On 3 November 2017, the Dutch Supreme Court (Hoge Raad) handed down a landmark decision on the infringement of second medical use patents in the Merck Sharp & Dohme Corp. (“MSD”) v. Teva Pharma B.V. and Pharmachemie B.V. (“Teva”) case relating to MSD’s Swiss type second medical use patent protecting a combination therapy of ribavirin and interferon alpha for a specific group of hepatitis c patients.

The Supreme Court held that a manufacturer or seller of a generic product directly and indirectly infringes a Swiss type second medical use claim if it is reasonably foreseeable that the generic product will be used intentionally for the patented use. The Supreme Court further held that second medical use claims relating to a ‘new’ patient subgroup convey the same protection as second medical claims relating to a ‘new’ indication. The Supreme Court also held that a reasonable protection for the patentee justifies that indirect infringement of Swiss type claims is possible in the same way as an EPC 2000 claim, as there is no real difference between the two. One can at the same time directly and indirectly infringe a Swiss type claim, according to the Supreme Court.

Background

MSD is the owner of EP 0 956 861 (“EP 861”). EP 861 protects a combination therapy of ribavirin and interferon alpha for a specific group of hepatitis c patients. The claims of EP 861 are drafted in Swiss type format.

Teva had introduced a generic ribavirin product on the Dutch market. The product was accompanied with a skinny label, in which the indication according to the combination therapy of EP 861 had been carved out. There was no disagreement between the parties that there was a substantial market for both a ribavirin therapy according to EP 861 and for a ribavirin therapy that was not protected by EP 861 (or by any other patent).

On 11 December 2009, MSD instituted proceedings against Teva seeking, amongst other things, a permanent injunction against Teva on the basis of EP 861. Teva filed a counterclaim seeking a declaration of non-infringement. Teva also filed a conditional counterclaim seeking the revocation of EP 861. That claim was only filed in case Teva was held to infringe EP 861.

On 10 November 2010, the District Court of The Hague denied the claims of MSD and granted the declaration of non-infringement. On 14 July 2015, the Court of Appeal of The Hague confirmed the first instance decision by making an abstract, categorical distinction between second medical use patents relating to a product for the treatment of a ‘new’ indication and second medical use patents relating to a ‘new’ patient subpopulation. The District Court and the Court of Appeal did not have to deal with validity, as they both held that Teva did not infringe EP 861. MSD lodged an appeal against the decision of the Court of Appeal before the Supreme Court.

Legal test

Direct infringement

The Supreme Court held that there is no room for an abstract, categorical distinction between second medical use patents relating to a product for the treatment of a ‘new’ indication and second medical use patents relating to a ‘new’ patient subpopulation under the legal framework of the European Patent Convention.

The Supreme Court held that a manufacturer or seller of a generic product directly infringes a Swiss type second medical use claim if it is reasonably foreseeable that the generic product will be used intentionally for the patented use.

This requirement is satisfied, according to the Supreme Court, if the skilled person will assume that the product is intended or suitable (or also intended or suitable) for the patented treatment on the basis of the SmPC, PIL or other circumstances of the case. If this is the case, the manufacturer or seller will have to take all effective measures that can reasonably be requested to prevent that the product will be provided for the patented second medical use.

The Supreme Court held that in the present case it generally cannot be considered sufficient to merely carve out the patented second medical use in the SmPC or PIL to escape direct infringement. The Supreme Court held that for finding direct infringement of Swiss type second medical use claims it is sufficient that:

a. the skilled person would assume that the product is intended or suitable (or also intended or suitable) for the patented use;

b. the manufacturer or seller reasonably foresees that the product will intentionally be used for the patented second medical use; and

c. the manufacturer or seller fails to take all effective measures that can reasonably be requested to prevent the product from being used for the patented second medical use.

Indirect infringement

The Supreme Court also held that a reasonable protection for the patentee justifies that Swiss type claims can also be indirectly infringed (in the same way as an EPC 2000 claim).

The Supreme Court held that the patented use protected by Swiss type claims constitutes a ‘means relating to an essential element of the invention’ which is a requirement for finding indirect infringement pursuant to Article 73 Dutch Patent Act. Accordingly, the supplier of a generic product indirectly infringes a Swiss type claim in the event that it is known or reasonably foreseeable that the generic product is suitable and intended for the patented second medical use. This is a clear deviation from an earlier decision of the District Court in The Hague that an indirect infringement of a Swiss type claim would not be possible.

The Supreme Court held that finding direct infringement does not preclude the Court from also finding indirect infringement. Swiss type claims can be infringed both direct and indirectly all at once. In an obiter dictum the Supreme Court provided guidance on its previous case law on indirect infringement. The Supreme Court held that not only elements of a claim or elements of the characterizing part of a claim can constitute ‘means relating to an essential element of an invention’. Instead, the assessment of a ‘means relating to an essential element of the invention’ requires construction of the patent and is closely linked to the assessment of facts of a case. By doing so, the Supreme Court overturned its own ruling in Sara Lee v Integro in which it said that a ‘means relating to an essential element of the invention’ is the element which distinguishes the patent from the prior art. The Supreme Court noted that the specific wording in the Sara Lee v Integro decision should be interpreted within the context of the arguments between the parties.

Comment

The decision handed down by the Dutch Supreme Court in the MSD v Teva (ribavirin) case is a landmark decision in Dutch patent law. It provides very helpful guidance on the infringement of Swiss type claims. The decision makes clear that inventions protected by patents with Swiss type claims are entitled to a fair protection, just like any other patent.

MSD is represented by Bert Oosting and Klaas Bisschop of Hogan Lovells. Tobias Cohen Jehoram and Vivian Rörsch of De Brauw Blackstone Westbroek also represented MSD for the Supreme Court proceedings.