Generics companies score a win against Novartis in battle over fingolimod

Numerous generic drug manufacturers may now enter the German market with their own fingolimod products. In a major blow for patent holder Novartis, Düsseldorf Higher Regional Court has overturned a preliminary injunction issued by the court of first instance.

For over a year, a fierce battle has raged across many European countries over Novartis’ EP 2 959 894. The second medical use patent covers 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.

All over Europe

In January, Düsseldorf Regional Court issued a preliminary injunction which prevented generic drug companies from entering the German market with their own fingolimod products.

Now seven generics manufacturers, including Viatris, Zentiva, and Ratiopharm, have won an important victory. Last week, the Düsseldorf Higher Regional Court overturned the PI judgement in the second instance.

This opens up the possibility for generic drug manufacturers to enter the German market. A certain risk remains for the generics companies if Novartis files a main action for infringement – but it is not yet known whether the patent holder will take this step. 

Novartis started taking action against generic drug companies last year. The company filed suits in multiple countries, including the UK, the Netherlands, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal, and Switzerland.

First attempt failed

Novartis attracted particular attention last summer with its first application for a preliminary injunction.

The extended market exclusivity for Gilenya had ended on 22 March 2022. At that time, the EPO had not yet officially granted EP 894. The EPO had, however, given the green light for the granting of the fingolimod dosage patent in the spring.

Shortly after, Novartis requested an initial PI against Ratiopharm, AbZ Pharma, and Puren Pharma at the Regional Court Düsseldorf, but in September this was unsuccessful. The originator argued that it is immoral to sell generics that infringe a patent when it is considered certain that the EPO will grant the patent in question. However, the court did not follow this view, confirming that injunctive relief exists only for a granted patent.

In other countries, such as France and the Netherlands, Novartis also failed in its attempt to protect the not-yet-granted patent through a PI.

Novartis tries again in Germany

Subsequently, after the EPO granted EP 894 in October 2022, Novartis requested a second PI at Düsseldorf Regional Court and this time the company was successful. However, the PI has now been overturned in the second instance. Nevertheless, Novartis managed to keep the generic fingolimod products off the market for another seven months.