Rospatent to Be Empowered to Fine for Pharmaceutical Patent Infringement: Draft Law Published

The Ministry of Economic Development proposes toughening penalties for infringing drug patents and involving Rospatent in recording violations. This follows from the published draft federal law amending the Code of the Russian Federation on Administrative Offences (CAO RF).

As noted in the explanatory memorandum, Russia currently lacks an efficient mechanism for protecting exclusive rights to inventions: patent litigation lasts from one year to several years, and the infringer manages to sell the counterfeit goods and withdraw the proceeds before a ruling is issued. Part 2 of Article 7.12 of the CAO RF, which provides for liability for infringing inventor's and patent rights, has been effectively unenforced since 2024 — after the police were stripped of the relevant powers, no authority was designated to draw up protocols.

Key novelties of the draft law:

• Turnover-based fine for legal entities. Article 7.12 of the CAO RF is supplemented with parts 3 and 4, establishing liability for the unlawful use of an invention relating to a chemical compound (nucleic acid or protein) in the circulation of medicinal products for medical use. For the sale of such medicines, legal entities face a fine of 50% to 200% of the proceeds from the sale of goods in which the invention was unlawfully used; officials — from RUB 10,000 to 50,000.

• New type of administrative penalty. Part 1 of Article 3.5 of the CAO RF is supplemented with item 22, establishing the offender's proceeds from the sale of goods in which the invention was unlawfully used as the basis for calculating the fine.

• Seizure of funds. Article 27.20 of the CAO RF is supplemented with a reference to part 4 of Article 7.12, allowing funds in the accounts of patent infringers to be seized as a measure to secure enforcement of rulings.

• Rospatent's powers. Drawing up protocols under parts 3 and 4 of Article 7.12 is proposed to be assigned to officials of the authority responsible for patent rights protection (item 75 of part 2 of Article 28.3 of the CAO RF); Rospatent is proposed to be designated as such authority. According to the drafters, the service's expert competencies will enable faster detection of violations and shorter patent and technical examinations.

• Entry into force — 1 September 2027; this is due to the need to organize the work of the intellectual property authority.

The explanatory memorandum emphasizes that the mechanism does not affect the powers of the Federal Antimonopoly Service (FAS Russia) to suppress unfair competition (part 2 of Article 14.33 of the CAO RF).

The text of the draft law is available at: https://regulation.gov.ru/projects/172297/