16 November 2017

Dutch Supreme Court landmark ruling on second medical use patents has international impact

This keenly anticipated ruling of the Dutch Supreme Court was given in a case between MSD and Teva on the protection of second medical use patents. It is the first ruling by the highest court in a European country on this matter. MSD was successfully represented before the Supreme Court by De Brauw, in cooperation with counsel in first and second instance, Hogan Lovells. The Supreme Court allowed both direct and indirect infringement on second medical use patents and set a substantially lower threshold than the court of appeal. The Supreme Court also “reinterpreted” its case law on indirect patent infringement in general. This ruling has a significant impact – well beyond Dutch borders – on pharmaceutical research aimed at second medical use and on return on research costs through meaningful patent protection. The ruling is also important for other markets where patentees rely on indirect patent infringement for effective protection (such as commercially relevant aftermarkets).

Background
MSD holds a patent aimed at second medical use for a known drug. The patent has Swiss-type claims. It was disclosed in the art that this drug could be used for a treatment of chronic hepatitis C, but no differentiation was made in this respect when it came to the genotypes (1 to 6) of the hepatitis virus. The patent in essence concerns the use of the known drug for a specific subgroup, in particular differentiating between genotypes of the hepatitis virus.

MSD holds market authorisation for the specific drug and it markets capsules and tablets in accordance with the patent. Teva obtained market authorisation for a generic version, with MSD’s products as reference products, and subsequently started marketing generic tablets. Teva uses a skinny label in the marketing of its product, carving out the patented subgroup but only in certain categories of the summary of the product characteristics (SmPC), that is, in the categories 4.1 Therapeutic indications, and 4.2 Posology, and manner of administration. Category 5.1 of Teva’s SmPC does, however, refer to clinical studies relating to the patented subgroup.

Court of appeal’s decision
MSD filed infringement proceedings against Teva in the Netherlands, but its infringement claims were denied in the first and second instance. In its decision in the second instance, the court of appeal made a distinction between (i) the “classic” second medical indication (aimed at a “new” indication), and (ii) subgroup indications (aimed at a subgroup for which the known indication “was already being used”). According to the court of appeal, protection for subgroup second medical use patents would be substantially limited compared to other second medical use patents. The extent of protection of a subgroup second medical use patent would categorically be limited to the situation where the third party specifically indicates that the generic substance is intended for the patented subgroup. Hence, the court of appeal denied MSD’s direct and indirect infringement claims. In its ruling on indirect infringement, the court of appeal referred to the Supreme Court’s Senseo decision. Following this decision by the court of appeal, MSD lodged an appeal with the Dutch Supreme Court.

The Supreme Court’s ruling
The Supreme Court overturned the court of appeal’s decision. The Supreme Court – in line with MSD’s arguments – held that there is no place in the European Patent system for a categorical distinction between the two types of second medical indications as made by the court of appeal. The threshold for direct patent infringement should be set at a low level. The Supreme Court also denied Teva’s arguments to the effect that indirect infringement on patents with Swiss-type claims would not be possible, and the Supreme Court set a similarly low threshold here. In addition, the Supreme Court provided general guidance on indirect infringement.

Direct patent infringement
For direct infringement – as argued by MSD – on all second medical use patents with Swiss-type claims, the Supreme Court considers essential:

  • that the manufacturer or seller of a generic substance foresees or ought to foresee that the generic substance manufactured or offered by him will intentionally be used for the patented second medical indication;
  • this requires that the average person skilled in the art will consider (based on the SmPC, the product information leaflet or other circumstances) that the substance is suited or intended, or also suited or intended, for such treatment;
  • in this case, the manufacturer or seller has to take all effective measures reasonably required of him to prevent his product from being used for the patented second medical indication.

Indirect patent infringement on patents with Swiss-type claims
As to indirect infringement on second medical use patents with Swiss-type claims (and EPC 2000 claims), the Supreme Court held that the purpose given to the product (the drug), that is, the purpose claimed in such second medical use patent, is “an essential element of the invention” of the second medical use patent. Hence, a manufacturer of a generic drug can also indirectly infringe the second medical use patent, if he supplies, or offers to supply, the drug to persons not entitled to work the invention and where he knows, or should know given the circumstances, that the drug is suitable and intended for the patented second medical indication.

Indirect patent infringement in general
With regard to indirect infringement in general, the Supreme Court – following MSD’s line of argument – went on to “reinterpret” its long-standing case law: the Senseo decision (from 2003). The Supreme Court held that the Senseo decision should only be read in light of the debate between the parties in the Senseo case. The decision should not be read as requiring that only elements of a patent claim, let alone only elements of the characterising part of a claim, can form “means relating to an essential element of the invention”. What is understood by “means relating to an essential element of the invention” requires construction of a patent. In general – following case law of the German Bundesgerichtshof – those means must be capable of serving the concept of the invention, that is, what the invention is based on, and must contribute to the realisation of the teachings in the patent. The judge may in this respect also take the ratio of indirect infringement into account: preventing third parties from directly making unauthorised use of the invention by supplying unprotected material.

Click here for an English translation of the Supreme Court’s ruling, and here for the Dutch version.