In the Dutch saga of the cross-border legal dispute between Novartis and Sun regarding commercialisation of zoledronic acid for treating osteoporosis, the Hague District Court in proceedings on the merits ruled in a verdict of April 5 2017 (ECLI:NL:RBDHA:2017:3430) that Sun directly infringes a Swiss-type medical use claim in European patent 1 296 689 B3, owned by Novartis.
It is the general opinion that Swiss-type medical use claims are in the category of claims directed to methods for manufacturing medicaments. In its decision, the District Court argued that the phrasing "for (the treatment of)" in the Swiss-type medical use claim at issue encompasses a mental element, namely knowledge of the fact, or foreseeability, that the manufactured zoledronic acid is to be marketed for the patented indication, namely treatment of osteoporosis.
Although the generic zoledronic acid was produced in India by a company in the Sun concern, the District Court expressly noted that this might not prevent Sun from literally infringing the Swiss-type medical use claim as a process claim in the Netherlands. The reason is that Sun provided the Indian manufacturer with specific instructions on packaging and patient leaflet information, held a manufacturing/import authorisation and executed product quality control in the Netherlands. Under these circumstances, Sun could potentially be considered a co-manufacturer according to the Court. Nevertheless, the ruling of direct infringement was based on the fact that Sun knew, or could foresee, that the medicament directly obtained by the Swiss-type medical use claim would be commercialised for the patented indication. Interestingly, with this decision, the District Court accepts that a Swiss-type medical use claim also, to some extent, confers purpose-limited product protection.
The mental element was considered to be present, for the reason that (1) Sun's marketing authorisation was inter alia obtained for the patented use, (2) the online SmPC and patient information leaflet did not contain the carve-out for the patented use, (3) the tender of health care insurance company VGZ, which Sun won, did not distinguish between patented and non-patented indications and (4) the size of the market for zoledronic acid, and the sales numbers, were such that it was foreseeable for Sun that the product was also sold for the patented indication.
Carnegieplein 5, 2517 KJ
Tel: +31 70 416 67 11
Fax: +31 70 416 67 99