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Supplementary Protection Certificates – Three post-Medeva Decisions of the CJEU of Dec 12, 2013

The CJEU Court of Justice of the European Union has handed down rulings for the following important SPC Supplementary Protection Certificate cases on December 12, 2013:
 Actavis Group v Sanofi (C-443/12),
 Eli Lilly v Human Genome Sciences (C-493/12) and
 Georgetown University (C-484/12).

Background


These are follow-up cases from the Medeva (C-322/10) landmark decision of 2011. In Medeva, the CJEU was faced with the question “What are the criteria for deciding whether a product is protected by a basic patent?” (“Medeva question”) and ruled that “SPCs can only be granted for active ingredients that are specified in the claims”. The Medeva ruling raised more questions than it answered.

Questions and Answers

The crucial questions of the post-Medeva cases were:


  • What are the criteria for deciding whether a product is protected by a basic patent? – No answer (Actavis and Eli Lilly)
  • Is a structural definition in the claim necessary in case of a claim to an antibody? – No (Eli Lilly)
  • Can more than one SPC per patent be granted? – Yes (Actavis and Georgetown)

Results of the Rulings

As expected, the CJEU has not provided a simple checklist of criteria in response to the Medeva question.

However, the Eli Lilly ruling at least clarifies that the active ingredient does not have to be characterized in the claims by a structural formula in order for it to be protected by the basic patent. A functional formula covering the active ingredient, for example an antibody may be sufficient if in the light of the description, the claims relate specifically to the active ingredient.

Moreover in the Eli Lilly case, the CJEU surprisingly ruled that the interpretation of the extent of protection of the claims is to be determined by the national courts. This means a return to the pre-Medeva practice.

Finally, the Georgetown ruling makes it clear that in principal more than one SPC can be granted per patent. This precludes that the different active ingredients are individually protected as such by the patent.

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