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.
The question whether SPCs should be available for new therapeutic applications of previously approved active ingredients has been a matter of debate ever since the SPC Regulation for Medicinal Products came into force in the European Union more than a quarter-century ago. While a literal reading of the SPC Regulation would clearly seem to exclude…
With the rendering of the judgment in Royalty Pharma (C-650/17) by the Court of Justice of the European Union today on 30 April 2020, a series of referrals relating to the interpretation of Article 3(a) of the SPC Regulation, which requires that the product of an SPC must be “protected” by the basic patent, finally…
The IP Tribunal of the Supreme People’s Court (SPC) recently issued a decision in Dunjun v. Tengda ((2019) SPC IP Civil No. 147), holding that the manufacturer’s making and selling of routers directly infringed a telecommunication method-of-use patent even though the manufacturer itself did not perform one single step of the patented method. This article…
Today, Advocate General (AG) Mr. Giovanni Pitruzzella handed down his opinion in the referral C-673/18 (Santen). The case concerns an SPC based on a second medical use/formulation patent and stems from a referral to the CJEU made by the Paris Court of Appeal with decision of 9 October 2018 in Santen v. INPI (see here…
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…
