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CJEU Gives Green Light to Negative term Supplementary Patent Certificates

08 December 2011

LONDON, 08 DECEMBER 2011 – Hogan Lovells has successfully represented Merck & Co before the Court of Justice of the European Union (CJEU) today, after 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.

Why have the SPC system?

The aim of the SPC system is to compensate for loss of patent protection due to regulatory delays in obtaining marketing authorisation. The 20 year patent monopoly starts to expire on the day the patent is filed.

Pharmaceutical companies cannot, however, exploit that monopoly until they get marketing authorisation. But getting marketing authorisation takes years - sometimes 10 or 15 years.  SPCs compensate for up to five years of this lost patent protection. 

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.

Negative SPCs – what are they?

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. 
Hogan Lovells partner Andreas Von Falck said:

"The decision will help to ensure that medicines used to treat the paediatric population are subject to high quality ethical research and are appropriately authorised for such use.  The decision is great news for the pharmaceutical industry because it encourages companies to invest in this costly but essential research required to develop medicines for the pediatric population.”

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