Diversifying and 'pharmerging' markets, innovative finishing procedures and global distributions, decreasing spending for the national health service and expiring patents are changing the global pharmaceutical landscape dramatically. We are dedicated to the pharmaceutical sector and support you in a proactive manner to help you face these challenges.
Our broad network covering Europe, Asia, and the Americas has been focusing the pharmaceutical market for over twenty years. We assist our clients on a full range of issues including:
- Multi-jurisdictional regulatory reviews and regulatory advice in M&A transactions and joint ventures
- Controlling R&D costs for targeted medicines while responding to demands in broadening the product portfolio
- Ensuring compliance with changing regulatory requirements and industry codes of conduct
- Protecting patents including patent pooling and cross licensing
- Accessing the market with authorisations and reimbursement
- Performing clinical trials, post market surveillance studies and data collection and registry studies
- Complying with laws on advertising
- Implementing immediate actions in the case of product recalls and product liability cases
- Digital transformation of supply chains and production lines.
- E-health projects (e.g. healthcare apps, electronic therapy plans, digital set-up of trials and studies, etc.
Client experience
- Pfizer, on its award winning long term strategic collaboration with Russian pharmaceutical company NovaMedica; on the IPO of its former animal health business, Zoetis; in a multi-million litigation concerning claim for damages regarding the breach of patent license for Pfizer, as well as the accusation of contra bonos mores damnification
- Fresenius Kabi on the acquisition of Merck KGaA’s biosimilars business
- Fidia Farmaceutici in relation to the sale of its ophthalmic business to Bausch & Lomb and in relation to its joint venture with Bionicle Sciences in relation to the development and sale of biotech medical products for the US market.
- Amgen on the acquisition of Micromet.
- Bayer Pharma AG during the sale of a portfolio of substances related to the field of molecular diagnostics (molecular imaging) to Piramal Imaging SA, an affiliate of Piramal Health Care Ltd.
- Representing an international gas supplier in interim injunction proceedings before the District Court and a Higher District Court of Düsseldorf and Hamburg and parallel nullity proceedings at EPA (application of NO)
- Representing a medical device company in 3 parallel patent infringement cases against a competitor before the District Court of Saarbrücken in relation to products containing Polihexanid-Betain for oral and external application
- US pharmaceutical product manufacturer during the acquisition of a European company, including comprehensive FCPA Due Diligence
- The major German association of pharmaceuticals (Bundesverband der Arzneimittelhersteller e.V./BAH) and the trademark association before the Federal Institute for Drugs and Medical Devices (BfArM) regarding new rules to prohibit the use of umbrella trademarks for pharmaceuticals with different substances. The opinion was indicative for the whole pharma industry and led to a significant change of the more restrictive draft guidelines issued by the Federal Institute
- Counsel to two pharmaceutical manufacturers and their joint venture in an internal investigation into allegations of bribery and fraud in central Europe
- Revision of the regulations and codes for the Association for "voluntary self-oversight for the pharmaceuticals industry" (FSA) based on the mandates of the EFPIA code, including antitrust advice regarding registration with the Federal Oversight Office, and ongoing advice regarding all compliance-legal questions
Directory listings and client comments
- The team is known for a market-leading practice that offers a comprehensive service in the healthcare, life sciences and chemicals sectors. Recognised strength in IP, patent law and product liability matters. Highly active in corporate transactions in the sector. Adept at assisting clients with regulatory requirements and compliance issues. Predominantly acts for major multinationals in the pharmaceutical sector.
Strengths Clients recognise the firm's leadership in the market: "They are just the best – it is a very big, respected and creative team which gets good results for business."
Chambers Europe Life Sciences 2017