Novartis ‘abused’ discovery process for Zolgensma patent

Two subsidiaries of French pharmaceutical giant Sanofi have accused rival Novartis of abusing the discovery process in a previous lawsuit, concerning royalties from a gene therapy treatment for spinal muscular atrophy.

In their complaint, filed at the US District Court for the District of Delaware on May 19, Genzyme and Aventis allege “wilful” patent infringement in the earlier Genzyme Corporation et al v Novartis Gene Therapies (Genzyme I) case first filed in February 2022.

In that lawsuit, Genzyme and co-plaintiff Aventis made a routine request for access to the Biologics License Application (BLA) for Zolgensma—known as one of the most expensive drugs in the world at a value of $2.1 million per dose when it came to market in 2019.

But, the plaintiffs argue, rather than produce the information in the form of an unredacted US Food and Drug Administration (FDA) application for the drug, co-defendants Novartis Gene Therapies and Novartis Pharmaceuticals “refused to produce the critical portions of the BLA and hid material information from discovery.”

Novartis was obliged under a court order to produce the BLA, which contained “unequivocal evidence establishing infringement” of a related patent (US patent no. 10,429,288).

But by then, it was too late to add the ’288 patent infringement claim to Genzyme I, thereby making it necessary to file a new complaint in order to add this patent to the dispute.

Genzyme and Aventis now claim that Novartis’ development of Zolgensma relies on this patented method for weighing and evaluating recombinant adeno-associated viral (rAAV)  preparations.

Gene therapy for children

Zolgensma is an adeno-associated virus (AAV)-based gene therapy product intended to treat certain children under two years of age with spinal muscular atrophy (SMA).

It delivers a copy of the human survival motor neuron (SMN) gene into target motor neuron cells of the child, which results in expression of the SMN protein in the motor neuron cells, thus treating SMA.

The ‘288 patent, titled ‘Analytical Ultracentrifugation for Characterization of Recombinant Viral Particle’, is directed to methods to characterise a preparation of rAAV particles using analytical ultracentrifugation and was assigned to Genzyme by the US Patent and Trademark Office (USPTO) in October 2019.

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