Merck Sharp & Dohme v Teva Pharma (HR, 15/04934, 2017)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Supreme Court of the Netherlands (Hoge Raad) set aside the judgment of The Hague Court of Appeal of 14 July 2015, which had rejected any infringement by Teva’s generic ribavirin of a second medical use patent directed to a subgroup of hepatitis C patients, and remitted the case (para 4). It rejected any distinction in principle between a classic new indication and a subgroup indication: for every Swiss-type claim, direct infringement requires, and is established where, the skilled person understands the product to be (also) intended or suitable for the patented treatment, the manufacturer foresees or must foresee its deliberate use for that treatment, and it fails to take the effective measures that can reasonably be expected of it (paras 3.4.4 and 3.5). A carve-out alone is generally not enough to rule out direct infringement (para 3.4.4). A Swiss-type claim can also be indirectly infringed (para 3.6.3).

Facts and procedure

Prior patent Grint (EP 0 707 855) disclosed ribavirin combined with interferon alpha without distinguishing genotypes (para 3.1(ii)). MSD holds EP 0 956 861, whose Swiss-type claim 1 covers 40 to 50 weeks of treatment for naive patients infected with genotype 1 and a viral load above 2 million copies per ml; the patent was upheld unamended after opposition and appeal (para 3.1(iii) and (iv)). In 2009 Teva obtained central marketing authorisations for generic ribavirin whose SmPC excludes naive genotype 1 patients in sections 4.1 and 4.2 (para 3.1(vii) and (ix)), and launched its tablets in the Netherlands in 2011 (para 3.1(xi)). The Hague District Court and then the Court of Appeal rejected infringement, the latter confining the protection of a subgroup patent to cases where the third party specifically indicates that the product is intended for the subgroup (paras 3.2.2 to 3.2.5).

The applicable law

Swiss-type claims, allowed by the EPO Enlarged Board of Appeal in 1984, are purpose-limited process claims whose protection extends to directly obtained products (Article 64(2) EPC); since the introduction of Article 54(5) EPC they are no longer allowed for new applications (G 2/08), without retroactive effect (para 3.4.2). Scope of protection is governed by Article 69 EPC and its Protocol (para 3.4.3), indirect infringement by Section 73 of the Dutch Patents Act 1995 (ROW 1995) (para 3.6.2). Article 11 of Directive 2001/83 allows patented indications to be left out of a generic’s SmPC (para 3.1(vi)).

Question

Does the scope of protection of a subgroup patent differ from that of a classic second medical use patent, and can a Swiss-type claim be indirectly infringed?

Decision

Through Article 64(2) EPC, a Swiss-type claim would otherwise reach manufacture for the first indication after the patent covering it has expired, which would conflict with the freedom to use expired teaching and with Article 69 EPC; hence the test for direct infringement (para 3.4.4). That test applies to all Swiss-type claims: the categorical, abstract distinction drawn by the Court of Appeal has no place in the EPC system (para 3.5). On indirect infringement, the reasonable protection for the patentee required by Article 1 of the Protocol justifies accepting it for Swiss-type claims on the same footing as for claims under Article 54(5) EPC, as held by the German Federal Court of Justice (X ZR 29/15) and the UK Supreme Court ([2017] UKSC 48) (para 3.6.3). A generic manufacturer may therefore infringe indirectly if it supplies the medicine to persons not entitled to use the invention, knowing, or it being obvious in the circumstances, that it is suitable and will be intended for the patented indication; the same conduct may amount to both direct and indirect infringement (para 3.6.4). For the remitted proceedings, the 2003 Senseo judgment does not confine means relating to an essential element of the invention to elements of the claims (para 3.6.6).

Key points for practice

• A single test for direct infringement applies to all Swiss-type claims, subgroup claims included (paras 3.4.4 and 3.5).
• A Swiss-type claim can be indirectly infringed, including by the generic manufacturer itself (paras 3.6.3 and 3.6.4).
• Practical point: a generic company launching with a skinny label must document the effective steps taken to keep its product away from the patented indication, since leaving the indication out of the SmPC is not on its own a sufficient defence (para 3.4.4).

Provisions applied

European Patent Convention

Art. 53(c); Art. 54(1), (4) and (5); Art. 64(2); Art. 69

Protocol on the Interpretation of Article 69 EPC

Art. 1

Directive 2001/83/EC

Arts 6, 8, 10 and 11

Vienna Convention on the Law of Treaties

Arts 31 and 32

National law

Sections 4, 53 and 73 ROW 1995; Article 1019h Rv

Case law cited

EPO, Enlarged Board of Appeal, G 1/83, G 5/83 and G 6/83; EPO, Enlarged Board of Appeal, G 2/08; BGH, 14 June 2016, X ZR 29/15; UKSC, [2017] UKSC 48; HR, 14 April 2017, ECLI:NL:HR:2017:692; HR, 5 February 2016, ECLI:NL:HR:2016:196 (Bayer/Sandoz); HR, 31 October 2003, ECLI:NL:HR:2003:AI0346 (Senseo); Gerechtshof Den Haag, 27 January 2015, 200.150.713/01 (Novartis/Sun)

Related decisions

• Sun v Novartis, Hoge Raad, 14 April 2017, cited on the measures expected of a generic company (para 3.4.4).
• Pemetrexed, BGH, 14 June 2016, cited on indirect infringement of Swiss-type claims (para 3.6.3).
• Actavis v Eli Lilly, UK Supreme Court, 12 July 2017, cited on the same point (paras 3.6.3 and 3.6.4).
• G 2/08, EPO Enlarged Board of Appeal, 19 February 2010, cited on the end of Swiss-type claims (paras 3.4.2 and 3.6.3).

Prepared by Dhenne Avocats from the text of the decision (rechtspraak.nl, Dutch text), consulted on 11 October 2026. Only the official text is authoritative.