Novartis is fighting in multiple countries against various generic drug manufacturers over EP 29 59 894. This second medical use patent pertains to a 0.5mg per day dosage of active ingredient fingolimod, which forms the basis of Novartis' drug Gilenya. The product is used to treat relapsing-remitting multiple sclerosis (RRMS).
While extended market exclusivity for Gilenya ended on 22 March 2022, the dispute is based on the EPO not yet formally granting the dosage patent EP 894.
Novartis application rejected
In November 2019, Novartis filed an application for a second medical use patent on the 0.5mg dosage of fingolimod to treat RRMS. However, in 2020, the EPO Examining Division refused to grant the patent based on lack of novelty. The examiners referred to a study published in 2006 and a corresponding press release by Novartis, according to which medical professionals can use fingolimod to treat RRMS at a dose of 1.25 or 0.5 mg. The company appealed against this decision.
Then, in February 2022, the Technical Boards of Appeal overruled the Opposition Division's original decision. This cleared the way for the EPO to grant the patent based on the main claim. But, since this has not yet taken place, the patent is not yet officially granted.
Market approval for Zentiva
In parallel, in December 2020, Zentiva received market approval in France for its own fingolimod product in 0.5mg capsules. Thus, the country included the generic in the list of pharmaceutical products for which health insurers cover the costs.
In April 2022, Zentiva announced that it would market its generic product on the French market. As such, Novartis filed an infringement suit against Zentiva in May, based on the EPO Board of Appeal's decision that the office should grant EP 894. Novartis then sought an injunction prohibiting Zentiva from marketing its generic fingolimod product on the French market until 25 June 2027.
However, the 3rd Chamber of the Judicial Court of Paris has rejected the application.
Novartis stumbles in the Netherlands
Zentiva argued that Novartis' action related only to the patent application, and not to a patent that is already granted. On the other hand, according to the defendants, Article L.615-3 of the Intellectual Property Code – which provides for preliminary injunction in the case of patent infringement – refers only to granted patents. Like the Opposition Division of the EPO before it, Zentiva also questioned the validity of EP 894 due to lack of inventive step.
Novartis is also taking action in other countries, including the UK, Netherlands, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal and Switzerland. The suits are against generic drug manufacturers which are entering local markets, following expiration of patent protection for Gilenya.
Similarly, in the Netherlands, Novartis suffered a defeat in the spring. The District Court of The Hague rejected a request for a preliminary injunction. The Dutch court recently published an interim decision declaring the patent invalid.
Source: juve-patent.com-Konstanze Richter
Editor: IPR Daily-Selly