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Food and Drug Administration (FDA) Pharmaceutical Patents Federal Register

Foley & Lardner LLP

Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

Foley & Lardner LLP on

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more

Foley & Lardner LLP

USPTO Discusses Duty of Disclosure and Duty of Reasonable Inquiry

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On February 23, 2023, the U.S. Patent and Trademark Office (USPTO) held a virtual panel discussion on the duty of disclosure and duty of reasonable inquiry. While both duties apply regardless of technology area, the...more

Foley & Lardner LLP

FDA Xyrem Meeting Materials Qualify As Printed Publication

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In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on...more

Patterson Belknap Webb & Tyler LLP

First Federal Register Notice of BPCIA Suit

Yesterday, FDA published notice of Janssen’s lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register. Although Janssen’s lawsuit...more

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