Next to that, Teva argued that the SPC was ineffective pursuant to Article 13 of the EC Regulation 1768/1992, establishing that the SPC is enforceable for a period equal to the period that elapsed between the date on which the application for a basic patent was filed and the date of the first authorization to place the product on the market in the EC, reduced by a period of five years. If the first authorization was granted in 1963 –Teva alleged- then that protection period was ineffective.
Again, the Court of Appeal discarded Teva’s argument, by saying that the EC Regulation 1768/1992 requires that the first marketing authorization was granted in accordance with the Directive 65/65/EEC on the approximation of legislation relating to medicinal products, not having Teva demonstrated that the Austrian or the German original authorizations were granted pursuant to any proceedings equivalent to that one set fort in the Directive 65/65/EEC.
Concerning the lack of inventive step of the basic patent, the Court of Appeal rejects Teva’s argument on the grounds that the technical evidence submitted by said company reflects an ex post facto analysis when assessing the obviousness of successfully treating the Alzheimer disease with a drug prepared with the active compound galantamine. On the contrary, the Court asserts that there were no indicia in the state of the art leading in an obvious manner to that solution, which could even be deemed surprising.
Read the judgment (in Spanish) here.