Category Archives: Generics / ANDA

DC obviousness and procedural ANDA-related decisions affirmed

Posted on April 23, 2024 by Patrick J. Halloran, Ph.D., J.D.

Salix Pharm., Ltd. et al. v. Norwich Pharm. Inc. Docket No. 2022-2153, -1952 (https://cafc.uscourts.gov/opinions-orders/22-2153.OPINION.4-11-2024_2300049.pdf) LOURIE, CHEN, CUNNINGHAM April 11, 2024 Brief Summary:  DC obviousness of method of treatment and polymorph patents and ANDA-related (FDA cannot approve current ANDA, correctly denied … Continue reading →

Posted in Generics / ANDA, Infringement, Method claims, Obviousness | Leave a comment

DC findings regarding two UT Orange Book patents affirmed (including that pending appeal of IPR decision for one of the patents has no bearing here)

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

United Therapeutics Corp. v. Liquidia Technologies, Inc. Docket No. 2022-2217, 2023-1021 (https://cafc.uscourts.gov/opinions-orders/22-2217.OPINION.7-24-2023_2161663.pdf) LOURIE, DYK, STALL July 23, 2023 Brief Summary:   DC decisions regarding infringement, that a pending IPR proceeding has no bearing on this appeal, infringement but anticipation, and … Continue reading →

Posted in Anticipation (35 USC 102), Functional limitations, Generics / ANDA, Inducement to Infringe, Infringement, Inter Parties Review (IPR), IPR | Leave a comment

DC findings that Vanda’s method of treatment claims are invalid for obviousness affirmed

Posted on May 16, 2023 by Patrick J. Halloran, Ph.D., J.D.

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. and Apotex, Inc. et al. Docket No. 2023-1247 (https://cafc.uscourts.gov/opinions-orders/23-1247.OPINION.5-10-2023_2124577.pdf) (Non-Precedential) DYK, BRYSON, PROST May 10, 2023 Brief Summary:   DC obviousness findings regarding Vanda’s method of treatment claims affirmed. Summary:  Teva and … Continue reading →

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

FC panel affirms DC finding that Amgen’s Otezla® composition patents are not invalid, but also that method of treatment claims are invalid, for obviousness

Posted on April 21, 2023 by Patrick J. Halloran, Ph.D., J.D.

Amgen Inc. v. Sandoz Inc. et al. Docket No. 2020-1147, 1149-51 (https://cafc.uscourts.gov/opinions-orders/22-1147.OPINION.4-19-2023_2113208.pdf) LOURIE, CUNNINGHAM, STARK April 19, 2023 Brief Summary:   DC finding that two of Amgen’s Otezla® composition patents not invalid for obviousness affirmed.  DC finding that another of … Continue reading →

Posted in Enablement, Generics / ANDA, Inherency, Method claims, Obviousness, Obviousness (Secondary Considerations), Obviousness-Teaching Away, Priority, Written description | Leave a comment

DC finding of UCB’s OB ‘589 patent invalid for anticipation and obviousness affirmed

Posted on April 18, 2023 by Patrick J. Halloran, Ph.D., J.D.

UCB, Inc. et al. v. Actavis Laboratories UT, Inc. / Mylan Technologies, Inc. Docket No. 2021-1924, -2336 (https://cafc.uscourts.gov/opinions-orders/21-1924.OPINION.4-12-2023_2109643.pdf) MOORE, CHEN, STOLL April 12, 2023 Brief Summary:   DC finding UCB’s ‘589 patent invalid for anticipation and obviousness affirmed. Summary:  UCB … Continue reading →

Posted in Anticipation (35 USC 102), Claim Construction, Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Obviousness-Teaching Away, Ranges | Leave a comment

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