KRKA argues with AstraZeneca over a drug for the Russian Federation

The Slovenian pharmaceutical company KRKA, operating in Russia, has achieved a retrial in the Presidium of the Intellectual Rights Court (IPR), which could lead to the revocation of AstraZeneca’s patent for dapagliflozin, used in the treatment of type 2 diabetes. The rights to the drug were expiring this year, and KRKA planned to bring its product to market. But AstraZeneca received a new patent for the same substance, extending its validity. Now the court has decided that this practice is illegal. Lawyers believe that the outcome of the dispute may lead to a new wave of litigation in the pharmaceutical industry and some of the already issued patents will be revoked.

In October 2023, the Presidium of the IP ordered Rospatent to reconsider two objections from the Slovenian KRKA to the issuance of patents for the active substance dapagliflozin for type 2 diabetes and for the method of its preparation, Kommersant found in the file of court cases. This drug from the British-Swedish AstraZeneca is the leader in government procurement among glucose-lowering drugs. In the first half of this year alone, government customers purchased it, according to Headway Company, for 6.56 billion rubles. KRKA did not respond to Kommersant’s request.

Initially, the patent for the active ingredient dapagliflozin expired in 2023. Since 2022, five companies, including KRKA, have registered their generics. But in 2021, AstraZeneca received another patent for the same substance, extending it until mid-2028, subject to the abandonment of the original patent, said managing partner A. Zalesov and partners” Alexey Zalesov, who represented the interests of KRKA in court.

KRKA filed objections to Rospatent in 2021, which left them unsatisfied. The company disputed this in the SIP. In the first instance, KRKA failed to achieve a review, but the decision of the Presidium of the IP to reconsider KRKA’s demands turned out to be precedent-setting.

AstraZeneca registered the disputed patents under divisional applications. This is when pharmaceutical companies create a chain of patent applications that protect one drug, isolating one from another. Moreover, all applications usually received priority according to the original one, which linked them into one complex with a single validity period. In the dispute over dapagliflozin on October 2 of this year, the Presidium of the SIP concluded that a divisional application for a method of obtaining a drug has priority over the original one only if at the time of its filing a patent was not issued for the original application. In the case of AstraZeneca, this certificate has already been issued. Consequently, the patent under the divisional application becomes “independent”, and then, as the court found, the invention does not meet the criterion of novelty. The court made a similar decision on October 16 regarding the patent for the main substance of dapagliflozin, but its reasoning has not yet been published.

AstraZeneca considers the decision of the Presidium of the Court to be unfounded, since “the court actually took on the functions of a legislator”, formulating new rules that radically change the situation. They note that patent owners may lose intellectual property protection. Alexey Zalesov emphasizes that the opportunity to submit all allocated applications with priority from the initial one actually gave AstraZeneca the opportunity to obtain new certificates for 20 years.

Since the judicial act has retroactive force, the fate of similar allocated applications may be at risk of filing new objections on formal grounds, says Mikhail Pasynok, head of the Chemistry and Pharmaceuticals department of Online Patent. Alexey Mikhailov, head of patent practice at Patentus, notes that foreign manufacturers, who often resorted to filing a chain of separate applications, should seriously adjust their approaches, and Russian companies should audit reports on patent clearance. According to his calculations, at least 60 patents in the field of pharmaceuticals and medicine alone may be at risk of being challenged. President of the Chamber of Patent Attorneys, Alexander Khristoforov, talks about more than 800 patents in various industries. This, he said, could lead to the early entry into the market of products of competitors of patent holders and lead to a decrease in interest in the development of innovations.

Polina Gritsenko