At present, Many generic manufacturers seem to be able to take their own versions of phingomode with them (fingolimod) The product has entered the German market. That's because it wasn't that long ago, The Dusseldorf High Regional Court has just overturned a preliminary injunction issued by the trial court. evident, For patent owner Novartis, This is a major blow.

For more than a year, Around Novartis No EP2959894 The patent battle has spread to several European countries. The dosage of the active ingredient of Phingomode is daily 0. 5 milligram, In addition to "Gilenya" As its trade name. This product is primarily used for the treatment of relapsing-remitting multiple sclerosis.

Ripple across Europe

This year 1 month, The regional court in Dusseldorf issued a preliminary injunction, Several generic drug companies were banned from entering the German market with their own Fingomode products.

merely, Now includes Viatris, Zentiva and Ratiopharm Seven generic drug makers, including the US, have finally won an important victory. Not so long ago, In the second instance, the Dusseldorf High Regional Court overturned the decision on the preliminary injunction. This result opens up the possibility for generic drug manufacturers to enter the German market. Of course, If Novartis chooses to take further action, There are still risks for generic drug companies, However, it is unclear whether the patent owner will do so.

Novartis has made a series of moves against generic drug companies since last year. The company has filed lawsuits in several countries, This includes the UK, Holland, Spain, Greece, Germany, Sweden, Denmark, Austria, Finland, Belgium, Italy, Portugal and Switzerland.

The first attempt ended in failure

Last summer, Novartis first asked the court for a preliminary injunction, This has aroused great concern from all concerned parties.

Gilenya The market exclusivity is in 2022 years 3 month 22 diurnal. then, European Patent Office (EPO) Not yet officially awarded EP2959894 Patent no. merely, EPO The green light was quickly given that spring for the patent involving Fingomode.

Shortly after this, Novartis then asked the Dusseldorf District Court to file a lawsuit Ratiopharm, AbZ Pharma and Puren Pharma Wait for a preliminary injunction, But the request was made in the same year 9 The month ended in failure. Novartis believes that, Before it can be inferred EPO Will certainly grant the relevant patent case, It is clearly unethical for these companies to still sell generic drugs that infringe their patents. merely, The court did not accept that view, It also makes it clear that injunctive relief can only apply to patents that have already been granted.

At the same time, In other countries, Such as France and the Netherlands, Novartis's plan to use preliminary injunctions to protect patents it had not yet been granted also failed.

Novartis is making a comeback in Germany

therewith, in EPO in 2022 years 10 Monthly Grant EP2959894 post-patent, Novartis filed a second request for a preliminary injunction with the Dusseldorf Regional Court. The company succeeded this time. merely, As mentioned above, The preliminary injunction was overturned in a second judgment. In spite of this, Novartis still keeps those copies of Fingomode off the market 7 For months.

It is worth mentioning that, At the same time Novartis initiated preliminary injunction proceedings, Add up to 23 One of the companies that objected to the No EP2959894 The patent took action, And witnessed it together EPO One of the largest dissent proceedings in history, These companies are represented in court by well-known patent law firms from Europe. (Be compiled from www. juve-patent. com)

TRANSLATORS: Liu Peng　proofread: Rason group



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