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Patent Validity Written Descriptions Abbreviated New Drug Application (ANDA)

Robins Kaplan LLP

Astellas Pharma Inc. v. Zydus, Inc. I

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Myrbetriq is a drug used to treat overactive bladder. It utilizes a hydrogel-based sustained-release oral tablet formulation to control the rate at which the active ingredient,...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

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