Life Sciences

Legal strategies empowering life-changing innovation.

Our Scope

Our life sciences lawyers are trusted advisers to companies seeking to develop, market, monetize, and defend their innovative products, operations, and industry investments. We help navigate complex patent and regulatory issues; address novel AI and privacy considerations; advise on strategic alliances, acquisitions, and divestitures; and aggressively litigate disputes to advance our clients’ business goals.

Our life sciences lawyers serve 1,000+ industry companies across the pharmaceutical, biotechnology, medical device, veterinary, agricultural, and industrial life sciences sectors; nonprofit and academic research organizations; CROs and CMOs; and investment firms, venture capital companies, and lending institutions. We advise on:

Corporate and commercial transactions, including M&A, IPOs, spin-offs, joint ventures, strategic alliances, research platform deals, and development and commercialization collaborations
Pharmaceutical, controlled substance, nutraceutical, and medical device product regulatory strategies, approvals, and compliance in the United States and beyond, including orphan, expedited, and accelerated pathways, clinical testing, manufacturing and inspections, and enforcement actions such as warning letters, recalls, and consent decrees involving the FDA, USDA, DEA, and FTC
Complex commercial litigation and bet-the-company claims, including consumer class actions, post-M&A disputes, crisis management, product liability, trademark, copyright, trade secret, unfair competition, patent infringement and post-grant proceedings, Hatch-Waxman and biosimilar matters, and pay-for-delay and other antitrust challenges
IP issues spanning all facets of the patent procurement process, patent enforcement and defense of infringement claims, licensing, IP audits, and due diligence
Life sciences-related financing transactions involving venture capital funds, private equity firms, investment and commercial banks, institutional lenders, and other investors
Exclusivity and product lifecycle issues, including regulatory and antitrust counseling and related competitor and government litigation
Drug pricing, reimbursement, and government contracting
Criminal, civil, and internal investigations and follow-on litigation involving Anti-Kickback, Physician Self-Referral investigations, healthcare fraud, and the False Claims Act, Foreign Corrupt Practices Act, and other criminal antibribery laws

Areas of Focus

Our firm represents clients across the global pharmaceutical and biotechnology industry, advising on the full array of transactions while also delivering zealous advocacy in regulatory matters and investigations and at trial. With offices in key pharmaceutical and biotechnology hubs across the United States, Asia Pacific, Europe, and the Middle East, we are where our clients are around the world, advising on:

M&A, licensing and collaboration, joint ventures, and financing agreements, as well as commercial contracts and distribution and R&D agreements
Crisis management, consumer class actions, product liability, patent infringement and lifecycle, post-M&A and contract litigation, white collar litigation, and government and internal investigations
Clinical trial and IRB strategies, protocols, and consents
FDA NDA/ANDA/BLA/351k approvals and cGMP and enforcement matters, including 483s, recalls, and warning letters
Drug pricing and reimbursement
Patent prosecution and protection
International regulatory advice and life sciences compliance

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Medical device law is being dramatically reconfigured in response to evolving technology. We represent top medical device companies, delivering seamless regulatory, IP, transactional, and litigation counsel to a range of medical device developers, manufacturers, wholesalers, distributors, and tech companies. We provide advice on:

FDA Premarket advice involving Section 510(k) notifications, PMAs, and IDE and HDE submissions, panel reviews, scientific disputes and appeals, and device modification analyses
Post-market counsel, including product marketing strategies, compliance, product liability exposure, medical device reporting, cGMPs, recalls, and field corrections
Enforcement actions, including FDA Form 483 and warning letter responses, import/export and consent decree issues
M&A, licensing, and collaboration, financing agreements and commercial supply, distribution, and other contracts
Crises management, mass tort and class actions, product liability, and commercial contract challenges
Patent prosecution and protection, trade secret, and trademarks
Antitrust, labor and employment, litigation, and tax issues

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