Various generics manufacturers have won in the second instance in the dispute over supplementary protection certificates for cholesterol-lowering drug Inegy. The Higher Regional Court Düsseldorf dismissed the appeal of US originator Merck Sharp Dome (MSD) (case IDs: I-2 U 58/18 - I-2 U 64/18 and I-2 U 82/18). The various pharmaceutical companies may continue to market imitation products in Germany, using the active substance combination ezitimibe and simvastatin.
19 March 2019 by Konstanze Richter
The SPC for ezitimibe expired in April 2018 (DE 103 99 001.1), after which various generic drug manufacturers entered the German market with imitation products.
However the SPC for the combination of ezitimibe and simvastatin (DE 12 204 000 026.1), on which MSD’s cholesterol-lowering drug Inegy is based, remains valid until April 2019. MSD thus filed an infringement suit before Düsseldorf Regional Court, which initially upheld the action with a temporary injunction. The generics manufacturers then withdrew their products from the market.
In the autumn of 2018, however, Düsseldorf Regional Court revoked the preliminary injunction issued in the spring. It reasoned that because an expired SPC for the active substance ezitimibe already existed, a further SPC for the combination was unjustifiable. The effect of the combination, a reduction in side effects, is due to a lower dose of simvastatin. The court of first instance did not recognise this as a separate inventive step.
The Higher Regional Court has followed the verdict of the first instance. Judge Thomas Kühnen pointed out that the CJEU has not conclusively clarified in its previous case law under which conditions an SPC also applies to a combination of active substances.
First-instance proceedings against the generic drug manufacturers 1 A Pharma, Hexal, Mylan dura, Ratiopharm, AbZ Pharma, Stada and Aliud were heard together. In the second instance, a further case against Klinge Pharma was added, making a total of eight defendants.
Parallel proceedings are pending against other national SPCs in the Netherlands, France, Austria, Ireland, Italy, Spain, Portugal and Belgium. All are based on the basic patent EP 0 720 599, which is due to expire this April.
So far, there is no uniform trend in the decisions of the national courts. Sometimes even the same court comes to different decisions, depending on the parties involved. For instance, the commercial court in Vienna issued a preliminary injunction against Stada in January while rejecting it in the case of Ratiopharm.
In the parallel nullity proceedings, the Federal Patent Court declared MSD’s SPC (DE 12 204 000 026.1) null and void at the beginning of October 2020 (case-ID: 3 Ni 4/19). The proceedings had previously moved from the 4th Senate to the 3rd.
The decision gives generic manufacturers the chance to claim damages from MSD. The damages cover the months in 2018 that the manufacturers were not allowed to sell their products on the German market, due to the preliminary injunction.
All patent firms maintain long-standing relationships with their clients, having advised them since the disputes began. Sometimes this also extends to pending nullity proceedings.
US pharmaceutical company Merck and its national subsidiaries, in this case MSD, rely on the team around the two Hogan Lovells partners Andreas von Falck and Miriam Gundt. Both partners recently represented the client in the dispute against Shionogi over compulsory licences for AIDS drug Isentress. Ties to Abitz patent attorney Monica Heinemann go back to 2011, when von Falck and Heinemann advised Merck on a CJEU case.
Bird & Bird regularly litigates for core client Teva and its subsidiaries Ratiopharm and AbZ Pharma. The team around Düsseldorf partner Oliver Jüngst and Hamburg partner Anne Wolters-Höhne recently won a case for Ratiopharm in the dispute over the second medical use of a breast cancer drug containing the active ingredient fulvestrant.
While Wolters-Höhne represents Ratiopharm and subsidiary AbZ in the current proceedings, Düsseldorf partner Jüngst advises Stada and its subsidiary Aliud. Jüngst is assisted by patent attorney Alexander Wittkopp, who advised Aliud in the dispute over the protection certificate for Truvada as part of a team together with Harmsen Utescher.
In the proceedings over the SPC for HIV drug Truvada, Taylor Wessing partner Christoph de Coster was retained together with patent attorney Bernd Aechter from Ter Meer Steinmeister by core client Hexal. However, Hexal does not rely exclusively on these attorneys; it regularly instructs Arnold Ruess for infringement proceedings, for example in the precedent case over fulvestrant’s second medical use patent.
Mylan dura also does not work exclusively with Taylor Wessing. In the Truvada case against Gilead, whereby Taylor Wessing represented Hexal, the company turned to Düsseldorf law firm Wildanger Kehrwald Graf v. Schwerin & Partner, and Maiwald partner Derek Vos.
For MSD (in all cases)
Hogan Lovells (Düsseldorf): Miriam Gundt (lead), Andreas von Falck; associate: Lukas Sievers
Abitz & Partner (Munich): Monica Heinemann (patent attorney)
For 1 A Pharma (I-2 U 64/18), Hexal (I-2 U 58/18) and Klinge (I-2 U 82/18)
Taylor Wessing (Munich): Jan Rektorschek, Nora Wessendorf, Anja Lunze
Maiwald (Munich): Derk Vos (patent attorney)
For Mylan dura (I-2 U 63/18)
Taylor Wessing (Munich): Christoph de Coster, Verena Bertram
Ter Meer Steinmeister & Partner (Munich): Bernd Aechter (patent attorney)
For Ratiopharm (I-2 U 62/18) and AbZ Pharma (I-2 U 59/18)
Bird & Bird (Hamburg): Anne Wolters-Höhne (lead); associates: Annika Schneider (Düsseldorf), Marie-Theres Schmid (patent attorney, Munich)
For Stada (I-2 U 61/18) and Aliud (I-2 U 60/18)
Bird & Bird (Düsseldorf): Oliver Jüngst, Moritz Schroeder
Hamm & Wittkopp (Hamburg): Alexander Wittkopp (patent attorney)
Higher Regional Court Düsseldorf, 2nd Civil Senate
Thomas Kühnen (presiding judge), Thomas Fricke, Ronny Thomas
This article was updated on 21 October 2020 following the nullity decision of the Federal Patent Court.