Sandoz SPC challenge unsuccessful at English High Court

The English High Court has concluded that a supplementary protection certificate (SPC) challenged by Sandoz is valid, dismissing the dispute.

The decision, which was handed down on Wednesday, May 3, favoured the challenged parties, G.D. Searle and Janssen Sciences Ireland.

Searle is the owner of the SPC and Janssen is the exclusive licensee.

The challenged SPC covers a product which is marketed in Europe by companies related to Janssen under the brand Prezista (darunavir), a treatment for HIV.

Searle and Janssen contended that the drug was protected by European patent 810,209, but Sandoz disagreed.

According to Sandoz, the SPC involved does not comply with the SPC regulation.

Sandoz sought to revoke the SPC, which expires in February 2019, so that it could bring a generic darunavir product to market.

Sandoz did admit that if the SPC were valid, then the marketing of its product before the expiry date of the SPC would infringe it, and agreed to give Searle and Janssen 30 days’ notice before launching its product.

But Searle and Janssen counterclaimed for an injunction.

In the decision, the court concluded that the SPC complies with the regulation.

The court has not yet heard the counterclaim, but said that it will “hear  further argument as to what relief, if any, should be granted on the defendants’ counterclaim.”

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