The District Court of the Hague has found the pemetrexed patent held by Eli Lilly not infringed by Fresenius in the Netherlands. The decision is contrary to earlier Dutch Court of Appeal decisions, as well as various parallel infringement cases in other European countries.
26 June 2019 by Amy Sandys
Cancer treatment pemetrexed is a chemotherapy drug. Pharmaceutical company 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. This combination forms the basis of Alimta.
Last week, 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 German healthcare company Fresenius has not infringed the pemetrexed patent held by Eli Lilly in its Netherlands jurisdiction. Hogan Lovells will appeal the decision on behalf of Eli Lilly.
A recent case before the Munich Regional Court in Germany saw pending injunctions lifted against healthcare brand Hexal, and Fresenius. A Higher Regional Court Düsseldorf judgment in 2015 in the pemetrexed patent dispute between Actavis and Eli Lilly triggered the German case.
Here the judges ruled in favour of Actavis on the question of patent infringement by equivalents. Consequently, Hexal and other generics manufacturers entered the German market with imitation products, causing Eli Lilly to sue the generics companies for infringement.
In 2017, the Munich Regional Court issued preliminary injunctions against the distribution of the generics in Germany. Hexal appealed the decision and in July 2018, the Federal Patent Court declared the patent invalid. As a result, last November the Munich Regional Court suspended enforcement of the injunction against Hexal.
Because of this, Eli Lilly appealed against the nullity ruling before the Federal Court of Justice in Germany. A decision is expected in the first half of 2020.
Proceedings regarding patent infringement by equivalents have also taken place in the UK, France, Spain, Italy, Denmark, Austria and Switzerland, as well as Germany and the Netherlands. Validity proceedings have mostly been in the latter two jurisdictions.
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 case for the Pemetrexed patent is co-ordinated from the Hogan Lovells office in London. The team there is behind the UK Supreme Court proceedings.
Hogan Lovells has a long-standing relationship with Eli Lilly. Multiple partners, including Bert Oosting, worked with the pharmaceutical company while it existed as both Hogan & Hartson and Lovells, before the two merged in 2010. Furthermore, Hogan Lovells acts for Lilly in other cases.
The Amsterdam office of DLA Piper is representing Fresenius in the Netherlands, with partner Paul Reeskamp taking lead. Alexis Fierens and Nicolas Becker, partner and senior lawyer at the Brussels office of DLA Piper, lead the parallel 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.
For Eli Lilly
Hogan Lovells (Amsterdam): Klaas Bisschop (lead), Bert Oosting (both partner); Dirk-Jan Ridderinkhof, Joost Duijm
V.O. (The Hague): Otto Oudshoorn, Henri van Kalkeren (attorneys)
In-house: No information
DLA Piper (Amsterdam): Paul Reeskamp (lead); Marijn van der Wal; Johan Renes (attorney)
DLA Piper (Belgium): Alexis Fierens; Nicolas Becker
In-house: Corinna Sundermann (lead)
District Court of the Hague, IP Chamber
Hans Van Walderveen (presiding judge, chair and president of IP chamber)