Unified Patent Court Repeals Amgen’s Cholesterol Drug Patent Against Sanofi And Regeneron

Unified Patent Court Repeals Amgen’s Cholesterol Drug Patent Against Sanofi And Regeneron

This was the Pan-European court’s first revocation judgment after opening a year ago

The Central division of the Unified Patent Court (UPC) in Munich has cancelled a key patent of Amgen in its dispute with rivals Sanofi and Regeneron. The ongoing battle is over cholesterol-lowering drugs.

The ruling will be effective across the 17 contracting member states of the UPC.

The 2014 dispute between the entities relates to the drugs that use PCSK9 monoclonal antibody treatments for high cholesterol.

The patent, EP 3666 797 B1 covers Amgen’s product Repatha, comprising an antigen-binding fragment, which lowers cholesterol. On the other hand, Sanofi and Regeneron manufacture Praluent.

Filed in 2008, EP797 was declared invalid for not including an inventive step over Lagace, a peer-reviewed 2006 article, used as an initiating theme by the court.

The bench stated, “The skilled person would, starting from Lagace as a realistic starting point in the prior art, arrive at the claimed subject matter without inventive skill.” It added that the patent was ‘revoked entirely’ and did not address other invalidity grounds.

Daniel Wise, the UK Partner at Carpmaels & Ransford advising Sanofi and Regeneron said, “This is an important win for Sanofi and Regeneron in this new, pan-European patent court.”

The firm’s other Partner, Agathe Michel-de Cazotte added, “This case has been about simplifying technical issues for the mixed panel of judges and challenging the literal meaning of the new rules.”

In June, Regeneron and Sanofi brought the revocation action on the patent, to which Amgen responded with an infringement claim.

Earlier, the Paris local division revoked the ruling, invalidating a patent of medtech company Dexcom in a dispute with Abbott over glucose-monitoring technology.

The Herbert Smith Freehills head of IP in the UK, Sebastian Moore and Laura Orlando, the global co-head of IP, commented, “These are the first pharmaceuticals cases to decide on the merits at the UPC.”

They added, “Both were filed on 1 June 2023, day one of the UPC, making the time to their decisions an impressive one year, one month and two weeks, and likely increasing the appeal of the UPC to those seeking to resolve patent disputes quickly, although also illustrating the risks to patentees of the UPC’s powers of central revocation.”

Meanwhile, Carpmaels & Ransford noted that a hearing was scheduled at the UPC’s Munich local division later this year to consider whether a parallel infringement action should be stayed. Additionally, a hearing on the validity was expected at the European Patent Office. That decision would apply to countries in addition to those covered by the UPC.

Sanofi and Regeneron were represented by specialist IP firm Carpmaels & Ransford, led by UK-based Partners Daniel Wise, Agathe Michel-de Cazotte and Senior Associate Emily Nikolić. They also worked with German-headquartered firms Hoffman Eitle, König Szynka Tilmann von Renesse and Zwicker Schnappauf & Partner.

Amgen was represented by Netherlands-based Brinkhof’s, Munich attorneys from Bardehle Pagenberg and German IP firm df-mp.