Category Archives: Generics / ANDA

DC decision of infringement and no invalidity of Pharmacyclic’s BTK inhibitor-related patents affirmed

Pharmacyclics LLC, Jannsen Biotech, Inc. v. Alvogen, Inc., Natco Pharma Limited Docket No. 2021-2270 (https://cafc.uscourts.gov/opinions-orders/21-2270.OPINION.11-15-2022_2033497.pdf) (Non-Precedential) CHEN, BRYSON, HUGHES November 15, 2022 Brief Summary:   DC decisions that Pharmacyclic’s patents were infringed and not invalid for lack of written description, … Continue reading

Posted in Anticipation (35 USC 102), Double Patenting, Enablement, Generics / ANDA, Incorporation by Reference, Infringement, Method claims, Obviousness, Obviousness (Secondary Considerations), Priority, Public Accessibility, Written description | Leave a comment

IPR finding that Mylan did not show Merck’s DP-IV claims invalid for anticipation or obviousness affirmed

Mylan Pharmaceuticals Inc. v. Merck Sharp & Dome Corp. Docket No. 2021-2121 (IPR2020-00040) (https://cafc.uscourts.gov/opinions-orders/21-2121.OPINION.9-29-2022_2010851.pdf) LOURIE, REYNA, STOLL September 29, 2022 Brief Summary:   Board IPR finding that Mylan did not show Merck’s DP-IV claims invalid for anticipation or obviousness affirmed. … Continue reading

Posted in Anticipation (35 USC 102), Conception and Reduction to Practice, Generics / ANDA, Inherency, Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations) | Leave a comment

DC decision of no infringement by Eagle’s ANDA specification and denial of DJ affirmed

Par Pharmaceutical, Inc. et al. v. Eagle Pharmceuticals, Inc. Docket No. 2021-2342 (https://cafc.uscourts.gov/opinions-orders/21-2342.OPINION.8-18-2022_1993064.pdf) MOORE, PROST, HUGHES August 18, 2022 Brief Summary:   DC finding of no infringement under 271(e)(2) affirmed based on Eagle’s ANDA specification to which Eagle is bound, … Continue reading

Posted in Claim Construction, Generics / ANDA, Infringement, Method claims, Safe Harbor, FDA exemptions (271(e)(1)) | Leave a comment

DC finding Actavis did not show Tris’ liquid formulation/blood concentration claims obvious affirmed

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. Docket No. 2021-1495 (https://cafc.uscourts.gov/opinions-orders/21-1495.OPINION.7-7-2022_1974736.pdf) (Non-precedential) MOORE, CHEN, HUGHES July 7, 2022 Brief Summary:   DC decision following remand finding Actavis did not show Tris’ claims obvious affirmed (e.g., “unexpected result”, long-felt unmet … Continue reading

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

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) Second Update (October 3, 2022): Petition for certiorari to SCOTUS denied. Related final written decision in … 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