7. July 2018
Lara Dorigo, Lenz & Staehelin

…but then the Rock crumbled – Disclosure Theory applicable to New SPCs

Sometimes, the short term is much shorter than expected. In fact, the Federal Patent Court’s judgment O2017_001 was appealed to the Federal Supreme Court (FSC), which decided in its judgment 4A.576/2017 to move away from the infringement test for future SPCs.

To add more detail, the FSC considered that the aim to harmonize the level of protection granted by Swiss SPCs with the level of protection applicable in the EU, also brought a certain necessity to follow EU practice in this respect, at least to the extent it reflects the solution enacted by the Swiss legislator and as long as there are no better reasons for a deviant Swiss practice. This is in line with previous considerations of the FSC when it decided the Fosinopril case that had bindingly introduced the infringement test in Switzerland (BGE 124 III 375; it should be noted that when the FSC decided the Fosinopril case, the infringement test still appeared to be the pertinent test in the EU countries, where this question had not yet been harmonized).

In consideration of the CJEU’s avowal for the disclosure theory in the Medeva judgment (C-322/10) and its subsequent confirmation thereof, the FSC thus concluded that the disclosure theory shall now also be applied in Switzerland, however only for new SPCs.

Hence, according to the FSC’s judgment, future SPCs for combination products can only be granted if all active ingredients are encompassed by the wording of the claims, either explicitly or, if construed in the light of the description, implicitly, but necessarily and specifically. The FSC therewith took up the Medeva and Eli Lilly (C-493/12) criteria.

Interestingly, the application of these criteria  had already been the subject of a consultation process started by the Federal Institute of Intellectual Property (FIIP) some years ago as part of an initiative of the FIIP to change its SPC granting practice in order to bring it in line with EU case law. After the FPC had confirmed the applicability of  the infringement test in O2017_001 and it became clear that the FSC would have to assess this question on appeal, the FIIP had stayed its initiative. However, now that the FIIP’s autonomous approach became the blessing of the FSC, the FIIP can rely on its previous work with respect to the application of the Medeva/Eli Lilly criteria.

Importantly, SPCs that have been granted prior to the FSC’s judgment dated 11 June 2018 remain subject to the infringement test. Pursuant to the FSC, SPCs granted by a formally final administrative act cannot be reconsidered or reversed on the basis of changed case law. The acquired legal positions continue to enjoy protection. The infringement test therefore remains applicable to SPCs granted prior to 11 June 2018.

This raises the question how pending SPC applications will be examined? The FSC did not explicitly address this issue. Against the background of its considerations, it would however appear that pending applications must be assessed under the newly applicable disclosure theory. There is not yet a formally final administrative act that needs to be respected. Furthermore, no legal position has been acquired so far, which could be weighed up against the public interests in health care and in a harmonization of the scope of protection of SPCs in our neighbouring countries. Should the FIIP follow this view, it will likely give applicants the possibility to amend their applications in view of the changed practice.