The Intellectual Property Court (IPC) supported the position of AstraZeneca and recognized the decision and order of the Federal Antimonopoly Service (FAS) of Russia as lawful. Earlier, the antimonopoly agency established signs of unfair competition in the actions of the company Axelpharm during the introduction into civil circulation of a reproduced analogue (generic) of the antitumor drug osimertinib (source).
The Core of the Dispute and the FAS Order
The original drug osimertinib is produced by AstraZeneca under the trade name Tagrisso. The medicine is protected by a patent in the Russian Federation until 2032. The production of the original drug is localized in the Kaluga region under a special investment contract (SPIC). According to the manufacturer, current production capacities can fully satisfy the Russian market’s need for this therapy.
Despite the active patent, Axelpharm launched a reproduced drug on the market. In this regard, the FAS of Russia obliged the company to stop the circulation of the generic and transfer to the federal budget the income received as a result of unfair competition. The recovery amount exceeded 560 million rubles.
Legal Context and the Company’s Position
Industry experts note that when making its decision, the IPC took into account a recent ruling by the Supreme Court of the Russian Federation, which had previously supported a similar FAS order in a case involving the illegal launch of an axitinib generic.
AstraZeneca emphasized that the position of the Supreme Court of the Russian Federation and the IPC decision are of fundamental importance for the protection of intellectual property and contribute to improving the investment climate in the pharmaceutical market. According to the manufacturer, the formation of such judicial practice significantly restricts the use of the launch at risk strategy (launching a generic on the market before the expiration of the patent for the original drug in order to gain competitive advantages).
“Moreover, confirming the legality of FAS orders to recover into the budget all income received by a generic as a result of unfair competition deprives violators of the economic benefit from the sale of an illegally launched drug.”
— AstraZeneca Press Service
Thus, the IPC decision solidifies the legal practice according to which the launch of generics in violation of existing patent rights entails not only a halt in sales but also the seizure of revenue gained in favor of the state.
