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Branded Manufacturers Decline to Remove Patents From the Orange Book After Receiving Letters From the FTC

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 to their patent listings...more

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more

The FDA Approves Two New Gene Therapies for the Treatment of Sickle Cell Disease

On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevyâ„¢ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more

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