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…

The District Court of the Hague granted a provisional injunction against Sandoz’ generic darunavir product. As it was already offered in the G-standard, price erosion was an imminent danger for which a provisional injunction was warranted, and the SPC appeared to be valid having been held so in the parallell procedure before the UK court….

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…