Russian Federation: Pharma Patents: Healing The Rights

Last Updated: 18 January 2019
Article by Valery N Medvedev

Most Read Contributor in Russian Federation, July 2019

The development of a new drug is a sophisticated process...

Scientists synthesize thousands of substances that could potentially become medicines. According to sources, only one of ten thousand obtained substances reveal properties that may be useful in treating a disease. After that preclinical and clinical studies follow, registration with the health authorities and finally, the drug goes to the patients. Pharmaceutical companies spend hundreds of millions or even billions of US dollars to find a substance useful for treating a particular disease. Development of a drug may take ten years and often more. Sometimes the obtained drug reveals unexpected properties as occurred with Viagra which was initially intended to treat ischemic heart disease but suddenly revealed other unexpected properties, thanks to which it became widely known.

It is common knowledge that the development of efficient drugs involves much effort and money. Pharmaceutical companies must offset huge expenses for the development of the drug and set aside money for future research. For that purpose, they obtain patents that give them a lawful monopoly for 20 or even 25 years. Registration of a trademark for the drug is not a bad idea either which helps to gain popularity of the drug.

Generic Drugs

Realities of life are such that where there is a good drug it attracts attention, not only of practicing doctors but also of the competitive companies wishing to have their unwelcome share of the successful drug. These companies are generally termed as generic companies. There is nothing bad in the idea itself. Generic drugs are produced and sold in many countries, their share being some 50 to 60 percent in a given market. This, however, is correct in a situation where the relevant patent has expired and the company producing the original drug has had its share of the market and is working on a drug of the next generation with improved properties. For example, Humira (stands for "human monoclonal antibody in rheumatoid arthritis) used in the treatment of many ailments needing immunosuppressive drugs were sold at more than $4000 per month in 2017. After expiry of the patent in Europe in 2018 generic companies were selling the drug for as little as several hundred USD. The UK ministry of health plans to save £300 million on Humira in 2019.

The problem of generics is also high on the agenda in Russia. Some generic companies are reluctant to wait until the patent dies and initiate production and sales of biosimilars before the expiration of a relevant patent. This has really been a headache for original pharmaceutical companies doing business in Russia. To a large extent, this is explained by the absence of patent linkage. The Ministry of Health does not check whether there is a valid patent and may issue a marketing authorization for generic drugs before the expiration of the relevant patent.

Protection of Drugs

Currently, there are two practically independent systems of protection of drugs. One concerns state registration of pharmaceuticals to prove their safety, efficiency, and quality. The procedure of registration is regulated by the Law "On the Circulation of Medicines". Another is patent protection endowing the patent owner with the legal monopoly for the use of the drug in which the invention is used. These two systems are independent. Russian courts recognize that registration of drugs per se does not infringe patent rights however patent owners rightly believe that such registration creates a threat of infringement.

This leads to the situation where a drug covered by a third party's patent may be registered and offered on the market. Only when the infringing medicine goes to the market the owner of the patent may sue the infringer, cancel the registration at the Ministry of Health and claim damages. The law of many countries including in one of the members of the Eurasian Economic Union, Kazakhstan, provides for the patent linkage. This means that the applicant for the registration of the drug should declare that he is not infringing other persons' rights while the patent owner may ask the registration authority to suspend the registration of the drug.

Russia is hopefully going to change the current situation and introduce patent linkage too. The Ministry of Health proposed amending the Federal law "On the Circulation of Medicines" related to the submission and examination of an application for the state registration of drugs. The bill provides that the pharmaceutical companies wishing to obtain marketing authorization should submit information on the valid Russian patents and trademarks and confirm that they do not infringe the rights of other persons.

Compulsory Licenses

The above is not the only hurdle in the business of pharma. There is another problem standing in the way of normal pharmaceutical business in Russia. Several years ago the Federal Antimonopoly Service (FAS) came up with a proposal to grant compulsory licenses on the basis of administrative decision instead of court. In fact, the concept of a compulsory license is not new. Compulsory licenses are provided in the patent laws of many countries and Russia is not an exception. Article 1362(1) of the Civil Code (CC) sets forth that if an invention is not used or used insufficiently during four years after the grant of a patent any person may ask the patent owner to issue a license, and, in case of refusal, sue the patent owner and obtain a license through the court judgment. This provision is dormant, however, not a single license has been granted on the basis of that article so far. Similar examples may be cited from other countries: there was a Bayh-Dole law of 1980 in the US providing for the grant of compulsory licenses if research was made with federal funding, however even in that case no compulsory licenses have been granted.

While promoting its proposal FAS made emphasis on Article 1360 CC (the use of an invention in the interests of national security) rather than on Article 1362. Article 1360 allows the government to grant permission for the use of the invention in the interests of defense and national security. It may be agreed that in some rare cases national security may be jeopardized because of insufficient health care so FAS (or another interested entity) holds it that a compulsory license could be issued in certain circumstances.

It seems that prospects of the proposal to become a law are obscure and are tapering off to zero. Being disappointed with the dim prospects of accepting FAS' proposals some Russian pharmaceutical companies tackled the issue from a different angle.

There is a provision in the Civil Code (Article 1362(2)) providing that if the owner of a patent cannot use his invention without infringing the rights for another (first) patent and the owner of that first patent refuses to grant him a license, the owner of the second patent may demand a compulsory license from the owner of the first patent in court.

The owner of the dependent patent when suing the owner of the original patent should prove that his invention is an important technical achievement and has significant economic advantages over the first invention. If this is proved the court may grant a compulsory license.

Proving a significant economic advantage may not be difficult for the prospective licensee. He did not spend money on extensive research and thus may afford cheaper prices riding on the findings of the owner of the original patent.

Important technical achievement is a requirement not easily defined

Some experts say that in many cases the results of preclinical trials of dependent inventions are not confirmed during clinical trials. Hence, in order to prove that the dependent invention is indeed an important technical achievement, the owners of such patents should conduct full-scale clinical trials in order to show advantages over earlier patents. They prefer not to do that but simply insist on the alleged importance of their technical achievement. With that poor armamentarium, they still go to court but may be expected to be dismissed. This issue is not simple.

Also, there has been a discussion in Russia about "evergreen" patents. When the owner of the original patent develops its continuation, a dependent invention and obtains a patent, he is sometimes accused of unfair behavior wishing to extend the validity of his patent to eternity. However when such dependent patent is obtained by a competitor (presumably unfair) he and his supporters claim to have made important technical achievement.

The question arises: how can attempts to use other people's inventions, for cheap be offset? There are several options confirmed by business and judicial practice. One is to file an appeal against the grant of a dependent patent with the Chamber of Patent Disputes of the patent office. Usually, the ground on which the appeal can be made is a failure to meet the "inventive level" requirement.

This seems to be a natural step because such "secondary" patents, in fact, they slightly modify the original patents with some minor modifications without any tangible improvements. They do not possess better medical effects nor are they free from negative side effects. This approach is for the most part sufficient to have the patent cancelled.

A different approach was demonstrated by companies in other cases. The holder of a patent for a dependent invention may obtain a marketing authorisation while the original patent is still in force. In this case, the owner of the original patent may sue the owner of the dependent patent and claim suspension or withdrawal of the marketing authorisation. It is obvious that while the original patent is not infringed at this stage nonetheless the marketing authorisation creates a threat for such infringement. If the dependent patent owner uses his marketing authorisation and launches the drug on the market the original patent owner will have to monitor the market, collect evidence of infringement and engage in much more costly court proceedings.

In order to make obtainment of marketing authorisation impossible, steps are being made to introduce patent linkage as mentioned above.

The bottom line: never give up; the stakes are too high to ignore the opportunity to bring false "innovators" in line.

Previously published in The Global IP Matrix magazine, issue 3, January 2019.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Gorodissky & Partners
Gorodissky & Partners
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Gorodissky & Partners
Gorodissky & Partners
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions