Bulgarian Supreme Court Issues Important Decision re SPC Application

On August 6, 2014, the Supreme Administrative Court of Bulgaria gave important guidelines on assessing the compliance of combination products with the requirements of Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products (SPC Regulation).

The case concerned an SPC application for a drug for treatment of HIV infection that consists of three active ingredients – efavirenz, emtricitabine and tenofovir disoproxil fumarate. It had to be decided whether the product fell within the scope of the basic patent BG 62612 – an essential requirement for the grant of an SPC.

The court ruled that the combination was not protected by the basic patent, particularly that it was outside the scope of claim 8 which protected “a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analogue having biological activity against HIV reverse transcriptase”.

The Court found that claim 8 protected only combinations of two active ingredients, while the product in question consisted of three. The Court also found that the third active ingredient, tenofovir disoproxil fumarate, was outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics.

The Supreme Administrative Court therefore reversed the decision of the court of first instance and upheld the decision of the Bulgarian Patent Office to reject the patent application of a foreign pharmaceutical company.

The Supreme Court’s decision contains important analysis concerning the methods of patent claims interpretation and the standards set by the ECJ in С-322/10 Medeva and C- С-493/12 Eli Lilly decisions in assessing the compatibility of combination products with the requirements of the SPC Regulation.

By: Dimitar Batakliev

For more information, please contact Dimitar Batakliev at our Bulgaria office.