The US patent on rituximab was issued in 1998 and will expire in 2015. However, the IP landscape in other countries differs, which provides opportunities for non-US companies to launch rituximab biosimilars, as Biocad did in 2014 (The Pharma Letter May 7, 2014). Roche lost up to 90% sales in hemato-oncology indications during the first year of the biosimilar sales in Russia.
Genentech additionally patented the method of using the innovator medicine. Earlier this year, the USA-based firm demanded a ban on the manufacture, offer for sale, sale and other introduction into civil circulation and storage of a biosimilar of this drug. Besides, Genentech sought exemption from civil circulation and destruction of the drug batch that had already been on sale. The statement of claim was submitted to the Moscow Arbitration Court on February 25, 2015. Despite Genentech’s expectations, the court dismissed the claim.
Trial decision no appealed
The trial court decision was not appealed by Genentech to higher courts in a timely manner and entered into force. “The patent described that rituximab can be used in combination with other drugs. The instructions to Biocad’s rituximab also indicated that the drug may be used in combination with other drugs. This complete coincidence of descriptions was the reason for the claim,” argues Aleksei Katkov, vice president for legal affairs at Biocad.
The expert notes that prior to this court dispute, there was no practice in Russia for patentees claiming to the judicial authorities for violation of patents for methods of using drugs, and further on in the event of similar disputes the lawyers will be guided by the decision of the Moscow Arbitration Court on this case.
Biocad in its turn filed for early termination of the patent for a method of using rituximab owned by Genentech. What is interesting is that Genentech voluntarily cancelled its patent without waiting for the proceedings in the Chamber of Patent Disputes, the Russian firm states.
“There are substantial patents when a company really protects its new products, and there are instruments for holding monopoly in the market. When deadline is due for patent protection of a molecule, manufacturers start making subsidiary patents for methods of treatment, use, etc, thus, extending the patent life of the drug,” Mr Katkov concluded.Tags: Biocad, Biosimilar, Genentech, MabThera, Moscow Arbitration Court, Patent dispute, Rituxan, Rituximab, Roche, Russia, Russia biotech, Russia IP, Russia’s Biocad vs Genentech, Swiss pharma giant Roche