Dutch Supreme Court in Merck v Teva holds that second medical use claims can be directly and indirectly infringed, no matter the type

They look a little different, but the Dutch Supreme Court
says that they should be treated just the same  

Yesterday afternoon, the AmeriKat's Dutch friend, Professor Tobias Cohen Jehoram (De Brauw Blackstone Westbroek) sent her, hot of the press, a copy of the Dutch Supreme Court's decision in Merck Sharp & Dohme v Teva delivered yesterday morning. The case concerned the use of ribavirin for the manufacturer of  a pharmaceutical composition for treating a specific sub-group (the G1N-subgroup) of HCV patients suffering with chronic hepatitis.  The Court held that second medical use claims can be directly and indirectly infringed and that there should be no distinction in the treatment as between the type of second medical use claims in issue - be it Swiss-type or EPC 2000.  

Although the English version of the decision is forthcoming (the AmeriKat will post it once it is ready), Tobias (who handled the Supreme Court litigation for Merck) helpfully provided a rough translation of some of the main extracts and summarized some of the key points as follows: 

• The standard applied for direct infringement is that "a producer or trader only directly infringes a Swiss type claim patent if he foresees or should foresee that the generic drug produced or offered by him will consciously be used for the treatment on which the patent reads. For that is it required that the average man skilled in the art will, on the basis of the SmPC or label, or other circumstances of the case, assume that the drug is intended or suitable (or also intended or suitable) for that treatment. The producer or trader will then have to take all effective measures that can reasonably be requested from him, to avoid that his product will be provided for the patented second medical indication. Only having a carve out in the SmPC and label of the generic drug – like in the case at hand- is generally not sufficient to exclude direct infringement." (emphasis added)

• The standard applied for indirect infringement is that "the producer of a generic drug can indirectly infringe a Swiss-type claim patent that reads on a second medical indication, which is the case if he offers or delivers the generic drug to people who have no license to apply the patented invention, while he knows, or it should be obvious to him given the circumstances of the case, that the drug is suitable for and will be used for the patented second medical indication."(emphasis added)

• In it's obiter dicta goes on to its own Senseo-ruling.  According to the Supreme Court, the Senseo-case should not be understood as requiring that only elements of a claim or elements of the characterizing part of a claim can form "means relating to an essential element of an invention." The specific wording in this ruling should (only) be seen against the background of the specific debate between the parties in the Senseo-case. Determining what "means relating to an essential element of the invention" means requires construction of the patent in suit (which is a factual assessment). A hard rule in this respect cannot be found in national or international case law or literature. It follows however from case law of the Bundesgerichtshof (from 4 May 2004) that the means should contribute to the "concept of the invention" - "that on which the invention is based" - and should contribute to realizing the teachings of the patent. In making his assessment the judge should also take into account the "ratio of indirect infringement": prohibiting third parties from directly unlawfully using the invention through the supply of unpatented means.

The rough translation of a key extracts on direct and indirect infringement applying to second medical use claims (as referred to above) is as follows:

"3.4.4 It should be accepted that a producer or trader only directly infringes a Swiss type claim patent if he foresees or should foresee that the generic drug produced or offered by him will consciously be used for the treatment on which the patent reads. For that is it required that the average man skilled in the art will, on the basis of the SmPC or label, or other circumstances of the case, assume that the drug is intended or suitable (or also intended or suitable) for that treatment. The producer or trader will then have to take all effective measures that can reasonably be requested from him, to avoid that his product will be provided for the patented second medical indication. Only having a carve out in the SmPC and label of the generic drug – like in the case at hand- is generally not sufficient to exclude direct infringement. 

3.4.5 As follows from the considerations in 3.4.4. above, in order to find (direct) infringement, it is in all cases involving Swiss type claims necessary, but also sufficient, that the average man skilled in the art will assume that the drug is intended or suitable (or also intended or suitable) for the treatment to which the second medical indication patent reads, the producer or trader foresees or should foresee that the generic drug produced or offered by him will consciously be used for that treatment, and he fails to take the measures described under 3.4.4. In the system of the EPC there is no room for an abstract, categorical distinction between both types of second medical indication patents, as the Court of Appeal made (…). (emphasis added)

3.6.3 Against the background of the reason behind accepting Swiss type claim patents, as well as in light of the possibility, introduced with the 2000 revision of the EPC, to use a product based substance or composition claim in order to protect a second medical indication, the reasonable protection of the patent holder prescribed by Art 1 of the Protocol justifies accepting that one can indirectly infringe a Swiss type claim in the same way it can be done on a claim according to Art 54 par 5 EPC. (emphasis added)

3.6.4 In case of a product based substance or composition claim, the use given to the product (drug) is an 'essential element of the invention' as referred to in art 73 DPA. The above means that also the producer of a generic drug can indirectly infringe a Swiss type claim patent that reads on a second medical indication, which is the case if he offers or delivers the generic drug to people who have no license to apply the patented invention, while he knows, or it should be obvious to him given the circumstances of the case, that the drug is suitable for and will be used for the patented second medical indication. That by doing so he can infringe the patent both directly and indirectly, does not stand in the way of this."

It is interesting to compare the forseeability language from the Dutch Supreme Court and with that of the Court of Appeal in Warner-Lambert (see IPKat post here). For an earlier excellent analysis of the earlier Dutch decisions in this and the Novartis/Sun case (with reference to the Warner-Lambert decisions), check out another IPKat friend, Rik Lambers' (Brinkhof) post on Kluwer here.  Look out for more analysis to come.