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08.01.2020

On December 26, 2019 the IP Court ruled in favor of the client of «A.Zalesov & Partners» Patent & Law Firm a Russian pharmaceutical distribution company «R-Pharm» in an invalidation trial over a secondary pharmaceutical Russian patent RU 2567537 belonging to «Nativa» Ltd., which was involved in a large and long lasting patent litigation over distribution of pharmaceutical products for cancer treatment comprising dasatinib produced by «Bristol Myers Squibb» and distributed in Russia by «R-Pharm». «Nativa»'s patent related to a novel crystalline form of a known compound dasatinib, and pharmaceutical composition having inhibiting activity of protein-tyrosine kinases comprising the indicated compound. It is important to mention, that «Nativa» Ltd. used this patent as a main argument having sued «Bristol Myers Squibb» for compulsory license of basic Russian patent RU 2260592 protecting dasatinib molecule (the court case regarding dispute between «Bristol Myers Squibb» and «Nativa» can be traced here). Patent disputes involving «Nativa» LLC are currently attracting the closest attention of the patent specialists and the pharmaceutical industry, as the company owns a portfolio of Russian patents and licenses for various crystalline forms of known substances for the treatment of cancer, and uses them as the basis for claiming compulsory licenses from originating companies if they sue «Nativa» for infringement of primary patents to the molecule. Disputes regarding lenalidomide («Nativa» vs. «Sugen» — № А40-71471/17, settled in cassation), sorafenib («Bayer» vs. «Nativa» — № А41-3828/18, «Nativa» vs. «Bayer» — № А40-157726/2018), sunitinib («Sugen» vs. «Nativa» — № А40-166505/2017 ) were first cases for compulsory licensing in Russia. This set of disputes around «Nativa»'s portfolio for crystalline forms of known substances was a trigger for introducing amendments into the patent prosecution procedure. One of them is already adopted by RU PTO (in force from December 15, 2018), which prohibited to include into claims features not directly relating to composition and declared that such features also won't be taken into consideration when assessing the «novelty» and «inventive step» requirements. Another initiative is still being under discussion by the Ministry of Economical Development. The successful invalidation of Nativa's patent in the case puts an end to the long lasting litigation and preserves interest of our client as a distributor and a licensee. «A.Zalesov & Partners» Patent & Law Firm LLC patent litigation team for the case included Managing Partner Dr. Aleksey Zalesov, Senior Partner Irina Ozolina, Partner Natalia Samsonova and Trademark Attorney Julia Dutikova.

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