Patents, Policy Statement

USA: Unpacking the shift – Heightened antitrust scrutiny on Orange Book listings

WilmerHale on 12/19/2024

Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more

FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a...

Troutman Pepper Locke on 10/7/2023

The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more

Patent Office Interim Process Aimed To Improve Consistency

Jones Day on 6/8/2022

On May 26, 2022, the Patent Office issued its “Interim Process for PTAB Decision Circulation And Internal PTAB Review”. The Office issued the Process to explain its new procedures for circulating pre-issuance decisions, which...more

DOJ and Commerce Department Issue Antitrust Guidance on SEPs

King & Spalding on 1/6/2020

On December 19, 2019, three federal agencies—the U.S. Department of Justice, Antitrust Division, the U.S. Patent and Trademark Office, and the National Institute of Standards and Technology—issued a joint policy statement...more

DOJ to Withdraw Assent to Standards-Essential Patent Policy Statement

Latham & Watkins LLP on 12/14/2018

Antitrust Division head calls for a more balanced discussion of competing interests when a standard-essential patent holder seeks an injunctive order. Overview - Assistant Attorney General Makan Derahim has announced...more

USPTO Patent Public Advisory Meeting - Highlights

Polsinelli on 5/15/2018

The USPTO's PPAC Quarterly Meeting took place on May 3 at its headquarters in Alexandria, Virginia. Various topics affecting the USPTO, prosecution practice, and PTAB proceedings were discussed as an effort to open dialog...more