NOVARTIS AG held European patent application designating France No. 2 959 894 (hereinafter EP 894) entitled “S1P receptor modulators for treating multiple sclerosis” filed as a divisional application of European patent application No. 2 698 154 (withdrawn) filed on September 27, 2013, which is itself a divisional application of European patent application No. 2 037 906 (withdrawn) filed on June 25, 2007. These applications are all issued from international patent application No. 2008/000419 filed on June 25, 2007, under the priority of UK application 20060012721 filed on June 25, 2006.

The invention relates to the use of an S1P receptor modulator, namely Fingolimod (or 2-amino-2-[2-(4-octylphenyl)ethyl] propane-1,3-diol known under the code “FTY720”), initially discovered in 1992 by a team of Japanese researchers and protected by an international patent application filed on October 18, 1994 (PCT No. 94/08943).

This international application subsequently led to the granting of European patent No. 0 627 406 entitled “2-amino-1, 3-propanediol compound and immunosuppressed”. This patent covered 2-amino-1, 3-propanediol derivatives, useful as immunosuppressive agents, which, by reducing the body’s immune defenses through lymphocyte sequestration, decrease the risk of transplant rejection.

This patent, whose effects were extended by the granting of a supplementary protection certificate (hereinafter SPC), expired on October 18, 2018.

The EP 894 patent application was published on December 30, 2015, in the European Patent Bulletin No. 2015/53. It was amended during the examination of the application before the Examination Division of the European Patent Office (hereinafter EPO).

Consequently, on November 18, 2019, NOVARTIS AG filed a new main application.

On November 2, 2020, the EP 894 patent application was rejected by the EPO’s Examination Division due to lack of novelty.

NOVARTIS appealed this decision before the EPO’s Board of Appeal.

BIOGARAN was granted on May 27, 2021, a marketing authorization in France for “FINGOLIMOD BIOGARAN 0.5 mg, capsule”, which is a generic version of GILENYA®. This product was listed in the Register of Generic Groups by decision of September 14, 2021.

Having discovered on October 4, 2021, that BIOGARAN was about to launch its generic specialty within six months following the publication in the Official Journal, NOVARTIS sent a cease and desists to BIOGARAN on January 17, 2022, not to infringe the commercial exclusivity and patent rights on Fingolimod. On February 16, 2022, NOVARTIS informed BIOGARAN that, by decision of February 8, 2022, the EPO’s Board of Appeal had overturned the initial decision of the Examining Division rejecting its patent application and had remanded the case to the Examining Division for the grant of claim 1 of the main request filed on November 18, 2019.

NOVARTIS AG and NOVARTIS PHARMA SAS filed a request to be authorized by the Court to be heard within a very short delay.

By decision of April 1, 2022, the Court scheduled the case hearing on April 13, 2022. This shows that for urgent patent matters, the Paris court may hear the parties within 10 days.

By order of June 3, 2022, the Presiding judge dismissed the objections raised by BIOGARAN on the inadmissibility of a claim based on a not yet granted patent application, but accepted BIOGARAN’s arguments to dismiss all NOVARTIS’ claims as there were serious arguments against the apparent validity of the opposed patent application.

NOVARTIS appealed this order on June 20, 2022.

During the proceedings before the Paris Court of Appeal, the EPO granted patent EP 894.

The Paris Court of Appeal granted its decision on March 20, 2023.

Regarding the admissibility of a request for a preliminary injunction based on a not yet granted patent, the Paris Court of Appeal overturned the initial decision. It clearly stated that a request for preliminary injunction cannot be founded on a patent application that has not yet been granted.

The Court of Appeal concluded that on the day the interim decision, the judge ruled on a patent application that had not yet been granted and that, therefore, NOVARTIS companies claims should have been deemed inadmissible.

However, the Court of Appeal considered that, due to the appeal’s devolutive effect principle, the NOVARTIS companies were now entitled to their requests for preliminary injunction, as, in the meantime, the patent had been granted.

However, the Paris Court of Appeal dismissed all of NOVARTIS companies’ claims. In a particularly detailed analysis, the Court noted that “the argument of lack of inventive step raised by BIOGARAN appears to be a serious one capable of challenging the apparent validity of this title”.

To date, NOVARTIS has not filed an appeal against this decision, and the infringement proceedings initiated by NOVARTIS are still ongoing before the Paris Court.