A Reasonable Approach To ‘Reasonable Pricing’?

Biopharma companies are preparing to fight a new Biden Administration proposal to allow price to be a factor in invoking ‘March In’ rights on US government funded patents. However, an argument can be made that the new framework would be better than the status quo.

guardrails
Industry may actually appreciate the guardrails in the proposed march-in process. • Source: Shutterstock

Biopharma companies are understandably upset by a Biden administration proposal to allow the National Institutes of Health to consider pricing as a factor that might prompt the agency to “March In” on patents licensed to commercial companies.

Key Takeaways
  • Industry will need to accept continued public pressure on the pricing of its products.

  • Given that, the NIST process...

After all, they were so close to having a regulation finalized that would have explicitly prohibited pricing from any consideration in suspending exclusive rights under the Bayh-Dole Act that governs...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By 

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By 

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

More from Pink Sheet

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By 

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 

Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.