Our life science team provides legal services to entities in the following industries: pharmaceutical, cosmetics, food, and medical. We advise on issues connected with the marketing of the following:
- medicinal products;
- food supplements;
- “borderline products”;
- food products;
- plant protection products;
- medical devices.
Advisory services with respect to advertising and promotion, as well as brand protection
Our law firm provides legal advisory services with respect to advertising and promotion, as well as brand protection to entities of the pharmaceutical, food, cosmetics, and medical sectors.
- Examining the lawfulness of advertisements and consumer information in relation to medicinal products, food supplements, cosmetics and the so-called borderline products;
- Representing pharmaceutical companies in proceedings before the Main Pharmaceutical Inspectorate (GIF);
- Issuing opinions on the level of security and identifying legal risk of advertising campaigns addressed to the general public as well as doctors and pharmacists;
- Developing templates of contracts as well as terms and conditions for the purposes of promotions, contests and lotteries;
- Issuing opinions of product placement projects concerning sensitive goods;
- Representing our clients in litigations concerning advertising, as well as in cases before the President of the Office of Competition and Consumer Protection (UOKiK) and in industry proceedings, e.g. before the Committee of Advertising Ethics;
- Providing legal support in selecting an appropriate method of protecting business brands and product brands;
- Providing legal advisory services in the case of image crisis.
Managing industrial property rights (patents, trademarks)
Together with our clients, we define the areas of innovation and develop a strategy for the protection of industrial property rights.
- Comprehensive support in the conduct of application proceedings for trademarks, inventions and other industrial property rights, in Poland and the EU, as well as at the international level;
- Assistance in managing the portfolio of existing industrial property rights, including day-to-day advisory services, consultancy and close cooperation in order to adapt the type of protection to our client’s business needs;
- Representing our clients in court proceedings in cases regarding patent infringement and trademark protection.
Advisory services with respect to regulatory and corporate matters
We provide support in regulatory issues to producers and distributors of the pharmaceutical, medical, cosmetics, and food industries.
- Providing support in cases related to marketing authorisations for medicinal products, including advisory services concerning the qualification of “borderline products”, as well as the selection of an appropriate registration procedure;
- Developing a procedure for authorising medicinal products, including under the Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP);
- Issuing opinions and drafting contracts concerning the distribution and manufacture of medicinal products, contracts for the disposal of rights to marketing authorisations, as well as contracts concerning clinical trials;
- Providing advisory services on the duration and scope of regulatory protection of medicine registration data, as well as refunds and official prices;
- Representing our clients in administrative proceedings for issuing authorisations to run pharmacies and pharmaceutical warehouses;
- Submitting notifications of medical devices to the Office for Registration of Medicinal Products (URPL), and provision of legal services during notification proceedings, as well as handling correspondence with the URPL.
Competition law and personal data protection
Our team of experts has extensive experience in conducting proceedings before the Office of Competition and Consumer Protection. We support clients in combating acts of unfair competition such as imitation of products or commercial designations and unfair advertising. In addition, our law firm provides specialised services with respect to personal data protection, taking into account the specific nature of the pharmaceutical, food, cosmetics, and medical sectors.
- Providing advisory services on compliance of contract (terms and conditions) templates and marketing activities with consumer protection regulations, and representing our clients in proceedings before the Office of Competition and Consumer Protection concerning an accusation of infringement of collective interests of consumers;
- Conducting compliance and due diligence audits with regard to personal data protection in the pharmaceutical and medical industries, including in respect of processing personal data in clinical trials;
- Representing our clients in proceedings related to the decisions of the Inspector General for the Protection of Personal Data (GIODO).
Distribution and public procurement
We cooperate with our clients in developing best solution projects related to distribution of pharmaceutical products, medical devices, and cosmetics, taking into account restrictions and regulations applicable to those markets. We also develop contracts as well as terms and conditions in line with those regulations. Moreover, our experts advise on and conduct proceedings based on the Public Procurement Law.
- Legal assistance with respect to authorisations to open and run pharmaceutical warehouses and pharmacies;
- Distribution contracts as well as terms and conditions in the aspect of infringements on the act on prices and the competition law, including reviews of contracts with distributors of pharmaceutical products and medical devices in terms of compliance with industry-specific laws and the competition law;
- Advisory services with respect to distribution models of medicinal products;
- Advisory services with respect to parallel import;
- Advisory services with respect to supplies of medicinal and pharmaceutical products for health care facilities through public procurement.
Court dispute resolution
Our team has extensive experience in preparing and handling disputes before courts of law, the Supreme Court, the Community Trademark and Industrial Design Court and the Arbitration Court for Internet Domains, as well as courts of arbitration and administrative courts. We assist our clients in resolving court disputes, and represent them before public authorities such as the Minister of Health, the Office for Registration of Medicinal Products (URPL), the Main Pharmaceutical Inspectorate (GIF), the Inspector General for the Protection of Personal Data (GIODO) and the Office of Competition and Consumer Protection (UOKiK), as well as before EU authorities and courts.
Our advisory services cover preparations for a trial, including in particular a review of available materials by determining the probability of the trail being a success. We develop a strategy and implement it. We represent our clients in court disputes with particular emphasis on precedent disputes, proceedings with a high level of complexity or high value of litigation, and in antitrust disputes.
In line with our experience, we represent our clients in cases such as:
- precedent cases of pharmaceutical patent infringement;
- cases concerning protection of reputable trademarks;
- cases of parallel import of goods;
- cases of unfair advertising, designations and marketing the so-called borderline products;
- cases of unlawful comparative advertising;
- cases of business name protection.
Training and workshops
Our experts conduct training and workshops, and hold conferences in the field of pharmaceutical law, industrial property, and issues relating to unfair competition for the pharmaceutical, medical, food and cosmetics industries. These include internal training and workshops, adapted to the legal and business environment in which our clients operate. They often concern new regulations, where interpretation and identification of the possible legal risk is particularly problematic. The training sessions are held in Polish or English.