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Will USPTO’s PTAB Undergo A Makeover? Senators Push Reform Bill, Patent Office Tweaks Policy

 
• By Brenda Sandburg

Parallel district court litigation would no longer be factor in deciding whether to institute PTAB review of patents under Senate bill. BIO favors PTO discretion, would like claim amendments to be addressed.

Patent trial board
Senate bill would alter proceedings of USPTO's Patent Trial and Appeal Board • Source: Shutterstock

Ten years after the Patent Trial and Appeal Board was established, fundamentally changing how patent disputes are waged, Congress is seeking to modify its proceedings. A bipartisan bill would impose limitations on the US Patent and Trademark Office, which could impact the outcome of biopharma cases.

Last month, Sens. Patrick Leahy, D-VT, John Cornyn, R-TX, and Thom Tillis, R-NC, introduced the Patent Trial and Appeal...

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Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By Leslie Small

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands

 
• By Cathy Kelly

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

More from Pink Sheet

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.