Cancer drug

Another win for generics manufacturers as fulvestrant patent revoked

The German Federal Court of Justice has declared AstraZeneca's formulation patent EP 1 250 138 for the breast cancer drug fulvestrant null and void. The decision follows the first-instance ruling from the Federal Patent Court. A nullity suit against the use patent EP 1 272 195 is still pending.

25 April 2019 by Konstanze Richter

Fulvestrant is the active ingredient in a solution used to treat breast cancer via intramuscular injection ©Giovanni Cancemi/Adobe Stock

The revocation of AstraZeneca’s patent represents another significant breakthrough for generics manufacturers in Germany (case ID: X ZR 59/17). The long-standing dispute over the cancer drug with the active ingredient fulvestrant revolved around the now invalid formulation patent 1 250 138 and the use patent EP 1 272 195.

Dirk Schuessler-Langeheine

In the parallel ongoing injunction proceedings at the Higher Regional Court Düsseldorf concerning the use patent 195, the judge dismissed AstraZeneca’s appeal and an application for a preliminary injunction in January.

AstraZeneca did not lodge an appeal against the decision. However, a further nullity suit against patent 195 is still pending at the Federal Patent Court (case-ID: 3 Ni 32/17). The case will be heard this November.

Different judgments in Europe

In addition, there is another formulation patent EP 2 266 573 with a very similar claim to patent 138, which was upheld by the Boards of Appeal at the European Patent Office at the beginning of the year. Infringement proceedings against the patent are pending in Germany at the Regional Court Mannheim.

Arno Riße

At the end of last year, the Court of Appeal in The Hague upheld both formulation patents 138 and 573 in a similar dispute between AstraZeneca and Sandoz. At the same time, the court upheld AstraZeneca’s infringement action.

Old acquaintances

As in the infringement proceedings, all parties retained their long-standing advisors, which have represented them since the beginning of the dispute.

Due to the importance of the case, AstraZeneca’s and Hexal’s counsel each called in lawyers appointed to the Federal Court of Justice that regularly appear in patent disputes. Christian Rohnke, for example, has advised on a large number of high-profile nullity cases, including Stada on the pemetrexed case. He also advised mobile phone providers in proceedings against Intellectual Ventures concerning mobile phone patents.

For AstraZeneca
Osterloh & Osterloh (Ettlingen): Arn Osterloh (lawyer appointed to the Federal Court of Justice)
Hoffmann Eitle
(Munich): Dirk Schüßler-Langeheine (lead), Clemens Steins, Thorsten Bausch, Ulrike Ciesla (both patent attorneys)
In-house (Macclesfield): Lucy Padget, Nonny Jones

For Hexal
Rohnke & Winter (Karlsruhe): Christian Rohnke (lawyer appointed to the Federal Court of Justice)
Arnold Ruess (Düsseldorf): Arno Riße (lead), Cordula Schumacher, Marina Wehler, Lisa Schneider
df-mp Dörries Frank-Molnia & Pohlman (Munich): Elisabeth Greiner, Holger Schimmel (both patent attorneys)
In-house (Holzkirchen): Patricia Paias, Waltraud Fauss-Berghus

For Ratiopharm
Bird & Bird (Düsseldorf): Oliver Jüngst, Anna Wolters-Höhne, Annika Schneider,
Lederer & Keller (Munich): Michael Best (patent attorney)

Federal Court of Justice Karlsruhe, 10th Civil Senate
Peter Meier-Beck (presiding judge)