The Supreme Court of the Netherlands has rejected an appeal from Fresenius over a patent concerning the chemotherapy drug pemetrexed. The appeal was against a preliminary injunction order from the two lower Dutch courts. Both courts ruled that Fresenius infringed a patent held by Eli Lilly for the drug. The Supreme Court has ordered Fresenius to pay legal costs to Eli Lilly.
15 June 2020 by Amy Sandys
Fresenius initially lodged an appeal against a Court of Appeal decision handed down in preliminary injunction proceedings. The court issued the decision on cancer drug pemetrexed just over two years ago, in May 2018 (case no. 200.228.753/01). This upheld an earlier decision made by the District Court of The Hague (case no. C/09/537158).
The Supreme Court of the Netherlands has rejected the appeal by Fresenius, and ordered the company to pay Eli Lilly €140,000 in legal costs. The parties have concluded parallel proceedings in the UK and Switzerland, but there are ongoing disputes in many other jurisdictions including Germany, Belgium, France and Italy.
Pemetrexed is a chemotherapy drug. Eli Lilly produces and markets the drug under the brand name Alimta. European patent EP 1 313 508 protects the use of the disodium salt of pemetrexed in combination with vitamin B12. The drug is formulated as a so-called Swiss-type claim, which forms the basis of Alimta.
In June 2019, in an infringement case on the merits, the District Court of the Hague ruled that the scope of the pemetrexed patent protection does not include the pemetrexed tromethamine combination used by Fresenius. Pemetrexed disodium is the only combination relevant to the scope of the patent protection. Consequently, the court found that Fresenius has not infringed the Eli Lilly patent in its Dutch jurisdiction.
However, this decision was contrary to earlier Dutch Court of Appeal decisions, as well as various parallel infringement cases in other European countries. The Court of Appeal will not publish its judgment on the merits until 7 July 2020.
A validity case for the same patent EP 508 is also pending before the Supreme Court of the Netherlands. But there is a lot riding on this hearing. If the court decides to uphold Fresenius’ appeal and revoke EP 508, all the injunctions granted against Fresenius so far will be void. The court will hear the case on 2 November, with a judgment expected at the end of 2020 or early 2021.
In its decision of 12 June 2020, the Supreme Court of the Netherlands held that it does not have to state its reasons behind the judgment. This is in accordance with section 81, paragraph 1 of the so-called Judiciary Organisation Act. However, observers speculate that the court might deal with the issues behind its rejection of Fresenius’ appeal in the upcoming proceedings on 7 July.
Furthermore, on 7 July the Federal Court of Justice in Karlsruhe will also hear an appeal in the German proceedings. In summer 2018, a Federal Patent Court ruling rendered the German part of EP 508 null and void. Although the Munich judges were critical of this decision, they rejected the applications for a preliminary injunction due to the lack of legal validity.
Eli Lilly lodged an appeal against the nullity ruling before the Federal Court of Justice, to be heard on the same day as the merits in the Netherlands.
Klaas Bisschop, partner at the Amsterdam office of Hogan Lovells, led the Netherlands infringement case for Eli Lilly. Hogan Lovells is active for Eli Lilly across most of the European jurisdictions for infringement proceedings and has a long-standing relationship with the pharma giant.
Multiple partners, including Bert Oosting, worked with Eli Lilly as legacy firms Hogan & Hartson and Lovells, before the two merged in 2010.
Hogan Lovells also acts for Lilly in other cases concerning EP 508. In the Supreme Court proceedings, Hogan Lovells also worked with Tobias Cohen Jehoram, a partner at the Amsterdam office of De Brauw.
This is because parties must be represented by a lawyer admitted to the Dutch Supreme Court. Hogan Lovells also worked with patent attorney firm V.O in the preliminary relief proceedings.
The Amsterdam office of DLA Piper represents Fresenius in the Netherlands, with partner Paul Reeskamp taking lead. Johan Renes left DLA Piper at the beginning of May 2020, but continues to work with his former firm in this case.
Although the wider law firm has been involved with the healthcare company in other legal proceedings, EP 508 is the first patent case in which DLA Piper has acted for Fresenius.
For Eli Lilly
Hogan Lovells (Amsterdam): Klaas Bisschop (lead), Bert Oosting (both partners); Dirk-Jan Ridderinkhof, Joost Duijm
De Brauw Blackstone Westbroek (Amsterdam): Tobias Cohen Jehoram
V.O. (The Hague): Otto Oudshoorn, Henri van Kalkeren (attorneys)
DLA Piper (Amsterdam): Paul Reeskamp (lead); Marijn van der Wal; Johan Renes (independent attorney)
Supreme Court of the Netherlands, The Hague
Robert van Peursem (advocate general); Ernst Numann (chairman); Gerbrant Snijders, Maarten Kroeze, Carla Sieburgh, Pieter Frans Lock, Edgar du Perron