Posted: June 2nd, 2014
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.
In October 2013, Sun participated in a public tender by health insurance company VGZ, which it won, meaning that its generic zoledronic acid is the only one the use of which will be reimbursed by VGZ. VGZ's tender conditions did not allow the limitation to any specific indications.
Novartis alleged that Sun's generic product infringed EP 689 and started preliminary injunction proceedings against Sun in order to stop it selling generic zoledronic acid in any case where Sun knows or has reasonable grounds to suspect that the procut will be used to treat osteoporosis, and to stop Sun participating in tenders unless those tenders are limited to Paget's disease.
Urgency is a given in matters of continuing IP infringement under standing Dutch case law, so the alleged infringement provided sufficient urgency.
Sun argued that EP 689 was invalid for lack of novelty over the Reid publication, while Novartis held that Reid was published after the priority date. However, the Court found that the priority right was most likely invalid, since the priority document US 689 in the opinion of the Court did not directly and unambiguously disclose the combination of intravenal use and the dosage range of "2 up to about 10 mg". As such, there was a serious, non-negligable chance that the patent would not survive proceedings on the merits (the validity test in Dutch preliminary injunction cases). The fact that the English courts (after extensive cross-examination of expert witnesses) found that claim 7 of the patent was invalid on comparable grounds, did not help Novartis' case.
Since there was a serious, non-negligable chance that the patent would not survive proceedings on the merits, the Court saw no reason to rule on infringement, rejected the claimed relief and ordered Novartis to pay Sun's costs of EURO 256.145,96.
Read the decision (in Dutch) here.
Head note: Maurits Westerik