Astellas defends cancer drug patent against generics manufacturers in UK

UK High Court judge James Mellor has upheld EP 1 893 196 and the SPC in its entirety. The patent is owned by The Regents of the University of California, Astellas is the licensee. EP 196 covers enzalutamide, the active ingredient in Astella’s major prostate cancer drug Xtandi.

No evidence of obviousness

In response to a counterclaim for infringement by Astellas, the generics manufacturers conceded that their products would infringe the patent. However, they argued that it was invalid due to lack of inventive step.

James Mellor

Judge Mellor rejected this in his ruling. He found that the generics companies failed to set out the evidence of the case of obviousness and considered the patent to be sufficient and plausible (case IDs: HP-2022-000030, HP-2023-000002, HP-2023-000011).

It is rare for a UK court to uphold a pharmaceutical patent in its entirety, as recent decisions such as in BioNTech vs. CureVac over mRNA patents or in Pfizer vs. GSK over an RSV vaccine show.

There are parallel proceedings pending against EP 196 in Europe, including the Netherlands and Germany. The UK decision is the first in this case. Further litigation in Europe is pending concerning a formulation patent.

JUVE Patent is not aware of whether the generic drug manufacturers will appeal the decision.

Pinsent for generics

All claimants relied on Pinsent Masons. London partner Catherine Drew represented Accord and Sandoz together with Natalie Coan and Josie Miller.

Another team around Charlotte Weekes and Ian Turner with Sian Banks and Regina Damigou advised Teva. The law firm has a long history of advising generic drug companies, with Accord and Teva among the long-standing clients.

On the barrister side, Justin Turner of 8 New Square, Anna Edwards-Stuart of 11 South Square acted for Accord and Sandoz. Joe Delaney of Three New Square also acted on the claimants’ side.

In the parallel Dutch proceedings, Brinkhof is representing the generics companies. A team around Mark van Gardingen is acting for Accord and Alexander de Leeuw takes the lead for Sandoz.

Kirkland stands with Astellas

For the defence of their blockbuster drug, The Regents of the University of California and Astellas relied on Kirkland & Ellis. London partners Nicola Dagg and Jin Ooi took the lead together with associate Alex Magnusdottir.

The barristers pleading the case for the defendants were Andrew Lykiardopoulos of 8 New Square and Thomas Lunt of Three New Square. The former recently worked with the Kirkland team for Intel against R2 Semiconductor.

Kirkland & Ellis has been active for Astellas in the past and the US office has a long-standing client relationship with the pharma company. In the pending litigation in the Netherlands, a team around Hoyng ROKH Monegier partners Frank Eijsvogels and Theo Blomme is acting for Astellas.