The Life Sciences Practice Group represents and advises innovative biotechnology, pharmaceutical and medical device companies on a wide range of legal, regulatory and strategic issues, including patent and product liability litigation, U.S. Food and Drug Administration (FDA) investigations and enforcement actions, and corporate transactions and financings. Many Gibson, Dunn & Crutcher lawyers hold advanced scientific degrees and have hands-on experience working in life sciences companies or within the government agencies that regulate the industry. Law360 named Gibson Dunn one of the top five Life Sciences Practice Groups of the Year for 2015.
In addition to advising biotechnology, pharmaceutical and medical device companies, we also regularly represent:
- Investment banks, venture capital funds, private equity firms, royalty monetization firms, private investment and hedge funds, as well as individual investors focused on funding life sciences-related companies
- Diagnostic companies, as well as companies developing and commercializing research tools for use in the life sciences industry
- Health care IT companies
- Academic medical centers and research institutions
- Veterinary, agricultural and industrial life sciences companies
The Life Sciences group has significant experience handling major litigation, transactional and other matters for companies engaged in the research and development of life science products and therapies. The wide range of skills, knowledge and experience of the group includes:
- Patent and product liability litigation
- Actions under the U.S. False Claims Act
- FDA regulatory compliance and enforcement
- White collar defense and investigations
- Antitrust and trade regulation
- Mergers and acquisitions
- Capital markets transactions
- Monetization and debt financing transactions
- Licensing, collaborations, joint ventures, and strategic alliances
The Life Sciences group's lawyers represent biotech, pharmaceutical and medical device companies in patent litigation, including matters involving the Hatch-Waxman Act, as well as in product liability and commercial litigation. The group also has a broad range of experience responding to regulatory investigations and enforcement actions involving life sciences companies, including FDA compliance and U.S. Department of Justice and Federal Trade Commission antitrust and consumer matters.
The group's lawyers have addressed and successfully litigated some of the most difficult topics facing the pharmaceutical industry, including the enforcement of second- and third-generation patents, combination drug patents, formulation patents, regulations governing patent listing and use codes, and follow-on antitrust litigation by direct and indirect purchasers. We also represent medical device companies in all forms of commercial litigation.
Our corporate lawyers have handled significant deals and financings in the life sciences sector. They routinely represent issuers, as well as financial institutions acting as underwriters, placement agents and financial advisers in industry transactions. Combined with our exceptional securities regulatory strength, we have breadth and insight that few firms can match in transactions including venture financing transactions, initial public offerings, public and private debt and equity offerings, PIPEs, stock and asset acquisitions, public and private mergers, and private equity and leveraged buyouts.