Chronic myeloid leukemia (HML)

2018: Nativa asserted the right to production of medicine for therapy of chronic myeloid leukemia

"R-Pharm" and Infarm, the representing interests of foreign producers of medicines, could not convince FAS Russia of unfair competition of the company Nativa. Antimonopoly department made the decision to dismiss the proceedings initiated on signs of antitrust violation due to the lack of the breaking actions reported in Nativa company on August 23, 2018.

The commission of antimonopoly department according to the results of consideration of the appeal of R-Pharm company and also association of Infarm with a request came to such conclusion to carry out an inspection of the Russian producer regarding unfair competition. The dispute arose in June, 2018 because of the reproduced medicine "Dazatinib-nativ" (MNN of Dazatinib), an analog of the original medicine "Spraysel" which rights to patent belong to "Bristol-Myers Skvibb Holdings Ayrlend" company. The last, in turn, localized production of medicine in the territory of the Russian Federation in partnership with JSC R-Pharm.

Dazatinib — antineoplastic means of directional effect which is applied in treatment of chronic myeloid leukemia and also has high efficiency at a metastatic melanoma.

Nativa registered the medicine in March, 2017 then "Bristol-Myers Skvibb" submitted a claim concerning it with the requirement to stop actions of the company for introduction of the medicine "Dazatinib-nativ" to civil circulation before expiration of the patent. In June, 2018 the arbitration court of the Moscow region refused "to Bristol-Myers Skvibb Holdings Ayrlend" this requirement. During judicial proceedings Nativa managed to prove existence of own patent for crystal modification of a dazatinib. Thus, by court it was established that the rights of the patent holder were not violated.

The essence of the next complaint of applicants, namely R-Pharm companies and associations of Infarm, was that Nativa LLC illegally used results of intellectual activity according to Article 14.5 of the law "About Protection of the Competition". Having analyzed the proofs which are available in case papers about antitrust violation, and set in the matter of a circumstance, having heard the persons who are involved in consideration of the case, the court made the decision to stop consideration of the case No. 1-14-93/00-08-18 due to the lack in actions of Nativa LLC of antitrust violation.

Dazatinib according to the order of the Government of the Russian Federation it is included in the list of vital and essential drugs — Alexander Malin, the CEO of Nativa company said. — If to limit turnover of the domestic reproduced medicine in the Russian market, it means that tens of thousands of Russian patients will depend on foreign producer of original medicine. Besides, the Russian reproduced medicine costs to the budget for 20% cheaper of a foreign analog. These dry digits say that the domestic analog will be available to the bigger number of patients.

In the FAS Russia's decision referred to the decision of arbitration court during which judicial patent technical expertize was carried out — Yulia Gerasimova, the deputy CEO for legal issues of Nativa LLC told. — This examination confirmed that the Nativa company by production of medicine uses the substance provided by patent No. 2567537 which belongs to Nativa company it is not disputed and is acting that, respectively, is not patent infringement.

The American company "Pfizer" concerning the antineoplastic medicine "Sutent" (MNN of Sunitinib) also filed a similar petition to antimonopoly department. Consideration of the case is postponed until September 10, 2018.