Patents diary: March 2020

March 2020

SPCs: Synergistic effects of a combination product may only be taken into account if specified in the basic patent

The facts

With a decision dated 31 May 2016, the German Patent and Trademark Office (GPTO) granted an SPC for the plant protection mono product mandipropamid. This SPC was based on European patent EP 1 282 595 (EP 595). On 19 December 2017, the applicant requested an SPC for a plant protection combination product containing as active ingredients mandipropamid and zoxamide. The request was based on the same patent (EP 595).

EP 595 mentions that mandipropamid can be combined with other active ingredients and that some of these combinations can have unexpected synergistic effects.The active ingredient zoxamide is also mentioned in EP 595. However, EP 595 does not disclose that the combination of mandipropamid and zoxamide belongs to the combinations which have unexpected synergistic effects.

With a decision dated 9 May 2019, the GPTO rejected the request for the combination SPC. According to the GPTO's decision, the requirement of Art. 3 para. 1 lit. c of EC Regulation No. 1610/96 was not met because the combination of mandipropamid and zoxamide was not inventive towards the mono product mandipropamid.

The applicant subsequently appealed the decision. In particular, the applicant argued that the combination product would have synergistic effects and would therefore be a separate invention towards the mono product.

The decision

With a decision dated 19 September 2019, the Federal Patent Court (FPC) confirmed the decision of the GPTO. The reasons behind this ruling were published recently.

The FPC held that the case law of the Court of Justice of the European Union (CJEU) on Art. 3 lit c of EC Regulation No. 469/2009 (SPCs for medicinal products) can be applied equally to Art. 3 para. 1 lit. c of EC Regulation No. 1610/96. The two regulations are mostly identical in objective, structure, subject matter, and wording. It was the intention of the legislature to provide similar regulations.

Therefore, the standard established by the CJEU in its decision Actavis/Sanofi (C 443/12) in relation to Art. 3 lit c of EC Regulation No. 469/2009 have to be applied in the case at hand. The relevant test in the case at hand is thus whether the combination of the inventive active ingredient mandipropamid and the known active ingredient zoxamide can be qualified as a separate invention towards the mono product mandipropamid.

On the basis of its findings, the FPC came to the conclusion that these requirements had not been met. In particular, the FPC held that the alleged synergistic effects of the combination cannot be taken into account since they are not specified in the basic patent, which merely discloses that some combinations have synergistic effects but does not disclose whether the combination of mandipropamid and zoxamide is one of these combinations.

Under these circumstances, findings obtained after the priority of the basic patent cannot be taken into account, either. Such findings could only be taken into account if the alleged synergistic effects had been specified in the basic patent.

Forum: German Federal Patent Court

Date: 19 September 2019

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