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 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…
In light of the Teva/Gilead-judgment handed down on 25 July 2018 by the CJEU (C-121/17) as well as the latest referral from the German Federal Patent Court dated 17 October 2017 in re Sitagliptin III (14 W (pat) 12/17), which is pending as C-650/17, Prof. Meier-Beck, the presiding Judge of the German Federal Supreme Court,…
In a recent decision The Hague Court of Appeal mixes a cocktail of SPC case law of the Court of Justice of the European Union. The ingredients: 1/3 Sanofi, 1/3 Boehringer and 1/3 Gilead and a sniff of Georgetown. Shake well with the skilled person’s common general knowledge and the basic patent’s description (warning: do…
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 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….
