Priority and indirect infringement of second medical use claims: when the Sun shines in the Netherlands

Last month, at the International Trademark Association (INTA) Meeting in Hong Kong, this blogger had the pleasure of an encounter with Jaap J.E. Bremer and his colleague Marleen van den Horst (both of the Dutch firm of BarentsKrans N.V.). There, in that undoubtedly trade mark-friendly environment, we discussed a case that Jaap and Marleen were involved in before the Provisions Judge of the District Court, The Hague, regarding indirect infringement of a second medical use patent and the validity of priority claims (among other things). The decision in this action has since been handed down and Marleen and Jaap have kindly treated PatLit readers to the tale of its outcome. As Jaap explains:

Zoledronate

"The case concerns Novartis’ patent EP 1 296 689 for a “Method of administering bisphosphonates”. It claims, inter alia, a dosage regime (2-10 mg once yearly) of the active substance zoledronic acid / zoledronate, administered intravenously for the treatment of osteoporosis. The Dutch litigation between Novartis and Sun Pharmaceuticals runs parallel to the case in England and Wales between Hospira & Generics UK (Mylan)/Novartis that was reported here on the IPKat weblog not too long ago. Marleen and I represented Sun.

Sun had obtained a marketing authorisation for generic zoledronate for the treatment of Paget’s disease and osteoporosis. The use of zoledronate for the treatment of Paget’s disease was not patent-protected. Sun had requested that the indication osteoporosis be removed ("carved out") from the Summary of Product Characteristics and patient leaflet of its product. In October 2013, Sun participated in a public tender by Dutch health insurance company VGZ, which it won. VGZ's tender conditions did not allow specification of the indication.

Novartis alleged that Sun's generic product (in)directly infringed EP 689. It started preliminary injunction proceedings against Sun, seeking an order (a) to stop it selling generic zoledronic acid to the extent that Sun knew or had reasonable grounds to suspect that its product would also be used to treat osteoporosis, and (b) to stop Sun participating in tenders, unless those tenders would allow designation of the product for Paget's disease only.

Sun disputed the allegations of (in)direct infringement and the orders requested by Novartis. In addition, Sun argued that EP 689 was invalid for lack of novelty over the Reid publication as Sun contested that Novartis was entitled to its priority claims. The PI judge of the District Court in The Hague held that the priority right was most likely invalid, since the priority document US 689 did not directly and unambiguously disclose the combination of intravenous use and the dosage range of "2 up to about 10 mg". The PI judge referred to the decision of the courts of England and Wales. The PI judge found that there was a serious, non-negligible chance that the patent would not survive invalidity proceedings on the merits (the validity test in Dutch preliminary injunction cases), rejected Novartis’ claims and ordered Novartis to pay Sun's costs The PI judge did not rule on the other grounds of invalidity, as presented by Sun, nor on the issue of (in)direct infringement".

Thanks to Marleen and Jaap, we also have an unofficial English translation of the Dutch decision of 12 May 2014. You can read it online here or download it here.