Patent ‘March-In’ Policy Shift Will Likely Drive Uncertainty More Than Price Drops

Biden administration’s new framework will consider whether a product’s price is reasonable in deciding whether to exercise march-in rights. Numerous other factors could limit provision’s impact, but industry is concerned it will discourage firms from licensing government-funded inventions.

marching band
• Source: Shutterstock

While the Biden Administration is advising federal agencies to consider product pricing in determining whether to invoke march-in rights to license a company’s patents, the directive may not change the status quo given all the other factors to be considered in taking such action. But industry is concerned that the new policy will be detrimental to government collaboration and product development.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

 
• By 

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

Viatris Puts Pen To Paper On $335m Opioid Settlement Agreement

 
• By 

Following recent agreements signed by Hikma and Amneal, Viatris has become the latest company to reach a cash settlement resolving allegations that its practices fuelled the US’ deadly opioid epidemic.

Spanish Authorities Investigate Sandoz Over Information-Sharing

 
• By 

Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.

Glenmark Dodges UK Dapagliflozin Injunction Ahead Of Patent Trial Decision

 
• By 

A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.

More from Generics Bulletin

Lupin Boosts UK Presence Through Renascience Acquisition

 
• By 

Lupin’s UK subsidiary acquired the British firm for an undisclosed sum of money, adding further assets into the company’s armamentarium.

Viatris Puts Pen To Paper On $335m Opioid Settlement Agreement

 
• By 

Following recent agreements signed by Hikma and Amneal, Viatris has become the latest company to reach a cash settlement resolving allegations that its practices fuelled the US’ deadly opioid epidemic.

Spanish Authorities Investigate Sandoz Over Information-Sharing

 
• By 

Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.