Category Archives: Generics / ANDA

DC order for Jazz to delist “computer-implemented system” claims from Orange Book affirmed

Posted on March 2, 2023 by Patrick J. Halloran, Ph.D., J.D.

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC Docket No. 2023-1186 (https://cafc.uscourts.gov/opinions-orders/23-1186.OPINION.2-24-2023_2085825.pdf) LOURIE, REYNA, TARANTO February 24, 2023 Brief Summary:   DC order for Jazz to delist “computer-implemented system” claims from OB affirmed. Summary:  Jazz appealed DC grant of an … Continue reading →

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

FC panel affirms DC obviousness and non-infringement findings regarding Genentech’s Esbriet® patents

Posted on January 13, 2023 by Patrick J. Halloran, Ph.D., J.D.

Genentech, Inc., Intermune, Inc. v. Sandoz Inc., LEK Pharmaceuticals, D.D. Docket No. 2022-1595 (https://cafc.uscourts.gov/opinions-orders/22-1595.OPINION.12-22-2022_2052253.pdf) NEWMAN, LOURIE, PROST December 22, 2022 Brief Summary:   DC findings that Genetech’s disputed Esbriet® patents are invalid for obviousness and not infringed by Sandoz’s ANDA … Continue reading →

Posted in Generics / ANDA, Infringement, Method claims, Obviousness, Obviousness (Secondary Considerations) | Leave a comment

DC findings of obviousness of certain claims affirmed and others vacated based on secondary considerations

Posted on December 27, 2022 by Patrick J. Halloran, Ph.D., J.D.

Arius Two, Inc., Biodelivery Sci. Int., Inc. v. Alvogen PB Res. & Develop. LLC, et al. Docket No. 2022-1394, -1449 (https://cafc.uscourts.gov/opinions-orders/22-1394.OPINION.12-21-2022_2051391.pdf) (Non-Precedential) CHEN, CLEVENGER, CUNNINGHAM December 21, 2022 Brief Summary:   DC obviousness findings for two patents affirmed; obviousness of … Continue reading →

Posted in Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Prosecution History Estoppel | Leave a comment

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

Posted on November 29, 2022 by Patrick J. Halloran, Ph.D., J.D.

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Limited Docket No. 2021-2270 (https://cafc.uscourts.gov/opinions-orders/21-2270.OPINION.11-15-2022_2033497.pdf) (Non-Precedential) CHEN, BRYSON, HUGHES November 15, 2022 Brief Summary:   DC decisions that Pharmacyclic’s patents were infringed and not invalid for lack of written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

Posted on October 3, 2022 by Patrick J. Halloran, Ph.D., J.D.

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

Posted on August 19, 2022 by Patrick J. Halloran, Ph.D., J.D.

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

Posted on July 20, 2022 by Patrick J. Halloran, Ph.D., J.D.

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

Posted on March 17, 2022 by Patrick J. Halloran, Ph.D., J.D.

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))

Posted on February 24, 2022 by Patrick J. Halloran, Ph.D., J.D.

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

Posted on February 17, 2022 by Patrick J. Halloran, Ph.D., J.D.

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