Context: If patents are challenged in the European Patent Office (EPO) during the nine-month opposition window, they can nevertheless become the subject of revocation (counter)claims in the Unified Patent Court (UPC). If one forum upholds and another invalidates, the patent is revoked with respect to the relevant countries. That possibility increases the risk to patentees.
What’s new: Today the UPC’s Munich Local Division (LD) announced its decision in multiple cases relating to Sanofi’s cabazitaxel cancer drug patent EP2493466 (“Novel antitumoral use of cabazitaxel”). As the name indicates, it’s a use patent targeting prostate cancer in particular patients. It also comes with a formulation element (“in combination with”). The Munich LD revoked (subject to an appeal) the patent further to the revocation counterclaims brought in three infringement proceedings (defendants: STADA, Zentiva, and Dr. Reddy’s), which were therefore dismissed. By the time this article was published, the decision(s) had not yet been published.
Direct impact: If this revocation decision was overturned on appeal, the patent could remain in force until late 2030.
Wider ramifications: Six months ago, a Technical Board of Appeal (TBoA) of the EPO upheld the patent. Petitions to the Enlarged Board of Appeal (EBoA) are pending now, but the statistical chances of them being granted are slim. Therefore, the patent’s fate will almost certainly be decided in only one venue: the UPC’s Court of Appeal (CoA).
We have obtained confirmation of the outcome, and information on the procedural context, from multiple firms involved in the proceedings.
The court held a two-day hearing, shortly before which Sanofi settled with Accord.
The court spent one full day and part of the next morning discussing validity with counsel and two experts. Infringement and certain procedural questions were not reached after the court indicate its inclination to revoke the patent. The revocation decision is based on the lack of an inventive step.
STADA’s counsel (the Bonabry firm) provided the following statement:
We are delighted that the Munich LD has performed a thorough and independent validity assessment. That is entirely consistent with our understanding of the UPC’s role as an independent forum with the authority to review EPO decisions.
Zentiva’s counsel (PENTARC) said:
We are very pleased that the LD Munich today revoked EP 466 for to lack of inventive step, thereby overturning the BoA’s decision that upheld the patent earlier this year.
Court and counsel
Panel: Presiding Judge Dr. Matthias Zigann, Judge Tobias Pichlmaier, Judge Alima Zana (Milan, Italy), and Technically Qualified Judge Carola Wagner.
Counsel for infringement claimant and revocation counterclaim-defendant
Sanofi: McDermott Will & Schulte’s FrĂ©dĂ©ric Chevallier.
Counsel for infringement defendants and revocation counterclaimants
Zentiva (three entities; case nos. UPC_CFI_148/2024 and UPC_CFI_503/2024): PENTARC‘s Dr. Anja Lunze and Dr. Aurel-Damian Roscher, and (for the revocation counterclaim) df-mp patent attorneys Dr. Elisabeth Greiner (who also took the lead for all the generics makers during the expert hot tubbing (concurrent expert evidence)) and Dr. Simon Geiger.
Dr. Reddy’s (three entities, among them betapharm; case nos. UPC_CFI_147/2024 and UPC_CFI_374/2024): Maiwald’s Dr. Christian Meyer, Tobias Matschke, and patent attorneys Dr. Andreas Ledl and Dr. Sandra Unterseer.
STADA (three entities; case nos. UPC_CFI_146/2024 and UPC_CFI_496/2024): Bonabry’s Daniel Hoppe, Konstantin Schallmoser and Yasmine Azzaoui, and Hamm & Wittkopp patent attorney Dr. Alexander Wittkopp.
Settled prior to hearing
Accord Healthcare: Taylor Wessing France’s Jules Fabre, Marina Jonon, Louise Millot, and ClĂ©mence de MarassĂ©-Enouf.