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Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard

 
• By Brenda Sandburg

After Federal Circuit vacates district court ruling that patent on method of dosing ImmunoGen’s mirvetuximab soravtansine is indefinite and obvious, PTO warns of ‘well-documented problem’ of drug manufacturers receiving follow-on patents for ‘trivial modifications’ that delay generics.

Ovarian cancer
USPTO is opposed to issuing patent on method of dosing ImmunoGen's ovarian cancer drug • Source: Shutterstock

The US Patent and Trademark Office took the unusual step of voicing concerns about the misuse of patent laws in a petition seeking a panel rehearing of a decision by the US Court of Appeals for the Federal Circuit. The commentary reflects the desire of the Biden Administration and members of Congress for the agency to consider the impact of patent practices on access to affordable drugs.

The Federal Circuit vacated a district court ruling that ImmunoGen, Inc.’s patent claims on a method of dosing its...

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• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.