Lucky No. 35? Sarepta And BioMarin Settle Global Patent Disputes

A legal settlement with BioMarin means that Sarepta doesn't have to worry anymore about the potential to infringe patents related to exon-skipping DMD therapies. Meanwhile, BioMarin gains some compensation for its ill-fated Prosensa buy.

Handshake of businessmen

Sarepta Therapeutics Inc. will pay BioMarin Pharmaceutical Inc. $35m up front, certain milestone fees and single-digit royalties in a patent settlement and license agreement related to exon-skipping therapies for Duchenne muscular dystrophy (DMD), reducing Sarepta's risk related to Exondys 51 (eteplirsen) and its other DMD product candidates, especially in ex-US markets.

The agreements give BioMarin some compensation for its ill-fated 2014 acquisition of Prosensa Holding BV, which eventually resulted in the purchased company's lead drug candidate for DMD being rejected by the US FDA, leading the acquirer to end development of Kyndrisa (drisapersen) and other compounds

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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

Regeneron Wins PCSK9 Court Battle Against Amgen

 

A federal court jury found Amgen liable for violating antitrust laws in allegedly preventing Praluent from competing against Repatha.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By 

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

More from Business

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

In Brief: Sanofi Commits $20bn To US R&D And Manufacturing By 2030

 

Move by French major aligns with broader industry efforts to localize production amid political pressure, as Trump pushes to onshore manufacturing and hints at easing tariff threats.

Eisai Forecasts 73% Leqembi Sales Rise In FY25 As Demand Expands

 
• By 

Eisai spent most of its FY24 earnings call discussing plans for growing sales of Biogen-partnered Alzheimer’s drug Leqembi from JPY44.3bn ($304.1m) to JPY76.5bn ($525.1m) in FY25.