SWITZERLAND Law and Practice Contributed by: Tobias Meili, Damian Schai, André S Berne and Isabel Wahl-Zeller, Wenger Plattner
of marketing authorisations are determined irre - spective of the existence of patents. Neverthe - less, the patent status could potentially be con - sidered by the FOPH in the determination of the reimbursement amount.
respect to generics are also broadly applicable to biologics and biosimilars. 3.5 Reimbursement and Pricing/Linkage Markets The provisions outlined in 2.5 Reimbursement and Pricing/Linkage Markets with respect to generics are also broadly applicable to biolog - ics and biosimilars. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Supplementary protection certificates (SPC) may be granted for active ingredients or for the com - bination of active ingredients in medicinal prod - ucts (Article 140a(1) PA). However, this requires that the product (ie, its active ingredients or combination of active ingredients) is protected “as such” and that a medicinal product contain - ing the product is authorised in Switzerland at the time of application (Article 140b(1) PA). The SPC is granted to the owner of the patent (Arti - cle 140c(1) PA) and is valid for up to five years (Article 140e(2) PA). Under specific conditions, an SPC may be extended once for an additional six months (Article 140n PA). In general, only one SPC will be granted for each product (Arti - cle 140c(2) PA). If several patent owners submit an application for the same product on the basis of different patents and no SPC has yet been granted, each applicant may be granted an SPC (Article 140c(3) PA). The Swiss Patent Act broadly aligns with the EU Regulation on SPCs for medicinal products (Regulation (EC) No 469/2009). Thus, the FSC generally follows the ECJ case law. However, there are exceptional circumstances where the
3. Biosimilar Market Entry 3.1 Infringing Acts
In contrast to other countries, the utilisation of biosimilars in Switzerland has thus far been limited. However, since costly biological active ingredients contribute significantly to increasing expenses in Swiss healthcare, the potential sav - ings from increased use of more cost-effective biosimilars are evident. Generally, the provisions outlined in 2.1 Infringing Acts with respect to generics, possess a broad applicability to bio - logics and biosimilars as well. 3.2 Data and Regulatory Exclusivity Biosimilars may only be authorised with refer- ence to a fully documented biological medicinal product. Consequently, biosimilars cannot be granted marketing authorisation as reference products. First-time-approved biosimilars are not classified as new active substances; thus, they do not receive data exclusivity, apart from in special cases, as outlined in 2.2 Regulatory Data and Market Exclusivity . 3.3 Acceptable Pre-Launch Preparations The provisions outlined in 2.3 Acceptable Pre- launch Preparations with respect to generics are also broadly applicable to biologics and biosimilars. 3.4 Publicly Available Drug and Patent Information The provisions commented on in 2.4 Publicly Available Drug and Patent Information with
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