A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
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…
In its judgment of 25 July 2018 (Case C-121/17 Teva v. Gilead), the CJEU had its latest say on the interpretation of article 3 (a) of Regulation (EC) 469/2009 concerning the Supplemental Protection Certificates for medicinal products (the “SPC Regulation”). In particular, it concluded that article 3 (a): “[…] must be interpreted as meaning that…
Whilst it is highly debatable whether the EU Withdrawal Agreement will get through the UK Parliament, the chances are that if any revised deal is struck later, the IP provisions will remain unchanged. (The Johnson brothers, and even Jacob Rees-Mogg are unlikely to be terribly exercised about matters such as the continued application post- 31…
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…
As previously reported, in 2017 the Danish Maritime and Commercial Court declined to grant an application filed by Gilead to grant an injunction against Accord offering the pharmaceutical a combination product consisting of Emtricitabine and Tenofovir Disoproxil (TD), holding that the granted SPC was invalid (Ground-breaking decision on Gilead’s Tenofovir SPC in Denmark). In a…
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…
In a decision issued this summer, the Swiss Federal Patent Court had the opportunity to comment on the catalogue of grounds for invalidity which can be brought against a Swiss SPC. The Federal Patent Court issued a PI based on Genzyme Corporation’s Swiss SPC for sevelamer, although it was unclear whether the Swiss Institute of…
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…
