Ribavirin - Netherlands

On Nov 03, 2017, Supreme Court of the Netherlands reversed the decision of Hague Court of Justice & found Teva’s label indirectly infringing the second medical use patent in Ribavirin case.

MSD is the holder of European Patent EP0956861. Claim 1 relates to use of ribavirin for the preparation of a pharmaceutical composition for the treatment of a patient with chronic hepatitis C infection, together with an active amount of alpha interferon wherein the subject is an anti-viral treatment naive patient with an HCV genotype 1 infection. MSD releases capsules and tablets according to EP’861 on the market under the trade names 'Rebetol' and 'Copegus', respectively. In June or October 2011, Teva introduced its generic ribavirin tablets on the Dutch market. MSD sought declaration of right that Teva generic products fall within the scope of EP 861, and claimed damages for state or profit. Teva counterclaimed in reconciliation (among other things) a declaration of non-infringement of the Dutch part of EP 861, and subject to the assumption of infringement, the destruction of the patent for the Dutch part.

Lower court held that Teva does not infringe the Dutch part of EP 861 as no acts of Teva fall within the scope of the claimed Swiss-type claims. Teva has adequately managed to ensure that it is out of scope for the Swiss-type claims of the patent by a so-called 'carve-out'. Teva has excluded the MSD-claimed patient category (naive and genotype 1 infection). That is enough to fall outside the scope of the patent. Based on the mentioned SmPCs and leaflets, therefore, there is no direct or indirect patent infringement by Teva, whether or not doctors or pharmacists prescribe Teva’s generic ribavirin (treatment of the G1N subgroup) and whether naive genotype 1 patients use that drug. In its action against unlawful action, MSD has not found any other facts than its claims for direct and indirect patent infringement. Merck appealed.

Supreme Court assumed that indirect infringement of a Swiss-type claim is conceivable. According to Art. 73 if a person offers or supplies resources for the use of the patented invention in or for his business, provided that person knows or is aware of the circumstances are clear that those means for that application are appropriate and intended. Court finally held that the manufacturer of a generic drug may indirectly infringe a patent for a second medical indication, namely if he offers or supplies the medicine to persons not entitled to use the invention and he know whether it is clear to him that the medicine is suitable and will be used for the patented second medical indication. Thus Supreme Court reversed the decision of Hague Court of Justice & referred the case for further consideration & decision.