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.
When a company is not prepared to charge a socially acceptable price in the Netherlands for a medicine, the government should use other instruments such as compulsory licences, encouraging pharmacy preparation and allowing patients to order medicinal products abroad in order to ensure that the medicine is available for patients. The Dutch Council for Public…
Just as the case has been in other European jurisdictions, Gilead is currently attempting to enforce its (Danish) SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine in Denmark. In the first decision regarding Gilead’s enforcement of this SPC in Denmark, the Danish specialty patents court, the Maritime and Commercial High Court, turned…
A positive view is spreading on post-filing experimental data in China since the recent official post of the proposed revisions to the Guidelines for Patent Examination (the “Guidelines”) by the State IP Office (the “SIPO”) of China. People tend to think that the window is about to open to post-filing experimental data, just like it…
by Steven Willis In a judgment handed down at the end of last week, Arnold J has indicated his intention to make a reference to the CJEU concerning the interpretation of Article 3(d) of the SPC Regulation i.e. the requirement for the marketing authorisation (“MA”) on which an SPC application is based to be the…
To ensure the continued development of medicinal products which are the result of enormous R&D costs the supplementary protection certificate (‘SPC’) was introduced into EU law in 1993 with the entry into force of the SPC Regulation (Council Regulation (EEC) No 1768/92). After the Ukraine’s declaration of independence, hard work on adopting new legislation began…
According to Spanish law, the decisions handed down by the Spanish Patents and Trademarks Office (“SPTO”) in relation to applications for Supplementary Protection Certificates (“SPCs”) may be appealed to the “High Courts of Justice.” These are regional courts with jurisdiction to review the legality of administrative acts dealing with certain specific matters. In the context…
Case reported and summarised by Gregory Bacon, Bristows LLP The UK does not operate a system of automatically staying proceedings which concern validity of a European patent where there are ongoing opposition proceedings at the EPO. Nevertheless, the Court retains discretion to stay such proceedings, and a recent judgment of Mrs Justice Rose on 18…
The European Commission has taken the first step towards creating a European Supplementary Protection Certificate (SPC). A Call for Tender for a ‘Study on the legal aspects of the supplementary protection certificates in EU’ was published last month. The deadline for the Call for Tender is 4 February 2016. After signing a contract, the study…
One of the legacies that the year we are about to leave behind will leave us is the Judgment of 6 October 2015 handed down by the Court of Justice of the European Union (“CJEU”) in Case C-471/14 Seattle Genetics Inc. v. Österreichisches Patentamt (“Austrian Patent Office”). The case had its origins in a request…
The lack of provisions on Supplementary Protection Certificates (SPCs) is seen as a major flaw in the new Unitary Patent (UP) system. Initiatives have been taken to address this issue and recently the European Commission put it on its action list. Why doesn’t the UP Regulation include a provision for SPCs? Anja Lunze, attorney at…
