Zoledronic acid - Netherlands

On Apr 14, 2017, The Supreme Court of the Netherlands issued preliminary injunction based on infringement of Swiss-type claim & ordered Sun pharma to pay the cost to Novartis.

Sun has appealed against the judgments of the lower court in C / 09/460 540 / KG ZA 14-185 & 200 150 713/01 cases.  Novartis decided to dismiss the appeal and order the Sun in the proceedings on the basis of art. 1019h Rv. Novartis also seeks statutory interest on the costs to be allocated, starting fourteen days after the verdict.

Novartis is the holder of European patent EP 1296689 (hereinafter also referred to EP 689 or the patent) for a "Method of Administering bisphosphonates". EP 689 is granted on an application of June 18, 2001, relying on the priority document US 597,135 of 20 June 2000 (hereinafter referred to as: US 135) and US 267 689 of February 9, 2001 (hereinafter referred to as: US 689).  Sun has its generic zoledronic acid 5 mg / 100 ml of the inclusion in the G-standard of the Z-index company. The product has been marketed in the Netherlands.

This interim relief seeks Novartis (among others) to ban (indirect) violation of EP 689 and an order to all insurance companies have issued a tender related to zoledronic acid 5 mg / 100 ml or intend to do so and all Sun parties with which an agreement on the matter has closed or which for this purpose Sun approach, to inquire about the conviction for patent infringement, and the fact that only Sun zoledronic acid 5 mg / 100 ml may provide for the treatment of Paget's disease.

With respect to correct priority issue, if priority is invoked, it should be investigated whether the priority document viewed in its entirety directly and unambiguously discloses the claimed invention to the man skilled in the art, who uses his common general knowledge. The Court of Appeal applied that correct standard. The Court of Appeal further correctly held that – taking as a starting point that indirect infringement of a ‘Swiss-type claim’ is legally possible – under the circumstances at hand the requirements of indirect infringement are met.

With respect to the indirect infringement of Swiss type claims, a producer needs to make an effort to prevent its product being prescribed in the patented indication, even if it is not within its power to prevent infringement in the distribution chain in its entirety. This should not withhold a Court of Appeal from issuing an injunction, as an injunction does not extend to actions of third parties the producer cannot prevent. An injunction which also limits trade in the non-patented indication, does not amount to a violation of competition law.

Now the Sun fails in its entirety, the action must be dismissed. Sun to pay the costs of the proceedings in cassation, estimated up to this judgment on the part of Novartis at € 90.000, - plus statutory interest on those costs if the Sun has not paid within fourteen days from today.