Overview of Buchalter’s MedTech & Life Sciences Industry Group
The attorneys in our MedTech & Life Sciences Industry Group provide legal advice to a broad range of companies in the medical technology and life sciences industry, from startups to more mature medical device, digital health, health care, and bioscience companies, as well as non-profit life sciences research institutes, universities, and research hospitals.
Our team, which featuring experts across multiple disciplines, counsels these clients regarding a wide spectrum of legal matters and strategic business planning regarding FDA regulation, intellectual property rights and data rights, technology transfer and commercialization, corporate/tax, litigation (including business and intellectual property-related litigation), and compliance (including complex government investigations).
More Details about Buchalter’s MedTech & Life Sciences Industry Group
The following provides more details about the assistance and guidance that the attorneys in our MedTech & LIfe Sciences Industry Group provide to our clients.
FDA Regulation We guide clients through the intricate FDA regulatory pathway, from pre-submission strategy and clinical trial design through approval, post-market compliance, and enforcement actions. Our regulatory team maintains strong relationships with agency officials and stays ahead of evolving guidance to help clients achieve timely market entry while minimizing regulatory risk.
Intellectual Property We help protect and maximize the value of life sciences innovations through strategic IP portfolio development, filing global applications for patent and other IP registrations, freedom-to-operate analysis, and the overall enforcement of patent, trademark, copyright, trade secret and other IP rights. We understand that in the med tech and life sciences sectors, robust IP protection often determines commercial viability and competitive advantage.
- Patent Protection: We craft and prosecute U.S. and foreign patent applications covering a wide range of technologies, including medical devices and digital health tools.
- Trademarks and Other IP Rights: We assist clients with their global trademark portfolios and overall global strategies for protecting their software tools, other copyright-protected works, technical know how, trade secrets, and other intellectual property rights
Data Rights and Privacy. We assist clients regarding strategic business and legal issues involved in identifying ownership rights in, and the licensing/sharing of, valuable data, including data generated by artificial intelligence tools, which are increasingly used in the med tech and bioscience industry sectors. We also assist our clients regarding the myriad of legal issues involved in the protection of data, including any Protected Health Information governed by HIPAA.
Technology Transfer and Commercialization. We facilitate our clients’ critical movement of their innovations from the initial research and development stages to the global commercialization stage. In particular, we assist our clients regarding the structuring of joint technology developments, collaboration agreements, complex IP licensing arrangements, sponsored research agreements, and the myriad of other business transactions that advance transfer of discovery to commercialization.
Corporate/Tax. From startup formation to multi-billion dollar mergers, we structure and execute transactions that drive growth in the life sciences ecosystem. Our corporate and tax teams handle corporate formation, tax, joint ventures, strategic investments, and M&A transactions with an understanding of the unique valuation and diligence challenges in this sector.
Litigation. Our litigation capabilities encompass the full spectrum of disputes facing med tech and life sciences companies. We defend and prosecute cases with the scientific rigor and strategic sophistication these high-stakes matters demand.
- IP Litigation: When intellectual property disputes arise, we bring formidable courtroom experience in Hatch-Waxman litigation, biosimilar disputes, patent challenges, and trade secrets litigation across all life sciences technologies. Our track record includes victories in bet-the-company cases.
- Business Litigation: We handle complex commercial disputes, in both federal and state courts and in domestic and international arbitration, involving product liability defense, breach of contract actions, partnership dissolutions, and securities litigation unique to the life sciences industry. Our litigators understand the business and scientific context that drives favorable resolutions.
Compliance and Investigations. We help life sciences companies build robust compliance programs and defend against government investigations involving the False Claims Act, Anti-Kickback Statute, Foreign Corrupt Practices Act, and other regulatory enforcement actions. Our team provides rapid response to FDA warning letters, DOJ investigations, and whistleblower allegations while implementing preventive measures to minimize future risk.
