 2022):  Biogen’s petition for rehearing en banc was denied.  Judges Lourie, Moore and … Continue reading

Posted in Generics / ANDA, Written description | 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”) (petition for rehearing en banc denied (2/11/22))

GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals USA, Inc. Docket No. 2018-1976, -2023 PROST, NEWMAN, MOORE October 2, 2020 Update (2/11/22):  Petition for rehearing denied.  Judges Moore, Newman, O’Malley, Taranto, Chen and Stoll concurred to address dissents by Judges Prost, … Continue reading

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

DC decision finding Adapt’s naloxone formulations obvious affirmed

Adapt Pharma, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al. Docket No. 2020-2106 (https://cafc.uscourts.gov/opinions-orders/20-2106.OPINION.2-10-2022_1906561.pdf) NEWMAN (D), PROST, STOLL February 10, 2021 Brief Summary:  DC decision finding Adapt’s naloxone formulations obvious affirmed. Summary:  Adapt appealed DC final judgment finding … Continue reading

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

Single mention of dose at lower end of range is insufficient written description, DC decision affirmed

Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc. Docket No. 2020-1933 (https://cafc.uscourts.gov/opinions-orders/20-1933.OPINION.11-30-2021_1871902.pdf) O’MALLEY (dissent), REYNA, HUGHES November 30, 2021 Brief Summary:  DC decision finding a lack of written description based on “[t]he specification’s sole reference to” the claimed dosage … Continue reading

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

DC finding that Horizon’s OB patents are obvious and/or not infringed affirmed

Horizon Medicines LLC v. Alkem Laboratories Ltd. Docket No. 2021-1480 (https://cafc.uscourts.gov/opinions-orders/21-1480.OPINION.11-16-2021_1865455.pdf) (Non-precedential) DYK, O’MALLEY, HUGHES November 16, 2021 Brief Summary:  DC refusal to change inventorship, finding of obviousness and no infringement of Horizon’s patents affirmed. Summary:  Horizon appealed DC finding … Continue reading

Posted in Anticipation (35 USC 102), Claim Construction, Conception and Reduction to Practice, Generics / ANDA, Inventorship, Obviousness | Leave a comment

DC Hatch-Waxman decision finding improper venue and failure to state a claim affirmed

Celgene Corp. v. Mylan Pharmaceuticals Inc., et al. Docket No. 2021-1154 (https://cafc.uscourts.gov/opinions-orders/21-1154.OPINION.11-5-2021_1860406.pdf) PROST, CHEN, HUGHES November 5, 2021 Brief Summary:  DC finding of improper venue and failure to state a claim affirmed. Summary:  Celgene sued Mylan for infringement under the … Continue reading

Posted in Generics / ANDA, Infringement, Jurisdiction, Venue | Leave a comment

FC panel affirms DC decision that Torrent did not show obviousness of Takeda’s algoliptin claims

Takeda Pharm. Co. et al. v. Torrent Pharm. Ltd., et al. Docket No. 2020-1552, -1598 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1552.OPINION.2-16-2021_1733600.pdf) (Non-Precedential) DYK, MAYER, CHEN February 16, 2021 Brief Summary:  DC holding that Torrent did not show Takeda’s claims related to algoliptin obvious affirmed. Summary:  … Continue reading

Posted in Double Patenting, Generics / ANDA, Obviousness | Leave a comment

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

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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