Novartis AG v. Sun Pharmaceutical Industries (Europe) BV, preliminary injunction case before the District Court of The Hague, the Netherlands, 12 May 2014, case number C/09/460540 / KG ZA 14-185
A predecessor of Novartis invented the biphosphate zoledronic acid, used for oncological medications. Novartis created a product with zoledronic acid as the active ingredient, which it markets under the name Zometa®.
Zoledronic acid was protected until 16 May 2013 by European Patent EP275821 and the corresponding supplementary protection certificate 300058. Currently, Novartis markets Aclasta®, which also contains zoledronic acid as the active ingredient.
Novartis also owns parts of the European Patent EP1296689 ('EP 689') for a “Method of administering bisphosphonates”, filed 18 June 2001, invoking priority from US 597135, filed 20 June 2000 ('US 135') and US 267689, filed 9 February 2001 ('US 689').
On 29 July 2013, Sun was granted a market authorisation by the Dutch medicines evaluation board ("CBG") for generic zoledronic acid, for the treatment of osteoporosis and Paget's Disease. For its application, Sun referred to Aclasta® as the reference product. On 26 August 2013, Sun requested that the indication osteoporosis be removed ("carved out") from the SmPC, which was done the next day, but for policy reasons, the indication was not removed from the online information leaflets available from the CBG website.