Pharmaceuticals and Healthcare
The practice

As a response to the growth of the domestic pharmaceutical market, including the advance of Russian companies as well as international players, Egorov Puginsky Afanasiev & Partners have set up a practice dedicated to the legal support of pharmaceutical companies. The pharma industry is attracting an increasing amount of attention from the state, which is evident from the growing number of statutory acts regulating the industry, as well as more elaborate strategies to stimulate national production of pharmaceuticals.

Our experience of working with major Russian and foreign pharmaceutical companies allows us to utilize the unique skill-set of our specialists to form teams capable of executing assignments of the broadest nature and complexity.

One of the key capabilities of the practice is the legal assistance in conducting internal investigations to identify risks of violations of Russian legislation on the fight against corruption, as well as the relevant provisions of the law of foreign countries, particularly the US (FCPA) and the UK (UK Anti-Bribery Act).

Services

As part of an integrated service for companies in the pharmaceutical and healthcare sectors, Egorov Puginsky Afanasiev & Partners provides, inter alia, the following services:

  • due diligence of companies to identify existing and potential legal risks, as well as recommendations on minimizing risks following the due diligence results;
  • drafting documents required for the operation of pharmaceutical companies;
  • development and implementation of required internal policies, including anti-corruption and compliance procedures, as well as compliance with the regulator and prevention of conflicts of interest when doing business in the Russian Federation and within the Customs Union (CIS); 
  • extensive support in dealing with intellectual property issues arising out of doing business in the pharmaceutical sphere;
  • extensive support in relation to antitrust regulation, including the representation of the interests of pharmaceutical companies in investigations and examinations of cases of violation of the antimonopoly legislation;
  • extensive support in issues related to public procurement of drugs;
  • consultation and preparation of legal opinions on specific to pharma sector legislation;
  • legal support of pharmaceutical companies in court proceedings and representation in disputes related to the conduct of the pharmaceutical business.
Projects

Advising Bayer, owner of the innovative cancer drug Nexavar, in court proceedings against local manufacturers, distributing generic versions of the drug prior to the expiry of the original patent. We have protected Bayer’s patent rights, securing a precedent setting victory in the Intellectual Property Court for the German multinational Bayer, overturning previous court rulings in the case.

Advising Novartis in a case against a competitor, which registered a generic drug in the Healthcare Ministry of Russia, while a patent for the original cancer drug was expiring only in 2023. The relevant laws are in fact contradictory and, generally, do not permit preventive lawsuits. The strategy, developed and implemented by EPAM’s and co-counsel’s team resulted in a precedent-making court decision. The judge opined that the conduct of the opponent posed a threat of violation of the clients’ exclusive right to the original drug and compelled the opponent not to commercialize the drug in Russia until after the paten on the drug expires.

Advising one of the leading global pharmaceutical companies on competition law issues including drafting practical recommendations on interaction with distributors in the framework of the supply of medicines for the state needs as well as finalizing the draft of commercial policy and coordinating approval with the Federal Antimonopoly Service of Russia (the FAS Russia).

Conducting a targeted antitrust compliance audit on the supply of a antithrombotic drug upon the request of one of the leading global pharmaceutical companies.

Advising one of the world’s largest pharmaceutical companies on launching a new vaccine in Russia, including advice on public procurement regulations, budgetary financing of medicine procurement, the possibility of procurement of drugs with specified trademarks, etc.;

Representing a leading Asian pharmaceutical and biotech company in the Chamber for Patent Disputes of the Russian Patent and Trademark Office (PTO) in relation to a Russian patent dispute against a competitor.

Advising Hythiam, a leading US healthcare services management company, primarily involved in research, development, licensing and commercializing innovative technology, on setting up clinic operations in Russia and Ukraine, including advertising law issues related to treatment protocols on addictions.

Advising Invitrogen Limited on importation/distribution of biotech products in Russia.

Representing Antiviral, a Russian pharmaceutical company, in the FAS Russia in a case connected with the violation of Competition Law by the client’s competitor, who managed to register a client’s drug name as its trademark.

Advising a US pharmaceutical company on an acquisition, of one of the largest Russian pharma companies including post-merger integration and regulatory support.

Advising a major shareholder of a Russian pharmaceutical group on corporate restructuring and sale of a business unit possessing IP rights to certain trademarks.