The Unified Patent Court’s (UPC) central division in Munich has delivered its first revocation judgment a little over a year after opening, invalidating a key patent owned by Amgen in the latest round of its ongoing battle with rivals Sanofi and Regeneron over competing cholesterol-lowering drugs.

The patent, EP 3666 797 B1 (EP797 patent), covers Amgen’s cholesterol product Repatha and involves an antigen-binding fragment that helps to lower cholesterol. Sanofi and its partner Regeneron sell rival product Praluent. 

The ruling, delivered yesterday (16 July), will be effective across the 17 contracting member states of the UPC and comes hard on the heels of last week’s revocation ruling from the Paris local division, invalidating a patent of medtech company Dexcom in a dispute with Abbott over glucose-monitoring technology.

Amgen has been in dispute with Sanofi and Regeneron since 2014 over the drugs that use PCSK9 monoclonal antibody treatments for high cholesterol.

Filed in 2008, EP797 has now been declared invalid following the UPC central division’s determination that it does not involve an inventive step over Lagace, a peer-reviewed article from 2006 that the court used as a starting point for its deliberations.

“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,” the court said.

It concluded that the patent “is revoked entirely” and it did not address the other grounds of invalidity.

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-based attorneys from Bardehle Pagenberg and German IP firm df-mp.

Wise said: “This is an important win for Sanofi and Regeneron in this new, pan-European patent court.”

Michel-de Cazotte added: “This case has been about simplifying technical issues for the mixed panel of judges and challenging the literal meaning of these new rules."

Commenting on the decision, an Amgen spokesperson said that the patent "covers a narrow class of anti-PCSK9 antibodies that are highly effective at reducing low density lipoprotein cholesterol (the bad cholesterol) and the risk of cardiovascular disease."

The spokesperson pointed out: "This decision does not impact Amgen’s ability to continue providing Repatha to patients in Europe."

On the day the UPC opened last June, Regeneron and Sanofi brought the revocation action and Amgen responded that same day with an infringement claim relating to the same patent.

Carpmaels & Ransford notes that following this decision, there will also be a hearing later this year at the UPC’s Munich local division to consider whether a parallel infringement action should be stayed. In addition, a further hearing on the subject of validity is expected to take place in late 2024, this time at the European Patent Office and that decision will apply to countries in addition to those covered by the UPC’s decision.

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

The Brinkhof team representing Amgen included partners Koen Bijvank and Daan de Lange, counsel Rik Lambers, and advocates Jonathan Santman and Roza Rijpkema. It was also represented by Bardehle Pagenberg’s Munich-based attorney-at-law, Johannes Heselberger, and patent attorney Axel Berger and df-mp partner H. Ulrich Dörries, who is also located in Munich.