Facts
Teva Pharma AG submitted an application to the Swiss Agency for Therapeutic Products Swissmedic for the approval of the generic drug Ribavirin-Teva, film-coated tablets, as a generic to the original products Rebetol and Copegus. Swissmedic rejected the application, as the approvals for Rebetol and Copegus were based on documents for Peginterferon alfa-2b and Peginterferon alfa-2a, which were still under first applicant protection.
Teva Pharma AG filed a complaint against the decision. The Federal Administrative Court confirmed Swissmedic's decision. Teva Pharma AG then filed a public law appeal with the Federal Supreme Court.
Considerations
The Federal Supreme Court stated that the first applicant protection for the combination product Peginterferon stands in the way of the simplified approval of the generic drug Ribavirin-Teva. Since Ribavirin and pegylated Interferon alfa-2b are mandatory combination partners, they are to be considered as a single medicinal product, which is subject to the first applicant protection as a whole.
However, the refusal to approve Ribavirin-Teva in combination with non-pegylated interferon is not justified. It is undisputed that Rebetol is approved in combination with both non-pegylated and pegylated interferon. Ribavirin-Teva in combination with non-pegylated interferon is therapeutically…