The introduction of an SPC manufacturing waiver in the European Union is now all but a done deal. Following the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal products (COM(2018) 317 final) issued on 28 May 2018, the European Parliament’s Committee on Legal Affairs (JURI) adopted its final…
The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…
Gilead Sciences vs Sandoz – Round One The history of the case started in 2018, where Gilead Sciences Inc., brought preliminary injunctions before the court against several companies. On 7 March 2018, the High Court of Eastern Denmark delivered a preliminary injunction against Accord Healthcare Limited, thereby reversing an earlier decision from the Danish Maritime…
Regardless of whether someone intends to enforce their own supplementary protection certificate (SPC) or finds themself at the receiving end of an SPC infringement action, the question which grounds of invalidity justify the revocation of an SPC may become highly relevant. This question is all the more intriguing in light of the CJEU’s corresponding case…
A quarter-century after supplementary protection certificates (SPCs) were introduced in the European Union, there are still a number of unresolved questions as to which types of products are, in principle, eligible for SPC protection. One further important piece in this puzzle will be provided by the CJEU’s forthcoming decision in the pending referral Abraxis Bioscience…
With the Danish patent litigation community being limited in numbers and the pool of legal judges and expert judges available to the Danish specialty patents court being likewise limited in numbers, The Maritime & Commercial High Court (“MCC”) – along with its appellate branches – has long since decided that judges deciding an application for…
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 Court of Justice of the European Union (CJEU) has clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of the SPC Regulation. In a long awaited preliminary ruling, the CJEU decided last week that: ‘Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May…
Establishing a unitary SPC is one of the recommendations of the study carried out by the Max Planck Institute for Innovation and Competition for the European Commission. Either an (existing or a future) EU authority or the European Patent Office can be charged with granting these unitary SPCs. According to the study, the choice between…
The European Commission has proposed to introduce an ‘export manufacturing waiver’ to Supplementary Protection Certificates (SPCs) to ‘help Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU’. According to a press release of 28 May 2018, ‘Supplementary Protection Certificates extend patent protection for medicinal products which must…
