Cancer drug

Bayer in Munich: injunctions against generics over cancer drug

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

Bayer, generic drug manufacturers, patent litigation Bayer's injunctions from the Munich Regional Court against seven generic drug manufacturers are valid until the Federal Patent Court ruling on validity ©RFBSIP/ADOBE STOCK

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.

Ready, set, generics

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.

Peter Meyer, Simmons & Simmons, patent litigation, Bayer

Peter Meyer

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.

Validity called into question

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.

Initial win for Bayer

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.

Cordula Schumacher, Arnold Ruess, patent litigation

Cordula Schumacher

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.

Bayer counts on Simmons again

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 for Zentiva

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.

Oliver Jüngst, Bird & Bird, patent litigation

Oliver Jüngst

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 Bayer
Simmons & Simmons (Düsseldorf): Peter Meyer
Weickmann & Weickmann (Munich): Wolfgang Weiss; Hans Weickmann (both patent attorneys)

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)

For Teva/Ratiopharm
Bird & Bird (Düsseldorf): Tobias Wielcke (public knowledge)
Lederer Keller (Munich): Michael Best (patent attorney)

For Hexal
Bird & Bird (Düsseldorf): Oliver Jüngst (public knowledge)

For Mylan
Taylor Wessing (Munich): Anja Lunze (public knowledge)

For Betapharm
Maiwald (Munich) Marco Stief (public knowledge)

For IFA
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)