1. Generics Bulletin
  2. >>Legal & IP

EU Firms Up Plans For Unitary Supplementary Protection Certificates

An Impact Assessment Is On The Way

 
• By Ian Schofield

A unified system for granting SPCs would significantly reduce the burden of seeking protection in up to 27 different EU countries, and would sit well alongside Europe's future unitary patent system, says the European Commission. It now preparing an impact assessment for the proposal.

IP concept
SPCs extend effective patent protection on pharmaceuticals • Source: Alamy

The European Commission has published details of its proposed centralized scheme for granting supplementary protection certificates with EU-wide validity that it says would cut costs and effort for innovators, offer more certainty to the off-patent pharmaceutical industry, and complement the future EU unitary patent scheme.

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
Start Free Trial

Already a subscriber?

More from Legal & IP

Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.

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

 
• By Dean Rudge

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 Dean Rudge

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 Dave Wallace

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.

More from Generics Bulletin

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

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

 
• By Dean Rudge

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.