It’s the third resolution of its type in France. Whereas the primary two involved defendants Biogaran and Zentiva, the subsequent firm in Novartis’ sights was French Mylan subsidiary, Viatris Santé (case ID: 22/54655),
Novartis is preventing in a number of international locations in opposition to numerous generic drug producers over EP 29 59 894. This second medical use patent pertains to a 0.5mg per day dosage of energetic ingredient fingolimod, which kinds the premise of Novartis’ drug Gilenya. The product is used to deal with relapsing-remitting a number of sclerosis (RRMS).
Dosage patent not granted
Prolonged market exclusivity for Gilenya ended on 22 March 2022. Nevertheless, the dispute is predicated on the EPO not but formally granting the dosage patent EP 894. In February, the Technical Boards of Attraction cleared the way in which for the EPO to grant the patent primarily based on the principle declare.
Again in France, Novartis additionally took motion in opposition to Biogaran and Zentiva. In each instances, the Paris Judicial Court docket rejected a preliminary injunction (case IDs: 22/52718 and 22/54367). In all instances, the goal of Novartis’ purposes was to ban the generics corporations from advertising their merchandise on the French market at some stage in the second medical use patent till 25 June 2027.
Though a distinct decide of the third Chamber selected every case, all questioned the validity of the patent as a result of lack of novelty. This adopted a important argument of the defendants.
Fingolimod for RRMS
Denis Schertenleib
Equally to the EPO’s Opposition Division, the judges referred to a examine printed in 2006 and a corresponding press launch by Novartis. In response to this, medical professionals can use fingolimod to deal with RRMS at a dose of 1.25 or 0.5 mg.
However Novartis factors to the Boards of Attraction resolution, which overturned the Opposition Division’s discovering and ordered the EPO to grant the patent. Nevertheless, the granting has not but formally taken place, with the EPO register’s newest updating stating that examination stays in progress.
No luck for Novartis
Novartis can be taking motion in different international locations, together with the UK, Netherlands, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal and Switzerland. All fits are in opposition to generic drug producers getting into native markets following expiration of the patent safety for Gilenya.
Within the UK, for instance, Teva filed a nullity go well with in opposition to EP 894. The proceedings are pending. Novartis, for its half, was unsuccessful with its infringement go well with in March 2022 and its purposes for preliminary injunctions in opposition to Teva, Dr. Reddy’s, Zentiva, Tillomed and Glenmark.
Equally, within the Netherlands, Novartis suffered a defeat in opposition to Mylan within the spring. The District Court docket of The Hague rejected a request for a preliminary injunction. Novartis appealed in opposition to this resolution. The Dutch court docket just lately printed an interim resolution declaring the patent invalid.
Marianne Gabriel
In Germany, the District Court docket of Berlin rejected an utility for a preliminary injunction in opposition to Mylan in April 2022. In Greece, the place Novartis additionally sued Mylan, the court docket didn’t grant an interim injunction.
Solely Finland and Spain differ
Solely in Finland and Spain has Novartis been profitable to this point. For instance, in March, a court docket in Finland granted a brief advertising ban in opposition to Ratiopharm, Teva, Mylan and Viatris on the premise of EP 894. The choice on an injunction in opposition to Teva and Mylan remains to be pending. Nevertheless, Novartis failed in its utility for a so-called protecting transient earlier than the Finnish Business Court docket.
In Spain, additionally in March, the Barcelona Business Court docket imposed an injunction in opposition to Teva and Mylan till the start of July.
Different injunction instances are pending in Italy, Belgium (each in opposition to Mylan), Denmark (in opposition to Teva and Zentiva) and Switzerland (in opposition to Teva and Mepha).
Jules Fabre
In-depth pharma data
Novartis retained Allen & Overy associate Laetitia Bénard to characterize it within the French a part of the dispute. She has a few years of expertise in pharma litigation, additionally performing for the shopper in different disputes.
Within the Netherlands, the pharma originator depends on the Amsterdam workforce of Freshfields. The agency additionally commonly acts for the shopper in Germany.
Mylan relied on Denis Schertenleib, a long-time advisor, for the defence of its French subsidiary Viatris. His IP boutique is understood for its in-depth data of the prescribed drugs market, specifically generic medication, and commonly advises Mylan in disputes.
Biogaran was represented within the parallel proceedings by its common advisors from the standard French IP legislation agency Casalonga. The workforce across the famend litigators Arnaud Casalonga and Marianne Gabriel included associate and lawyer Jean-Baptiste Lecoeur, in addition to associate and patent lawyer Gérard Dossmann.
The Paris workforce of Pinsent Masons acted for Zentiva, with the agency coming to the present case via Fabre’s contacts on the firm.
For Novartis
Allen & Overy (Paris): Laetitia Bénard
For Mylan/Viatris Santé (case ID: 22/54367)
Schertenleib Avocats (Paris) Denis Schertenleib
For Zentiva (case ID: 22/54367)
Pinsent Masons (Paris): Jules Fabre; affiliate: Marina Jonon
In-house (Prague): Kristin Cooklin (head of IP), Alessandro Pontiroli (lead patent counsel), Cecile Teles (head patent lawyer)
For Biogaran (case ID: 22/52718)
Casalonga (Paris): Marianne Gabriel, Arnaud Casalonga, Jean-Baptiste Lecoeur, Gérard Dossmann (patent lawyer)
Judicial Court docket Paris, third chamber
Nathalie Sabotier (case ID: 22/54655)
Gilles Buffet (presiding decide) (case ID: 22/54367)
Catherine Ostengo (presiding decide) (case ID: 22/52718)
