Law to improve accessibility to marketing authorisations for drugs could have some nasty side-effects

16 April 2019

Originally published in IAM Media.

Precis: The Russian Ministry of Health has introduced a draft bill that clarifies the application process for marketing authorisations for a drug. There is concern that the new accessibility could lead to infringement when authorisation is sought for generic drugs. However, a proposed unified registry could prevent this. 

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.

The draft bill was open to public discussion and was also being reviewed for corruption by experts at the end of January. 

Ramifications associated with the possible inaccuracy of an applicant’s information, as well as its accountability for providing either incomplete or false information, are not covered by the new draft bill. But even if the issue of possible sanctions imposed on an applicant can be resolved on the basis that provisions already exist, the information provided by the applicant could still be inaccurate and unreliable. 

In addition to this bill, the Patent and Trademark Office (Rospatent) is working with Minzdrav to develop a unified registry that will reflect the information related to patented reference drugs and marketing authorisations for generic drugs. In January 2019, a roundtable titled “Intellectual property pertaining to medicines as a factor for achieving socially important indicators and as a tool for entering the international pharmaceutical market” was hosted by the Gaidar Forum (an annual international conference that covers practical sciences and economics in Russia), during which Grigori Ivliev, the head of Rospatent, presented a draft proposal for a unified register: the Unified Register of Pharmacologically Active Substances Protected by a Patent for an Invention.

This idea has been around for a while. The database would carry data on patented inventions of active substances in reference drugs, the patent number and its validity period, as well as information on the patent holders. Minzdrav would also enter information about generic drug marketing authorisations, as well as information about the drug’s rights holder and its launch. Ivliev proposed that Minzdrav would be able to delay the registration of a generic drug depending on the expiry date of the patent for the original drug.

Although the proposed bill and unified registry require further development, together they could foster greater transparency in the marketing system and provide more reliable legal protection for original manufacturers.

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