Pemetrexed in Germany: Federal Court of Justice sets aside decision of Appeal Court – infringement of Eli Lilly’s EP’508 by Actavis’ pemetrexed product has to be reconsidered

After an oral hearing held on 14 June 2016 in the Pemetrexed-proceedings initiated by Eli Lilly against Actavis the German Federal Court of Justice (FCJ) has set aside the decision of the Higher Regional Court and referred the case back for reconsideration whether Actavis’ pemetrexed product does infringe Eli Lilly’s EP 1 313 508 (“EP508”).

Facts

In 2012, Eli Lilly initiated proceedings against Actavis at the Regional Court Düsseldorf claiming that Actavis’ pemetrexed product infringes its EP508.

Claim 1 of EP508 relates to the use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals. Actavis argues that its pemetrexed product does not fall within the scope of protection of the patent because it does not contain pemetrexed disodium but pemetrexed dipotassium.

Previous decisions

In its decision dated 3 April 2014 the Regional Court Düsseldorf held that the use of pemetrexed dipotassium instead of pemetrexed disodium constitutes an infringement of EP508 under the doctrine of equivalence.

This first instance decision, however, was reversed on appeal. By decision of 5 March 2015 the Higher Regional Court Düsseldorf followed Actavis line of arguments and denied literal as well as infringement under the doctrine of equivalence. In its reasoning the Court referred to the Okklusionsvorrichtung-decision of the FCJ which says that if the patent discloses several ways to achieve a certain effect, but only one of these ways is claimed, the other ways generally cannot constitute infringement under the doctrine of equivalence, because the person skilled in the art has to respect the choice made by the patentee.

Against this background, the Higher Regional Court pointed out that in the case at hand there is an evident discrepancy between the broad patent description which says that the effects of the invention can be achieved by any antifolate, i.e. also pemetrexed itself or any derivatives of pemetrexed, and the patent claim which expressly only refers to pemetrexed disodium. However, if the applicant does deliberately restrict the subject matter protected by the patent claims during the grant procedure in such a way, the scope of protection cannot be extended in later infringement proceedings by way of the doctrine of equivalence.

Decision of the FCJ

With decision dated 14 June 2016 the FCJ has held that the decision of the Higher Regional Court has to be set aside and that the question whether Actavis’ product infringes EP508 has to be reconsidered by the Appeals Court.

The reasoning of the decision is not yet published. However, in the oral hearing the FCJ has indicated that the case at hand is different from the above-mentioned Okklusionsvorrichtung-decision because the allegedly infringing embodiment (pemetrexed dipotassium) was not explicitly mentioned in the specifications of the patent.