News & Analysis as of

Patent Validity Abbreviated New Drug Application (ANDA) Pharmaceutical Industry

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

Robins Kaplan LLP on

Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

Alston & Bird

Patent Case Summaries | Week Ending April 11, 2025

Alston & Bird on

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 2023-1977 (Fed. Cir. (D. Del.) Apr. 8, 2025). Opinion by Murphy (sitting by designation), joined by Moore and Chen. Azurity owns a patent directed to non-sterile...more

Fish & Richardson

Hatch-Waxman 201

Fish & Richardson on

For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...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

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Will Not Read Safety and Efficacy Limitations into Pharma Method Claims

On July 24, in United Therapeutics Corporation v. Liquidia Technologies, Inc., the Federal Circuit addressed whether safety and efficacy are required for pharmaceutical method claims to be sufficiently enabled and supported...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Bradley Arant Boult Cummings LLP

A Federal Circuit Prescription to Take Away the Pain for Generics - Intellectual Property News

The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in May 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA intended to curb REMS “abuses,” and case law developments at the Federal...more

8 Results
 / 
View per page
Page: of 1

"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