Intellectual Property: Aligning Interests for the Industry’s Development

The pharmaceutical industry traditionally operates in an environment that features strict government regulation, major social obligations, and capital-intensive processes for developing innovative drugs. Ensuring the market is supplied with high-quality innovations is essential to achieving a nation’s pharmaceutical security and technological sovereignty. Accomplishing this goal requires the establishment of a stable operating environment for the industry in which one of the key components is an effective mechanism for enforcing patent rights regarding innovative drugs. At the same time, the government, as the guardian of public interests, is duty-bound to introduce legal instruments that are designed to safeguard such interests in situations where risks of drug shortages arise. One such tool is compulsory licensing – a mechanism that grants the government the power to authorize domestic entities to manufacture or import pharmaceutical products prior to the expiration of their patent, subject to the fulfilment of certain obligations to the patent holder. It is crucial for the sector to strike a balance in which the interests of the industry and society do not come into conflict, and market participants can achieve harmonization through systematic dialogue. How can we reconcile the reliable protection of patent holders’ intellectual property with the state’s right to safeguard public interests in situations involving drug shortages? How can the compulsory licensing mechanism be applied in a manner that eliminates any risks of unfair competition, while ensuring a balance in terms of improving the investment climate? What alternative mechanisms could serve as measures to protect national interests? What measures for protecting intellectual property rights could simultaneously take into account the interests of both manufacturers of innovative drugs and the state? What solutions can Russian and foreign companies propose to balance these interests?