SWITZERLAND Law and Practice Contributed by: Tobias Meili, Damian Schai, André S Berne and Isabel Wahl-Zeller, Wenger Plattner
Swiss legislator may have intended to estab - lish a different set of rules, which would be the only exception to this rule. As an illustration, the FSC ruled unequivocally, based on the ECJ case C-322/10 “Medeva”, that if the basic patent designates only one of two active substances, a product cannot be granted an SPC after market - ing authorisation if it is composed of two active substances (FSC 144 III 285). It is worth mentioning that an application for an SPC must be submitted within six months of the initial authorisation of a medicinal product containing the product in Switzerland, or within six months of the patent grant if the patent was granted subsequent to the marketing authorisa - tion to obtain an SPC (Article 140f(1) PA). Failure to meet the deadline will result in the rejection of the application (Article 140f(2) PA). The aim of this process is to establish legal certainty by informing the public and competitors in advance that a medicinal product will not be released at the end of the patent term, but at a later date. In addition (and unlike in the EU), Switzerland has yet to implement a manufacturing waiver for SPCs. 4.2 Paediatric Extensions Swiss patent law provides for both independ - ent paediatric SPCs (Article 140t et seq PA) and paediatric extensions of SPCs (Article 140n(1) PA). Both can be granted for a period of six months. A paediatric SPC may only be issued in the absence of an “ordinary” SPC (Article 140t(2) PA). Consequently, ordinary SPCs and paediat -
tus of a medicinal product or the existence of a patent at all, as outlined in 2.5 Reimbursement and Pricing/Linkage Markets . However, some links exist – eg, a marketing authorisation hold - er that no longer intends to market a medicinal product authorised for a paediatric indication or use for which a SPC was granted must publicly announce this intention in an appropriate man - ner (Article 16a(4) TPA). Furthermore, a paediatric investigation plan must be formulated for each medicinal product to obtain a marketing authorisation outlining the developmental requirements for paediatric use (Article 54a(1) TPA). The procedure is stream - lined up to a certain level due to the possible consideration of a paediatric investigation plan evaluated by a foreign authority (Article 54a(3) TPA) and the alignment of Swiss paediatric investigation plan requirements with regulations of the European Union (Article 54a(2) TPA). 4.4 Orphan Medicines Extensions Swiss law lacks specific provisions for SPCs applicable to orphan medicines. Consequently, the general provisions, as outlined in 4.1 Sup- plementary Protection Certificates , also apply to these medicinal products.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Should the court-imposed preliminary injunction be deemed unjustified, the plaintiff may be held liable for the payment of damages. The defend - ant must prove the damage, which may be a challenging task, particularly in cases where the defendant was not selling the product at the time the preliminary injunction was issued. It is diffi - cult, and thus rare, in Switzerland to claim dam -
ric SPCs are mutually exclusive. 4.3 Paediatric-Use Marketing Authorisations
The issuance of marketing authorisations, which is regulated by the Therapeutic Products Act (TPA), is not contingent upon the patent sta -
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