Pharma update: Indirect infringement of Swiss type claims is possible

In its judgment of 3 November 2017 in the case between Merck Sharp & Dohme (‘MSD’) and Teva, the Dutch Supreme Court ruled (ECLI:NL:HR:2017:2807) that indirect infringement of a ‘Swiss type’ second medical use patent claim is possible. In addition, the Supreme Court found that there is no difference in the scope of protection of second medical use patents and subgroup indication patents.

In this case, which was already discussed briefly in our Pharma Update of 4 October 2016, the main question was whether Teva had infringed MSD’s patent (EP 0 956 861) which claims, in the form of a Swiss type claim, the use of ribavirin in the preparation of a medicament for the treatment of chronic hepatitis C, for a duration of about 40-50 weeks, and where the patient is a naive patient with a HCV genotype 1 infection.

Indirect infringement of patent

MSD asserted that Teva had indirectly infringed its patent, since Teva offered for sale and supplied generic ribavirine, which had (also) been used for the treatment of the aforementioned subgroup of patients. In the Supreme Court proceedings, the main question was whether or not indirectly infringing a second medical use patent with a Swiss type claim is legally possible. If the doctrine of indirect infringement were applied literally, for a Swiss type claim this would mean that means would have to be offered for sale or supplied suitable and intended for the preparation of the medicament. A literal explanation would therefore not be whether means were to be offered for sale or supplied which are suitable and intended for the treatment of the patient / the claimed condition.

The answer to this question is of great interest, also in light of the various diverging court decisions in the Netherlands and other European countries. For instance, in the Sun v Novartis case, the The Hague Court of Appeal found, in PI proceedings, that indirect infringement of a Swiss type claim was possible, while the The Hague District Court, in final relief proceedings, expressly considered indirect infringement impossible since the means were not supplied for the preparation of the medicament.

Revision European Patent Convention

The Supreme Court ruled that the reasons behind accepting the patentability of Swiss type claims, as well as the revision of the European Patent Convention (EPC) in 2000 should be taken into account when assessing whether indirect infringement of a Swiss type claim is legally possible. The EPC 2000 revision introduced purpose-limited protection for the products mentioned in second medical use claim (the medicaments). According to the Supreme Court, the reason behind this revision was not to break with the existing patentability of substances by means of a Swiss type claim. Therefore, the Court rules, a Swiss type claim may be infringed in the same manner as a purpose-limited product claim in accordance with the present article 54 (5) EPC. The Supreme Court thus follows the German Bundesgerichtshof and the UK Supreme Court in the Eli Lilly v Actavis cases, in which judgments were rendered earlier this year.

Scope of protection subgroup indication patent

With respect to direct infringement of the patent, the The Hague Court of Appeal had found that, since the patent indicates a certain subgroup of patients who have been treated with the claimed substance (ribavirin) before, the scope of protection of this so-called subgroup indication patent should be smaller than that of other second medical use patents.

The Supreme Court disagrees. It rules that the applicable standard is whether the person with ordinary skill in the art would assume that the medicament is (also) intended or suitable for the treatment of the medical indication mentioned in the claim. In addition, it is relevant whether the producer or trader foresees or should foresee that the (generic) medicament will consciously be used for that treatment. According to the Supreme Court the system of the EPC does not allow a distinction to be made between different kinds of second medical indications.