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Recent case law on data exclusivity

On August 14, 2015 the Ninth Appeal Arbitrazh Court issued the Decision on a high-profile pharma dispute between Swiss Novartis Pharma AG and Russian Biointegrator LLC (case No. A40-188378/2014).

Under the merits of the case, Novartis Pharma AG claimed that Biointegrator LLC had infringed Swiss company’s clinical trial and pretrial data in the process of state registration of its generic product “Nescler”. Biointegrator LLC challenged the claims referring to the fact that an application for “Nescler” state registration (April 2, 2012) had been made prior to the date the data exclusivity clause became effective in Russia (August 22, 2012).

Having analyzed certain aspects of pharmaceutical products registration (scope of data exclusivity protection, commercial transfer of a state registration application, etc.), the Panel of Judges has found that Biointegrator LLC did actually infringe the regime of data exclusivity.

The Ninth Appeal Arbitrazh Court has established that the data exclusivity clause protects originators against only those generics applied for state registration after August 22, 2012.

However the Panel of Judges has noted that Biointegrator LLC cannot be exempted from liability based on the date of an application made by another company, which subsequently transferred it to Biointegrator LLC under a commercial agreement. The Panel of Judges has motivated its position by absence of such an opportunity under Russian law.

The Ninth Appeal Arbitrazh Court has also interpreted the scope of the data exclusivity clause in a broad way: the clause shall protect the whole clinical trial and pretrial data disclosed by an originator in the process of state registration, regardless of whether it has been published or not.

Finally, the Panel of Judges has specified that invalidation of a generic’s state registration is an effective remedy in such infringement disputes between originators and generics, despite previous negative case law1.

Should Biointegrator LLC file a cassation appeal, we expect that tense legal struggle between a Swiss originator and a Russian generic will continue.


1Decision of the Moscow District Federal Arbitrazh Court darted July 04, 2005 (case No. A40-11390/2004)

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