ST. PETERSBURG, Russia, November 3, 2015 /PRNewswire/ --
Claim on rituximab IP violation by Genentech (subsidiary of Hoffmann-La Roche, Switzerland) was dissolved by Russian biotechnological company BIOCAD.
Rituximab (initial trade names Rituxan, MabThera ) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B cells and is therefore used to treat diseases, which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells. This includes non-Hodgkin’s lymphomas, leukemias, and autoimmune disorders with WW sales 7,356 mln USD in 2014. It is on the World Health Organization’s List of Essential Medicines.
The U.S. patent 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. Roche lost up to 90% sales in hematooncology indications during the first year of the biosimilar sales.
Corporation Genentech, Roche’s American subsidiary, additionally patented the method of using the innovator medicine. Earlier this year, the American pharmaceutical company demanded to ban 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 expectations, the court dismissed the claim.
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,” - convinces Aleksei Katkov, Vice-President for Legal Affairs of 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.
“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,” - comments Aleksei Katkov .
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