Seth Silber

Wilson Sonsini Goodrich & Rosati

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Latest Posts › Food and Drug Administration (FDA)

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FTC Disputes Patent Listings of 10 Brand Drug Makers as Improperly Listed in FDA’s Orange Book

On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more

11/16/2023 / Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , FTC Act , Hatch-Waxman , Orange Book , Patent Infringement , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Unfair Competition

The Life Sciences Report – January 2022

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an interview with Foresight Diagnostics co-founder and CEO Jake Chabon conducted by Matthew Meyer, the firm’s Chief...more

1/25/2022 / Antitrust Litigation , Antitrust Violations , Food and Drug Administration (FDA) , Intellectual Property Protection , Life Sciences , Medical Devices , Patents , Pharmaceutical Industry

FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

7/17/2015 / Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Generic Drugs , Healthcare , Orange Book , Patents , Pharmaceutical Industry , Pharmaceutical Patents

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

2/12/2015 / Antitrust Litigation , Biosimilars , Citizen Petitions , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry

FTC Workshop to Revisit Competition Issues Regarding Follow-On Biologics

Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...more

11/21/2013 / Biologics , BPCIA , Competition , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Hatch-Waxman , Pharmaceutical Industry , Prescription Drugs

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