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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

Federal Circuit Revisits Standard for Enablement of Antibody Claims

In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the...more

Disclaimed Patent Claims Fail to Give Rise to an Article III Case or Controversy

SANOFI-AVENTIS U.S., LLC v. FRESENIUS KABI USA, LLC - Before Lourie, Moore, and Taranto. Appeal from the United States District Court for the District of New Jersey. Summary: District courts lack the authority to...more

The Future of “Single Use Restrictions” in Jeopardy

In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices. Mallinckrodt, Inc. v....more

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