Russia - Improvements in the protection of pharmaceutical inventions, Part 3: Consequences of the planned legislative changes
As soon as the changes to the law mentioned in Part 1 and 2 will come into force, this will have a noticeable impact on the pharmaceutical industry on the Russian market. Above all, legal certainty for research-based pharmaceutical companies and protection against possible patent infringements should be significantly improved.
1. Applicants for a Russian marketing authorization will in future be legally obliged to disclose those IP rights (Russian and Eurasian patents, trademarks) that are known to them and that are related to the preparation or drug that shall be registered. In addition, the applicant for a marketing authorization must submit a confirmation in writing that his preparation does not infringe any third-party IP rights. In this way, the Russian Drugs Act is in principle brought into line with the unified Eurasian Regulations for the registration of drugs. Violations of these Regulations or false information by generic manufacturers can therefore in future be punished in Russian courts due to a violation of a Russian law.
2. The Russian Patent Office, in cooperation with the Regulatory Authority, is creating a “Register for patent-protected pharmaceutically active compounds”. This Register should only contain compound-patents that protect an active ingredient per se. Patents on "new forms of a known compound (salts, solvates, hydrates, polymorphs, derivatives)", patents for the new use of a known active ingredient, or a method of treatment are explicitly excluded from inclusion in this Register.
The question concerning product-patents such as patents directed to a new formulation of a known active ingredient or a combination of two (or more) active ingredients (e.g. with a synergistic effect) has not been fully clarified.
2.1. Compound patents that protect an active ingredient (INN) will be entered into the Register at the request of the patentee after examination by an expert committee of the Patent Office (with due support of the Regulatory Authority).
Patentees of patents protecting pharmaceutically active substances should therefore endeavor to have their patents entered into the Register.
3. While up to now under the Russian patent legislation the question of whether a generic drug would infringe a given patent has exclusively been within the responsibility of the courts, in the future this question will also fall within the competence of the Patent Office, which is responsible for the management and maintenance of the above-mentioned Register.
In this context, the entry of a patent in said Register represents an official and reliable proof of the existence of valid patent protection for a certain active ingredient. Further evidences of whether a generic drug with a defined active ingredient really infringes a patent, which is protecting this active ingredient, are strictly speaking no longer required in a potential infringement proceeding, as this question has already been checked. An entry in the register may thus, among others:
- be used as support in a cease-and-desist letter
- serve as evidence of the “threat of a possible patent infringement” in court if a generic drug has been approved at a relatively early point of time
- serve as evidence of a patent infringement in court
4. The Russian jurisdiction provides for the option of a Preliminary Injunction. In practice, however, this remedy has (almost) never been granted by Russian courts in case of a patent infringement in the field of pharmacy. This could change as soon as the above-mentioned Register goes online and the responsible judges, when receiving an application for a Preliminary Injunction, do already have reliable official information at hand whether or not the active ingredient in question is protected by a patent.
5. In the future, the Ministry of Health should no longer permit generic preparations for state tenders for drugs in which the active ingredient is protected by a registered patent, as long as the active ingredient is labelled in the Register as 'patented'.
6. If in the future a generics company applies for a marketing authorization for a generic preparation, the entries in the above-mentioned Register will be taken into account. If, according to the register, there is patent protection for an active ingredient and the applicant cannot submit a license for the corresponding patent, then the marketing authorization will be granted with a note that this authorization comes into force only after the actual expiry date of the corresponding patent. This should prevent the premature launch of generics before the patent protection for the active ingredient has expired.
7. When disclosing the relevant IP rights that are known to the applicant in connection with an application for a marketing authorization, which the applicant has to submit to the Regulatory Authority, unfortunately the Russian Register hardly will play a significant role, since only compound-patents are allowed here. In contrast to the Russian register, the corresponding Eurasian Medicines Register, which went online on March 1, 2021, contains a much broader spectrum of inventions in the field of pharmacy. Regarding this matter, it would indeed be desirable if the Russian register would be brought into line with the scope of the Eurasian Pharmaceutical Register so that the Regulatory Authority would be in a position to verify the relevant information which they receive from applicants for generic preparations.