News & Analysis as of

Life Sciences Abbreviated New Drug Application (ANDA) Food and Drug Administration (FDA)

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...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

Generic Launches - Abbreviated New Drug Applications and 505(b)(2) Applications

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....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

ANDA Approvals - New Drug Applications and 505(b)(2) Applications: Third Quarter

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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)

Robins Kaplan LLP on

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)

Robins Kaplan LLP on

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)

Robins Kaplan LLP on

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)

Robins Kaplan LLP on

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

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

Robins Kaplan LLP on

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

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - New ANDA Cases

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

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - Generic Launches

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Robins Kaplan LLP

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Litigation Settlements

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

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Approvals

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Troutman Pepper

Federal Circuit Decision Clarifies Obviousness-Type Double Patenting and Patent Term Adjustments in Allergan v. MSN Laboratories

Troutman Pepper on

On August 13, the Federal Circuit issued a precedential ruling in Allergan v. MSN Laboratories (Case No. 24-1061). This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re:...more

Robins Kaplan LLP

Pharmacyclics LLC v. Alvogen Pine Brook LLC - Imbruvica® (Ibrutinib)

Robins Kaplan LLP on

Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.) - Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC - ProAir® HFA (Albuterol Sulfate)

Robins Kaplan LLP on

Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 2024) (Chesler, J.)....more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Tolmar, Inc. - Invega Sustenna® (Paliperidone Palmitate)

Robins Kaplan LLP on

Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc. - Invega Sustenna® (Paliperidone Palmitate)

Robins Kaplan LLP on

Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J.,...more

Robins Kaplan LLP

Salix Pharms., Ltd. v. Norwich Pharms. Inc. - Xifaxan® (Rifaximin)

Robins Kaplan LLP on

Case Name: Salix Pharms., Ltd. v. Norwich Pharms. Inc., No. 2022-2153, 2023-1952, 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024) (Circuit Judges Lourie, Chen, and Cunningham presiding; Opinion by Lourie, J.; Dissenting-in-part...more

Robins Kaplan LLP

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. - Vascepa® (Icosapent Ethyl)

Robins Kaplan LLP on

Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews,...more

Jones Day

Federal Circuit Revives Induced Infringement Claims Despite "Skinny Label" Carve-Out

Jones Day on

The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more

Alston & Bird

Patent Case Summaries | Week Ending June 28, 2024

Alston & Bird on

Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., No. 2023-1169 (Fed. Cir. (D. Del.) June 25, 2024). Opinion by Lourie, joined by Moore and Albright (sitting by designation). Amarin markets and sells...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

119 Results
 / 
View per page
Page: of 5

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide