Life Sciences

This is an exciting time for the Life Sciences industry. Technological and medical breakthroughs, legislative changes, evolving jurisprudence and heightened regulatory scrutiny are revolutionizing the Life Sciences industry. It is also a challenging time with respect to developing, obtaining approval for, commercializing, and protecting the intellectual property (IP) associated with your drug, device or biologic.

Saul Ewing’s Life Sciences team can help. Although we are seasoned lawyers, we are also advisors to venture capitalists, engineers, scientists and patent and biotechnology professionals, all of whom speak your language and know the unique nuances of the Life Sciences community. We are passionate about helping clients overcome the challenges associated with funding, compliance and IP protection – bringing their products to market – and protecting those products and related IP after they enter the marketplace.

Our interdisciplinary approach means that attorneys specializing in different legal fields – corporate, litigation, real estate, and insurance, in addition to patent law – are all a part of our Life Sciences team. Our collective background in the sciences, the courts, and a wide array of technological realms is an advantage that can help you grow and compete in the Life Sciences industry.

Industry Focus

Saul Ewing’s Life Sciences team recognizes that the Life Sciences industry encompasses a range of companies that are involved in various stages of research, development, technology transfer and commercialization, including:

• Pharmaceutical companies
• Medical Device companies
• Diagnostic companies
• Biotechnology companies
• Nutraceuticals and cosmeceuticals
• Universities and health systems
• Clinical research facilities

Services Provided

Whether your Life Sciences company is large or small, we understand your legal needs specific to the development, approval and sale of your products. We advise and represent Life Sciences industry clients in the following areas:

• Patent, preparation, prosecution and enforcement, freedom-to-operate, and landscape analysis
• Advice and protection for intellectual property, including trade secrets and copyrights
• Hatch-Waxman Act patent infringement (ANDA) litigation
• Commercial litigation including contractual disputes over proprietary intellectual property, trademark infringement, and misappropriation of trade secrets
• Preliminary injunctions/temporary restraining orders to protect intellectual property
• Government and third-party subpoenas
• Nondisclosure, joint research and licensing agreements
• Strategic alliances
  • Material transfer
  • Clinical trial
• FDA
  • Safety and effectiveness
  • Market approval/clearance and regulatory compliance
• Payment and reimbursement, including as it relates to clinical trials and FDA labeling
• Anti-kickback Statute (42 U.S.C. § 1320a-7b), Stark Statute (42 U.S.C. § 1395nn) and Qui Tam Statute (31 U.S.C. § 3729, et seq.)
• HIPAA compliance
• Government contracts, including Small Business Innovation Research (SBIR) grants
• Individual, class action, mass tort, and Multidistrict Litigation lawsuits throughout the U.S.
• Product liability actions, including defense of failure to warn, design defect, and manufacturing defect claims as well as defense of claims for violating state consumer fraud statutes

In addition to legal advice specific to the Life Sciences industry, we advise and represent our Life Sciences clients on general business matters, including:

• General corporate matters, such as financing and capital investment, commercial agreements and securities compliance
• General litigation risk management and exposure
• Real estate, such as facilities leasing, build out and construction
• Tax matters
• Branding issues, such as Trademark and Service Mark
• Labor and employment
• Internal investigations
• Civil and criminal governmental investigations