Generic drug companies are temporarily banned from selling their competing products to Bayer's Nexavar on the German market. Several preliminary injunctions issued by Munich Regional Court are in effect until the Federal Patent Court rules on the patent's validity at the end of September.
17 August 2021 by Konstanze Richter
The patent in suit EP 2 305 255 protects the compound of a tosylate (a type of salt) of the active ingredient sorafenib. It is the basis of Bayer’s drug Nexavar, which is used to treat various types of cancer, including kidney, liver cell and thyroid cancer.
EP 255 is still valid until mid-2022, but the original patent for sorafenib has already expired. When the SEP based on the basic patent also expired in mid-July 2021, imitation products threatened to enter the German market.
A total of seven generic drug companies have applied to the IFA to list their products containing the active substance sorafenib in the German pharmaceutical database “Lauer Taxe”. The IFA is an information service provider which maintains an online database containing information on the medicinal products and pharmaceuticals available in Germany. Products that are not listed in the IFA database cannot be sold at pharmacies.
The generic drug companies in the dispute are Zentiva, Ratiopharm (Teva), Hexal, Mylan, Betapharm, Stada and its subsidiary Aliud Pharma.
The originator manufacturer Bayer still considers its drug Nexavar to be protected by EP 255. The company filed for preliminary injunctions against all seven generic drug manufacturers before Munich Regional Court in order to prevent them from entering the market.
The generic drug manufacturer Ratiopharm, on the other hand, questions the validity of Bayer’s patent. The Teva subsidiary therefore filed a nullity suit against EP 255 in Germany (case ID: 3 Ni 12/20) and the UK in 2020. Stada also filed a nullity suit against the patent.
In April 2021, the Federal Patent Court published a preliminary notice on the validity of EP 255. The court described the question of priority as unclear and indicated doubts in its reasoning as to inventive step.
In a first decision, the Munich court granted Bayer’s application for an injunction against Zentiva (21 O 9793/21), further injunctions against the other generic drug manufacturers followed. Zentiva appealed against the decision (6 U 5004/21) and at the same time applied for a stay of enforcement of the first-instance injunction.
The Higher Regional Court Munich dismissed the latter at the beginning of August. The reason for this was that no written grounds for the first-instance judgment were yet available.
Zentiva also applied for a preliminary injunction at Frankfurt Regional Court against the IFA in order to enforce the listing in the Lauer-Taxe. However, Zentiva withdrew its application for a listing in the Lauer-Taxe following the decision from Munich.
On 29 September 2021, the Federal Patent Court invalidated EP 255 for lack of inventive step. The patent court ruled on both nullity suits brought by Ratiopharm and Stada. As a result, the temporary preliminary injunction has now expired. The generic drug companies still expect the Munich Regional Court to lift these injunctions retroactively. If so, they could claim damages for the period in which they were prevented from offering their products on the market.
Patent holder Bayer has appealed the Federal Patent Court’s decision. However, EP 255 expires in 2022, with the Federal Court of Justice unlikely to issue a final decision on the patent’s validity until after it expires. Therefore, the court’s decision will primarily be relevant with regard to the potential payment of costs and damages.
Shortly after the ruling, various generic drug manufacturers applied to have the IFA list their products. As such, the companies should be able to launch the drugs on the market from mid-October.
Simmons & Simmons is frequently involved in litigation for Bayer. However, the life science group also relies on other law firms, such as Allen & Overy. The latter is representing the company in the proceedings against Ceva, which are also currently ongoing.
In the dispute over sorafenib, Simmons & Simmons is also active in the parallel proceedings in the UK. London partner Andrew Hutchinson is advising the client in the UK nullity proceedings.
Düsseldorf Simmons partner Peter Meyer advised Bayer in the current case, while the patent attorneys of Weickmann & Weickmann advised on technical issues. Wolfgang Weiss is also responsible for filing the patent application and represents Bayer in the German nullity proceedings.
Arnold Ruess has also represented Zentiva in infringement proceedings for years. For example, the team of Cordula Schumacher and Theresa Schulz advised the client in the protracted proceedings against Eli Lilly for pemetrexed.
The advisors on the defendant side are frequently active for generics companies in infringement cases. Bird & Bird advised two of the generic drug manufacturers; Teva and its subsidiary Ratiopharm regularly rely on the firm.
A team led by Düsseldorf partner Oliver Jüngst also advised Hexal. The Novartis subsidiary also instructs Taylor Wessing on a regular basis.
In this case, however, the firm was active for Dutch pharmaceuticals manufacturer Mylan. The latter often retains Maiwald for infringement cases but the firm represented Betapharm here.
Similarly to Bird & Bird, Preu Bohlig partner Daniel Hoppe also advised two generics companies, namely Stada and its subsidiary Aliud Pharma.
The IFA turned to Düsseldorf boutique Novacos, which specialises in healthcare law.
For Zentiva (case ID: 21 O 9793/21)
Arnold Ruess (Düsseldorf): Cordula Schumacher, Theresa Schulz
Reddie & Grose (Munich): Robin Ellis (patent attorney)
In-house (Prague): Kristin Cooklin (Head of IP)
For Stada/Aliud Pharma
Preu Bohlig & Partner (Hamburg): Daniel Hoppe (public knowledge)
Bird & Bird (Düsseldorf): Oliver Jüngst (public knowledge)
Taylor Wessing (Munich): Anja Lunze (public knowledge)
Maiwald (Munich) Marco Stief (public knowledge)
Novacos (Düsseldorf): Christian Stallberg, Marc Oeben
In-house (Frankfurt): Axel Röpke
Regional Court Munich, 21st Civil Chamber
Tobias Pichlmaier (presiding judge)
Regional Court Frankfurt, 10th Chamber for Commercial Matters (case ID: 3-10 O 64/21)
Eric Urbach (presiding judge)
This article was updated on the 11.10.2021 to reflect the latest development from the Federal Patent Court.