Zoledronic acid – Netherlands

Zoledronic acid – Netherlands

On Apr 05, 2017, The District Court of Hague delivered judgment in Sun Pharmaceutical Industries (Europe) B.V. v. Novartis AG, Novartis Pharma GmbH case.

Zoledronic acid, 5mg / 100mlis prepared by Sun Pharmaceutical Industries Limited, established in Halol, Gujarat in India (hereinafter: Sun India). Orders are placed worldwide by Sun Pharma Global FZE, United Arab Emirates (hereinafter Sun FZE), which then order with Sun India. Sun also places its orders with Sun FZE. The ordered products are introduced by Sun in the Netherlands and then bring the generic zoledronic acid in Europe, including the Netherlands market. Sun and Sun FZE both indirect subsidiaries of Sun India.

Sun Pharmaceutical Industries (Europe) BV charges since January 2014 its generic product Zoledronic acid 5mg / 100ml in the market for the treatment of Paget’s disease. Sun Pharma supplies its product expressly not for the treatment of osteoporosis, because the indication is protected by a patent from Novartis. This means that Zoledronic acid 5mg Sun / 100ml not allowed to be prescribed / used for osteoporosis. Use of the product for any other purposes is excluded from that patent.

Novartis believes that Sun allows direct infringement of claim 7 of EP 1296689 B3, and proposes to this end in that the infringement is carried out, because – in short -:
(I) Sun it brings (also referred to as direct infringement sub (i)) product directly obtained from the process (the zoledronic acid) in the Netherlands on the market, and it is doing in the knowledge that it is going to be used for the patented indication osteoporosis;
(Ii) Sun the process (co) is used – among other things – now they are the zoledronic acid, in each case in pharmaceutical sense, also prepares, in the sense that they are in accordance with Novartis completes the active substance prepared by Sun India and finish (Sun is responsible the packaging, the package leaflet and SPC as well as testing of the batch and the release of the drug), so that the drug substance in the Netherlands can be marketed her as a manufacturer (hereinafter: direct infringement under (ii) ), while they know the drug for the patented indication osteoporosis is used.
Sun has against this, the following reasons – fed defense – briefly. With respect to the they are not disputed direct infringement in (i) set by Novartis that the product marketed by Sun in the Netherlands has been directly obtained by application by Sun India of the patented process according to claim 7 of EP 689 B3. They argued that only science / predictability of the use of the drug for the patented indication of Sun India as a manufacturer (and not as trader Sun) is important, and at the time of preparation of the generic product Sun India science / foreseeability had not. Moreover, to the extent that knowledge would have existed, Sun and Sun India did all that could reasonably be expected of them to avoid infringement, still according to Sun. With respect to the alleged direct infringement by Novartis under (ii) has argued that Sun does not carry out certain operations and, therefore, cannot be regarded as a processor as defined in claim 7 of EP 689 B3. Sun therefore believes that its no direct infringement of claim 7 of EP 689 B3 may be faulted.

The question then emerges whose knowledge or foreseeability is relevant. The court believes that Sun knew, or at least must have been for her foreseeable that its generic product would be used in the Netherlands deliberately to treat osteoporosis, while not sufficiently done to prevent the use of the patented indication.  Thus Sun has been guilty and it is guilty of direct infringement under (i) in claim 7 of EP 689 B3 (namely, in the Netherlands on the marketing of the product directly obtained from the process).
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