Pharmaceutical IP and competition law in the Russian Federation: overview

A Q&A guide to pharmaceutical IP and competition law in the Russian Federation

The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Russian Federation: overview.

To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition law Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Anna McDonald, Snezhana Sharova and Oxana Pishvanova, Dentons
Contents
1. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

Conditions and legislation

The legal conditions for patent protection in Russia are established by the Civil Code (Part IV) and the international agreements to which Russia is a party, including the:

  • WIPO Paris Convention for the Protection of Industrial Property 1883 (Paris Convention).

  • Patent Cooperation Treaty (PCT).

  • Eurasian Patent Convention (EAPC))

Under Russian law, an invention is a technical solution in any area related to:

  • A product (including, without limitation, a device, substance, micro-organism culture, plant or animal cell culture).

  • A method (process of conducting actions in respect of a material object with the use of material means).

  • The use of a product or method for a particular purpose, if such product or method meets certain criteria.

Patent protection can be granted to a product (substance, micro-organism culture, cell culture of plants, and cell culture of animals) and to a method if they are:

  • New.

  • Have the necessary degree of inventiveness.

  • Can be applied on an industrial scale.

The following cannot receive patent protection in Russia if they contradict the public interest and humane and moral principles:

  • Methods for human cloning and a clone from them, and modifying the genetic integrity of human embryo cells.

  • Use of human embryos for industrial and commercial purposes.

  • Any results of intellectual activities even if they meet the requirements for inventions, utility models and industrial designs but contradict public interests and principles of humanity and morality.

None of the following items qualifies as a patentable invention:

  • Discoveries.

  • Scientific theories and mathematical methods.

  • Solutions concerning only the appearance of articles and aimed at meeting aesthetic needs.

  • The rules and methods of games and of intellectual or economic activities.

  • Computer programs (subject to copyright protection under the Civil Code).

  • Solutions only consisting of the presentation of information.

These objects cannot be deemed inventions to the extent a patent application for an invention concerns the respective object as such.

The following items do not qualify as inventions and therefore are not subject to patent protection, but are protected by means other than a patent under the special procedures in the Civil Code:

  • Plant varieties, breeds of animals and the biological methods for producing them, that is, methods consisting in full of cross-breeding and selection, except for microbiological methods and products made by such methods.

  • Integrated circuit layout designs.

 
2. How is a patent obtained?

Application and guidance

To obtain patent protection in Russia, a patent application is filed with the Russian PTO (www.rupto.ru/rupto/portal/start?lang=en) or the Eurasian Patent Organisation (www.eapo.org/en/) (Eurasian PTO). The Eurasian PTO, acting on the basis of the Eurasian Patent Convention (EAPC), provides protection to inventions as a regional authority. A patent issued by the Eurasian PTO covers eight countries, including Russia.

Guidance on the filing procedure and requirements for the national application to the Russian Patent and trade mark office (PTO) are provided on its website, in Russian only.

Fees for inventions include:

  • A filing fee (about US$35 for the first 25 claims).

  • Examination fee (about US$50 for each independent claim).

  • Issue fee (about US$65).

Maintenance fees must be paid on granting of the application, starting from the third year counted from the application filing date (or international filing date, for PCT-based applications). The amount of maintenance fees varies from year to year, increasing from about US$20 (the third and fourth years) to about US$200 for the 20th year.

Guidance on the filing procedure and requirements for the Eurasian PTO are given at www.eapo.org/en/documents/norm/, including legal acts, implementing regulations and the statute on fees.

Process and timing

The time required to obtain a patent depends on whether a request for substantive examination is filed at the time the application is filed or at a later stage (it can be done within three years from the application filing date). The Russian PTO formal examination typically takes about two months, while substantive examination takes about 12 to 15 months. If the examiner raises any objections, the process can be extended for several years.

If the arguments and amended patent claims provided in the response (or responses) to the examiner's inquiry(ies) are not accepted by the Russian PTO and a final rejection is issued, the rejection can be appealed to the Chamber for Patent Disputes of the Russian PTO, provided the appeal is filed within seven months after the final rejection is issued.

The decision of the Chamber for Patent Disputes of the Russian PTO can be further appealed to a court.

 
3. How long does patent protection typically last? Can monopoly rights be extended by other means?

Duration and renewal

Inventions are generally provided with legal protection in Russia for 20 years. Utility models are protected for ten years, and industrial designs are protected for five years. The patent validity term for industrial designs can be renewed several times for five-year periods, but not for more than 25 years in total.

No renewal is allowed for inventions and utility models, except for inventions for some products including medicines (see below, Extending protection).

Extending protection

The supplementary protection certificate (SPC) option does not apply in Russia. However, patent protection granted to products such as medicines, pesticides or agrochemicals which require marketing approval can be extended on expiry of the initial term, if more than five years have passed between the patent application filing date and the date of issue of the marketing approval for the product.

In this case, the term of the patent can be extended for the period by which the time between the patent application filing date and the date of issue of the marketing approval exceeds five years, but not for more than five years.

A request for this extension must be filed with the patent issuing authority within six months of the later of the date of issue of the first marketing approval for the product and the patent issue date.

 
4. How can a patent be revoked?

A patent/patent application can be revoked by the patent holder at its own discretion.

A patent application can be revoked by the Russian PTO if an examiner's request remains unanswered or the applicable official fees are not paid in due time.

A patent can be revoked by the Russian PTO for failure to pay maintenance fees.

If the patent was registered, its validity can only be challenged through court proceedings, and the patent can be revoked (annulled) by a legally effective decision of the Russian court upon the claim of any third party whose rights are breached by the patent in question.

 
5. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?

Conditions for infringement

A patent is infringed if the product or a method produced/used by a third party contains every feature indicated in the patent claim.

Claim and remedies

An infringement claim is filed with the respective court in accordance with the domicile of the infringer.

The patent holder can demand cessation of the infringing actions and reimbursement of damages or payment of monetary compensation (RUB10,000 to RUB5 million, or double the fee payable under the typical patent licence granted in similar conditions). However, the ultimate amount to be paid by the infringer is determined at the court's discretion.

A patent owner can defend its exclusive rights for as long as the respective patent remains valid.

Only the Russian courts have authority to confirm the fact of patent infringement, impose injunctive measures and award damages. Patent infringement can incur:

  • Civil liability, that is, reimbursement of damages or payment of monetary compensation (RUB10,000 to RUB5 million, or double the fee payable under the typical patent licence granted in similar conditions).

  • Administrative and criminal (when applicable) liability.

A patent infringement claim can also be filed with the police (since patent infringement can be a crime under Russian law). On completion of the investigation, the police will submit the matter to a court for further consideration and can hold the relevant individuals criminally liable.

Measures such as warning the alleged infringer by sending a cease and desist letter can be used as a legal tool for combating and preventing infringements before initiating legal action.

 
6. Are there non-patent barriers to competition to protect medicinal products?

The general data exclusivity period for the results of pre-clinical and clinical trials is six years from the date of issue of a marketing authorisation to a medicine. During this period the results of the clinical trials cannot be obtained by, disclosed to, and/or used by any third party for commercial purposes or for obtaining a marketing authorisation, without the consent of the sponsor of the clinical trials. This requirement applies to all categories of medicines.

Any medicines registered in breach of these requirements are prohibited from having access to the market. Also, civil, administrative and criminal liability can be incurred by companies and their officers breaching these restrictions.

There are no separate market exclusivity periods in Russia.

 

Trade marks

7. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?

Conditions and legislation

Under Russian law, a trade mark is a mark individualising the goods of a legal entity or of an individual entrepreneur. A word, graphic, multi-dimensional or other sign, or any combination of them, can be registered as a trade mark. The trade mark can be registered in any colour or combination of colours.

The legal conditions and procedure for trade mark protection in Russia are established by the:

  • Civil Code (Part IV).

  • International agreements to which Russia is a party (including the Paris Convention and the WIPO Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989.

Russia is a first to file country. Legal protection arises under national (Russian) trade mark registration or international (Madrid system) registration duly extended to Russia. Both national and international registrations have equal legal protection in Russia. Only legal entities or private entrepreneurs are entitled to be trade mark owners.

Scope of protection

A trade mark is protected within the limits of its registration, in relation to the trade mark image and the goods/services it covers.

To be registered as a trade mark, the sign is examined by the Russian PTO from both the prior third-party rights perspective (relative grounds) and its ability to function as a trade mark irrespective of the prior rights (absolute grounds).

A sign cannot be registered as a trade mark if it does not distinguish the products it represents from other products, or if it consists solely of the following:

  • Elements that have become commonly used generic terms to identify the products of a certain type.

  • Elements that are commonly used symbols and terms.

  • Elements that characterise the products themselves, including those indicating the type of goods, their quality and quantity, characteristics, purpose of use and value, as well as time, place and method of their manufacturing and sale.

  • Elements comprising the shape of the goods, if the shape is determined solely or mainly by the characteristics of the goods or by their purpose.

These elements can be included in the trade mark as non-protected elements if they are not dominating in the trade mark.

In addition, the following signs cannot be registered as a trade mark:

  • Signs that appear to be descriptive or misleading with respect to goods and services for which the trade mark protection is sought.

  • Signs that reproduce official symbols.

  • Signs in breach of moral or public interest.

These are absolute grounds for rejecting the registration of a trade mark.

International non-proprietary names (INNs) of medicinal products are not subject to legal protection as a trade mark in Russia, as they represent chemical substances and not particular products.

Descriptive elements can be included in the registered trade mark without giving the owner the rights to prohibit use of such elements by a third party, unless the owner provides evidence that these elements have acquired distinctiveness during their active use by the owner, and the Russian PTO accepts this evidence.

A medicinal brand can qualify as a trade mark, subject to the absolute rejection grounds described above.

 
8. How is a trade mark registered?

Application and guidance

An application to register a trade mark is made with the Russian PTO (www.rupto.ru/rupto/portal/start?lang=en) or with WIPO if an international registration of a trade mark including Russia is sought (www.wipo.int).

If the applicant resides outside Russia, an application to the Russian PTO must be filed by a Russian licensed trade mark attorney.

The form (in Russian only) and the official fees (determined in Russian roubles) are available at the Russian PTO website (www.rupto.ru/rupto/portal/start?lang=en). The official fee for filing and examination of a trade mark in one class is the Russian rouble equivalent of about US$300, plus about US$30 for each additional class at the current exchange rate. If the examination on both relative and absolute grounds is successfully completed, the official registration fee of about US$350 has to be paid. This registration fee also covers the issue of the registration certificate and publication of the trade mark in the PTO's official bulletin.

An application for the registration of a trade mark must include:

  • A trade mark image.

  • Full name and address of the applicant.

  • List of goods and services for which the registration is sought, grouped according to the International Classes as per the Nice Classification.

If the applicant has a trade mark application filed in a country member of the Paris Convention, it can claim a priority date in Russia as of the date of the first application, if the Russian filing for the trade mark is done within six months of the first filing. A similar rule can apply for claiming priority based on the date of first posting of the trade mark at an international exhibition held in a member state.

Process and timing

Russian law does not set a deadline for the Russian PTO to complete examination of a trade mark application. If no preliminary rejection is issued by the Russian PTO, the registration process can take about 12 to 14 months. This includes:

  • Formal examination (official notification of the completion of this stage is issued within one month after the filing date).

  • Examination of the compliance of the statement of goods/services (official notification of the completion of this stage is issued in about seven to eight months after the filing date).

  • Examination of the trade mark (official notification of the registration of the trade mark which concludes this stage of the process is issued in about ten to 12 months after the filing date).

Once the official notice of registration is issued, the registration fee must be paid within six months of the date of this notice. If the applicant fails to pay the fee the Russian PTO abandons (revokes) the application.

If the Russian PTO issues a preliminary rejection to register, the applicant can file its substantiated objections within six months of the rejection. If the applicant's arguments are not accepted by the Russian PTO, a final rejection is issued.

A final rejection can be appealed to the Chamber for Patent Disputes of the Russian PTO, provided the appeal is filed within four months after the final rejection is issued. A decision of the Chamber for Patent Disputes of the Russian PTO can be further appealed to a court.

 
9. How long does trade mark protection typically last?

A trade mark registration is valid for ten years commencing on the application filing date. The trade mark registration can be renewed an unlimited number of times, subject to payment of the renewal fees, unless it is terminated earlier by its owner or by a court on a claim of an interested third party. Depending on the nature of the cancellation grounds, a cancellation action can be filed with the Chamber for Patent Disputes of the Russian PTO, or with the Court for Intellectual Property Rights.

 
10. How can a trade mark be revoked?

A trade mark owner can revoke a trade mark application/registration at its own discretion, by filing a request with the Russian PTO.

A trade mark can be declared invalid upon a third party's claim, for example if the trade mark has been registered contrary to absolute or relative grounds and such registration breaches the third party's rights (see Question 7).

A trade mark application can be revoked by the Russian PTO if:

  • An examiner's request remains unanswered or the applicable official fees are not paid in time.

  • The renewal fees are not paid in due time.

 
11. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?

Conditions

Putting any goods on the Russian market under a trade mark that is identical or confusingly similar to the registered trade mark without the registered trade mark owner's consent is an infringement, provided the goods are of the same type as included in the registration of the infringed trade mark.

Claim and remedies

A trade mark owner can defend and exercise its exclusive rights to the trade mark as long as the respective trade mark registration remains valid.

Only the Russian courts are authorised to determine whether an infringement has taken place, and can impose the following:

  • Civil liability, that is reimbursement of damages or payment of monetary compensation (RUB10,000 to RUB5 million, or double the fee payable under the typical trade mark licence granted in similar conditions).

  • Administrative liability.

  • Criminal liability, on individual infringers only.

Measures can be used to combat and prevent infringements before initiating court proceedings, such as warning the alleged infringer through a cease and desist letter, and requesting the Russian Customs to watch the import of goods under the registered trade mark by a third party other than a duly authorised importer.

In addition, the trade mark owner or licensee can rely on Russian anti-trust legislation, on the ground that unauthorised use of the trade mark is unfair competition and should be prohibited. The Federal Anti-monopoly Service can impose administrative fines for breach of the Russian anti-trust legislation but cannot award damages, which can only be claimed through court proceedings

 
12. Outline the regulatory powers and enforcement action against counterfeiting in the pharmaceutical sector.

The following is a list of recommended actions for a registered trade mark owner, to reduce the possibility of counterfeit products under its trade mark appearing in the Russian market:

  • Include the registered trade marks in the Russian Customs IP Register (Customs watch), which helps to prevent parallel imports.

  • Monitor the market and, if counterfeit products are found, report the alleged infringement to the police and file a request to initiate an investigation. Trade mark infringement can be a crime under Russian law if damage caused to the trade mark rights holder is at least RUB250,000.

  • Send cease and desist letters to the alleged infringers once they are identified. If the matter is further submitted to a court, this may be used as an argument in favour of the trade mark owner.

  • Initiate unfair competition proceedings at the Russian Federal Antimonopoly Service (FAS).

  • File a civil law suit for the compensation of damages in court.

IP and competition law issues

13. Briefly outline the competition law framework in your jurisdiction and how it impacts on the pharmaceutical sector. In particular, the competition authorities and their regulatory powers, key legislation, whether pharmaceutical investigations are common, key recent activity and case law.

The competition authority in Russia is the Russian FAS (http://en.fas.gov.ru). It has broad authority to ensure compliance of market participants with competition principles, including in the pharmaceutical market. In particular, FAS:

  • Controls prices for essential drug list (EDL) products.

  • Monitors interactions between competitors (including, in particular, unfair competition activities) and between pharmaceutical companies and their distributors, including potential abuses of a dominant market position and discriminatory or concerted actions.

  • Controls public and private tenders.

  • Carries out market studies in various market sectors. In addition, FAS supervises criteria elaborated by pharmaceutical companies based on which third parties (distributors) are chosen.

FAS acts on the basis of the Law on Protection of Competition dated 26 June 2006, No. 135-FZ, as amended (Competition Law), as well as various regulations covering specific FAS functions.

Pharmaceutical and medical devices and equipment market sectors are a focus of attention for FAS, which monitors and audits market players on a regular basis.

Most recent FAS inspections have resulted from economic sanctions imposed by the EU and US governments on their companies doing business in Russia. FAS has checked whether medicines that do not have analogues in Russia continue to be supplied to Crimea, as the cessation of their supply by Russian subsidiaries of foreign companies to that region (as required by the sanctions) would constitute a breach of the Competition Law.

In its investigations in the pharmaceutical sector, FAS mainly focuses on state procurement tenders in which pharmaceutical companies participate directly or through their distributors.

FAS is an active initiator of legislative changes in the pharmaceutical sector. A number of amendments to the Federal Law on Circulation of Medicines dated 12 April 2010, No. 61-FZ, as amended (Law on Medicines), were initiated by FAS and approved by Russian legislation. Among other things, the most recent:

  • Introduced the notion of replaceable medicines.

  • Established the possibility to annul registration of medicines that are not circulated in Russia for over three years.

  • Provided for the possibility to apply for registration of a drug as an orphan drug.

 
14. Briefly outline the competition issues that can arise on the licensing of technology and patents in a pharmaceutical context.

Agreements restricting competition and allowing for abuse of dominant position are generally prohibited under the Competition Law. However, such prohibitions do not apply to agreements/actions aimed at providing, granting or alienating intellectual property rights (including trade mark, patent and know-how rights) (Articles 10.4 and 11.9, Competition Law).

In practice, it is not always obvious whether this exemption is available. However, trade mark and patent licensing agreements and agreements granting the rights to use know-how should clearly fall under this exemption. Therefore, a company granting exclusive rights to use its intellectual property can control and limit the activities of the recipient of such rights.

In practice, such rights may lead to a restriction of market competition. Sometimes agreements granting intellectual property rights contain direct instructions related to circulation of goods, such as where, when, how and at which price products must be sold. In theory, the exemption in Articles 10.4 and 11.9 of the Competition Law applies to such agreements. However, FAS currently intends to exclude this exemption from the Competition Law, as it creates grounds for abuse and anti-competitive behaviour.

Recent court practice shows that Russian anti-monopoly restrictions can apply to activities not directly related to agreements granting intellectual property rights. On 12 March 2015, the Commercial Court of the Moscow Region confirmed FAS's position on applying restrictions in the Competition Law to a company with a dominant position refusing to supply its products, even though the products are protected by patent rights, and on imposing the fine for non-compliance with these restrictions (TEVA case, regarding Copaxon). Despite subsequent appeals by TEVA, the higher courts have maintained the position of the Commercial Court of the Moscow Region and TEVA has paid the fine imposed on it by FAS.

 
15. Are there competition issues associated with the generic entry of pharmaceuticals in your jurisdiction?

Patent disputes between patent owners for original products whose patents have expired and generic producers are not infrequent. However, such disputes are mostly considered and resolved outside Russia.

As a generic product is a product the patent for which has already expired, generic products are not protected under Russian patent law. However, branded generics continue to be protected by trade mark law irrespective of the expiration of the relevant patent (the brand is registered as a trade mark that can only be used by its owner or with the owner's consent, and the registration continues for an indefinite period of time, subject to payment of annuity fees).

FAS's main focus in the Russian generics market is aimed at recognising generics replaceable based on their INN. In particular, FAS closely monitors state procurement tenders for generics to ensure that generics with the same INN but under different brands are treated as replaceable for state procurement purposes.

FAS, in co-operation with the Ministry of Health, controls the interaction between representatives of pharmaceutical companies and healthcare professionals and pharmacists from the conflict of interest perspective, to ensure that the patient receives information about all medicines suitable for the patient's case (not just about branded medicines, without mentioning non-branded products that are much cheaper).

 
16. Have abuse of dominance issues arisen in the pharmaceutical sector in your jurisdiction?

Cases related to abuse of dominant position in the pharmaceutical sector are quite frequent in Russia. The most widely publicised recent examples include Baxter and Novo Nordisk. Both had a dominant position in the respective market sector and refused to supply their products to certain distributors, without sufficient economic grounds for the refusal. For these reason, pharma companies are tending to develop and formally adopt policies to set criteria to select their distributors.

 
17. Have parallel imports of pharmaceuticals raised IP and competition law issues in your jurisdiction?

Parallel imports are currently an infringement of IP rights, and are not allowed and can be prosecuted in Russia. However, FAS has been viewing the prohibition of parallel imports as an unlawful restriction of competition in the Russian market. Recent public governmental discussions show that parallel imports of pharmaceutical products (medicines and devices) may be permitted in the near future.

 
18. Does a patent or trade mark license and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body? How is such a license made enforceable?

Under Russian law, a patent or a trade mark licence is only valid if it is made solely with respect to patents/trade marks that are valid in Russia and if the licence is registered with the Russian PTO.

No further approval for the payment of royalties to a foreign licensor by any governmental or non-governmental agency is required.

 

Contributor profiles

Anna McDonald, Partner, Co-head of Russian Life Sciences practice

Dentons

T +7 405 6440500
F +7 405 6440599
E anna.mcdonald@dentons.com
W www.dentons.com

Professional qualifications. Moscow State University, 1989, Law Degree, with Honours.

Areas of practice. Life sciences and healthcare

Recent transactions

  • Advising pharma clients on structuring relations between various players in clinical trials of pharma products in Russia, and preparing and negotiating contracts required to achieve this.

  • Advising on licensing requirements (manufacturing, storage and wholesale) for pharma companies and their distributors.

  • Advising pharma clients on licence, manufacturing, marketing and distribution agreements, including Russian regulatory issues in connection with marketing authorisations for products covered by such agreements.

  • Negotiating lease contracts for storage of pharma products and medical equipment.

  • Advising on pricing issues.

  • Advising on various pharma regulatory issues.

Languages. Russian, English

Snezhana Sharova, Associate

Dentons

T +7 405 6440500
F +7 405 6440599
E snezhana.sharova@dentons.com
W www.dentons.com

Professional qualifications. Higher School of Economics, 2010; University Paris I Pantheon Sorbonne, Master of EU Public Trade Law, 2011.

Areas of practice. Life sciences and healthcare.

Languages. Russian, English, French

Oxana Pishvanova, Associate

Dentons

T +7 405 6440500
F +7 405 6440599
E oxana.pishvanova@dentons.com
W www.dentons.com

Professional qualifications. Moscow Institute of Law, Degree in Civil Law, cum laude, 2007.

Areas of practice. Intellectual property

Non-professional qualifications. Moscow Foreign Languages Institute, Translation Department, Diploma in Spanish and English, cum laude, 1981; School of Letters at the University of Havana, Cuba, 1980

Languages. Russian, English, Spanish


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