The Court of Appeal of The Hague has overturned a decision in the pan-European pemetrexed patent case between Fresenius and Eli Lilly. Previously, the District Court of the Hague found a patent held by Eli Lilly not infringed by Fresenius in the Netherlands. But now the Court of Appeal has issued a new ruling, and an injunction against Fresenius.
4 November 2020 by Amy Sandys
In June 2019, the District Court of the Hague ruled that Fresenius has not infringed the pemetrexed patent in its Netherlands jurisdiction. According to the first instance court, the scope of a pemetrexed patent held by Eli Lilly did not include the pemetrexed tromethamine combination used by Fresenius. However, the Court of Appeal overturned this decision in October 2020, in a judgment based on equivalence.
Cancer treatment pemetrexed is a chemotherapy drug, marketed by pharmaceutical company Eli Lilly 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. Pemetrexed disodium is the combination relevant to the scope of the patent protection in the case between Fresenius and Eli Lilly.
Eli Lilly’s patent claims a combination of vitamin B12, and B12 with a folic binding protein. Generic companies argued that their formulations, which use different salt combinations, constitute a new formulation. Therefore, Fresenius argued, its combination did not constitute infringement of EP 508.
However, the Court of Appeal of The Hague concluded Fresenius had infringed the patent based on equivalence. Furthermore, the court has not requested Fresenius recall its products. Fresenius could still appeal the findings. The company has a three-month window in which to do so.
Although the judgment is contrary to the initial findings of the Dutch court, it is not unsurprising in the context of the drug’s European scope. The dispute is multi-jurisdictional. Courts in the UK, Germany and France had previously ruled that Fresenius did indeed infringe EP 508. Some patent lawyers in the Netherlands laud the decision as helping align European patent law in terms of infringement proceedings.
In July this year, the German Federal Court of Justice upheld the patent in full in a validity trial (case ID: X ZR 150/18). In doing so, the court overturned a July 2018 decision of the Federal Patent Court. Later in July, Eli Lilly also achieved a ban on the sale of imitation pemetrexed products, after the Regional Court Munich issued preliminary injunctions against generics companies Stada, Zentiva and Hikma.
In France, in September Eli Lilly secured exclusivity to the French market through a sales ban handed down to Fresenius by the Judicial Court of Paris. The court ordered Fresenius to withdraw its product and awarded Eli Lilly 28 million euros in damages.
In other EP 508 proceedings, in summer 2020 the Supreme Court of the Netherlands rejected an appeal by Fresenius. The appeal was against a preliminary injunction order from the two lower Dutch courts. However, the Supreme Court rejected the appeal on procedural grounds and ordered Fresenius to pay legal costs to Eli Lilly. An infringement case is still pending in Belgium.
Hogan Lovells represents Eli Lilly in all major disputes across Europe. Klaas Bisschop, partner at the Amsterdam office of Hogan Lovells, led the Netherlands infringement case for Eli Lilly. Similarly, Hogan Lovells is active for Eli Lilly across most of the European jurisdictions for infringement proceedings.
The Dutch office of Hogan Lovells has a long-standing relationship with Eli Lilly. Multiple partners, including Bert Oosting, worked with the pharmaceutical company at legacy firms Hogan & Hartson and Lovells, before the two merged in 2010.
In France, Eli Lilly is a core client of young partner Stanislas Roux-Vaillard’s team. The London office of Hogan Lovells co-ordinates proceedings for the pemetrexed patent, through partner Daniel Brook. On the patent prosecution side, Hogan Lovells worked with Ivan Burnside, in-house at Eli Lilly.
Across Europe, Fresenius relies on a mixture of national boutiques and large firms. The company works with patent attorneys and lawyers from Bird & Bird in Germany, while the Amsterdam office of DLA Piper represents Fresenius in the Netherlands. Here, partner Paul Reeskamp takes the lead. Reeskamp also leads the proceedings in Belgium.
Although the wider law firm has been involved with the healthcare company in other legal proceedings, this is the first patent case on which Fresenius has worked with DLA Piper.
In France, Elisabeth Berthet-Maillols of French litigation boutique Promark represented Fresenius.
Parallel proceedings between Eli Lilly and Sandoz are also underway in the Netherlands, although the court suspended a hearing due to be heard on 2 November. Here, Daan de Lange, partner at Dutch firm Brinkhof, leads proceedings.
For Eli Lilly
Hogan Lovells (Amsterdam): Klaas Bisschop (lead), Bert Oosting (both partners); associates: Dirk-Jan Ridderinkhof, Joost Duijm
V.O. (The Hague): Otto Oudshoorn, Henri van Kalkeren (patent attorneys)
In-house (Surrey, UK): Ivan Burnside (chief patent counsel, international litigation)
DLA Piper (Amsterdam): Paul Reeskamp (lead); Marijn van der Wal; Johan Renes (patent attorney; now in-house)
In-house: Alexander Dettmer (senior VP corporate business development), Corinna Sundermann (senior vice president, IP)
Court of Appeal of The Hague
Peter Block (presiding judge), J Frieling, M van der Burg; J Pinckaers (cause list justice)