The generic drug companies won an important lawsuit against Novartis in the battle over the patent of fingolimod, the active ingredient that underlies the drug Gilenya, used for the treatment of relapsing multiple sclerosis. Indeed, several makers of fingolimod-based generics will now be able to enter the German market after the Higher Regional Court in Düsseldorf overturned a preliminary injunction issued by the lower court in January, which prevented generic drug companies from selling in the German market its products based on fingolimod.
Now, the seven generic manufacturers involved will be able to enter the German market with their drugs, unless Novartis files an appeal, but it is not yet known whether this step will be taken.
The story originated when some generic drug companies planned to launch their generic fingolimod drugs in March 2022, when Gilenya’s marketing exclusivity period expired. At the time, Novartis held a patent application covering fingolimod for use in the treatment of relapsing multiple sclerosis, an application which in November 2020 was rejected by the EPO. However, following Novartis’ appeal, in February 2022 – shortly before the expiry of Gilenya’s market exclusivity – the Board of Appeal ordered the grant of the patent, published in October 2022.
As a result, many generic manufacturers in Europe have taken advantage of the gap between the end of market exclusivity and the official granting of the patent to sell their generics in various markets. Novartis’ reaction was to request urgent preliminary injunctions, on the assumption that the competitors would take an unfair advantage of the sale of generics in the period which would necessarily have elapsed between the expiry of Gilenya’s commercial exclusivity and the publication of the patent.
On the merits, the judges did not accept Novartis’ request and confirmed that an injunction is possible only in relation to a patent actually granted.