Genericness Banned In Russia

• Published date: 17 August 2022
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Gorodissky & Partners
• Author: Mr Vladimir Biriulin

The story started back in 2019. At that time, SUGEN, INC. and PHARMACIA & UPJOHN COMPANY Pharmacia Upjohn sued Nativa, a Russian company, The Ministry of Health of the Russian Federation and Oleg Mikhaylov, the third person closely associated with Nativa against infringement of their patent No 005996 for Pyrrole substituted 2-indolinone protein kinase inhibitors (case No А40-166505/17-15-1481).

Earlier, Nativa had sought a license from the plaintiffs but was refused and sued them claiming a compulsory non-exclusive license in court. Nativa also asked the court to recognize its patent No 567535 dependent upon plaintiffs' patent No 005996.

The plaintiffs argued that the respondent produced a generic named Sunitinib-nativ and sold it infringing their patent. However, the court opined that the plaintiffs had no base to make their claims and, on the contrary, the respondent had the right for a compulsory license because his drug was based on his own (dependent) patent. The owner of the dependent patent may claim a compulsory license if his invention is 1) an important technical achievement and has 2) substantial economic advantages over the original patent.

The court ordered expert examination which produced contradictory conclusions. The court nevertheless ruled that the compulsory license should be granted because it satisfied the above (1,2) conditions.

The plaintiffs appealed the judgment. They argued that the use of the patent owned by the respondent does not relieve him from liability for infringement of their patent. The respondent did not prove that his invention is an important technical achievement nor does it have substantial economic advantages. The court of appeal confirmed however the judgment of the 1st instance court.

The plaintiffs again appealed the judgment with a cassation complaint. This time at the IP court. They repeated the earlier arguments and argued that the respondent's invention had no advantages in comparison with the original patent. They also pointed out inconsistencies in the experts' reports. The reports do not contain convincing information about the importance of the technical achievement, nor do they demonstrate any economic advantages.

Notwithstanding, IP court upheld the previous judgments. This ended the series of hearings in 2019.

Further, the plaintiffs appealed the judgment at the Supreme court in February 2020. The judge of the Supreme court examined the case and found that the case had no grounds for being eligible...