Why would anyone want to have their own supplementary protection certificate (SPC) revoked? – The answer is, quite simply, Article 3(c). Under Article 3(c) of Regulation (EC) 469/2009 on SPCs for medicinal products (and, likewise, under Article 3(1)(c) of Regulation (EC) 1610/96 on SPCs for plant protection products), an SPC shall be granted only if…
A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were the ambitious aims set out in the European Union’s single market strategy adopted in 2015. This was followed by a comprehensive evaluation of the legal aspects…
Over the past few years the pan-European and parallel national patent litigation based on Eli Lilly’s pemetrexed patent has attracted considerable attention, as it has resulted in a number of diverse land mark decisions in relation to the doctrine of equivalence, as evidenced by the various posts on the Kluwer Patent Blog. By way of…
In order to provide adequate incentives for the research and development of high-quality medicinal products adapted for paediatric needs, special rewards, such as a 6-month paediatric extension of the term of a Supplementary Protection Certificate (SPC) have been made available in the EU since 2007. Switzerland, which participates in the EU’s single market and traditionally…
The Swiss Patent Office issued a brief notice regarding a change of practice in the granting of supplementary protection certificates (SPCs) as well as corresponding detailed information on 22 October 2018. Following the Swiss Federal Supreme Court’s judgment 4A_576/2017 of 11 June 2018 relating to the SPC for Truvada, the requirement under Article 140b(1)(a) Swiss…
Practitioners dealing with supplementary protection certificates (SPCs) have been holding their breath at the unfolding of the “Truvada saga” around Gilead’s SPCs for the HIV medicament Truvada, which contains the active ingredients tenofovir disoproxil and emtricitabine. The lawsuits involving the Truvada SPCs in various European countries have already given rise to such noteworthy decisions as…
The SPC system was introduced in the European Union in 1992 to compensate for the heavy penalties imposed on pharmaceutical research due to the curtailment in effective patent term resulting from time-consuming and costly regulatory review. As expressly noted in the Explanatory Memorandum to the original SPC Regulation (COM(90) 101 final-SYN 255), the legislative intent…
Supplementary protection certificates (SPCs) used to be granted in the European Union only for novel active ingredients, but not for new therapeutic applications of previously authorized active ingredients. While this practice fundamentally changed as a result of the CJEU’s landmark decision Neurim (C-130/11) of 19 July 2012, the scope of this ruling has given rise…
