Life Sciences

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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.

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Life Sciences Goals Graphic for Webpage

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

 

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Life Sciences Ceros Thumbnail

 

 

An interactive look at our Life Sciences Group

 

 

Key Contacts
Kermit J. Nash
Charles M. Lizza
William Baton's Headshot
Kathryn Doyle
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The Regulatory Roundup
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Regulatory updates on the food, beverage and agribusiness; cannabis; tobacco; and life sciences sectors