Posted: November 14th, 2017
Merck Sharp & Dohme Corp. v. Teva Pharma B.V. and Pharmachemie B.V., Supreme Court of The Netherlands, The Hague, 3 November 2017, Case no ECLI:NL:HR:2017:2807
The Supreme Court holds that indirect infringement of a Swiss type claim is possible. A Swiss-type claim is in the form of a purpose bound method claim. If such a claim is read to the letter it could, according to the Supreme Court, be argued that an intermediary dealing in a pharmaceutical composition does not indirectly infringe. After all, he does not deliver means that can be used in the claimed method on use of a substance for the making of that pharmaceutical composition for the treatment of a disease.
However, according to the Supreme Court, against the background of allowing Swiss-type claims – i.e. circumvention of the exclusion of patentability of therapeutic treatment methods –, and against the fact that under the current EPC2000 it is possible to claim a second medical use in the form of a purpose bound product claim, the reasonable protection that must be awarded to a patentee under Article 1 of the Protocol on Article 69 EPC justifies that indirect infringement can be made on a Swiss-type claim, in the same manner as on an EPC 2000 purpose bound product claim. The Supreme Court points to BGH 14 June 2016 (Eli Lilly) and UKSC 12 July 2017 (Eli Lilly) in support of this.
The Supreme Court also decided on the evidentiary threshold for proving direct infringement on a Swiss-type claim. According to the Supreme Court, a manufacturer or trader is only liable for direct infringement if he foresees or must foresee that the pharmaceutical composition that is manufactured or offered by him will be consciously used in the treatment to which the second medical use claim relates. For this it is required that there a circumstances, such as the content of the SmPC or PIL, on the basis of which it can be held that the pharmaceutical composition is (also) suitable and intended for the patented treatment. If this is the case, the manufacturer or trader must take all effective measures that can reasonably be asked of him, in order to prevent that his product will be delivered for the patented second medical indication. A carve out as such is not sufficient in this respect.
Finally, the Supreme Court clarifies the meaning of “essential element” in the context of the indirect infringement rule. It had held in an earlier case (Supreme Court 31 October 2003, Senseo) that the meaning of an “essential element” is restricted to those elements with which the invention distinguishes itself from the prior art.
This seemingly very strict approach was heavily criticized. The Supreme Court clarifies that its considerations in Senseo were intricately linked to the facts and circumstances in that case. In more general terms the means must, according to the Supreme Court, attribute to the concept of the invention and to that on which the invention is founded, and attribute to accomplishing the teaching of the patent. In deciding on this, the lower Courts may include the question if the means fulfill such a role in the application of the teaching of the patent that the ratio of the indirect infringement-figure is met: to prevent that third parties make illegitimate direct use of the invention by the delivery of (unprotected) means.
A copy of the Supreme Court decision can be read here.
A copy of the opinion of the advocate general can be read here. The opinion was followed.
A copy of the decision of the Court of Appeal can be read here.
Headnote: Geert Theuws, HOYNG ROKH MONEGIER