Session on Intellectual Property in the Pharmaceutical Sector at the KILF: Striking the Balance in Legal Regulation

2026-09-25 19:14

On September 25, the Kazan International Legal Forum (KILF-2026) hosted a session titled "Law in Medicine and Pharmacy: The Balance of Technology and Safety." This event brought together legal experts, academics, regulators, and pharmaceutical industry representatives to discuss critical issues at the intersection of law and healthcare. The session marked another milestone in the strategic partnership between the Association of International Pharmaceutical Manufacturers (AIPM) and the O.E. Kutafin Moscow State Law University.

Lyudmila Alexandrovna Novoselova, Head of the Department of Intellectual Property Law at O.E. Kutafin, moderated the discussion. The session centered on key legal aspects affecting the healthcare system, including interim measures in patent disputes over medicinal products, the status of proposed legislation transferring compulsory licensing cases to the Intellectual Property Court, criteria for compulsory licensing and their assessment methods, and intellectual property protection in public procurement.

Participants of the discussion: Larisa Matveeva (AIPM Executive Director), Olga Ruzakova (Deputy Head of the Staff of the State Duma Committee on State Construction and Legislation), Dmitry Zaitsev (General manager of JSC “Pharmstandard”), Evgeny Zuev (Business Partner for Legal Issues and Compliance, JSC “Roche‑Moscow”), Nikolai Lyskov (Head of the Center for Chemistry, Biotechnology and Medicine at the Federal Institute of Industrial Property), as well as representatives of the scientific community: Ruslan Sitdikov (Professor at the KFU) and Darya Mikhailova (Lecturer at the Ural State Law University).

Lyudmila Novoselova noted that the current procedure for applying interim measures does not always effectively prevent infringement of patent rights in pharmaceutical disputes:

"The key problem in law enforcement is that courts refuse to apply interim measures in patent disputes, and the patent holder practically loses its position as a person with a “legal” monopoly even before the dispute is resolved on its merits. We propose amendments to the Arbitration Procedure Code of the Russian Federation: to establish special rules on interim measures in patent disputes, including in the pharmaceutical sector, as well as the court’s right, if necessary, to hold a hearing within 15 days and invite the interested parties.”

Larisa Matveeva, AIPM Executive Director, discussed access to medicines within the legal framework. She outlined the industry's proposals:

"When examining cases of compulsory licensing, it's crucial to confirm an actual drug shortage and determine if it results from the patent holder's inadequate use in Russia. If the argument hinges on one invention's dependence on another, we must assess whether the dependent invention yields an independent technical outcome and substantial economic benefit. Equally important is ensuring the patent holder can secure timely legal protection, including interim measures."

The discussion revealed a strong demand for predictable legal mechanisms to establish uniform practice, which simultaneously protect the legitimate interests of patent holders, support fair competition in the market, and, most importantly, ensure patients timely access to therapy using both innovative and generic drugs.

The photo is provided by AIPM