Introduction
In this case,
(1) the Patent and Market Court of Appeal (PMCA) addressed the fundamental issue of which documents are relevant for defining the “product” in the sense of article 1(b) of Regulation No. 469/2009 (SPC Regulation).
In summary, the issue concerned whether only the marketing authorisation (MA) and its annexes, including the summary of product characteristics (SmPC), should be of relevance, or whether other evidence such as the European Public Assessment Report (EPAR), expert opinions and publications may be considered. In essence, the PMCA held that consultation of the EPAR is acceptable to answer obscurities in the MA but dismissed the sought grant of a supplementary protection certificate (SPC). The PMCA’s reasoning is well worth studying closely by litigators and patent attorneys.
Facts
A patent holder to an immunogenic composition, a vaccine comprising a truncated protein, applied for an SPC for various product
definitions relating to the truncated protein.
