On 31 of January 2012, Presidium of the Supreme Arbitration Court of the Russian Federation rendered a decision that Serum Institute of India Ltd. does not infringe Combiotech’s patent for a recombinant hepatitis B vaccine. The suit was initiated in September 2009 and lasted for nearly three years

The Combiotech’s patent in question (RU2238105) has the priority date of 14 March 2003 and covers recombinant hepatitis B vaccines comprising a HBV antigen, the antigen being produced by cultivating either one of two specific strains of genetically engineered Hansenula polimorpha (Pichia angusta) yeast.

In 2006, Serum Institute of India entered the Russian vaccine market with its globally known since 2001 ( hepatitis B vaccine licensed from Rhein Biotech GmbH (Germany). Originally, Combiotech’s complaint was based on the fact while the instruction accompanying the vaccine imported from Serum Institute of India indicated that the vaccine is produced using Hansenula polimorpha recombinant yeasts, while the particular strain used was not specified. Thus, the plaintiff party assumed that SII must be using one of their patented strains or equivalent thereof. Subsequently, Combiotech appealed further that since SII vaccine is not protected by a patent of RF it cannot be legally marketed in Russia.

The trial arbitration court held that there was no patent infringement and declared Combiotech’s complaint invalid. Combiotech was not satisfied with this decision and the case had to come through review procedures in a court of appeal and a court of cassation that both surprisingly granted judgment in favor of a plaintiff before culminating in the Supreme Arbitration court that left standing the first instance court decision in favor of the Indian company and recalled judgments of two reviewing courts.

We heartily congratulate Serum Institute of India Ltd. on this significant win. We also thank our colleagues from ‘Sergunin and partners’ bar association for their contribution in the litigation process.

Depending on the detailed court opinion that is to be issued within several days, the present Supreme Court’s jundgement can establish a valuable precedent on enforcing rights in IP field of the Russian Federation by clarifying principles of applying art. 1358 of the Civil Code of the Russian Federation which defines patent infringement. The Supreme Court’s decision can be of particular importance for pharmaceutical companies as it strengthen their protection against patent trolls.