Pharmaceuticals and Healthcare - PRACTICE AREAS

The practice

The Firm’s life sciences and pharmaceutical law practice was established during a period of rapid industry growth, marked by the launch of new manufacturing facilities and the expansion of major international pharmaceutical companies in the Russian market. Today, amid the localisation of production, the strengthening of Russian pharmaceutical companies, the transformation of international business models in Russia, and the increasing importance of regulatory factors, our many years of experience and expertise are in particularly high demand.

We represent clients across a broad range of matters, including the protection of intellectual property rights, the prevention of unfair competition, regulatory advisory work, transaction structuring and support, as well as litigation and cross-border disputes.

Our clients include major Russian and international pharmaceutical companies, pharmacy chains, medical centres, digital health companies, as well as private investors and investment funds, including R-Pharm, Novartis, Bayer Healthcare, Orion Corporation, VITA/VITA Express, LabQuest, the Mother and Child clinic network, Vivira, and other market participants.

The pharmaceutical industry and the healthcare sector have traditionally remained in the focus of government attention, as reflected in the continuous development of regulation and the growing complexity of the regulatory environment. Our team helps clients not only navigate this constantly evolving framework, but also develop practical legal solutions tailored to the specific needs of their businesses.

We advise on the key regulatory and commercial aspects of operations in the pharmaceutical and medical sectors, including the circulation of medicinal products and medical devices, the obtaining of licences and permits, the negotiation and conclusion of commercial contracts, interaction with physicians, pharmacy chains and medical organisations, as well as other day-to-day operational matters. The team also supports clinical trials and the subsequent registration of medicinal products and medical devices.

Among the projects we have delivered are recommendations on legislative amendments aimed at removing barriers to the development and market entry of biomedical cell products, as well as advice on the procurement of medicinal products for state and municipal needs.

When providing comprehensive legal support on projects, we follow a “one-stop shop” approach, bringing together experts from across the Firm’s different practice areas. This approach enables us to address the full range of legal issues that arise within a single, coherent strategy. Our practice includes lawyers with experience of working in the legal departments of international pharmaceutical companies.

Compliance and internal controls are of particular importance in this sector. We provide legal assistance in connection with internal investigations aimed at identifying risks of non-compliance with Russian anti-corruption legislation, as well as with relevant provisions of foreign laws.

Another key area of our work is handling complex, precedent-setting disputes and protecting intellectual property rights. We have represented major pharmaceutical companies in litigation involving challenges to the registration of generic versions of originator drugs and their launch on the Russian market before the expiry of our clients’ patent protection, as well as in disputes concerning the grant of compulsory licences for originator drugs. We have also represented a pharmaceutical manufacturer in a dispute with a distributor of a generic product manufactured in infringement of a patent, as part of an unfair competition case.

The team has a successful track record in supporting projects related to the creation and development of medical and pharmaceutical infrastructure.

The Firm’s lawyers have advised on the construction of a pharmaceutical manufacturing plant for an international pharmaceutical company and have also provided advice on selecting the most suitable legal structures for co-investment in the construction of a medical centre.

The practice’s leading position in the sector is confirmed year after year by awards and top placements in leading legal rankings, including Kommersant, Pravo-300 and Best Lawyers.

Services

We provide comprehensive legal support, representing industry participants across a wide range of sector-specific matters.

Corporate law

Auditing existing and potential legal risks and developing recommendations for their mitigation.
Drafting and preparing the full set of agreements required for the operation of a pharmaceutical company.
Supporting the entry of foreign suppliers of pharmaceutical products into the Russian market, including the establishment of a comprehensive contractual framework.

Intellectual property

Advising on the use of intellectual property assets and the protection of intellectual property rights.

Dispute resolution

Supporting litigation and representing clients in disputes of all categories.

Competition law

Conducting litigation and representing clients’ interests in disputes of all kinds.

Compliance and interaction with regulatory and supervisory authorities

Advising on matters related to public procurement of medicinal products, including procurement carried out under federal targeted programmes, as well as procurement conducted by certain categories of legal entities in accordance with Federal Law No. 223-FZ.
Developing and implementing the necessary set of internal policies and procedures, including anti-corruption and compliance procedures aimed at identifying and preventing corruption risks.
Supporting complex market-entry models for Russian and foreign companies in the pharmaceutical markets of the Russian Federation and the EAEU, including those involving innovative solutions in customer services for purchasers of pharmaceutical products and the use of new technologies in manufacturing, design and marketing.
Providing advice and preparing legal opinions on legislation governing pharmaceutical activities.

Construction and real estate

Supporting the full contractual cycle, from site investigation and design to general contracting and integrated supply arrangements, including design, construction and reconstruction agreements, project management agreements, technical customer services, EPC contracts, and others.

Projects

Among the practice’s successful projects are:

Successfully defending the trade mark of the federal pharmacy chain VITA Group before the Chamber for Patent Disputes.
Representing Novartis Pharma (part of the Novartis Group) before the Federal Antimonopoly Service of Russia and the courts in a dispute initiated by the competition authority regarding the review of the price of a medicinal product that was not subject to price regulation.
Representing a global pharmaceutical company in a dispute with a pharmacy chain that used signs confusingly similar to the client’s trade marks.
Advising Pfizer and representing its interests before the Federal Antimonopoly Service of Russia on issues related to the inclusion of vaccines for the prevention of pneumococcal infection in the National Immunisation Schedule.
Protecting the interests of an international pharmaceutical company in a dispute with the Federal Antimonopoly Service of Russia concerning the annulment of tender results in which the client had been declared the winning bidder.
Representing an American pharmaceutical company on matters relating to compliance with legal and regulatory requirements applicable to its operations in Russia.
Representing a Russian pharmaceutical company before the Presidium of the Intellectual Property Court in an unfair competition dispute concerning a competitor’s acquisition and use of exclusive rights to a trade mark.
Protecting the interests of major pharmaceutical companies, including Novartis and Bayer Healthcare, in litigation against a Russian company that had registered generic versions of originator drugs and attempted to launch them on the Russian market before the expiry of the clients’ patent protection.
Analysing the prospects of challenging a refusal to register a medical device for a company manufacturing dermatological products.
Representing R-Pharm in a dispute with the Federal Antimonopoly Service of Russia in cartel cases arising from tender procedures.

Reputation

“They have significant experience in advising clients in the pharmaceutical sector.” (Chambers Europe)
“They have extensive experience and strong expertise in the pharmaceutical sector. They are highly skilled professionals with considerable experience, deep knowledge and strong commercial awareness.” (Chambers Europe)
“EPAM Law is a strong brand with a substantial portfolio of high-profile client projects in the life sciences and healthcare sectors.” (Chambers Europe)
“A highly skilled team for pharmaceutical patent disputes.” (Chambers Europe)
“EPAM Law is the best firm with a strong understanding of the pharmaceutical industry; their expertise is impressive. They advise many Russian and international pharmaceutical companies on competition and corporate law, intellectual property, and represent their interests in court.” (Chambers Europe)

Practice Members