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.
On 5 December 2019, the IP Tribunal of the Supreme People’s Court (SPC) handed down two decisions in which – in a first for China, the SPC heard and decided on both the patent validity and infringement disputes in one consolidated proceeding. Background The two actions arose out of a patent infringement dispute between the…
By Sarah Blair This panel session provided an update on the current state of play of Brexit and its impact on intellectual property law. The panel’s moderator, Daniel Cheng Yong Lim (Kirkland & Ellis), opened the session by providing a brief introduction to the current situation: the UK is currently set to leave the EU…
One of the features that render the European Union’s Supplementary Protection Certificate (SPC) unique in comparison to similar legal instruments in other jurisdictions, including the United States and Japan, is that there is no legal provision expressly calling for any specific relationship or agreement between the patent proprietor (and SPC applicant) on the one hand,…
In the field of supplementary protection certificates (SPCs) in the European Union, the majority of all CJEU referrals resolved to date have dealt with the interpretation of the – presumably simple – condition that an SPC can only be granted for an active ingredient (or a combination of active ingredients) that is “protected” by the…
The legislative procedure introducing an SPC manufacturing waiver in the European Union has been completed today on 11 June 2019 with the publication of the corresponding new Regulation (EU) 2019/933 of 20 May 2019 (PDF) in the Official Journal of the EU. The manufacturing waiver provisions will enter into force on the 20th day after…
After the European Parliament adopted a controversial new regulation introducing an SPC manufacturing waiver for export and stockpiling in its last plenary session on 17 April 2019, as previously reported on this blog, the corresponding legislative act has now also been adopted by the Council of the European Union in its meeting today on 14…
The European Parliament has finally adopted the legislation introducing an SPC manufacturing waiver in its last plenary session before the upcoming European elections. The corresponding legislation was endorsed today on 17 April 2019, with 572 votes in favor, 36 votes against, and 22 abstentions. The vote was preceded by a discussion in plenum yesterday late…
The Court concluded that the compound darunavir was not protected by a patent within the sense of Art. 3 of the SPC directive because, following the CJEU decision in Teva v Gilead, it is necessary that the compound for which the SPC is granted can be specifically identified in the patent. Case date: 08 January…
In a post yesterday our colleagues at Vossius commented on the CJEU’s decision, which had just been handed down in Abraxis*. As Vossius have explained, although the decision appears to give clarity for new formulations of old products, it remains unclear as to how this can be reconciled with Neurim, which was not overturned. In…
The eagerly-awaited judgment of the Court of Justice of the European Union (CJEU) in the SPC referral Abraxis Bioscience (C-443/17) has been handed down today. In the case underlying this referral, the UK IPO had refused an SPC application filed by Abraxis Bioscience for the product “paclitaxel formulated as albumin-bound nanoparticles” (nab-paclitaxel; marketed as Abraxane®)…
