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.
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In its carefully reasoned judgment, the Dusseldorf District Court touches on various legal points the most important of which are the prerequisites for and analysis of equivalent infringement. On the issue of equivalence, the judgment notes that "…the use of a patent with equivalent means is not excluded in the field of chemistry and pharmacy.". The decision is also of note in relation to the admissibility of the action in light of Art. 27 Reg 44/2001/EC and the requirements the court sets for the establishment of the required danger of first infringement.
In its judgment, the Dusseldorf Court draws the line between literal and equivalent infringement according to German law. It denies literal infringement with the argument that while the person skilled in the art reading the patent would recognize that "pemetrexed disodium" in the claim consisted of a pemetrexed anion and two sodium cations of which only the pemetrexed ion was relevant for the teaching of the patent, this would not lead the person skilled in the art to understand pemetrexed disodium to mean pemetrexed and all pharmaceutically acceptable salts thereof.
The Court then analyzes equivalent infringement and – considering expert evidence filed by both parties – comes to the conclusion that the use of pemetrexed dipotassium instead of pemetrexed disodium in a combination therapy as protected by the patent is an equivalent infringement. Having explained the prerequisites for equivalent infringement, the court finds that these are fulfilled as regards pemetrexed dipotassium because, among other factors, the toxicity – amelioration of which by combination therapy with vitamin B12 without negatively effecting anti-tumor efficacy is the teaching of the patent – is caused by the pemetrexed ion only.
The actions against Actavis Deutschland and the general manager were dismissed due to lack of danger of first infringement. The Court did not see sufficiently serious and tangible real indications that the said defendants would infringe Lilly's patent.
Read the judgment (in German) here.
Read the judgment (in English) here.
