EPLAW Patent Blog

DE - Eli Lilly v. Actavis

Eli Lilly and Company v. Actavis Group PTC ehf, Actavis Deutschland GmbH & Co. KG and the general manager of its managing entity; Dusseldorf District Court, judgment dated 3 April 2014, docket no. 4b O 114/12, with thanks to Andreas von Falck, Daniel Brook and Stephan Neuhaus, Hogan Lovells, for sending in the judgment, as well as a translation and a summary in English

On 3 April 2014, the Dusseldorf District Court issued an injunction against Actavis Group PTC ehf based on equivalent patent infringement of the German part of Lilly's dosing regimen patent EP 1 313 508. The patent protects the approved use of Lilly's anti-cancer drug Alimta with Vitamin B12. The injunction prohibits Actavis Group PTC ehf from importing or marketing a generic medicament which contains pemetrexed dipotassium (the claim of Lilly's patent refers to pemetrexed disodium as does the marketing authorisation for Alimta) after expiry of Lilly's compound SPC on pemetrexed in December 2015 in Germany. The complaint was dismissed as regards Actavis Deutschland and its general manager. The judgment is not final and can be appealed.

DE - Mölnlycke / comment: ruling gives more effect to torpedo actions

German Federal Supreme Court ruling on Mölnlycke case gives more effect to torpedo actions, by Dietrich Kamlah and Christof Höhne, Taylor Wessing

"In a recently published decision (ref. no. X ZR 70/12 – Wundverband), the German Federal Supreme Court ruled that an exclusive licensee cannot bring patent infringement proceedings, if the patentee himself has already brought patent infringement proceedings against the same defendant and the license was granted only after proceedings by the patentee had been initiated. This decision might limit the options of a patentee to sue an infringer who has already filed a “torpedo” action under the same patent."

Read the entire contribution here.

DE - First Munich International Patent Law Conference

On the 14th of June 2013 the first Munich International Patent Law Conference will take place.

The conference is organized by (amongst others) the District Court of Munich I, the Bavarian State Ministry of Justice and the Technical University of Munich. The European Patent Office and the Munich Patent Litigators (a group of presently 18 law firms with a strong patent litigation practise, which was formed for this purpose) support the conference.

This year's topic is: "Calculating Damages in Patent Infringement Cases". Language of the conference is English.

Please find the entire programme and the registration form here.

DE - Accord/Teva/Hexal v. AstraZeneca / Seroquel XR

Accord Healthcare Ltd., Teva Deutschland GmbH and Hexal AG v. AstraZeneca AB; Federal Patent Court, Germany, 13 November 2012, 3 Ni 43/10 (EP) 3 Ni 24/11 (EP) and 3 Ni 25/11 (EP), with thanks to Anja Lunze, Taylor Wessing, for sending in the head note and a translation of the decision in English

Upon request of the three plaintiff’s the Federal Patent Court invalidated AstraZeneca’s patent EP (DE) 0 907 364, which was for a sustained release formulation of an anti-psychotic drug quetiapine (marketed as Seroquel XR).  After the decision Astra Zeneca renounced on the further enforcement of several interim injunctions that had been granted on the basis of the AstraZeneca patent against generic companies by the Düsseldorf court in May 2012. 

The decision of the Federal Patent Court follows a series of other decisions in Europe dealing with the validity of the AstraZeneca patent. The results have been mixed: In Spain and the Netherland (see this blog here) the patent was upheld, in UK the patent was invalidated (see this blog here) 

The Federal Patent Court invalidated the patent for lack of inventive step. The reasoning that was just issued by the Federal Patent Court is similar to the reasoning of the UK High Court.

The Federal Patent Court found that it was clear from the prior art (e.g. Gefvert) that a once daily administration of an immediate release formulation of quetiapine was not sufficient to ensure an effective treatment.  The person skilled in the art was motivated to consider an SR formulation since he could assume that such formulations would not only reduce the frequency of administration but also improve patience compliance and lead to a constant plasma level of the active agent which is a particular important clinical advantage. Formulating the quetiapine using a gelling agent was obvious to try and just required routine tests. The Federal Patent Court rejected the argument of the patentee that certain specific properties of quetiapine would have deterred the skilled person from considering an SR formulation of quetiapine. According to the Court there are no hints in the patent specification that such problems indeed existed and had to be solved by inventive activity.

Read the judgement in English here

Read the judgement in German here

DE - Huawei v. ZTE / Referral CJEU re Standard Essential Patents

Huawei v. ZTE, District Court Dusseldorf, Germany, 21 March 2013, case no. 4b O 104/12

Huawei has sued ZTE for infringement of a patent related to the LTE-standard, which Huawei has declared as being essential to the LTE standard towards the European Telecommunication Standards Institute (ETSI). ZTE has distributed base stations for mobile communication using LTE related software.

In 2009, the German Federal Supreme Court ruled out in “Orange Book Standard” that the enforcement of a cease and desist claim based on standard essential patents may be abusing antitrust regulations in case the defendant has offered taking a license under specific conditions and has complied with the license provisions. Subsequently, German instance courts had often to deal with the compulsory license defence in standard essential patent cases. In particular, there was no established case law whether the license offer can be made under the condition that the patent has in fact been used by the defendant and that the patent is considered to be valid.

The District Court Dusseldorf now decided to request the CJEU to clarify specific questions related to the compulsory license defense in standard essential patent cases. The court stated that there are conflicting legal opinions on these questions and referred to the “Orange Book Standard” decision and the press release of the European Commission of December 21, 2012, according to which the enforcement of a cease and desist claim based on standard essential patents was considered by the European Commission as abusing antitrust regulations, if the defendant was open to negotiate taking a license.

It is to be expected that the statement of the CJEU would clarify the conformity of the “Orange Book Standard”-based German case law with European antitrust regulations and would also conclude many open aspects of the conflicting arguments.

Read the judgement (in German) here.

Head note: Thomas Schachl

DE - Huawei v. ZTE, District Court Dusseldorf, Germany, March 21, 2013, case no. 4b O 104/12

Huawei has sued ZTE for infringement of a patent related to the LTE-standard, which Huawei has declared as being essential to the LTE standard towards the European Telecommunication Standards Institute (ETSI). ZTE has distributed base stations for mobile communication using LTE related software.

In 2009, the German Federal Supreme Court ruled out in “Orange Book Standard” that the enforcement of a cease and desist claim based on standard essential patents may be abusing antitrust regulations in case the defendant has offered taking a license under specific conditions and has complied with the license provisions. Subsequently, German instance courts had often to deal with the compulsory license defence in standard essential patent cases. In particular, there was no established case law whether the license offer can be made under the condition that the patent has in fact been used by the defendant and that the patent is considered to be valid.

The District Court Dusseldorf now decided to request the EUECJ to clarify specific questions related to the compulsory license defense in standard essential patent cases. The court stated that there are conflicting legal opinions on these questions and referred to the “Orange Book Standard” decision and the press release of the European Commission of December 21, 2012, according to which the enforcement of a cease and desist claim based on standard essential patents was considered by the European Commission as abusing antitrust regulations, if the defendant was open to negotiate taking a license.

It is to be expected that the statement of the EUECJ would clarify the conformity of the “Orange Book Standard”-based German case law with European antitrust regulations and would also conclude many open aspects of the conflicting arguments.

Read the judgement (in German): http://www.justiz.nrw.de/nrwe/lgs/duesseldorf/lg_duesseldorf/j2013/4b_O_104_12_Beschluss_20130321.html

DE - Bundesgerichtshof rules that patents on embryonic stem cells are partially valid

In a fundamental decision on 27 November 2012 (BGH Decision of 27 November 2012, case no.: X ZR 58/07) the Bundesgerichtshof ruled that a patent (DE 197 56 864) registered in favour of the German stem cell researcher, Oliver Brüstle, is invalid in part.

The subject of the patent, which was applied for in 1997, is the protection of neural precursor cells and the procedure to cultivate these cells and use them in therapy of neural defects. Using the invention by Mr Brüstle upon which the patent is based, transplantation of neural precursor cells in the nervous system can play an important role in treating Parkinson's disease and multiple sclerosis in the future. Such neural precursor cells are usually obtained from embryonic stem cells and can then be used as transplant material.

The European Patent Office deemed that such neural precursor cells, the method for producing them and their use in therapy of neural defects were patentable, and in 1999 granted the patent which Oliver Brüstle applied for, and registered it in the patent register.

Greenpeace e.V. filed an action for annulment of this patent before the Federal Patent Court. According to Greenpeace the subject of this patent violated public policy and accepted principles of morality insofar as it concerned precursor cells which were developed from human embryonic stem cells. Use of such cells is also being discussed because the state of the art at the time destroyed the embryo when the neural precursor cells were produced.

DE - leflunomide and teriflunomide

Leflunomide and teriflunomide, Bundesgerichtshof, Germany, 24 July 2012, Case no. BGH X ZR 126/09

In its decision BGH X ZR 126/09 as of 24 July, 2012, the Bundesgerichtshof nullified a patent that claimed a composition of leflunomide and teriflunomide. Leflunomide is, i.a. used against rheumatoid arthritis, whereas teriflunomide is the active metabolite of leflunomide, that means that within a usual storage period, leflunomide is metabolized to teriflunomide. It One skilled in the art would have come to a formulation comprising leflunomide as only therapeutic agent before the priority date without being inventive. However, the person skilled in the art had no incentive to come to a combination of leflunomide and teriflunomide in the amounts as claimed in the patent.

The Bundesgerichtshof ruled that despite the fact that the claimed combination was novel and inventive, the patent had to be nullified, because the combination of the two components occurred necessarily within usual storage periods from the single agent medicine comprising only leflunomide as active ingredient. Therefore, the only question to decide was if it would have been novel and inventive to the person skilled in the art to come to a single agent leflunomide preparation. The Bundesgerichtshof denied this question and nullified the patent, because the result of the work of the person skilled in the art necessarily revealed the claimed combination of leflunomide and teriflunomide.

DE - Agfa v. Papier Union

AgfaGraphics N.V. v Chengdu Xinggraphics Co.Ltd; German Federal Supreme Court, Germany, 14 August 2012, Case No. X ZR 3 /10, with thanks to Julia Bödeker and Christoph de Coster, TaylorWessing, for sending in the judgment and a head note in English

In the above judgement, the German Federal Supreme Court made its final ruling in the long pending dispute between Agfa Graphics N.V. and Chendgdu Xingraphics Co.Ltd. concerning a key patent on lithographic printing plates. The German Federal Supreme Court overruled the decision of the Federal Patent Court and fully re-established the patent as granted.  The dispute is accompanied by infringement actions filed by Agfa in Germany and the Netherlands. The EPLAW Patent Blog published a previous decision from the Netherlands here.

The Court ruled on the priority claimed by a Art 54 III EPC application. The Court made a distinction between the novelty test and the priority test, emphasizing that examples that inherently disclose a certain element of a technical teaching (in this case UV-insensitivity) might anticipate that teaching, but do not necessarily establish the basis for claiming priority. Such a priority claim does not only require that the element is specifically disclosed in the previous application, but further that it is disclosed as being part of the invention (Art. 88 IV EPC). According to the court there is no direct and unambiguous disclosure of the whole technical teaching in the priority document if examples are described that inherently disclose all elements of the technical teaching but do not enable the person skilled in the art to make a purposeful selection between examples featuring all elements of the technical teaching and examples not featuring all of them.

 Read the decision (in German) here.

DE - Sanofi v. Actavis

Sanofi SA v. Actavis Deutschland GmbH & Co, Düsseldorf Regional Court, Düsseldorf, Germany, 15 August 2012, Case No. 4a 0 109/12, with thanks to Pierre Véron and Isabelle Romet,  Véron & Associés, for sending in the judgment and the translation in English

A preliminary injuction against Actavis was awarded. Read more here.

Read the decision (in German) here.
Read the decision (in English) here.

DE - German Supreme Court "Pallet Container II"

German Supreme Court, 17 July 2012, docket no. X ZR 97/11 - "Palettenbehälter II"

The decision “Pallet Container II” deals with the important distinction between the permissible “repair” of a patented product and the impermissible “renewed-manufacturing” of this product. From a practical point of view, the decision addresses the legal boundaries to aftersales competition regarding “wear-and-tear-parts” and consumables (e.g. coffee pads or ink cartridges). As will be detailed below, in the future the “end customer’s perception and understanding” will play an important role in order to decide whether these boundaries are crossed or not.

Whereas in Germany a “repair” of a patented product is considered as its “intended use” and therefore warranted under the principle of exhaustion, the “renewed-manufacturing” is considered as a further commercial exploitation of the patented invention which is only permissible with the patentee’s consent.