Now available!: English translation of Dutch Supreme Court decision in MSD v Teva highlights UK Supreme Court's Actavis decision

The AmeriKat is no longer in the dark about what
the Dutch Supreme Court were saying in
MSD v Teva

Thanks to a wonderful Kat friend, readers can now benefit from the translation of the recent Dutch Supreme Court's decision in MSD v Teva (as reported here).   You can access the document here.

As a reminder 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.

The relevant extracts previously referred to in the AmeriKat's post are now set out below:

"Extent of protection of Swiss-type claims

Direct infringement

3.4.4 The difficulty arises with a patent containing a Swiss-type claim, which is formulated by its nature as a process claim (see 3.4.2), since as a result of the effect of Article 64(2) EPC or section 53(1) preamble and at b DPA 1995 (cf. above in 3.4.2), the extent of protection would also extend to the manufacture or application of the substance for the first medical indication if that patent has expired. This would be incompatible with the principle underlying patent law to the effect that anyone is at liberty to apply the doctrine of a patent that is no longer in effect, and also with the principle expressed in Article 69 EPC that the extent of protection of a patent should not extend beyond what is justified by the invention. For this reason, it must be assumed that a manufacturer or seller will only then directly infringe a patent with a Swiss-type claim if he foresees or ought to foresee that the generic substance he manufacturers or offers will intentionally be used for treatment covered by the second medical indication patent. This requires that the average person skilled in the art, on the basis of the SmPC and/or the product information leaflet or some other circumstance, 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 generally not sufficient to rule out direct infringement. (Cf. Supreme Court 14 April 2017, ECLI:NL:HR:2017:692, NJ 2017/296, para. 3.5.2).

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.

Indirect infringement 

. . . . 

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."

The AmeriKat was specifically struck by this comment at para 3.6.3:

"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)." 

So it seems, the Actavis v Lilly ripple effect (although on a different point) is definitely being felt far and wide, including in the Dutch Supreme Court.