Sun Pharmaceutical Industries v Novartis (HR, 15/01813, 2017)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Supreme Court of the Netherlands (Hoge Raad) dismissed Sun’s appeal against the judgment of The Hague Court of Appeal of 27 January 2015 which, in interim proceedings, had prohibited Sun from indirectly infringing Novartis’s patent on spaced intravenous administration of zoledronic acid for osteoporosis (paras 3.2 and 4). It stressed that whether a Swiss-type claim can be indirectly infringed at all, as the Court of Appeal had assumed, was not before it (para 3.3(a)). It did, however, endorse what had been required of the generic company: knowing that its product would almost inevitably be dispensed for the patented indication, it had to show what it had done to prevent this, and a carve-out plus an email to wholesalers and hospital pharmacies was not enough (para 3.5.2). The judgment bears directly on skinny label generic launches against second medical use patents.

Facts and procedure

Novartis markets Aclasta, a 5 mg/100 ml zoledronic acid solution given once a year for osteoporosis and also authorised for Paget’s disease (para 3.1(iv)). The active ingredient was protected until 16 May 2013 by EP 275 821 and a supplementary protection certificate (para 3.1(iii)). Novartis holds EP 1 296 689, limited in central EPO proceedings, whose Swiss-type claims cover periodic intravenous administration for osteoporosis at intervals of at least about six months (para 3.1(v) and (vi)). Sun obtained a marketing authorisation for a generic on 29 July 2013 and asked for osteoporosis to be carved out of its SmPC and leaflet, but the policy of the Dutch medicines authority (CBG) kept the indication in the version published online (para 3.1(vii) and (viii)). Sun won a tender run by the health insurer VGZ which did not distinguish between indications (para 3.1(x)). The interim relief judge dismissed Novartis’s claims; the Court of Appeal granted them subject to penalty payments (para 3.2).

The applicable law

Section 73(1) of the Dutch Patents Act 1995 (ROW 1995) defines indirect infringement (para 3.5.2). A priority claim requires the priority document, read as a whole, to disclose the claimed invention directly and unambiguously to the skilled person using common general knowledge, following opinion G 2/98 of the EPO Enlarged Board of Appeal (para 3.4.3). Enforcing a patent restricts competition, but that restriction is justified unless, in the circumstances, enforcement breaches competition law (para 3.6.2).

Question

Was priority validly claimed, and does a generic company which must know that its product will be dispensed for the patented indication indirectly infringe if it fails to take effective measures to prevent this?

Decision

On priority, the Court of Appeal applied the correct test: the skilled person could read a degree of extrapolation into the example of a 4 mg annual dose, and this did not amount to a lax application of the test (para 3.4.3). On infringement, the Court of Appeal had found it all but impossible that Sun’s product would not be dispensed for osteoporosis; assuming that a Swiss-type claim can be indirectly infringed, the requirements of Section 73 ROW 1995 were met (para 3.5.2). It is not for the court to specify the measures a generic company should have taken; the company must show what it did to prevent infringement, and Sun was criticised only for failing to use the options available to it (para 3.5.2). The competition law complaint failed: any hindrance to sales for Paget’s disease was attributable to the insurer’s policy, not to Novartis (para 3.6.4). The injunction does not extend to third party acts that Sun cannot prevent, and Sun had not argued that it would be wholly ineffective (para 3.7.2). Sun was ordered to pay the costs of the appeal, fixed at EUR 90,000 (para 4).

Key points for practice

• The question of principle whether a Swiss-type claim can be indirectly infringed was left outside the cassation debate (para 3.3(a)).
• A generic company that must know its product will reach the patented indication has to prove the steps it took to prevent this; the court need not define them (para 3.5.2).
• An insurer’s tender that ignores the indication does not make the injunction contrary to competition law (para 3.6.4).
• Practical point: a carve-out and a bare notice to wholesalers are not enough; the generic company must be able to document concrete steps aimed at those who prescribe and dispense the product (para 3.5.2).

Provisions applied

European Patent Convention

Art. 105a

National law

Section 73 ROW 1995; Article 81(1) of the Judiciary Organisation Act (RO); Articles 419(2) and 1019h Rv

Case law cited

EPO, Enlarged Board of Appeal, G 2/98; ECJ, 8 June 1971, 78/70 (DGG v Metro); HR, 24 April 2015, ECLI:NL:HR:2015:1128; Rechtbank Den Haag, 25 November 2015, ECLI:NL:RBDHA:2015:14337, and 5 April 2017, ECLI:NL:RBDHA:2017:3430

Related decisions

• G 2/98, EPO Enlarged Board of Appeal, 31 May 2001, opinion cited for the same invention test for priority (para 3.4.3).

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.