Court of Justice gives go-ahead to negative term SPCs

The Court of Justice of the European Union gave its ruling this morning in Case C-125/10 Merck Sharp & Dohme Corporation. Infuriatingly, the recently-redesigned Curia website hasn't yet managed to make the ruling accessible -- but The SPC Blog has received the following information from Hogan Lovells LLP, which successfully represented Merck & Co. in these proceedings.  According to the Hogan Lovells media release, the Court of Justice has it ruled that negative term supplementary patent certificates (SPCs) are permissible:

" ... The decision means the SPC protection for the diabetes drug Januvia can be extended by two and a half months until mid-September 2022. This extension would reward Merck’s efforts to research and provide valuable information on the effects of Januvia in the child population. 

The issue came to the fore in 2007 when Merck applied for a negative SPC extension for Januvia in several EU countries. Januvia is Merck's registered trade mark for the active ingredient sitagliptin. 

Bulgaria, the Netherlands, and the United Kingdom granted negative term SPCs; Greece granted a zero term SPC; various other states, including Germany, refused to grant any SPC at all. 

In Germany Merck took its case against the national patent office to the Federal Patent Court, which referred the matter to the CJEU, asking whether it is permissible to grant negative or zero term SPCs. Merck was represented before the CJEU by Dr. Andreas von Falck and Miriam Gundt of Hogan Lovells' Dusseldorf office, and by Dr. Monica Heinemann of patent attorney firm Abitz & Partner. 

... In 2006 a six month extension to the SPC term was introduced to incentivize innovators to investigate and report on whether their products are suitable for use in the pediatric population. Prior to the introduction of this incentive, many products were used to treat the pediatric population without having been studied or authorized for such use ...

A negative term SPC, as the name suggests, offers a negative term of SPC protection after patent expiry because the period between filing the patent and wining marketing authorisation is less than five years. 

The value of a negative term SPC is that it forms the basis for an SPC extension of up to six months to reward studies of the medicine in the pediatric population ...".

The SPC Blog expects the judgment to be accessible here once it materialises online. At present all that is available is the Advocate General's Opinion, discussed on The SPC Blog here and indeed elsewhere.