Gide’s Life Sciences & Health Care practice keeps a close eye on all developments relating to medicines policies, legislative reforms, biotechnology or control of medical risks, all the while assessing the practical impact of these changes from the point of view of substantive law.
Our main areas of expertise are as follows:
- Transactional and Venture Capital
- Intellectual Property
- Personal Health Data
- Distribution and Marketing
- Regulatory / Licensing
- Ethics / Compliance
- Product Liability
- Antitrust / Competition
- Advertising & Unfair Competition
Transactional and Venture Capital
The Life Sciences & Health Care practice is called upon for its comprehensive expertise by pharmaceutical clients in their M&A transactions, ranging from simple portfolio disposals/acquisitions (including obtaining regulatory authorizations) to more complex asset combinations, outsourcing of manufacturing, restructurings and disposals/acquisitions of subsidiaries. The team helps established and emerging life science companies negotiate and structure deals that will help foster their growth and reach their goals. More specifically, our services dedicated to leading and emerging life science companies include:
- Corporate Structuring
- Tax Structuring
- Financing Arrangements
- Equity Investments
- Venture Capital
- Private Investments
- Public Offerings
- Royalty Monetizations
Our team is a key player in representing emerging life science companies and venture funds and is very active in private investments and IPOs.
The scope of Gide’s work in life sciences and healthcare covers all aspects of intellectual property, particularly patents and Supplementary Protection Certificates (SPCs), but also trademarks.
As regards patents and SPCs, Gide provides both advisory services, particularly on freedom to operate issues, and dispute resolution services, often in relation to pan-European patents and SPCs. The Life Sciences & Health Care Practice team also has experience in advising on issues surrounding employee inventions, including government officials.
Gide’s expertise in litigation of pharmaceutical and life-science patents is widely recognized. With one of the largest specialist IP teams in France, Gide has acted successfully in the biggest cases of the past twenty years, and was at the center of recent battles on the interpretation of the European Regulation on SPCs.
Gide advises on regulatory healthcare issues and has unique expertise advising on matters with high technological content, whether contracts relating to IP rights and know-how (assignments, licenses, R&D agreements, partnerships between manufacturers and universities, etc.) or intra-group restructuring. These activities are further enhanced by Gide’s comprehensive experience in dispute resolution.
Our firm also advises clients on matters relating to trademarks and unfair competition / free riding in relation to medicines, medical devices and cosmetic products.
Personal Health Data
Gide advises clients on rules applicable to personal health data, whether issued in the context of Directive 95/46 (including the MR 001 Reference Methodology on clinical trials), or related to health data providers.
The Life Sciences & Health Care practice team assists clients in ensuring the compliance of their data processing and activities, as well as in preparing the relevant filing formalities.
On these sometimes sensitive issues, the team assists clients in their contact with Data Protection Authorities, including in case of investigation/audit.
Gide also advises clients on international health data transfers, including outside the EU, when these are required by the client's activities.
Distribution & Marketing
Gide provides its clients with advice regarding the distribution and marketing of pharmaceutical products, medical devices, chemical products, food, food supplements and cosmetics, with particular expertise in:
- Setting up, implementing and monitoring different types of distribution networks (commercial agency agreements, medical representatives agreements, commissionaire and depository agreements, exclusive distribution agreements, etc.)
- Drafting general terms and conditions for the supply of drugs and medical devices, cooperation agreements with chemists, medical practitioners, clinics, etc.
Gide regularly assists major pharmaceutical companies and medical device manufacturers in this latter area.
Regulatory / Licensing
The Life Sciences & Health Care Practice team has gained extensive experience in guiding and assisting clients on regulatory issues regarding medicinal products, medical devices, biocide products, human cells/tissues, cosmetics and food, including:
- Analyzing health products and their qualification under the applicable regulations as well as liaising with administrative authorities
- Ensuring compliance with regulations as regards pricing, labeling, advertising and promotion of medicines and health products.
The team is experienced in risk management strategies and compliance with requirements in the case of adverse events (including pharmacovigilance and materiovigilance obligations).
Gide also assists companies in obtaining the licenses and registrations necessary for the operation or manufacturing, distribution or promotion of medicinal products and/or services, the practice of medicine or the operation of healthcare facilities and public or private institutions.
Ethics / Compliance
The Life Sciences & Health Care practice enjoys solid experience in analyzing the relationships of health sector companies with medical practitioners and chemists. Gide regularly reviews commercial practices for compliance with rules on medical ethics (namely rules against gifts to medical practitioners) and acts before professional associations for the clearance of cooperation agreements with medical practitioners (clinical trials, R&D, etc.).
The team is highly experienced in preparing codes of conduct and compliance programs and procedures, and regularly assists clients in drafting and implementing compliance programs that are suited to their specific needs (audit of distribution networks, assessment of practices according to the geographical location, etc.).
On an international level, Gide provides its clients with advice on compliance and prevention of risks related to their presence in various countries.
Gide is a recognized practitioner in the field of medical liability and health products safety. In particular, the team assists and represents its clients on product liability issues, through expert procedures and court actions, including negotiating settlement agreements with patients.
Gide assists in implementing recall procedures with public authorities, preventing and coordinating civil, criminal and disciplinary litigation at both national and international levels.
The team is currently acting in several proceedings before French courts for major product liability issues on behalf of its clients and monitors several significant expert proceedings.
Antitrust / Competition
The Life Sciences and Health Care practice team is frequently instructed to assess the compliance with competition law of commercial and cooperation agreements (such as R&D agreements, joint ventures, licensing agreements, parallel imports, etc.) in the pharmaceutical industry.
Gide also represents its clients before the European Commission and the national competition authorities in merger control clearance and/or antitrust proceedings.
Advertising & Unfair Competition
Our team handles all aspects relating to the advertising of medical products (comparative advertising, misleading advertising, prohibition of advertising prescription medicine) and of medical practitioners.