1 May 2012Big PharmaMaria Nilova and Vadim Chagin

A changing landscape: life sciences in Russia

In Russia, IP rights are regulated by the Civil Code of the Russian Federation (CCRF), and also subject to other legal provisions, such as the Law on Protection of Competition, Customs Code, Criminal Code, and others that form the legislative basis for the enforcement of IP rights. The Federal Law on Drug Circulation is often cited in pharmaceutical court cases when establishing the presence or absence of patent and trademark infringement.

Although the patent legislation in Russia is, in general, pro-patentee, in view of 80 percent of the commercial pharmacy market consisting of generics, the important question for many manufacturers would be the adoption of a ‘Bolar provision’, enabling them to start a lengthy market authorisation procedure before expiration of a patent. Changes to the Federal Law on Drug Circulation in 2010 have made such a provision possible.

According to CCRF, a patent for a product such as drug is infringed if the patented drug is manufactured, sold, offered for sale, imported or otherwise introduced into civil circulation. While scientific research in respect of a patented drug is excluded from infringing actions, it is not defined whether a registration of a patented drug is considered infringement.

The most recent version of the Law on Drug Circulation reads that “drugs are introduced into civil circulation upon registration by the respective authorised federal body”.

So although generic manufacturers cannot produce and market patented drugs before expiration of a patent, they can start the registration process— which is undoubtedly beneficial for the generic producer. That position was confirmed in the 2011 court decision in Pharmsynthes v Novartis, when the Russian pharmaceutical company was allowed to register Imatinib in Russia, although the key patent will expire in 2013.

Logistics and morality

In Russia, two agencies are responsible for granting patents. The Russian Federal Service for Intellectual Property can grant a Russian patent, and the Eurasian Patent Organization can grant a Eurasian patent valid in eight contracting states, including Russia, Belarus and Kazakhstan. Government organisations such as the Department for State Regulation on Medicines regulate the drugs and medical devices markets, but they do not affect the procedure for granting a patent.


Not all innovations can be patented. According to both Russian and Eurasian patent regulations, although methods for medical treatment of human and animals are generally patentable, those relating to human cloning, modification of genetic integrity of human germline cells, use of human embryos for industrial and commercial purposes, or solutions that are detrimental to the public interest, humanity and morality (such as means for euthanasia, instruments for execution and the like) are excluded from being patentable subject matter.

Since the list of objects that are not patentable on morality ground is not fixed, Russian patent examiners usually rely on the general notion of morality while considering the patentability of a particular invention.

Stem cells and genetics

In Russia, although increasing number of studies are focused on stem cells, stem cell research is not well regulated. Russia has not ratified the Convention on Human Rights and Biomedicine, and local legislative regulations on genetic engineering are still not developed. A similar situation pertains to the legal protection of results obtained in stem cell research.

According to CCRF, any technical solution related to a product or method is patentable, including substances, chemical compounds such as nucleic acids and proteins, genetic constructs, microbial strains, and plant or animal cell lines. While use of human embryos for industrial or commercial purposes cannot be subject to patent protection, manipulations of adult stem cells and genes as such are not mentioned among excluded subject matter.

However, the legislation specifically requires that a claim relating to nucleic acids or polypeptides either isolated from natural sources or otherwise obtained, indicates a biological function defining its purpose. For nucleic acid sequences encoding a polypeptide, the function or activity of the polypeptide shall be indicated in the claims.

Therefore, genetic sequences cannot be protected as such, but only when their biological function or that of the encoded polypeptide is known.

Compulsory licensing

According to current Russian legislation, a compulsory non-exclusive licence for use of patented inventions can be granted in Russia in two cases.

One case relates to a situation when the invention is not used or is insufficiently used by a patentee during the four years from the issue date. Additional considerations include insufficient offer of respective goods or services in the market and refusal of a patentee to give a licence. In this case, anyone willing and ready to use the invention can request a licence in court proceedings, which must be supported by sufficient argumentation and accompanied by a proposal for licence terms.

A compulsory licence can be also granted when a patentee cannot use an invention without infringing another patentee’s rights, who refuses to give a licence. In this case, the first patentee can initiate a legal action against the second patentee in order to obtain a compulsory licence for the invention.

Generally, court cases regarding compulsory licensing are rare in Russia and Commonwealth of Independent States (CIS) countries but recently, the court of the Republic of Belarus refused to grant a compulsory licence to an Indian company offering a much lower priced analogue of a drug, in view of insufficient argumentation.

Incentives for the future

At present, the Russian pharmaceutical market can be estimated roughly as 20 percent original drugs, 45 percent traditional and 35 percent generic; 76 percent of the total volume is imported and 24 percent is produced by domestic companies.

The level of counterfeit drugs in Russia is between 3 and 12 percent—lower than in many European countries, mostly because the market for traditional brands and generic drugs is obviously less profitable for counterfeiters and also in view of government measures to prevent distribution of counterfeit drugs.

Although traditional brands and generic products dominate the Russian market, some domestic pharmaceutical companies successfully develop original drugs and conduct research on new dosage forms, delivery vehicles, peptides, vaccines, antivirus drugs, anticancer compounds and others.


During recent years, several new drug molecules have been developed and successfully marketed in Russia, including popular antiviral drug Arbidol by Pharmstandard, anti-intoxication Zorex by Valenta, immunomodulating Neovir, anti-tuberculosis Fenazid, antitumor Sigedrin, (all Pharmsynthez products), and four more by the R&D Institute of Pharmacology in Moscow, including anxiolytic Afobazol, anti-astenic Ladasten, and neuroprotectors Noopept and Nooglutil.

To further promote and stimulate growth, in 2010, the Federal Program for the Development of Pharmaceutical and Medical Industry was launched by the Federal government.

Its total budget is more than $6 billion, with 80 percent for R&D and 20 percent for infrastructure. According to this programme, the volume of the pharmaceuticals and medical devices market is estimated to reach almost $60 billion by 2020, and 50 percent of this will be generated domestically, with 90 percent of the essential drug list being produced in Russia. The goal of the programme is stimulating creation of full cycle pharmaceutical enterprises and technical modernisation of the existing manufacturing sites.

Medical and pharmaceutical companies will receive government grants for R&D, manufacture and clinical testing of candidate pharmaceuticals and medical devices. Another focus is on infrastructure projects such as pharmaceutical clusters and so-called technological platforms on the basis of universities, academic and industrial enterprises using public-private partnership schemes.

Apart from the above programme, additional state funding is directed to creating pharma clusters in several regions, including St. Petersburg ($4 billion), Samara, Volgograd, Stavropol and Altay, that will facilitate collaboration of existing R&D institutions and high-tech industry enterprises of the pharmaceutical industry. Further clusters are planned in Zelenograd and Kaluga in the Moscow region, as well as in Rostov, Novosibirsk, and other regions.

Maria Nilova is a patent attorney and founding partner of Patentica. She can be contacted at:

Vadim Chagin is a patent attorney at Patentica. He can be contacted at:

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