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Renewed Efforts in Congress for Pharmaceutical Patent Reform

With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more

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

Litigation Misconduct Helps Render a Patent Unenforceable

In March 2014, Regeneron Pharmaceuticals, Inc. sued Merus B.V. for allegedly infringing U.S. Patent No. 8,502,018 (“the ’018 Patent"). The ’018 Patent generally relates to using vectors to modify genes and chromosomal loci...more

FDA Approves Keytruda as First Cancer Treatment Based on a Genetic Biomarker

The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more

The PTAB May Be Taking a More Balanced Approach in Biotech and Pharmaceutical IPRs

Patent challengers were first able to file inter partes review (IPR) petitions on September 16, 2012. Since then IPRs have become an increasingly popular way of challenging the validity of patents. In the first three months...more

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