US Patent Office To Consider Including Patient Voice In Patent Considerations
PTO judge says she is ‘intrigued’ by request for patients to be involved in patent discussions and examiner training. Patients advocated for a seat at the table during USPTO-FDA’s ‘listening session’ on initiatives to promote greater access to medicines.
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FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development
The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.
What Will USPTO-FDA Collaboration Look Like? Stakeholders To Weigh In On Proposed Initiatives
Agencies are holding public ‘listening session’ to get input on method of use patents and ‘skinny labeling,’ REMS patenting, PTAB proceedings and other topics.
False Claims Act Liability: Defendant’s Belief Claims Were False Matters, Supreme Court Finds
In unanimous decision, court backs whistleblowers’ fraud theory that SuperValu and Safeway defrauded Medicare and Medicaid by reporting higher retail prices than their discounted prices. BIO, AdvaMed and MIWG submitted amicus brief in support of the retail pharmacies.