Supreme Court of the Netherlands MSD/Teva Pharma (english translation)

Supreme Court of the Netherlands 3 November 2017, IEF 17300; LS&R 1539 (Merck Sharp & Dohme v. Teva Pharma and Pharmachemie; English translation of IEF 17241) Patent. Swiss-type claim. Classic second medical indication.

3.5 Against the background of all of the foregoing factors, cassation grounds 1.1, 1.2 and 1.3 correctly complain that the distinction drawn by the Appellate Court in the scope of protection of patents for the 'classic second medical indication' and the 'sub-group indication', mentioned at 4.2 of the contested judgment, is an incorrect distinction. As follows from the deliberations at 3.4.4 above, it is necessary in all cases of Swiss-type claims for (direct) infringement, and also sufficient, that the average person skilled in the art will consider that the substance is (also) intended for or suited to the treatment covered by the second medical indication patent, that the manufacturer or seller foresees or ought to foresee that the generic drug he manufactures or offers will intentionally be used for that treatment and that he does not take the steps specified above in 3.4.4. There is no place in the system of the EPC for a categorical distinction between the two types of second medical indications, introduced in abstracto, as done by the Appellate Court at the end of 4.4 – in relation to the specifically indicated use. The remaining complaints in cassation ground 1 require no discussion. The same applies to cassation ground 2.

3.6.3 As already held at 3.4.2 above, Swiss-type claims are recognized in order to be able to protect a second medical indication as a patent and they take the form of purpose-limited process claims. It could be argued that, taken literally, there cannot be an indirect infringement of such a patent, for instance by an intermediary, since he would after all not be supplying or offering to supply means that could be used for the process in the manner specified in section 73(1) DPA 1995, consisting of the use of the substance mentioned in the claim for the preparation of a pharmaceutical product. Against the background of the reason that gave rise to recognition of the Swiss-type claims, and also having regard to the possibility available in the EPC since the revision in 2000 of linking a product-bound result claim to a patent for the protection of a second medical indication (Article 54(5) EPC incorporated in the DPA 1995 as Section 4(6)) – a revision that did not intend to break with the patentability of substances or combinations, as developed in case law, by means of a Swiss type claim (see EBoA 19 February 2010, G 0002/08, at 5.10.1-4 and the Preparatory Documents MR/18/00 and MR/24/00 quoted therein) – the reasonable protection of the patent proprietor prescribed by Article 1 of the Protocol justifies accepting that there can be an indirect infringement of a Swiss-type claim, on the same basis as for a claim in accordance with the current Article 54(5) EPC. A finding along the same lines was made by the Bundesgerichtshof (BGH 14 June 2016, no. X ZR 29/15, GRUR 2016/921 (Eli Lilly v Actavis), paras. 83-85). The possibility of an indirect infringement of a Swiss-type claim has also been acknowledged by the Supreme Court of the United Kingdom (UKSC 12 July 2017, no. [2017] UKSC 48 (Actavis v Eli Lilly), paras. 103-112).

3.6.4 This means that, as is the case with a patent containing a claim such as those rendered possible by Article 54(5) EPC, an indirect infringement of a Swiss-type claim is possible. With a purpose-limited product claim, the purpose given to the product (the drug) is after all "an essential element of the invention" as specified in section 73 DPA 1995. The foregoing deliberations mean that the manufacturer of a generic medicine can also indirectly infringe a patent for a second medical indication, namely if he supplies or offers to supply the drug to persons not entitled to work the invention and where he knows or it is obvious given the circumstances, that the drug is suitable and intended for the patented second medical indication. It is not an objection to this that he can therefore both directly and indirectly infringe such a patent. The UKSC has also held, as is apparent from the case law cited at 3.6.3, that the same conduct may amount to both direct and indirect
infringement.

3.6.6 With a view to the disposal following referral, it should further be noted that the decision in SC 31 October 2003, ECLI:NL:HR:2003:AI0346, NJ 2006/600 ('Senseo') should not be understood such that there can only be 'means relating to an essential element of the invention' as specified in section 73(1) DPA 1995, if it concerns an element in the patent claims, let alone in that part of the claims (often introduced with words such as 'characterized in that') containing a description of how the invention differs from the prior art. The formulation of the passage in question must be read in the light of the debate between the parties in that case and the findings made by the Appellate Court on that point. What is understood by 'a means relating to an essential element of the invention' requires interpretation of the patent and is strongly intertwined with assessments of a factual nature. Neither Dutch nor foreign case law and literature provide any clear description in general terms of what is understood by this. It may be inferred from the judgement of the BGH dated 4 May 2004, cited by the Appellate Court at 6.4, as well as the formulation by Benyamini quoted in that case, that the means must be able to serve the concept of the invention, that which the invention is based upon, and must contribute to the realization of the teachings in the patent. In each individual case, based on his interpretation of the patent, the judge must ask himself whether this is the case, which may involve asking whether the contentious means plays such a part in the application of the doctrine in the patent that the ratio behind the existence of the notion of indirect patent infringement is satisfied; in the words of the Advocate-General in his statement for the Senseo judgment (at 3.4), preventing third parties from directly making unauthorized use of the invention through the supply of (unprotected) material.

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