Novartis dropped its Kymriah patent. Really?

17 december 2019

Many news sites brought the ‘victorious’ news: Novartis retracts its European patent on gene therapy product Kymriah, useful for treating blood cancer types. The product works by delivering specific genes into the body of a patient. In particular, Kymriah is chimeric antigen receptor T cell (CAR-T) therapy for use in patients with B-cell acute lymphoblastic leukemia (ALL) and large B-cell lymphoma, two rare diseases. A many gene therapies, also a Kymriah treatment is particularly expensive: approximately 300.000 euro for one treatment course. By dropping their European patent EP3214091B1 after two NGOs (Doctors of the World and Public Eye) opposed the latter, it was reported that the medicine would now become cheaper. But is that really the case? And did Novartis really simply abandoned their Kymriah patent rights? Let’s have a closer look.

Novartis foto

The technology behind Kymriah was developed by the University of Pennsylvania, who filed for patent protection on their CAR-T technology in many countries, including US and Europe. Penn and Novartis already joined forces in 2012 to push the CAR-T technology to the market, providing Novartis an exclusive license on parts of the technology. The collaboration between both parties was renewed in September 2019, now focusing on specific projects involving clinical trials for myeloma, brain cancer glioblastoma and blood cancers.

Recent reports disclosed that Penn University holds 428 patent rights on 54 separate CAR-T cell related inventions, and is thereby the leader of the CAR-T patent pack.

One of these CAR-T cell related inventions is the patent family to which EP3214091 belongs, describing use of a CAR-T cell in cancer therapy. In US, there are currently 13 (!) granted patents in this family, and the number can still grow. Next to the European patent that was now abandoned, two other active European rights exist within this family: one granted patent protecting CAR-T treatment in cancer patients and one pending application that is still undecided in scope. In addition, Penn may still extend their European further patent rights within the same family, if desired. All options are thus still open.

The now abandoned patent was challenged by four parties last July. Penn replied that although the arguments raised by the opponents were considered without merit, they requested the immediate revocation of their patent. By doing so, Penn and Novartis avoided a discussion on the merits of EP ‘091, a discussion which could have otherwise also impacted patent rights in other jurisdictions. In other words: in the game of Patent Stratego, Penn/Novartis deliberately sacrificed an explorer, but the flag is still protected.

It’s unlikely that this event on its own will have a huge impact onthe current price setting of Kymriah in Europe. In a separate statement, a Novartis spokesman said that the patent wasn't critical for Kymriah's continued development or marketing. Just this month Novartis opened its newest cell and gene facility in Switzerland in order to allow Novartis to manufacture tailored cell therapies for European patients. Novartis would not make the investment if it wasn’t sure that it somehow would be paid back. While the opponents may have won the battle concerning EP3214091, this small victory thus has little meaning considering the mine field of patent rights that still surround the CAR-T technology.

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