SWITZERLAND Law and Practice Contributed by: Tobias Meili, Damian Schai, André S Berne and Isabel Wahl-Zeller, Wenger Plattner
do not generally enable a party to bring an action for infringement. This exception to the patent’s effect is restricted to circumstances where the quantity produced or imported does not exceed the quantity nec - essary for the marketing authorisation process. Purposeful stockpiling for future market supply is not encompassed within the scope of the privilege. Production is restricted to the quantity specified by the authorisation authority (ie, vali - dation batches). Situations not encompassed by this exemption render actions for infringement conceivable. This also pertains to preliminary injunctions in cases where an imminent infringe - ment has not yet commenced (see 1.3 Prelimi- nary Injunction Proceedings ). 2.2 Regulatory Data and Market Exclusivity For medicinal products, the Swiss Agency for Therapeutic Products (“Swissmedic”) grants the following data exclusivity periods: • ten years for a medicinal product that includes a novel active substance; • three years for a modified dosage or route of administration; • three years for a new indication; however, Swissmedic may grant a period of ten years if the new indication is anticipated to yield a substantial clinical advantage over estab - lished treatments; • ten years for a fixed combination of medicinal products if at least one new active substance is prevalent; • ten years for medicinal products intended exclusively and specifically for paediatric use, provided that pertinent clinical data substanti - ates the indication; and • 15 years for essential medicinal products for orphan diseases.
Swissmedic’s decisions regarding data exclusiv - ity are susceptible to appeal to both the Federal Administrative Court and, ultimately, the FSC. Appeals to the Federal Administrative Court can take 12–18 months, although the duration may be extended in cases involving high complexi - ties. In general, decisions regarding appeals to the FSC are rendered within six to 12 months. 2.3 Acceptable Pre-Launch Preparations See 2.1 infringing Acts . 2.4 Publicly Available Drug and Patent Information In Switzerland, no “Orange Book” equivalent exists. Patent rights are neither verified nor considered by Swissmedic prior to the issuance of marketing authorisations. Swissmedic pub - lishes all granted marketing authorisations in its monthly Official Journal. To obtain access to the contents of the marketing authorisations, a Free - dom of Information request must be submitted to Swissmedic. However, Swissmedic will refrain from disclosing any personal data, confidential information, or data protected by data exclusiv - ity regulations. Swissmedic does not proactively notify product marketing authorisation holders of any generic or biosimilar marketing authori - sations. 2.5 Reimbursement and Pricing/Linkage Markets The Federal Office of Public Health (FOPH) is the competent authority by default in Switzer - land regarding all public health matters concern - ing the pricing and reimbursement of medicinal products. Pricing and reimbursement, in addi - tion to the issuance of marketing authorisations, are not contingent upon patent status. Thus, in their regulatory supervisory activities, neither Swissmedic nor the FOPH consider patent sta - tus. In general, pricing approvals and issuances
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