News & Analysis as of

Intellectual Property Protection Patent Infringement Generic Drugs

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - April 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

BakerHostetler

A Later-Discovered Improvement to an Invention Cannot Be Used To Reach Back and Invalidate an Earlier-Filed Patent

BakerHostetler on

Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Senate Bill Seeks to Create New Skinny Label Protections

A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug...more

Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

Fish & Richardson on

In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Written Description and Enablement Depend on What a Patent 'Claims,' Not What the Claims Cover

The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. MSN Pharms., Inc.

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Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more

Robins Kaplan LLP

Galderma Labs., L.P. v. Lupin Inc.

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Oracea® (doxycycline USP) - Case Name: Galderma Labs., L.P. v. Lupin Inc., No. 2024-1664, 2024 WL 4998071 (Fed. Cir. Dec. 6, 2024) (Circuit Judges Moore, Linn, and Prost presiding; Opinion by Moore, C.J.) (Appeal from D....more

Robins Kaplan LLP

Purdue Pharma L.P. v. Accord Healthcare, Inc.

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OxyContin® (oxycodone HCl) - Case Name: Purdue Pharma L.P. v. Accord Healthcare, Inc., No. 2023-1953, 2024 WL 5244764 (Fed. Cir. Dec. 30, 2024) (Circuit Judges Prost, Reyna, and Taranto presiding; Opinion by Prost, J.)...more

Foley & Lardner LLP

Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

Foley & Lardner LLP on

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more

Alston & Bird

Patent Case Summaries | Week Ending December 20, 2024

Alston & Bird on

Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al., No. 2024-1936 (Fed. Cir. (D.N.J.) Dec. 20, 2024). Opinion by Prost, joined by Taranto and Hughes....more

DLA Piper

Case-Narrowing Decisions are a One-Way Street: Reviewing Exeltis USA v. Lupin Ltd.

DLA Piper on

Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more

DLA Piper

Silvergate Pharmaceuticals v. Bionpharma: The Relevance of Offers of Confidential Access Under the Hatch-Waxman Statute and Awards...

DLA Piper on

In Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., the US District Court for the District of Delaware decided an open question regarding pre-filing investigation and attorney fees under Title 35 of the US Code, Section...more

Robins Kaplan LLP

New ANDA Cases - Federal District Court Cases That Are Filed Pursuant to the Hatch-Waxman Act

Robins Kaplan LLP on

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Robins Kaplan LLP

ANDA Litigation Settlements - Reported Settlements in Federal District Court Cases

Robins Kaplan LLP on

This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Robins Kaplan LLP

Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd. - Viberzi® (eluxadoline)

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Case Name: Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., Civ. No. 23-794-RGA, 2024 WL 3444368 (D. Del. July 17, 2024) (Andrews, J.)....more

Robins Kaplan LLP

Otsuka Pharm. Co., Ltd. v. Lupin Ltd. - Jynarque® (tolvaptan)

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Case Name: Otsuka Pharm. Co., Ltd. v. Lupin Ltd., Civ. No. 21-900-RGA, 2024 WL 3618123 (D. Del. July 31, 2024) (Andrews, J.)....more

Robins Kaplan LLP

Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc. - Exparel® (bupivacaine)

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Case Name: Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc., Civ. No. 21-19829, 2024 WL 3812188 (D.N.J. Aug. 9, 2024) (Arleo, J.)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. MSN Pharms. Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)....more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - ProAir® HFA (albuterol sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more

Robins Kaplan LLP

Exeltis USA, Inc. v. Lupin Ltd. - Slynd® (drospirenone)

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Case Name: Exeltis USA, Inc. v. Lupin Ltd., Civ. No. 22-434-RGA, 2024 WL 4040470 (D. Del. Sept. 4, 2024) (Andrews, J.)....more

Robins Kaplan LLP

Purdue Pharma L.P v. Accord Healthcare Inc. - OxyContin® (oxycodone HCl)

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Case Name: Purdue Pharma L.P v. Accord Healthcare Inc., Civ. No. 22-913-WCB, 2024 WL 4120717 (D. Del. Sept 9, 2024) (Bryson, J.) Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone HCl); U.S. Patent No. 11,304,908 (“the...more

Robins Kaplan LLP

Allergan USA, Inc. v. MSN Labs. Private Ltd. - Viberzi® (eluxadoline)

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Case Name: Allergan USA, Inc. v. MSN Labs. Private Ltd., 111 F.4th 1358, 2024 WL 3763599 (Fed. Cir. Aug. 13, 2024) (Circuit Judges Lourie, Dyk, and Reyna presiding; Opinion by Lourie, J.; Opinion concurring-in-part and...more

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