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Patent Challenges Via IPR Still Pretty Scary, Even After Acorda's Win

 
• By Brenda Sandburg

Reform efforts gain steam, but hedge fund manager Kyle Bass' attack on Acorda's patents was denied based on specifics of prior art, not biotech's arguments about abuse of the system.

While Acorda Therapeutics Inc. defeated Kyle Bass’ attack on its Ampyra (dalfampridine) patents, other firms targeted by the hedge fund manager may remain vulnerable.

The Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) denied two inter partes review (IPR) petitions filed by...

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More from United States

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COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
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Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
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The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

More from North America

Trump Administration Closer to Unprecedented Drug Price Transparency Requirements

 
• By Tim Casey

New rules requiring more granular drug pricing data to be disclosed in machine-readable files will go into effect in 2026.

Orphan Drug Relief Still In Budget Bill But Uncertainty Remains

 
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The budget reconciliation bill nears final passage without pharmacy benefit manager reforms or provisions that would facilitate access to cell and gene therapies for children, but its Medicaid cuts pose a significant threat to prescription drug access.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.