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Pharmaceutical Industry › Disclosure Requirements › Pharmaceutical Patents

Morgan Lewis - As Prescribed

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

Morgan Lewis - As Prescribed on

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

Mintz - Intellectual Property Viewpoints

Is Your Enantiomer Possessed? Patenting of Enantiomers – Does Written Description Require More Than Actual Possession?

Mintz - Intellectual Property Viewpoints on

It is well established that an enantiomerically pure compound exhibiting advantageous properties not present in its isomer or its corresponding racemic mixture, can be patented even if its corresponding racemic mixtures are...more

Saul Ewing LLP

FTC Supports Proposed PTO Rule Mandating Disclosure of Agreements Between Litigants in Disputes Before the Patent Trial and Appeal...

Saul Ewing LLP on

Introduction - On June 18, 2024, the Federal Trade Commission (“FTC”) unanimously agreed to submit a comment supporting a recent proposed U.S. Patent and Trademark Office (“PTO”) rule that would mandate the disclosure of all...more

International Lawyers Network

Information on Filed Applications for Registration of Drugs has Become Publicly Available in Russia

International Lawyers Network on

Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more

Smart & Biggar

Rx IP Update - July 2018

Smart & Biggar on

IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Patterson Belknap Webb & Tyler LLP

Disclosure Requirements Under the BPCIA

Patterson Belknap Webb & Tyler LLP on

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more

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