Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard
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.
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FDA, USPTO Collaboration Could Expand Review Of Pharma Patents, Explore ‘Skinny Label’ Policy
The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.
FDA, USPTO In Middle Of Congressional Tug-Of-War Over Patents And Drug Pricing
Senators Hassan and Cassidy contend the lack of coordination between the two agencies may allow patent thickets to grow. Meanwhile, Sen. Tillis is pushing the agency to refute data alleging patents are to blame for high drug prices.
ASCO Data Could Clarify Ocular Toxicity Concerns For ImmunoGen’s Mirvetuximab
ImmunoGen may need to mount an aggressive education campaign to get in front of issues like blurred vision and keratopathy, with ocular toxicity being common among antibody-drug conjugates.