The mere circumstance of a carve-out not sufficient to rule out direct infringement of the second medical indication. Distinction drawn by the Appellate Court in the scope of protection of ‘classic second medical indication’ and ‘sub-group indication’ is incorrect. Direct infringement of Swiss-type claims if: 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, 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 to prevent his product from being dispensed for the patented second medical indication. Indirect infringement of Swiss-type claims possible on the same basis as for a claim in accordance with Article 54(5) EPC: if the manufacturer supplies or offers 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. Explanation concept of ‘means relating to an essential element of the invention’ as specified in section 73(1) DPA 1995: pertains not only an element in the patent claims, let alone in that part of the claims containing a description of how the invention differs from the prior art, 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, and in each individual case 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.
Appeal against the judgment of the Appellate Court of The Hague of 14 July 2015, in which it ratified the judgment of the District Court of The Hague of 10 November 2010 that Teva was not indirectly or directly infringing EP 861. This patent concerns a second medical indication patent for the use of the combination of interferon alpha and ribavirin for the treatment of Hepatitis C.
The first cassation ground contests that the distinction drawn by the Appellate Court between the ‘classic second medical indication’ and ‘sub-group indication’ is incorrect. The Supreme Court considered that a manufacturer or seller only infringes a patent with a Swiss-type claim when he foresees or ought to foresee that the generic drug he manufactures or offers will intentionally be used for that treatment for the patented second medical indication. This requires that the average person skilled in the art, on the basis of the SmPC and/or the product information leaflet, will consider that the substance is (also) intended for or suited to that treatment. The manufacturer or seller will then have to take all effective measures that can reasonably be required of him to prevent his product from being dispensed for the patented second medical indication. The mere circumstance of a carve-out in the SmPC and product information leaflet of the generic drug – as in the present case – is, according to the Supreme Court, generally not sufficient to rule out direct infringement. The NLSC refers to to the Sun v Novartis case (April 2017). Against this background it is considered 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’ is an incorrect distinction. 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 to prevent his product from being dispensed for the patented second medical indication.
Cassation ground 3 contests the findings of the contested judgment, where the Appellate Court investigated whether Teva was indirectly infringing EP 861 and where it appeared that the Appellate court was proceeding on the assumption that an indirect infringement of a Swiss-type claim was conceivable. The Supreme Court considered that 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, 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.
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. According to the Supreme Court, it is not an objection to this that he can therefore both directly and indirectly infringe such a patent.
With a view to the disposal following referral, the Supreme Court notes that the decision in SC 31 October 2003, (‘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. The Supreme Court refers to 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.
