On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, affirming a lower court decision that ...
On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes ...
Expansion to FTC’s Orange Book Campaign Leads to Calls for More Clarity from Pharmaceutical Industry
“The FTC acts as if the agency is being perfectly clear on what it’s subjecting companies to, but there’s never been a conversation around what it means for a patent to claim a drug product.” – Hans ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
"Innovator companies should expect Orange Book patent listing challenges to emerge as an additional and simpler tool for overcoming ANDA litigation," write Peter J. Butch III and Howard S. Suh. A ...
The Federal Trade Commission announced on Wednesday that Teva Pharmaceutical (TEVA), under pressure from the agency, has requested the removal of more than 200 patents improperly listed in the FDA’s ...
“There is no dispute that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate. Amneal contends that the Inhaler Patents do not meet the requirement that they ...
To advance policies that secure the future of a leading U.S. innovative industry, it is important in this instance to gain a deeper understanding of what generic drugs are, what the FTC is challenging ...
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