Second medical use

AstraZeneca appeal rejected in generics-favourable decision

Second medical use is currently a hot topic in pharmaceutical patents. In the dispute over the breast cancer drug containing the active ingredient fulvestrant, the generics manufacturers have landed a further victory. Düsseldorf Higher Regional Court yesterday dismissed AstraZeneca's appeal and an application for a preliminary injunction after only two hours of negotiations (case IDs: I-2 U 27/18, I-2 U 28/18, I-2 U 29/18).

10 January 2019 by Konstanze Richter


AstraZeneca’s use patent EP 1 272 195 protects treatment with fulvestrant in breast cancer patients, where the disease shows a specific progression. The current dispute focuses on the stage of breast cancer treatment in which the active substance is used.

Treatment is divided into the adjuvant phase, which is the initial treatment immediately after surgical removal of the tumour, and the palliative phase. This entails further therapy if the cancer recurs after pre-treatment.

Cordula Schumacher

Plaintiff pleads for broader interpretation 

Following surgery, patients generally undergo a form of therapy that blocks the formation and activity of the female hormone oestrogen. This is intended to prevent the growth of hormone-sensitive tumour cells.

The patient is initially treated with the oestrogen inhibitor tamoxifen for two to three years. Since it has considerable side effects, many patients subsequently switch to a so-called aromatase inhibitor, which prevents the conversion of an oestrogen precursor in muscle and fat tissue. This therapy is frequently called switch therapy.

The defendant generics manufacturers claim the patent is limited to the use of fulvestrant in the palliative phase, i.e. when the cancer recurs within 12 months after completion of switch therapy.

Yesterday’s hearing saw the plaintiff AstraZeneca argue for a broader interpretation of the patent. This includes the administration of fulvestrant when the first therapy has failed, regardless of the exact phase of treatment and the period in which a tumour recurs. However, AstraZeneca was unable to convince the Düsseldorf Higher Regional Court.

The judges did not allow an appeal and set the amount in dispute at 1.5 million euros per judgment.

Second medical use legislation favourable for generics

Previously German courts were known as patent holder-friendly. However, the current ruling constitutes a further decision in favour of generic manufacturers. And it is not only German courts that are taking a narrower interpretation of use patents with second medical use. The UK Supreme Court recently also ruled in favour of generic manufacturers in the Warner Lambert case concerning pregabalin.

Similarly to the British proceedings, the current dispute between AstraZeneca and Hexal and Ratiopharm has a long history, conducted very intensively due to the high economic significance of the patent.

Concerning its formulation patent (EP 1 250 138), AstraZeneca initially made a successful claim against Hexal by way of an injunction. Following its defeat at Düsseldorf Regional Court, the originator then won in the second instance and attacked Ratiopharm with a preliminary injunction.

The German Federal Patent Court then overturned the formulation patent; Hexal and Ratiopharm successfully applied for the revocation of the two injunctions. At the same time, AstraZeneca appealed against the nullity decision of the Federal Patent Court.

A nullity suit against the use patent (EP 1 272 195) is also pending before the German Federal Patent Court, which will be heard in autumn 2019. Proceedings are also underway in various other countries.

Dirk Schüßler-Langeheine

Usual suspects 

As in the regional court proceedings, all parties turned to their long-standing advisors, which have represented them since the beginning of the dispute.

For AstraZeneca
Hoffmann Eitle (Munich): Dirk Schüßler-Langeheine, Michael Pfeifer, Thorsten Bausch, Ulrike Ciesla (both patent attorneys)
Novacos (Düsseldorf): Christian Stallberg
In-house (Macclesfield): Lucy Padget (senior patent director)

For Hexal
Arnold Ruess (Düsseldorf): Cordula Schumacher, Marina Wehler, Lisa Schneider
df-mp Dörries Frank-Molnia & Pohlman (Munich): Elisabeth Greiner, Holger Schimmel (both patent attorneys)
Taylor Wessing (Munich): Manja Epping
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)

For Betapharm
Maiwald (Munich): Marco Stief, Heike Röder-Hitschke, Dirk Bühler, Renate Rieder (both patent attorneys)
In-house (Cambridge): Mujeebur Rahiman (head IP Europe Dr. Reddy’s)

Higher Regional Court Düsseldorf, 2nd Civil Chamber
Thomas Kühnen (presiding judge)