Generics succeed against Sanofi over cancer drug cabazitaxel

Recently, the Munich local division of the Unified Patent Court (UPC) ruled the second medical use patent for cabazitaxel (EP 2 493 466) held by Sanofi invalid, determining that the patent lacks novelty and inventive step and is therefore not entitled to protection. The patent relates to the second medical use of cabazitaxel for treating hormone-refractory metastatic prostate cancer (mCRPC), and the corresponding originator drug is marketed under the brand name Jevtana®. This ruling marks a key development in the patent dispute between Sanofi and multiple generic drug manufacturers over cabazitaxel.

Background: Years of Patent Battles, Generic Manufacturers’ Counterclaims Drive Invalidation Proceedings​

The patent dispute between Sanofi and generic manufacturers such as Accord Healthcare, Zentiva, Stada, and Dr. Reddy’s has been ongoing for years. As the originator company, Sanofi has long asserted monopoly rights over the specific indication of cabazitaxel through the EP 2 493 466 patent. In May 2024, Sanofi filed an infringement lawsuit with the UPC Munich local division, accusing the above generic manufacturers of infringing its patent by selling generic versions of cabazitaxel and seeking to block the market entry of the related products.

In response to the infringement claims, the generic manufacturers filed counterclaims, requesting the court to declare the EP 2 493 466 patent invalid. The trial focused on the validity of the patent, with both parties debating core issues such as prior art and the scope of the claims.

Reasons for the Ruling: Lack of Novelty and Inventive Step, Overly Broad Scope of Protection​

In its ruling, the Munich local division stated that the EP 2 493 466 patent does not meet the requirements for novelty and inventive step under the European Patent Convention, primarily based on two points:

First, prior art had already disclosed relevant technical teachings. The court found that, prior to the patent filing date, publicly available literature had documented Phase I and Phase II clinical trial data for cabazitaxel, and Phase III clinical trials for the indication “hormone-refractory metastatic prostate cancer” claimed in the patent were already underway. This prior art was sufficient for a person skilled in the art to derive the technical solution of using cabazitaxel for this indication, and therefore the patent lacked novelty.

Second, the claims did not specify a concrete treatment scenario, resulting in an overly broad scope of protection. The patent claims only vaguely described “cabazitaxel in combination with prednisone or prednisolone for treating cancer,” without clearly defining the specific indication of “hormone-refractory metastatic prostate cancer,” nor distinguishing key details such as first-line or second-line treatment. Such ambiguous claims led to a scope of protection that exceeded the actual innovative contribution, failing to meet the inventive step requirement.

Impact and Next Steps: Generic Drugs Expected to Enter the Market Faster, Sanofi Plans to Appeal​

This ruling is one of the landmark patent invalidation decisions in the pharmaceutical field since the UPC officially began operations in 2023. According to the ruling, the EP 2 493 466 patent has been declared invalid in all UPC member states, including Austria, Belgium, Germany, Denmark, France, Italy, Portugal, Sweden, and the Netherlands. This means that generic manufacturers in these countries can legally produce and sell generic versions of cabazitaxel based on the ruling, which is expected to significantly reduce medication costs for patients.