European Court of Justice Makes Key Pharma Ruling

A European Court ruling is expected to have a significant influence over the pharmaceutical industry.

The decision of the of Court of Justice of the European Union in favour of Seattle Genetics will be welcomed by pharmaceutical companies all over the world.

Seattle Genetics went before the European court regarding the duration of supplementary patent protection afforded to the pharmaceutical industry.

EU legislation provides the possibility of a supplementary protection certificate to compensate a patent holder.

This is necessary due to the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation.

However, it is currently European law that no medicinal product may be commercially exploited before the relevant authority has issued marketing authorisation.

Prior to the Seattle Genetics case, there was confusion regarding the duration and calculation of a supplementary protection certificate.

EU legislation suggests that the certificate should be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”.

But confusion reigned regarding what constitutes the date of the first authorisation.

The ruling thus addresses this issue and creates a president in European law.

The Court of Justice ruled that “Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.”

Although this may seem an extremely technical and obscure issue, the ruling is nonetheless expected to have a significant influence over the pharmaceutical industry in the foreseeable future.

The court decision puts an end to any uncertainty faced by both innovative and generic pharmaceutical industry companies regarding the duration of effective patient protection, which will have potentially significant effect on the industry.

This is due to the fact that the marketing of medicinal products will often reach its peak towards the end of the patent term.

When one considers the vast number of pharmaceutical products that this ultimately relates to to, the potential delays involved are certainly not insignificant.

Additionally, following the Court of Justice’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation.

This will enable patent holders to be certain of a uniform duration throughout the EU.

Commenting on the court ruling, Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, was naturally pleased with the decision:

“The CJ’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJ on this matter.”

 

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