Healthcare and Pharmacology

International pharmaceuticals and healthcare undergo a period of substantial changes.  Many experts point out that the industry is currently undergoing through transformation process while moving to a new operational model of personalized pharmaceuticals.  Scientific research and biotechnologies continue to play a key role in the segment development and competition for a spot on the market, and yet there are other areas which also require increased attention. Such areas include control over compliance with the international and national regulations, optimization of supplies’ structure, increased quality of marketing measures, antimonopoly and customs regulations, protection of intellectual property. All these issues are important for the Russian pharmaceutical market; however such market has certain specific characteristics and is facing its unique challenges. 

Resolution of legal issues arising in the field of pharmacology and healthcare poses a requirement that the legal consultants are to understand details of business practices and industry-specific legal regulations. The lawyers of the Law Firm provide comprehensive legal support while working both on particular projects or supporting overall business activities of pharmaceutical companies, drug stores, producers of health and beauty items, medical equipment, companies working in the field of biotechnology as well as structures offering financing solutions and investments in this industry.

Industry Specific Consulting:

  • Legal support in the field of production, registration and turnover of pharmaceuticals;
  • Unfair competition, representation in the agencies under the Federal Antimonopoly Service of the Russian Federation including with respect to violations of the laws on advertising;
  • Recommendations for marketing initiatives, legal support for advertising campaigns;
  • Consulting on the current business issues for the pharmaceutical companies;
  • Complex support in pharmaceutical production, interaction with the government and municipal agencies;
  • Complex support of investment projects, including venture financing projects for pharmaceutical and biotechnology companies.

Consulting in the Intellectual Property Field:

  • Compliance verification and evaluation of risks involved with the use of the intellectual property items (Free-To-Operate Research);
  • Renewal of pharmaceutical patents;
  • Registration of intellectual property items in Russia and worldwide, representation in Rospatent or Patent Disputes Chamber;
  • Support during patent disputes in Patent Disputes Chamber or courts;
  • Elimination of unfair competition that involves intellectual property items, support during proceedings in antimonopoly agencies;
  • Implementation of measures aimed at protection of intellectual property at the customs agencies, elimination of parallel import and entry of goods infringing on intellectual property rights;
  • Protection of intellectual property rights on a pre-trial and trial basis: forensic and attorney investigations, collection and submission of evidence of rights violations, complains, litigation support, court award compliance.

Corporate Consulting, Transactions and Investment Projects Support:

  • Support for transactions of sale/acquisition of assets in the fields of pharmaceutical production or turnover, medical goods and equipment or brining in financial investors (M&A);
  • Legal and tax due diligence for potential customers/investors or current business owners including as may be required to enter the public capital market;
  • Search for the most effective task specific ownership, management and operations structures for the groups of companies exercising business activities in this area, in order to reduce risks and increase assets protection effectiveness;
  • Drafts of documentation that regulate corporate management in the company/group of companies.

Tax Consultations and Support during Tax Disputes:

  • Challenge of awards or other documents of non-regulatory nature or actions/omissions of tax authorities, on a trial and pre-trial basis, including with respect to complains concerning validity of deductions claimed for certain types of pharmaceutical and accompanying products;
  • Support during tax inspections, tax consultations to minimize the tax losses, to fully apply existing tax benefits and with respect to current operational issues.

Consultations Regarding Customs Issues:

  • Consultations in the field of customs regulations including regarding determination of customs value of imported goods and additional costs to be included in the goods’ customs value;
  • Representing clients in courts and customs agencies.