EU Commission interpretation of extended market exclusivity for non-patented orphan medicine cannot be challenged in court

A biopharmaceutical company, Shire Pharmaceutical Contracts, wrote to the EU Commission last year indicating its plans to extend the marketing authorisation for its medicine Xagrid to include paediatric use. Given that Xagrid is an off-patent orphan medicine for the treatment of a rare genetic blood disease, the company requested a meeting with the Commission to discuss the possibility for a non-patented orphan medicine - such as Xagrid - to benefit from the two-year extended market exclusivity under Article 37 of the Paediatric Regulation.

About a month later, the company received the Commission's reply refusing a meeting. The Commission also explained in its letter that it did not share the company's interpretation of Article 37. The Commission repeated this position in response to a second letter sent by the company asking for further clarification. Unhappy with the Commission's reply, the company went to the EU General Court to get the Commission letters annulled. The company took the view that these letters contained the Commission decision refusing to recognise that its medicine Xagrid qualifies for extended market exclusivity.

In its order of 3 September 2014, the General Court dismissed the entire case as inadmissible (T-583/13, Shire Pharmaceutical Contracts Ltd -v- Commission). Although a Commission decision can sometimes take the form of a simple letter, the Court concludes that in this case the Commission letters only expressed an "informed opinion" on the application of Article 37 in general and hypothetical terms. Since the letters are unable to produce any binding legal effects for the company, they cannot be challenged in court. This Court order is in line with previous case law.

Please click on the links below for the other articles in the November 2014 EU life sciences and regulatory newsletter:

• Simplified authorisation procedure applies to double importation of plant protection products
• Advocate General explains Specific Mechanism for parallel imports of medicines
• ECJ confirms "well-established use" medicine can serve as reference product
• ECJ concludes EU Commission respected the limits of its implementing powers
• EU General Court annuls ECHA decision imposing manifestly disproportionate administrative charge
• New actions before the EU Courts