Donor: ITPC –  UNITAID
Geography: Ukraine, Molodova, Georgia
Implementation Period: 01.01.2024-31.12.2027

The goal of the project is to prevent, reduce, and overcome legal barriers related to intellectual property rights that hinder patients’ access to medicines, biologics, vaccines, and diagnostic tools.

The project is aimed at expanding access to healthcare for people in low- and middle-income countries.

Project Implementation Includes:

• Reforming intellectual property legislation
• Filing patent oppositions
• Advocacy and public awareness activities

The  “Solidarity” project is implemented with co-funding from Aidsfonds through the BRILIANT project.

Key Achievements:

In May 2025, the Verkhovna Rada of Ukraine adopted Draft Law No. 13087 «On Amendments to Certain Legislative Acts of Ukraine Regarding the Implementation of the Bolar Exemption». The adopted Law eliminates obstacles to the earliest possible market entry of generic medicines. From now on, a generic medicine can be registered while the patent on original drug is still in force and, accordingly, can enter the market the day after the patent expires.

In 2023, the Ukrainian National Office for Intellectual Property and Innovations (UANIPIO) issued an official clarification stating that the controversial Law No. 2174 “On the Protection of the Interests of Persons in the Field of Intellectual Property During Martial Law Introduced in Connection with the Armed Aggression of the Russian Federation Against Ukraine” does not extend the validity of intellectual property rights for inventions whose maximum term of protection expired during martial law and whose validity can no longer be maintained or extended in accordance with the Law of Ukraine “On the Protection of Rights to Inventions and Utility Models”. In April 2025, Law No. 2174 was officially cancelled.

Proposals requiring that substantial changes in therapeutic efficacy be taken into account during conducting patent application examination of new forms of drugs known from the level of technology — with the aim of ensuring stricter and higher-quality patent examination (#stop evergreening patents) — were incorporated into the Rules for Drafting, Submission, and Examination of Applications for Invention and Utility Model, approved by the Ministry of Economy of Ukraine on 9 September 2024 (Order No. 23301).

Participation in drafting the National Strategy on Intellectual Property until 2030 (section “Intellectual Property and Pharmaceuticals”). Active participation in working groups under the Ministry of Economy of Ukraine and the Ministry of Health of Ukraine.

As a result of a patent opposition concerning bedaquiline secondary patents and supplementary protection certificates in Ukraine, Janssen renounced all challenged patents and SPCs, opening the door for generic versions to enter the Ukrainian market.

Since 2024, 100% LIFE has actively used the pre-grant opposition mechanism — submitting objections/comments to UANIPIO before patent issuance. Five pre-grant oppositions have already been filed:

• Rilpivirine: treatment/prevention of HIV using rilpivirine or its pharmaceutically acceptable salt in combination with hyaluronidase; pediatric formulation
• Bedaquiline: long-acting formulations
• Lenacapavir: therapeutic compounds for HIV infection
• Delamanid: compositions containing delamanid

With technical-legal support from 100% LIFE, several regulatory and legal changes were achieved in partner countries such as Georgia and Moldova:

• Amendments were introduced to Article 17 of the Patent Law of Georgia. In particular, substances obtained by chemical means (including pharmaceutical substances), as well as biotechnological objects, were excluded from protection as utility models.
• The draft law amending the Law of the Republic of Moldova “On the Protection of Inventions” containing TRIPS flexibilities, was approved by the Parliament of the Republic of Moldova. As part of the revision of the National Clinical Protocol on HIV Pre-Exposure Prophylaxis in Moldova, lenacapavir was included in the updated version of the protocol.

The project’s achievements were presented at several international conferences, including the International AIDS Conference and the Union World Conference on Lung Health.