Biotechnology

Legislation in the biotech and pharmaceutical industry involves a balancing act between conflicting interests, such as technical breakthroughs, the protection of personal privacy, ethical restrictions, and public interest.  In response to the rapidly changing industry models and regulatory advisory needs, Lee, Tsai & Partners has established a dedicated team whose responsibility is to continuously follow up on and research laws, policies and regulatory systems for the biotech and pharmaceutical industry to assist our clients in obtaining the latest legal information regarding biotech and pharmaceutical law and to provide them with comprehensive and integrated legal services.  We aim to assist our clients in maintaining a leading position, ensuring regulatory compliance, and effectively managing legal risks in biotech and pharmaceutical industries.  


Our services include but are not limited to:

• Intellectual Property Planning and Management: Providing advice regarding the strategic planning and management of IP rights in relation to the biotech and pharmaceutical industry, including but not limited to obtaining patents and trademarks, IP licensing issues, and litigation.

• Biotechnology and Pharmaceutical Regulatory Advisory: Providing legal counseling services covering all stages of the biotechnology and pharmaceutical industries, including early-stage R&D, clinical trials, registration and permit applications, market sales and advertising compliance, post-market safety surveillance, and related regulatory requirements.

• M&A and Strategic Planning: Assisting biotech and pharmaceutical clients in formulating merger and acquisition plans, providing advice on acquisition strategies and methods, and supporting cross-border M&A transactions by coordinating with local counsel to ensure smooth execution.

 
Representative Cases

• Provided advice to a multinational pharmaceutical research firm on reorganization, mergers and acquisitions and assisted the client in completing the acquisition transaction.

• Represented an international biomedical company in their patent filing, patent protection, and patent licensing and enforcement in Greater China region and the world.

• Regulatory Compliance Advisory:

  • Advised a listed U.S. medical device company on pharmaceutical law issues.

  • Advised a listed Taiwan pharmaceutical company on legal issues related to sales of pharmaceutical products and retention of clinical research organization.

  • Advised a foreign company group listed in Taiwan on legal matters involving medical devices, medical institutions, regenerative medicine and investments.

• Represented a U.S. pharmaceutical manufacturing and chemical engineering company in a civil lawsuit and other legal matters in relation to hemophilia patients in Taiwan who were infected with HIV through the use of contaminated plasma products.