As most readers will know, yesterday the European Commission published a proposal to amend Regulation 469/2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”) aimed at introducing a so-called “manufacturing exemption for export purposes” (in short, a “manufacturing waiver”). The rationale behind it is that the introduction of this new exemption to…
During the past decade, Spanish courts have debated the impact of the TRIPS Agreement (“TRIPS”) on patents the applications of which were filed before 7 October 1992, that is, before Spain’s Reservation under Article 167 of the European Patent Convention (“EPC”) expired. According to this Reservation, European patents would not have any effects in Spain,…
The Finnish Supreme Court held that the reversal of the burden of proof stipulated in Article 34 TRIPs as implemented in the Finnish Patent Act does not per se require a party to disclose its manufacturing process, but only to prove that it used a different process than that specified in the patent. The threshold…
TRIPS has historically been criticized on the grounds that it makes access to medicines in developing countries more difficult. To address this concern, on 30 August 2003 the World Trade Organization (“WTO”)’s General Council approved a Decision aimed at implementing the famous paragraph 6 of the Doha Declaration of 14 November 2001. To sum up,…
