Life Sciences

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:

Intellectual Property:

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

Corporate:

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

Cybersecurity and Privacy:

Data privacy compliance and pre-cybersecurity incident preparation
Cybersecurity incident response and investigation
Post-cybersecurity incident defense

Product Liability:

Litigation
Risk reduction
Regulatory compliance

Commercial Litigation:

Breach of contract
Class actions
Shareholder disputes
Partnership disputes
Unfair competition

Real Estate:

Leasing
Acquisition/disposition of properties
Environmental issues with properties

Labor and Employment:

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