Medicine & Healthcare / Pharmaceuticals
Arzinger continues to expand its industry capabilities, diversifying its offering and client base. The 15-lawyer strong team co-headed by Timur Bondaryev and Lana Sinichkina advises domestic and international companies, the number of which exceeded 50. Both professionals are highly regarded by peers. The team’s strong standing is demonstrated by a solid mandates list, including recent participation in structuring business development deeds in Ukraine for an international innovative pharmaceutical company and implementation of the project on contractual manufacture of medicinal products in Ukraine for an international pharmaceutical player. The team often advises on IP, delivery, public procurement, compliance, personal data processing, corporate, promotion and advertising, and especially on clinical trial issues. Throughout 2013 the firm developed an anti-corruption compliance service and pharmaceutical antitrust. Lana Sinichkina, who was promoted to a partner last July, is known for her ongoing advice to pharma companies and understanding their practical needs. Another team member, associate Igor Svitlyk, was also mentioned during the poll.
Legal Alliance Company, a niche domestic firm, has a consistent position and standout name in medicine, healthcare and pharmaceuticals. Possessing a traditionally strong regulatory side, the past year the firm has been involved in drafting legislative documents for the governmental bodies. Recent highlight was bringing the legislation of Ukraine in compliance with the requirements of the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria. Another notable project was governance of activities of the medical device market operators developed within the framework of the operation of the Association of Market Operators of Medical Devices. The tremendous reputation of Legal Alliance Company for pharmaceutics enables it to demonstrate an impressive rise in the number of clients. These include Apotex, Astellas, Bayer, Boehringer Ingelheim, Dr. Reddy’s, Ipsen Pharma, Jadran, Johnson & Johnson, Novartis Pharma, Takeda, Roche Ukraine, STADA, Teva, Bosnalijek. In 2013 the firm assisted clients in import, clinical trials, promotion, distribution matters, compliance, etc. Partners Oleksii Bezhevets and Illya Kostin are eminent figures in the market. Illya Kostin and associated partner Andriy Gorbatenko win praise of colleagues for their expertise in regulatory and compliance affairs for pharma and medical devices companies, IP support and litigations for pharma. Dmytro Aleshko became a member of the Public Council in State Administration of Ukraine on Medical Products.
In December 2013 two domestic players, the Danevych Law Firm and Ulysses, merged their operations. The amalgamated firm operates under the brand name Marchenko Danevych. The consolidated life sciences practice offers advice on a broad range of issues to top-name clients, including AbbVie, Actavis, Alpen Pharma, Aspen Pharma, Association of Pharmaceutical Research and Development, Bionorica, Eli Lilly Vostok S.A., Herbion, Novo Nordisk A/S, Polpharma, Teva. The practice team regularly provides advisory on legal regulation of industry, including IP, marketing, advertising, promotion, personal data, pricing, public procurement, production, distribution, employment, competition, antitrust, tax matters. This team is a legal counsel to Johnson & Johnson, Eli Lilly Vostok S.A.and AstraZeneca. The firm stands out for its consistent cooperation with sector associations and organizations, as well as continuous impact on all key developmental legislative processes in the field of life sciences in Ukraine. The practice is led by partner Borys Danevych, a highly-recognized practitioner, whois especially regarded for his in-depth knowledge of the industry. The dedicated team was reinforced after the merger and included partner Oleh Marchenko, counsel Maksym Sysoiev and associate Leonid Cherniavskyi.
Law Offices of OMP demonstrates a growing presence in the pharma sector and stands out for its impressive clientele from top market players. The 6-member strong team, co-headed by Mykola Orlov and Igor Ogorodniychuk, acted on numerous projects on structuring of activities, trade, coproduction, clinical trials and restructurings of pharmaceutical companies in Ukraine. The dedicated team delivered complex servicing of restructuring of pharmaceutical companies in Ukraine: Sandoz, Ipsen, Recordati, Ima Medical, Ferring, Egis from a representative office to a legal entity in Ukraine. Mykola Orlov and senior associate Yevheniya Yarmolyuk are referenced for deep knowledge of regulatory, tax and corporate affairs, marketing and promotion activity in the pharma sector.
Asters demonstrates multi-disciplinary coverage of this industrial specialization, combining expertise of M&A, regulatory, tax and customs, distribution, product liability, clinical trial material issues, IP issues, financing. The firm has an impressive roster oftop-name clients. Being an antitrust market leader, the practice often gets queries for the most relevant projects. For example, the antitrust team led by partner Igor Svechkar has been busy obtaining merger clearance for the acquisition by Baxter International Inc. of all of the shares and voting rights in Indap Holding AB. The firm is seen actively advising in the cosmetics industry. Due to established dedication finance practice, Asters played a remarkable role in providing financing in the pharma industry. The sectoral mandates are guided by partners Armen Khachaturyan, Oleksandr Padalka*, Oleksiy Didkovskiy, Vadym Samoilenko, Igor Svechkar, according to their practice competences. Oleksandr Padalka is known in the market for his participation in many notable projects.
In 2013 Ilyashev & Partners confirmed its reputation as a strong litigation force, notably handling IP rights protection matters. The team has acted on refusal of registration of “Miramistin” trademark and defense of IP rights on “Okomistin” trademark. Another notable representation touched upon the temporary prohibition of “Mildronate” medicine circulation in Ukraine. JSC Grindeks, the leading pharmaceutical company in the Baltic States and Mitek, a medicine distributor, belongs to the irm’s clients. Irina Kirichenko is a well-established IP practitioner focusing on representation of pharma companies.
The 10-lawyer practice team of AstapovLawyers international law group has wide-ranging expertise working with pharmaceutical producers as Baxter, Herbapol Wroc?aw S.A., Bioton, Hythiam, Arterium, Apotex Inc. and others. Throughout the past year the team added new clients and increased the number of instructions, including regulatory, compliance, corporate, antitrust, IP and employment issues. With the strong position in the competition area, the firm is seen in delivering subsequent advice to sectoral clients. Partner Oleh Malskyy, Victoria Buzhor and Bohdan Dmukhovskyy are the main practitioners in the team.
Vasil Kisil & Partners, is a standout legal counsel with the wealth expertise and strong positions of the firm in IP, labor and employment. The IP practice, as led by partner Oleksandr Mamunya, is actively involved in patent projects. The team recently acted for a majorIndian pharmaceutical manufacturer in the course of patent clearance, patentability and data exclusivity advice. Oksana Voynarovska, partner and head of its labor and employment practice, expended the scope of sectoral queries, getting Dentsply International Inc., MAKE, Synteract HCR, Zoetis to its clients list. Another notable highlight for the firm was advising European leading producer and distributor of food supplements Natural Pharmaceuticalson legal, regulatory and customs issues related to the supply of products into Ukraine. Denis Lysenko, partner, and Ivan Yurchenko, counselor, guided the project.**
** In August 2014 five partners – Denis Lysenko, Mariya Nizhnik, Anna Babych, Oleksandr Mamunya and Yulia Kyrpa left Vasil Kisil & Partners and established Aequo law firm.
Baker & McKenzie regularly acts as a legal counsel to international and domestic pharmaceutical and healthcare players across corporate, antitrust, labor, migration, customs and tax issues. Mariana Marchuk is appreciated by peers for her experience in regulatory and compliance work for pharmaceutical companies.
The Kiev office of Dentons combines broad based expertise of sectoral work, including corporate and M&A, regulatory, competition and antitrust, licensing, distribution, IP, tax, employment, litigation, bankruptcy and restructuring matters. Dr. Falk Pharma GmbH and Solvay are among the clients. The multipractice team includes partners of different competences breakdown: Oleg Batyuk (corporate), Volodymyr Monastyrskyy (competition, employment), Markian Silecky (corporate, real estate) and Ihor Mehedynyuk (corporate, real estate).
In September 2013 antitrust boutique Droit Law Firm was established by Victoria Ptashnyk, former associate partner of Legal Alliance Company. Given her previous experience of pharmaceutical antitrust, the new compact team added to its recent project profile representation of clients in the Ukrainian competition authority in course of investigations on concerted actions on pharmaceutical producers and their distributors; and advised on distribution of misleading information and protection of clients interests in a respective violation case. Roche and Materia Medica enriched the client base of the team.
In 2013 Sayenko Kharenko’s sectoral workload included regulatory issues, competition law matters, international trade, taxation and international arbitrations. As for regulatory assignments, the team advised several global pharmaceutical companies on import licensing, data exclusivity and personal data protection, as well as consulted the European cell therapy company on procurement, transferring, handling, export/import of human issues under Ukrainian law. Given its strong competition practice, the firm supported several acquisitions in the pharma industry. The arbitration team successfully represented a leading Ukrainian medical products manufacturer in the arbitration over factoring dispute before the International Commercial Arbitration Court at the RF Chamber of Commerce and Industry. Counsel Nataliya Mykolska is the core contact in this area. Associate Anzhela Makhinova has a special industry-focus on the pharmaceutical sector and regularly advises on regulatory, customs, IP protection, and trade issues.
The recent workload of Integrites has been boosted by contentious matters. One of the largest Ukrainian pharmaceutical companies, Farmak, has given the firm a plenty of instructions. The team, as led by Vyacheslav Korchev, senior partner, Denys Kytsenko, counsel, assisted Farmak in a dispute with VVS Ltd, one of the largest Ukrainian pharmacy distributors and in a case to prove the business reputation. Oleksandr Aleksyeyenko advised Experimental Plant SMSC, a producer of medicinal and prophylactic products, on invalidation of the patents for inventions of competitors.
Putting the pharma sector as a priority on its schedule, DLA Piper advises several major pharmaceutical companies, both Ukrainian and international, on wide spectrum of issues important for this highly regulated market such as antitrust, pricing regulations, anti-money laundering, data protection, clinical trials, tax and transfer pricing. Tailored tax advice and litigation is a niche strength offered by the team to its pharmaceutical clients. Among them are Pfizer, Sanofi, GlaxoSmithKline. The leading pharma lawyers of the Ukrainian team are Svitlana Musienko and Natalia Pakhomovska, partners, and Dmytro Donets and Natalia Kirichenko, senior associates.
Established in March 2013 domestic firm Vox Legum possessed pharmaceutical law as one of its primary specializations. The compact team, as led by managing partner Mykhailo Spasov, offered a range of services on regulatory, import licensing of medicinal products, trademarks to well-known international pharmaceutical companies. The client list contains J.B. Chemicals and Pharmaceuticals Ltd, Torrent Pharmaceuticals Limited and Fitofarm.
KPMG Ukraine reinforced its pharmaceutical practice. Aspen Pharmacare Holdings Limited, a leading generics manufacturer, enlisted the Kiev team to provide legal and tax advice on operating the pharmaceuticals business in Ukraine. The client list includes a range of leading importers and manufacturers of pharmaceuticals, consumer healthcare companies. Sergey Popov, partner, Tatiana Zamorska, director, and Oksana Olekhova, senior manager, were involved in recent projects.
CMS Cameron McKenna maintains stable presence in pharma sector. Recent activity includes advising clients on Ukrainian merger law, competition, employment and equity investment. Key contacts are diversified on specializations: Graham Conlon and Olexander Martinenko supervise corporate-related matters; Nataliya Kushniruk handles real estate-related matters; tax-related matters are in the field of Andriy Buzhor’s responsibility and Nataliya Nakonechna are in charge of commercial-related matters.
In 2013 the Kiev office of Beiten Burkhardt worked on several projects. Julian Ries and Daniyil Fedorchuk were highlighted for their litigation work for international cosmetics manufacturer and advising Austrian medical company on the delivery of equipment under a state guarantee and public procurement issues. Since 1 January 2014 the team of nine lawyers, including the above-mentioned practitioners, joined the Kiev officeof Gide Loyrette Nouel.
Gide Loyrette Nouel’s Kiev office represents leaders of pharmaceutical industry in commercial litigations, debt recovery, IP and business reputation issues. Bertrand Barrier and Evgenia Paliy are the key contacts. The firm strengthened its positions with the recent arrival of the legal team from Beiten Burkhardt.
The renowned IP boutique of Doubinsky & Osharova was fairly visible through the pharmaceutical sector. For instance, the boutique defended rights of Glaxo Group Limited, Abbott Laboratories and Lek farmacevtska dru?ba D.D. The main figure is Victoria Sopilnyak, partner, who specializes in pharma cases.
Kharkov-based Kibenko, Onika & Partners continues to be legal counsel to Clinic of Professor Feskov, a major clinic involved in reproductive medicine. The firm acted in obtaining a license on medical practice, drafting contracts on medical services as well as providing legal support in conducting the procedure of surrogacy. Olena Kibenko, Maksim Sheverdin and Anastasiya Lytvynenko are involved.
In 2013 the FCLEX, as led by Victor Barsuk and Oleg Malinevskyi, advised Kievmedpreparat, Galychpharm and corporation Arterium on issues of corporate law, commercial as well as sale-purchase and supply contracts, IP and a foreign trade. The recent highlight included USD 115.5 million intra-group sale-purchase contracts for corporation Arterium; USD 36.5 million additional equity offering by Kievmedpreparat; dispute over the land and two construction-in-progress facilities for the Ukrainian Pharmaceutical Centre.
The Kharkov-headquartered ILF focused on litigation work, and handled representation of the National University of Pharmacy in tuition debt recovery cases and advises on day-to-day issues. Serhiy Silchenko is a key contact.
Egorov Puginsky Afanasiev & Partners (EPA&P) is active in various instructions, in particular, regulatory advice, GMP, licensing, public procurement, promotional activities, compliance issues and others. The practice is led by Taras Kyslyy, counsel.
Aleksey Pukha & Partners consults clients on pharmaceutical law of Ukraine and the conducting of clinical trials. The competition team of Clifford Chance, as led by Ulyana Khromyak, advised Abbott Laboratories on antitrust issues with respect to the acquisition of Russian pharmaceutical company Petrovax Pharm. In 2013 Mykola Stetsenko, managing partner of Avellum Partners, guided his strong corporate/M&A team in course of corporate restructuring mandates. Olena Vardamatska, the Kiev office of Wolf Theiss, advised Alvogen on establishing a company in Ukraine. Volodymyr Vashchenko, partner of VB PARTNERS, recently advised Chauvin Ankerpharm GmbH on taxation risks for representative offices.
Oksana Guz, an independent attorney, operates as a principal lawyer of the National Institute of Surgery and Transplantology named after A. A. Shalimov, and is an experienced specialist involved the resolution of disputes between medical institutions and patients. Elena Bedenko-Zvaridchuk of MedAdvokat provides legal support to the medical business. Medical law is the core specialization of Babich, Sysoenko and Partners.
Shevchenko National University of Kiev, National University of Kyiv Mohyla Acadamy, University of London
Mykola Orlov supervises work on major international projects in the fields of pharmacy business & healthcare. In 2013 alone, he advised restructuring of representative offices of several non-Ukrainian pharmaceutical companies, also in connection with enforcement of both Ukrainian and non-Ukrainian antimonopoly and anti-corruption legislation (using forms FCPA and UK Bribery Act), purchase of the leading Ukrainian chain of medical clinics Dobrobut, sale of a leading Ukrainian feed producer and structuring of Ukrainian operations of several international pharmaceutical groups.
Mykola was named among the TOP 100 leading legal experts in Ukraine. He is repeatedly listed among top Ukrainian lawyers according to the research Ukrainian Law Firms 2013. A Handbook for Foreign Clients and rating GVardiya law firms — 2013 newspaper Contracts.
Mykola Orlov is the author of numerous publications and seminars on healthcare, tax & land law.
Pharmaceutical, land, agriculture, construction, banking law, as well as domestic and international tax planning
Ukrainian, Russian, English