Russian Federation is going to impose a law for the Improvement of Access to Marketing Authorizations for Drugs

In October 2018 the Russian Ministry of Health (Minzdrav) introduced a draft bill for public discussion. It proposed that in order to obtain marketing authorisation for a drug, applications must include:

  • information on any relevant patents that are valid in Russia with an indication of the patent number, its date of issuance, validity period and the name of the patentee;
  • information on any trademark registrations in Russia, including the registration number, date of issuance, validity period and name of owner; and
  • confirmation that all data in a registration dossier has been obtained and is in good order and does not violate any third parties’ IP rights.

In addition, the following documents are required:

  • written confirmation from the applicant that the marketing of the medicine will not violate third-party IP rights;
  • in the case of a medicine protected by one or more patents, a copy of those patents or a copy of a licence agreement that gives the applicant the right to manufacture and sell the medicine for which approval is sought; and
  • a copy of any applicable Russian trademark registrations or a copy of any licence agreements or other documents confirming the right to use the trademark registrations.

These requirements could be seen as a threat to original drug patent owners. However, marketing authorisation for a generic drug cannot directly violate the exclusive rights of an innovator’s protected patent for an original drug until the generic drug is actually launched. Generic drug manufacturers can market, but not actually launch or sell, their drugs before the expiration of original drug’s patent protection.

However, the accessibility of marketing authorisations for medicines on the Vital and Essential Drugs list means that manufacturers of generics can see maximum sales prices and anticipate State tenders. This is a violation of Russian law and leads to unfair market competition. Minzdrav has proposed new requirements for the approval of medicines in order to strengthen the protection of the patentee’s rights and regulate the launch of generic drugs.