A Russian pharmaceutical company is challenging the cancellation of a patent for its generic drug. Litigation.
The dispute arose between LLC "Nativa" and the American company Pfizer (acting through its structure Sugen). This company owns the rights to the anticancer drug sunitibin, marketed under the name Sutent. LLC "Nativa" managed to register the rights to its analogue or generic (a drug that contains an active ingredient identical to the previously registered drug) sunitibin as its own invention. Sugen applied to the Court of Arbitration for annulment and received a positive decision, as the original is protected by a patent until 2022. In fact, the exclusive right of the American company was recognized and Nativa LLC was prohibited from selling the drug.
However, the litigation lasted several years (the patent was granted in 2017), as a result, the Russian company's income from the sale of the generic amounted to more than 2 billion rubles against 900 million rubles of the copyright holder's revenue from the sale of the original product. The requirement to apply interim measures in the form of a ban on sale by the court was not satisfied.
Now LLC "Nativa" is trying to challenge the cancellation of the patent through the intellectual property court. The company was founded in 2010 and has close ties with the largest pharmaceutical companies in Russia, Pharmcompany LLC and Pharmstandard LLC. LLC "Nativa" works at the production facilities of LLC "Pharmstandard" and issues registration certificates for its drugs for it. Nativa LLC also has an ongoing litigation with Bayer on a similar issue, the German company is trying to cancel the patent for sorafenib (an antitumor drug), to which it has exclusive rights until 2022.
Patent disputes are specific to the field of pharmacology and are explained by the patent legislation in force in Russia, established judicial practice and law enforcement practice. Rospatent does not go into the verification of generics too much and satisfies about 75% of applications immediately for 20 years, although the payback period for drugs is half as long. Pharmaceutical companies receive income from the state, which purchases drugs for beneficiaries using budget funds. It is beneficial for the state customer to buy the cheapest means, which are jereniki. Since litigation involves government agencies, they last for years, while only a quarter of applications for the revocation of patents are satisfied.
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