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Sun Pharmaceutical Industries (Europe) B.V. v. Novartis AG, Novartis Pharma GmbH, District Court The Hague, 5 April 2017, Case No. ECLI:NL:RBDHA:2017:3430

The 5 April decision is the final decision in first instance. A previous interim decision was rendered on 25 November 2015 and was published on this blog here.

Sun sued Novartis in main proceedings claiming invalidity of EP 1 296 689 B3. The Swiss-type second medical use claims are (in summary) directed to the use of zoledronic acid in the preparation of a drug for the treatment of osteoporosis. Novartis counterclaimed for infringement arguing that Sun (in)directly infringed the patent.

As for the facts: while Sun had carved the claimed indication out of its SmPC, which left Paget’s decease as the only indication, it was clear from practice that Sun’s product was actually dispensed by pharmacies for treatment of osteoporosis patients.

Novartis had previously asserted the patent in PI proceedings. In its decision of 27 January 2015 the Court of Appeal of the Hague found the patent both valid and indirectly infringed. The Supreme Court appeal against this decision was dismissed by the Supreme Court on 14 April 2017. That decision can be read here.

In the interim decision dated 25 November 2015 the court found Novartis’s patent EP 1 296 689 B3 valid and, other than the Court of Appeal in PI proceedings, ruled that there was no indirect infringement of the Swiss-type claims. The court ruled that there cannot be an indirect infringement as there is no preparation step anywhere in the product chain after Sun delivers its zoledronic acid. With regard to direct infringement the court ordered both parties to file further briefs to specify their position. A further hearing was held on 26 April 2016.

With regard to protection of a Swiss-type claim, the Court in its final decision of 5 April refers to the UK Court of Appeal who interprets the term “for” in a Swiss type claim as a mental element to require that the manufacturer knows or can reasonably foresee the ultimate intentional use for the claimed indication. As both Sun and Novartis had agreed with this interpretation of the term “for”, also the court adopts this interpretation.

Novartis argued that there was direct infringement as (i) Sun offers a product that is directly obtained with the claimed proces in The Netherlands, knowing that the product will be used for the claimed indication and alternatively (ii) Sun uses the claimed process as it co-manufactures the product (Sun is responsible for the packaging, PIL, SmPC and batch testing) of which the active ingredient is made by its affiliate Sun India.

In relation to Novartis’ first direct infringement argument (i) Sun argued that only the knowledge of the actual producer of its zoledronic acid, Sun India, at the time of manufacturing of the active ingredient is to be considered. According to Sun, Sun India had no knowledge/could not foresee that the product would be used for the claimed indication. Sun’s knowledge is irrelevant. In case the court would disagree, Sun argued that both Sun and Sun India had done everything reasonably possible to prevent infringement. With regard to Novartis’ second direct infringement argument (ii) Sun argued that it cannot be considered as manufacturer as it is not involved in the manufacturing process (Sun India is).

The court rules that if Sun should not already be considered as the manufacturer of the generic product, at least Sun’s knowledge/foreseeability, as generic distributor of the product is important next to the knowledge of the actual manufacturer. According to the court a patentee would otherwise not be able to assert its Swiss-type claim against a generic company who orders its active ingredient from a third party and then relies on the fact that the third party did not know/foresee that the product would be used for the claimed indication.

With regard to Sun’s knowledge, the court concludes on basis of the facts that Sun knew, or that it would have been foreseeable for Sun, that its product would be used for the claimed indication. As Sun according to the court had not done everything reasonably possible to prevent the infringing use, the court concludes that Sun directly infringes EP ‘698.

A copy of the judgment can be read here.

Headnote: Mattie de Koning, Simmons&Simmons LLP