Industry-Specific, Business-Focused Legal Advice
Increased pricing pressure combined with a rise in generic competition and continued regulatory uncertainty have squeezed the margins of life sciences companies. Helping navigate this ever-shifting terrain, Saul Ewing’s Life Sciences Practice consists of approximately 50 professionals, the majority of whom have direct industry experience – including as scientists, engineers, entrepreneurs and investors. We are business people first. As a result, we provide legal advice that is practical and business-oriented, helping to advance the business goals of life sciences companies and organizations.
We represent companies and organizations across multiple sectors:
- Pharmaceuticals
- Medical devices
- Biotechnology
- University research programs and medical schools
- Services/clinical research
- Nutraceuticals and cosmeceuticals
- Diagnostics
- Bioinformatics
- Cannabis
- Industrial and consumer manufacturing
Our team advises on:
- Utility patent preparation and prosecution
- Technology transfer for colleges and universities
- Licensing, joint ventures, and research and development collaborations
- Patent litigation and enforcement, including Hatch-Waxman Act/ANDA litigation
- Trademarks and copyrights
- Mergers and acquisitions
- Securities transactions
- Financing transactions
- Corporate governance, fiduciary duties and risk mitigation
Regulatory Compliance and Enforcement:
Related to products regulated by:
- The U.S. Food and Drug Administration (FDA)
- The Federal Trade Commission (FTC)
- The U.S. Consumer Product Safety Commission (CPSC)
- State and federal health care laws
- Data privacy compliance and pre-cybersecurity incident preparation
- Cybersecurity incident response and investigation
- Post-cybersecurity incident defense
- Litigation
- Risk reduction
- Regulatory compliance
- Breach of contract
- Class actions
- Shareholder disputes
- Partnership disputes
- Unfair competition
- Leasing
- Acquisition/disposition of properties
- Environmental issues with properties
- Employment litigation
- Employment counseling
- Traditional labor relations
White Collar and Government Enforcement:
- Government enforcement actions
- Ethics and compliance-related investigations
- Counsel on a variety of statutes and regulations, such as:
- the False Claims Act (FCA)
- the Food, Drug and Cosmetics Act (FDCA)
- the Foreign Corrupt Practices Act (FCPA)
- the General Data Protection Regulation (GDPR) and other data privacy and cybersecurity regulations
