The regulatory framework for the Russian pharmaceuticals and medical devices market is set out in the Fundamentals of the Legislation of the Russian Federation on the Protection of Citizens' Health, No. 5487-1 and in Federal Law No. 323-FZ on Fundamentals of the Protection of Citizens' Health in the Russian Federation (the Fundamentals), which abolish the former legislation from 1 January 2012.
The main legislative act specifically regulating the circulation of medicines (including biological medicines) and the pharmaceuticals market is the recently introduced Federal Law No. 61-FZ on the Circulation of Medicines (Law on Circulation of Medicines). To date there is no legislative act specifically regulating medical devices in Russia. However, some preparation for adopting one is underway.
Other laws relevant to the circulation of medicines and medical devices include:
Federal Law No. 184-FZ on Technical Regulation (Law on Technical Regulation), governing, among other things, the procedure for declaring the conformity of medicines to the respective quality requirements.
Federal Law No. 38-FZ on Advertising (Law on Advertising), which regulates the advertising of medicines.
Federal Law No. 99-FZ on Licensing Certain Types of Activities (Law on Licensing), regulating the licensing of pharmaceutical manufacturing and pharmaceutical activities (retail sale, wholesale of medicines and preparation of medicines).
The regulatory bodies regulating the pharmaceuticals and medical devices market are the:
Ministry of Healthcare and Social Development (MOH).
Ministry of Industry and Trade (MIT).
Federal Service on Surveillance in Healthcare and Social Development (the Federal Service).
See box, The regulatory authorities.
Russian law does not yet contain the term "biological" product but uses the term "immunobiological" medicinal preparation. Immunobiological products are defined as medicinal products of biological origin, used for immunological diagnostics, prophylaxis and treatment of diseases. To the extent biological medicines do not fall under the definition of immunobiological products, they are regulated in the same way as other medicinal products. However, there are some important differences in the status of immunobiological products. For example, expedited expert examinations in the state registration procedure are not available for generic immunobiological products. They must be registered with submission of a full application dossier, including clinical trials data.
Combination products, that is, medicinal preparations containing combinations of international non-proprietary names (INN), are also regulated in the same way as any other medicinal product.
Price control of EDL medicines is an important tool used in the healthcare system's organisation, ensuring that essential medicines are accessible for all citizens. The current EDL was established by Government Ordinance No. 1938-r. The EDL will be updated in 2012 and a draft is currently awaiting governmental approval. By law, the EDL must be revised annually. The prices of EDL medicinal preparations are controlled through registration of maximum prices and the use of maximum mark-ups.
Prices for other medicines (that are not included in the EDL) are no longer regulated.
The most important government programme related to medicinal supply is the programme for additional medicinal supply to specific categories of citizen, referred to as the Programme for the Supply of Essential Medicines (DLO Programme or ONLS Programme). Under this programme, certain categories of citizens receive certain medicines free of charge. Purchases of medicines under the ONLS Programme are organised through auctions at a regional level. The current list of medicines included in the ONLS Programme was approved by MOH Order No. 665, as amended.
A programme to supply expensive medicines for the treatment of certain diseases (formerly part of the ONLS Programme) is organised at the federal level. Expensive medicines are purchased through auctions conducted by the MOH. The current list of such medicines was established by Government Resolution No. 2053-r. Purchases of medicines in these programmes, and other purchases of medicines for state or municipal needs or under other programmes, are carried out under Federal Law No. 94-FZ on the Placement of Orders for the Supply of Goods, Performance of Works and Rendering of Services for State and Municipal Needs, as amended.
Most pharmacists in Russia are not private practising pharmacists but are employed in pharmacy organisations. Therefore they are not separately compensated for their dispensing services. Their compensation is governed by their employment agreement.
A system of compensating pharmacy organisations involved in servicing state-run medicinal supply programmes previously existed but its current status is unclear and it is unlikely to continue to be operational.
The manufacture of medicines is subject to licensing. An application for a licence to manufacture medicines is made to the MIT.
The Regulation on Licensing the Manufacturing of Medicines, approved by Government Resolution No. 684 (Manufacturing Licensing Regulation), imposes certain requirements. In particular, the licensee must:
Either own premises and equipment that meet the applicable requirements and are necessary for carrying out the manufacturing activity, or have the right to use qualifying premises and/or equipment belonging to other manufacturers.
Comply with the duly established rules for organising the manufacture and quality control of medicines.
Have on its staff a qualified employee who, when releasing medicines into public circulation, confirms their conformity to the requirements imposed when they were registered, and guarantees they were manufactured according to the medicine manufacturing rules. This person must:
have a higher pharmaceutical, chemical or medical education;
have at least five years' professional experience in the area of manufacturing and quality control of medicines;
be duly attested.
Have specialists responsible for manufacturing and labelling medicines.
Comply with the prohibition on manufacturing medicines not in the state register of medicines. Medicines not in the state register can only be manufactured for clinical trials or export. The licensee must also comply with the prohibition on manufacturing falsified medicines.
Comply with the prohibition on selling spoilt, falsified and counterfeit medicines, and with the procedure for destroying these medicines.
Comply with the requirement for state registration of the maximum manufacturer's prices for EDL medicinal preparations.
Russian law does not directly prohibit foreign legal entities from applying for a licence to manufacture medicines in Russia. However, in a manufacturing licence application, an individual must enter the main state registration number of the applying legal entity (OGRN), and details of a document confirming entry of data for this legal entity into the Unified State Register of Legal Entities (Certificate of State Registration). The OGRN and the Certificate of State Registration can only be issued to a Russian legal entity. Therefore, the MIT always has a formally valid reason to decline an application for a licence made by a foreign legal entity.
The MIT must review an application and decide whether to issue a licence and notify the applicant about its decision within 45 days from the date when the application is submitted to the MIT (Law on Licensing and Manufacturing Licensing Regulation).
In practice, it is the preparation required to meet the licensing requirements and prepare the application file, rather than the review procedure itself, that requires most time.
The state fee for:
Issuance of a licence is RUB2,600 (Tax Code) (as at 1 November 2011, US$1 was about RUB30).
Issuance of a duplicate document confirming the licence is RUB200.
Reissuance of a licence varies, depending on the reasons for such reissuance (either RUB2,600 or RUB200).
Information about fees is available on the MIT website (www.minprom.gov.ru/eng).
A licence is issued for an indefinite term.
The relevant Russian state authorities can monitor compliance with licence terms and conditions, including through visits to the facilities where the manufacturing activity is conducted and performing examinations.
If a company that manufactures medicines does not comply with its licence's terms and conditions it can be subject to administrative fines and ultimately the manufacturing licence can be annulled through a court decision.
Clinical trials are regulated by the:
Fundamentals.
Law on Circulation of Medicines.
Rules of Clinical Practice, adopted by MOH Order No. 266.
The following Russian translations of the International Conference on Harmonisation, Good Clinical Practice (ICH-GCP) are also relevant:
Industry Standard OST 42-511-99, Good Clinical Practice.
National Standard of Russia GOST R 52379-2005, Good Clinical Practice, adopted by Order of the Federal Agency on Technical Regulation and Metrology 232-st.
Clinical trials are regulated by the MOH. Control is performed by the Federal Service.
A permit from the MOH is required to perform clinical trials. This permit is obtained by filing an application with the MOH, together with the necessary documents. The Ethical Committee conducts an expert examination of the relevant clinical trial documents at the request of the MOH, that is, no separate filing with the Ethical Committee is required.
A patient's consent for participation in a clinical trial is required before participation. It is obtained by the patient signing a patient's information leaflet, containing information on the clinical trial.
There are a number of conditions that each trial must meet, including that:
Written agreements are required between the entity that obtained the permit to conduct the clinical trials and duly accredited trial sites.
Mandatory insurance is required against harm caused to the life or health of the patient as a result of conducting a clinical trial of medical preparations for human use.
Compliance with these conditions is checked during the procedures for issuing authorisations for clinical trials.
Detailed procedural requirements for performing clinical trials are set out in the Rules of Clinical Practice. For example, after a trial, a report must be prepared and filed with the MOH.
Medicines are subject to compulsory state registration before their introduction into and circulation in the Russian market. An application for state registration of a medicine is submitted to the MOH.
For registration, each medicinal preparation must pass expert examinations proving its efficacy, safety and quality. In most cases, clinical trials of a medicinal preparation must be conducted at least partially in Russia to provide sufficient evidence to be used in the expert examinations. The registration process begins with filing an application and necessary documents with the MOH.
The marketing of medicines is also subject to a declaration of conformity and other state controls (see Question 11).
Each registered medicinal preparation has certain very specific technical conditions in respect of its handling, established in the course of its registration including, for example, maximum and/or minimum temperature of storage or special conditions of safe destruction. These conditions sometimes, but rather rarely, amount to dictating how a medicinal preparation is to be administered. For example, some botulinum toxin registrations require its application only in specialised medical institutions. However, it is understood that this is not a legal requirement, but rather a desire of the applicant to control administration of the product.
Typically, access of the patients to the medicinal preparation is not usually decided or conditioned at the moment of their state registration, aside from deciding whether the relevant medicinal preparation has a prescription or non-prescription status.
The complete state registration procedure for an original medicinal preparation, in relation to which no clinical trials have yet been conducted, should take no longer than 210 working days (excluding the time for conducting a clinical trial). Registration is initiated through an application with the required documents to the MOH. The MOH then orders two expert examinations:
An expert examination of the documents required for permission to conduct clinical trials of the medicinal preparation (performed by a separate federal state institution).
An ethical expert examination of the possibility of conducting the clinical trial of the medicinal preparation (that is, an ethical expert examination performed by an ethics committee).
On receiving positive conclusions in both expert examinations, the MOH suspends the registration procedure. After that, the applicant must apply for permission to conduct clinical trials, by submitting an application and additional documents.
After permission is obtained and the clinical trials are conducted and completed, the applicant must submit another application to the MOH to resume the registration procedure. More documents must be attached, including the report on the clinical trial conducted. After resuming the registration procedure the MOH orders two further expert examinations:
An expert examination of the suggested quality control methods for the medicine and of the quality of the supplied samples of the medicine using these methods (that is, an expert examination of the quality of the medicine performed by a separate federal state institution).
An expert examination of the ratio between the expected benefit to the possible risks connected with use of the medicinal preparation.
Positive conclusions of these two expert examinations lead to the registration of a medicinal preparation.
State registration of a medicinal preparation can be simplified if the necessary clinical trials are conducted before the registration process starts. Under current regulations, the only way to do this is by conducting an international multicentre clinical trial, partly in Russia. As the result of the prior clinical trial is initially submitted, the registration procedure is not interrupted to conduct a clinical trial.
The state fees for state registration are:
RUB300,000 for a medicine for which no clinical trials have been conducted (Tax Code).
RUB425,000 for a medicine whose clinical trial has been conducted in the form of an international multicentre clinical trial (Tax Code).
The costs of the expert examinations are now included in these state fees, while the cost of conducting the clinical trials necessary for the registration of a medicine is a separate expense. Information on state fees is not publicly available on the official MOH website.
The initial registration certificate of a medicinal preparation confirming its state registration is valid for five years. A registration certificate with an indefinite term of validity is issued for this medicinal preparation:
Once the initial registration certificate expires.
Subject to successful completion of the procedure of confirmation of state registration of a medicinal preparation.
The main post-marketing commitment for registration of a medicinal preparation is to keep it up to date, that is, file all variations whenever any changes relating to the medicinal preparation occur. The main pharmacovigilance reporting rule is under the Law on Circulation of Medicines (Article 64, part 3). This rule is further detailed in the procedure adopted by MOH Order No. 757n.
The rule states that persons circulating medicines must report the following under established procedure:
All cases of:
side effects, which are not specified in the usage instructions of a medicinal preparation;
serious adverse reactions;
unforeseen adverse reactions in the application of the medicinal preparation.
Details of the interaction of the medicinal preparations with other medicinal preparations, discovered in clinical trials and in the application of the medicinal preparation.
The established pharmacovigilance reporting procedure is as follows:
Any entity or individual circulating medicines must conduct ad hoc reporting under the procedure.
A periodic report on the safety of a medicinal preparation must be submitted either by the developing company, or the manufacturer in whose name the medicinal preparation registration certificate has been issued.
Also, regulations require submitting results of safety monitoring in the procedure for confirmation of the state registration of the medicinal preparation. The form for this submission is adopted in MOH Order No. 749n.
Contains the same pharmaceutical substance or combination of the same pharmaceutical substances in the same medicinal form as an original medicine.
Enters into circulation after the original medicine entered into circulation.
This procedure does not apply to immunobiological medicinal preparations, insulin or newly registered medicinal preparations.
The necessary expert examinations in this procedure should be completed within 60 working days. Otherwise, the procedure is similar to that for registration of other medicinal preparations.
To register a reproduced medicine, an applicant must generally rely on the results of its own clinical trial (in the form of a bioequivalence and/or therapeutic equivalence trial) and on the results of the clinical trials of the original medicine, as published in specialist publications.
Release of a medicine in consumer packaging in the Russian market must be preceded by a declaration of its conformity, during which compliance of the medicine with the normative documentation approved during its state registration is checked (see Question 9).
There are two additional forms of state control of a medicinal preparation already in circulation:
Selective state control.
State control performed when non-compliance with the licensing rules and/or respective good practices is detected.
If non-compliance of medicinal preparations with their normative documentation approved during state registration is discovered during the declaration of conformity procedure, the declaration of conformity is not registered and the medicines cannot be released into the Russian market. If non-compliant medicines are discovered after they are released into the market, for example during state control (see above, Monitoring compliance), the relevant batches of medicines are recalled from the market.
Further, manufacturing medicines that do not comply with their normative documentation, that is, medicines of poor quality, can be treated as a violation of the manufacturer's licence (if it is located in Russia) (see Question 6).
Registration of trade marks with the customs authorities was previously an effective tool for blocking parallel imports into Russia. However, because Russian courts no longer view parallel imports as a trade mark infringement amounting to an administrative offence, the customs authorities refuse to stop parallel imports, unless the trade mark owner starts civil enforcement actions against the parallel importer for trade mark infringement.
Overall, the issue of parallel imports of medicines is not critical in practice. This is because Russian rules and regulations contain very specific requirements, such as the labelling of medicines (see Question 16), therefore making it impossible to lawfully import medicinal preparations manufactured for another country. This particularity of the regulatory system also makes it necessary for foreign manufacturers to manufacture medicinal preparations specifically compliant with Russian rules, regulations and product registrations.
The Fundamentals establish a set of rules on the interaction of pharmaceutical and medical devices companies with Russian medical and pharmaceutical professionals (effective 1 January 2012). These rules:
Do not specifically restrict marketing activities, but will significantly affect them.
Are not aimed at restricting the lawful interaction of pharmaceutical and medical devices companies with Russian healthcare institutions.
The Fundamentals prohibit medical and pharmaceutical professionals from:
Accepting visits of representatives of such companies except:
in connection with ongoing clinical trials of medicinal preparations or medical devices; or
when they participate in meetings or other events related to professional development of healthcare professionals (HCPs) or providing information on the safety of medicinal preparations and medical devices in compliance with procedure established by the management of a medicinal organisation.
Accepting gifts or money including payments for entertainment, vacations and travel costs except for:
payment under agreements connected with clinical trials of medicinal preparations or clinical studies of medical devices; and
payment for teaching and/or scientific activities.
Participating in entertainment events held at the expense of companies or representatives of companies.
Accepting samples of medicinal preparations and medical devices for further distribution to patients (except in the context of clinical trials).
These restrictions will be supported by administrative liability both for medical and pharmaceutical professionals and for the companies concerned. The draft of the law introducing this liability has been prepared but its adoption and entry into force is uncertain.
In addition, any gifts made for marketing purposes are subject to general legal rules. The Civil Code prohibits gifts between commercial legal entities. If gifts are made to individuals, it must be ensured that the individual is not prevented from accepting gifts by his status (for example, as a state or municipal servant). Making undue gifts can in certain circumstances also cause administrative (for legal entities) and criminal (for individuals) liability for bribery or commercial bribery.
The anti-bribery regulation in general is established by Federal Law No. 273-FZ on Counteracting Corruption and Presidential Order No. 460 and liability for violations is under both the:
Criminal Code of the Russian Federation (Criminal Code).
Code of the Russian Federation on Administrative Offences (Administrative Code).
A plan on counteracting corrupt practices for 2010 to 2011 was approved by MOH Order No. 1001. It introduces a range of measures aimed at the prevention of corrupt practices, including, for example:
A committee regulating conflicts of interest.
Legal anti-corruption review of relevant draft laws.
Improvement of information and automation systems in the healthcare sector.
These laws cover active and passive, direct and indirect bribery, including cases involving foreign public officials and intermediaries.
The anti-bribery provisions of the Criminal Code specifically cover bribery involving foreign public officials. The legislation has further provisions that apply outside Russia, including when either:
Russian citizens or stateless persons residing in Russia commit a crime abroad.
Foreign citizens or stateless persons not residing in Russia commit a crime (and were not convicted in foreign states) against the interests of:
the Russian Federation;
its citizens; or
stateless persons residing in it or in cases established in an international treaty.
Extraterritorial application is theoretically possible under the Administrative Code (if established in an international treaty with the relevant country).
Advertising by e-mail also requires the prior consent of the addressee and is subject to a prohibition on the use of automatic sending systems. Specific rules regulating advertising by mail were abolished in Russia at the end of 2008, so this type of advertising remains subject to the general advertising rules.
The advertising of medicines is regulated by the Law on Advertising. The Federal Antimonopoly Service is the regulatory authority.
Only registered medicines can be advertised. Further, prescription medicines, as well as medicines that contain narcotic or psychotropic substances approved for medical use, can only be advertised in specialist printed publications intended for medical and pharmaceutical professionals, and at certain medical or pharmaceutical events.
The Law on Advertising contains general restrictions on advertising that apply to medicines as they do to any other product. There is a general requirement that advertising should be fair and true. However, the Law on Advertising also contains specific provisions applicable to medicines.
The Law on Advertising contains a requirement that the advertising of medicines must be accompanied by a warning about contraindications in their use, and the need to read the instructions on their use or the need to consult a specialist. However, this does not apply to advertisements:
Disseminated at certain medical or pharmaceutical events and contained in specialised printed publications for medical and pharmaceutical professionals.
Where the recipients are solely medical and pharmaceutical professionals.
Further, the advertising of medicines must not:
Be addressed to minors.
Contain references to specific cases of recovery from disease or improvement of health as a result of the advertised object being used (except in advertising exclusively for medical and pharmaceutical professionals).
Contain expressions of gratitude from individuals in connection with the use of the advertised object (except in advertising exclusively for medical and pharmaceutical professionals).
Create an impression of the advantages of the advertised object by reference to the fact that the trials required for its state registration have been conducted.
Contain statements or assumptions that consumers have certain diseases or impairments of health.
Facilitate the impression that a healthy person needs to use the advertised object (this does not apply to medicines used for prevention of diseases).
Create an impression that a person does not need to consult a physician.
Guarantee a positive effect of the advertised object, its safety, efficacy and absence of side effects.
Represent the advertised object as being a dietary supplement or other product that is not a medicine.
Contain statements that the safety and/or efficacy of the advertised object are guaranteed by its natural origin.
The Law on Advertising contains an important general prohibition on using images of medical and pharmaceutical professionals in any advertisements, except advertisements of medical services and of personal care products, and advertisements exclusively for medical and pharmaceutical professionals.
Internet advertising is subject to the general rules on advertising (see above, Legislation and regulatory authority and Restrictions).
The packaging and labelling of medicinal preparations is regulated by the Law on Circulation of Medicines. The MOH and the Federal Service enforce the relevant regulations.
The main requirements for labelling medicinal preparations are set out in Article 46 of the Law on Circulation of Medicines, which requires the following general information to be placed on the packages of all medicinal preparations:
On the primary packaging (except for medicinal herbal preparations):
name of the medicinal preparation (INN or chemical or trade name);
batch number;
manufacturing date (for immunobiological medicines);
shelf life;
dosage or concentration;
volume;
activity of a medicinal preparation (measured in units of effect) or number of doses.
On the secondary (consumer) packaging:
name of the medicinal preparation (INN or chemical or trade name);
name of the manufacturer of the medicinal preparation;
batch number;
manufacturing date (for immunobiological medicines);
registration certificate number;
shelf life;
mode of administration;
dosage or concentration;
volume;
activity of a medicinal preparation (measured in units of effect) or number of doses in the package;
medicinal form;
conditions of sale;
storage conditions;
warnings.
In addition:
Sera can only be released into circulation if they specify blood, blood plasma, as well as organs and tissues of the animal used in their manufacture.
The secondary (consumer) packaging of medicines made using blood, blood plasma, as well as human organs and tissues, must be additionally labelled "Antibodies to HIV-1, HIV-2, to hepatitis C virus and surface antigen to hepatitis B virus are absent".
The primary and secondary (consumer) packaging of radiopharmaceutical medicines should be labelled with the radiation hazard sign.
The secondary (consumer) packaging of homeopathic medicinal preparations must be additionally labelled "Homeopathic".
The secondary (consumer) packaging of herbal medicinal preparations must be additionally labelled "Product has passed radiation control".
The primary and secondary (consumer) packaging of medicinal preparations for clinical trials must be additionally labelled "For clinical trials".
The packaging of medicines manufactured solely for export must be labelled in accordance with the rules of the importing country.
A barcode must be placed on the secondary (consumer) packaging of medicinal preparations.
The information requirements must be stated in Russian (see above, Information requirements).
To obtain patent protection, an invention must be:
Novel.
Inventive (non-obvious).
Industrially applicable.
The most important patent legislation is in Part IV of the Civil Code.
An invention is a technical solution in any field that relates to either a:
Product (including a device, substance, strain of microorganisms, plant or animal cell culture).
Method (the process of carrying out actions relating to a material object by material means).
Methods or processes for treatment, diagnosis and prevention of diseases can be protected by patents. A Markush-type claim (that is, with a list of functionally-equivalent elements) is available for patent protection of substances and compounds. Several substances united by a general chemical structure can be protected within the scope of a single independent claim, or they can be claimed separately. "Use" format claims can also be used to protect pharmaceutical inventions.
The following cannot be protected by patents:
Human cloning techniques.
Techniques for modifying the genetic integrity of human embryo cells.
Use of human embryos for industrial and commercial purposes.
Other solutions inconsistent with the public interest and humane and moral principles.
There are two ways to obtain patent protection for an invention in Russia:
The national patent system (by applying to the Federal Service for Intellectual Property, Patents and Trade Marks) (Rospatent) (Russian Patent Office).
The regional Eurasian patent system (by applying to the Eurasian Patent Office).
The Eurasian regional patent system is generally similar to the European patent system. Under the Eurasian patent system one application and one patent covers nine jurisdictions in the CIS region (the contracting states), that is, Turkmenistan, Belarus, Tajikistan, Russia, Kazakhstan, Azerbaijan, Kyrgyzstan, Moldova and Armenia. A Eurasian patent is valid in the territory of those contracting states selected by the patent owner.
Applications for Russian patents must be filed with the Russian Patent Office. Applications for Eurasian patents are filed with the Eurasian Patent Office. Both offices are in Moscow.
Information on the application procedure and fees is contained on the official websites of the Russian Patent Office (www.fips.ru) and the Eurasian Patent Office (www.eapo.org).
Russian Patent Office fees are:
RUB5,400 for filing an application (including the first 25 claims), plus RUB810 for each claim exceeding 25 claims.
RUB8,100 for filing a request for substantive examination of one independent claim. This fee is reduced by 20% for applications with international reports.
RUB10,800 for issue and registration.
Eurasian Patent Office fees are:
RUB25,500 for filing an application (including the first five claims), plus RUB2,200 for each claim exceeding five claims. These fees are reduced by 25% for applications with international reports.
RUB25,500 for filing a request for substantive examination of one independent claim, and RUB44,500 for two or more independent claims.
Grant and publication fees are RUB16,000, plus RUB160 for each additional page exceeding 35 pages.
The procedure (from filing an application with the Russian Patent Office to a patent being granted) generally takes from one and a half to three years, if there are no complications. The filed application is examined under both a:
Formal examination (where formal requirements are checked).
Substantive examination.
According to Eurasian Patent Office procedures, a Eurasian patent can be granted in one year from the filing date if there are no complications, or up to two years if any issue arises during the application's examination.
Foreign applications can be extended to Russia under the Patent Cooperation Treaty 1970. This takes 31 months.
During the patent examination, a Russian application can be changed to a Eurasian application, and a Eurasian application can be changed to a Russian application.
There is no deposit system. All patent applications are first subject to formal examination by the Russian Patent Office.
Russian and Eurasian patents last for 20 years from the application filing date, subject to payment of annual fees. Patents cannot be renewed.
To keep a patent valid, annual maintenance fees must be paid. If a patent lapses early due to non-payment of annual fees, the patent can be reinstated within three years following the lapse date. If the patent is reinstated, a third party that started using the invention from the lapse date retains its right to use the patented invention, without extending the scope of such use.
If a patent covers an invention related to pharmaceuticals, pesticides or agrochemicals requiring specific authorisation, the patent term can be extended for up to five years in certain circumstances.
A patent can be invalidated on one of the following basic grounds:
Failure to meet patentability requirements.
The granted claims contain features that were absent in the application as filed.
A patent recognised as invalid, entirely or in part, due to an opposition filed with the Chamber for Patent Disputes is considered void, entirely or in part, from the date the patent application was filed.
A patent owner has an exclusive right to use and allow the use of the patented invention. Third parties are prohibited from using the invention without the patent owner's permission, except for specific cases such as for experimental and non-commercial purposes that, by law, do not infringe the patent owner's exclusive right.
For Russian and Eurasian patents:
The scope of legal protection conferred by a patent is determined by the granted claims.
A patented invention is deemed to be used in a product or method if the product or method contains either:
each feature of the invention covered by an independent claim of the invention; or
a feature equivalent to it having become known in this art before performance of actions that are a use of the patented product or method.
Any person or legal entity using a patented invention without the consent of the patent owner is considered to be a patent infringer.
A product obtained directly by a patented method or process also infringes the exclusive rights of the patent owner.
By law, Russian courts must treat Russian patents and the Russian part of Eurasian patents in the same manner.
For Russian and Eurasian patents, the following acts infringe a patent owner's exclusive right:
The manufacture, use, import, offer for sale, sale or any other form of marketing or storage for that purpose, of a product protected by a patent.
The use of a method or process protected by a patent or the offering of it.
The use, importing, offer for sale, sale or any other form of marketing or storage for that purpose, of a product directly obtained by a method or process protected by a patent.
The exclusive rights to a patented invention can be protected, among other rights or methods, in civil proceedings through:
Recognition of the right.
Cessation of the infringing actions or actions that create a threat of infringement.
Compensation for damage.
Publication of a court decision on the committed infringement.
Apart from civil liability, a patent infringement can involve administrative and criminal liability.
It is unclear whether the expedited procedure for expert examination within the state registration of a medicinal preparation (see Question 9) requires submission of data protected by the data exclusivity concept. The expedited procedure may therefore still be possible, despite the data exclusivity concept. The usual intended purpose of this concept may therefore not be achieved in Russia (that is, to effectively prevent registration of generic medicinal preparations for a certain period of time).
There are no other non-patent barriers to competition, such as marketing exclusivity periods.
A trade mark is a designation that individualises the goods or services of legal entities or individual entrepreneurs. Trade mark issues are regulated by Part IV of the Civil Code, which provides for a number of requirements for a trade mark. These are examined by the Russian Patent Office when the trade mark is filed for registration. For example, a trade mark must:
Possess sufficient distinctive character.
Not be contrary to the public interest or accepted principles of morality.
Not be misleading in relation to the origin of the relevant goods and services.
Not be similar to earlier trade marks, company names, commercial designations, and so on.
A name or brand of a medicinal product can be registered as a trade mark, provided that it complies with the trade mark registrability criteria. For example, it must not be identical or confusingly similar to other persons' trade marks protected in Russia (including under an international treaty Russia is party to) for identical or similar goods with an earlier priority.
The scope of granted protection is limited to the registered designation only and does not extend to the generic name or INN.
Russian trade mark applications must be filed with the Russian Patent Office.
The Russian Patent Office fees are:
RUB10,500 for filing an application for a trade mark in one class, plus RUB1,500 for each additional class.
RUB12,000 for registration of a trade mark.
After a trade mark application is filed, it undergoes formal examination, which may result in an office action stating the absence of required materials (for example, the document confirming payment of the official fee). If there are no complications, the Russian Patent Office accepts the application for further substantive examination. It usually takes about 14 to 16 months from the filing date to obtain a trade mark registration certificate.
A trade mark can also be revoked on a cancellation request if it is one of the following:
Not distinctive.
Does not meet the trade mark registration criteria.
Registered in breach of other Civil Code requirements (see Question 24).
A registered trade mark is deemed infringed if an unauthorised person uses an identical or confusingly similar mark for identical or similar goods or services, and this use may result in confusion.
The exclusive rights to a trade mark can be protected in civil proceedings by:
Recognition of the right.
Cessation of actions that infringe the right or create a threat of infringement.
Compensation of damage.
Withdrawal from circulation of infringing goods.
Publication of a court decision on the infringement.
The trade mark owner can claim cancellation of transactions and destruction (at the infringer's expense) of counterfeit goods, labels, packages of goods bearing an illegally used trade mark or a confusingly similar designation.
Instead of compensation of damage, the trade mark owner can claim statutory compensation.
Apart from civil liability, a trade mark infringement can involve administrative and criminal liability.
The Civil Code provides that patent and trade mark licences must be registered with the Russian Patent Office. Failure to register a patent or trade mark licence results in its invalidity.
The Russian Patent Office's fees are:
RUB10,000 for the registration of a licence covering one trade mark, plus RUB8,500 for each additional trade mark covered by the agreement.
RUB5,400 for the registration of a licence covering one patent, plus RUB2,700 for each additional patent covered by the agreement.
According to the Administrative Regulations of the Russian Patent Office, the normal timeframe for the registration of a licence is two months, starting the day when the application for its registration is received by the Russian Patent Office.
No separate approval by any government or regulatory body is specifically required for royalty payments to a foreign licensor. However, this type of payment must comply with the Russian currency control legislation requirements.
WIPO Paris Convention for the Protection of Industrial Property 1883 (Paris Convention).
Patent Cooperation Treaty 1970.
WIPO Trademark Law Treaty 1994.
WIPO Madrid Agreement Concerning the International Registration of Marks 1891 (Madrid Agreement).
WIPO Protocol Relating to the Madrid Agreement 1989.
WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1957.
Nairobi Treaty on the Protection of the Olympic Symbol 1981.
Singapore Treaty on the Law of Trademarks 2006 (entered into force for Russia on 18 December 2009).
Civil liability in Russia for death or damage to the health of patients caused by medicinal preparations is established by the:
Civil Code.
Fundamentals.
Federal Law No. 2300-1 on Protection of Consumer Rights, dated 7 February 1992, as amended (Consumer Protection Law).
Law on Circulation of Medicines.
Under the Civil Code, the substantive test for product liability in the context of medicinal preparations consists of three elements:
Death or damage to the health of a patient.
Defective medicinal preparation or incorrect information on the medicinal preparation.
Causal link between the defect or incorrect information and the damage caused.
A seller or manufacturer of a product must compensate for damage to the health or death caused to a consumer by a product's defects, or untrue or insufficient information about the product, irrespective of the fault or absence of contractual relations (privity) between the consumer and the seller or manufacturer (Article 1095, Civil Code). It is the consumer's discretion whether to sue the manufacturer or seller for compensation (Article 1096, Civil Code).
Compensation for injury is only recoverable if the injury occurred before the expiration date of the medicine (Article 1097, Civil Code). However, if accurate information on the medicine has not been provided to the injured person, liability may arise even after the expiration date.
Claims for compensation for death or damage to health caused to a person are not limited by time (they can be brought any time after the injury occurred) (Article 208, Civil Code). However, if a claim is made after three years from when the injury was caused, the claim is only satisfied and compensation provided for the three-year period preceding the time the lawsuit is brought.
Russian law does not use the concept of class actions as applied to product liability claims. A concept similar to class actions was recently introduced into the Code of Arbitrazh Procedure, which regulates procedures in state arbitrazh (commercial) courts. However, product liability disputes with consumers fall under the jurisdiction of courts of general jurisdiction, where disputes are resolved under the Code of Civil Procedure. Therefore, these new rules should not influence consumer product liability cases.
The state body for protecting consumer rights (the Federal Service for Monitoring Consumer Rights' Protection and Human Wellbeing) or a prosecutor can file a claim on behalf of an "unidentified group of consumers". In practice, court findings of a manufacturer's liability, illegality of actions or failure to comply with applicable regulations are relied on in separate proceedings by individual consumers claiming compensation for their losses against the same manufacturer.
The claimant does not have to be a resident of the Russian Federation (Article 398, Code of Civil Procedure). However, a claim is only accepted by the Russian courts if one of the following applies:
The claimant has a place of residence in the Russian Federation.
The damage to the claimant's health was incurred in the Russian Federation.
The respondent is located (has its place of residence) in the Russian Federation.
A force majeure circumstance.
A violation by the consumer of the rules for storage and use of the medicine.
Losses include both (Article 15, Civil Code):
Real damage, including current or future expenses on behalf of the injured person needed to cure the injury or connected to the injury.
Lost profits, consisting of the income that the injured person could have earned without the injury.
In addition to being entitled to compensation of losses (real damage and lost profits), the injured person can seek moral damages (Article 151, Civil Code). The extent of compensation for moral harm is determined by a court regardless of amounts paid in compensation for an injury. The court can consider various circumstances in determining the compensation amount.
Russian law does not use the concept of punitive damages as applied to product liability claims.
Further, a law governing medical devices is under discussion as well as future reforms of state funding of medicinal supplies.
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