Life Sciences

The regulatory and enforcement landscape for life sciences companies can be particularly difficult to navigate and even harder to predict. The life sciences team at Bass, Berry & Sims works with global companies across this diverse industry offering strategic legal guidance and compliance advice from product development to launch and promotion, and all the steps in between. This includes working with clients on the front end to implement effective compliance programs as well as on the back end to manage internal investigations and respond to government enforcement inquiries. We have experience working with both mature companies and start-ups, as well as the private equity funds and venture capitalists investing in this highly regulated industry.

Our life sciences clients include companies in the following industries:

  • Pharmaceuticals
  • Biotechnology
  • Medical devices
  • Agricultural biotechnology
  • Cellular, tissue and gene therapies
  • Chemicals
  • Consumer healthcare
  • Diagnostics
  • Digital health
  • Emerging technologies
  • Food and dietary supplements
  • Research centers
  • Veterinary products

Our team is comprised of attorneys with strong foundational knowledge in regulatory and compliance, investigations, litigation, intellectual property and technology, corporate and securities, mergers and acquisitions, financing, and other areas. The team includes attorneys and professionals with deep experience and includes registered patent attorneys and a former patent examiner with the U.S. Patent and Trademark Office in the biotechnology, medical diagnostics and medical device art units; and former federal prosecutors, including the former assistant chief for healthcare fraud at the U.S. Department of Justice’s Criminal Division who now represents clients in this industry as outside compliance and investigations counsel. Additionally, many of our attorneys have the technical background – in disciplines such as chemistry, molecular and cellular biology, chemical engineering, electrical engineering, physics, and others – that often is needed when navigating this complex industry.

From day-to-day guidance to audits and compliance reviews to creating complex joint ventures or advising on trade and distribution matters, our multi-disciplinary approach allows us to provide operational, transactional and litigation counsel to clients of various specialties and at various stages in an organization’s life cycle.

Our attorneys are experienced in representing life sciences companies in due diligence, compliance reviews, internal compliance investigations, government investigations, criminal prosecutions, and civil litigation in matters related to healthcare fraud and abuse under federal and state statutes and regulations including:

  • Anti-Kickback Statute (AKS) and Stark Law
  • False Claims Act (FCA)
  • Foreign Corrupt Practices Act (FCPA)
  • Food, Drug and Cosmetic Act (FDCA)
  • Federal Acquisition Regulation (FAR)

If facing a government enforcement action, our attorneys have experience responding to government requests, negotiating resolutions with the involved government agencies, and advocating for clients when the government seeks post-settlement compliance requirements or monitoring. Our attorneys also have experience working with life sciences companies already under corporate integrity agreements to identify and assess possible reportable events.

Our attorneys also work closely with life sciences companies to ensure protection of intellectual property. Our patent attorneys advise life sciences companies on the strategic international development and licensing of patent portfolios and have significant experience with patent office proceedings, including appeals, inter partes reviews, interferences and derivation proceedings before the U.S. Patent and Trademark Office (USPTO) and Patent Trial and Appeal Board (PTAB). We also advocate for our clients in the fast changing realm of intellectual property disputes in district courts and the Court of Appeals for the Federal Circuit.

The Bass, Berry & Sims team partners with life sciences clients to offer a tailored, full-service approach to help companies meet strategic business objectives and remain compliant with the various regulations within this highly regulated industry.

Taylor J. Ashley
Associate
Wilmoth H. Baker, IV
Associate
Shu Chen, Ph.D.
Associate
Terry L. Clark
Member
Meredith Edwards Collins
Associate
Wallace W. Dietz
Member
Kristin C. Dunavant
Senior Corporate Attorney
Lindsey Brown Fetzer
Associate
D. Lee Flaherty
Associate
John L. Fuller
Member
Courtney Ginn
Associate
Andrew Hard
Associate
Kaitlin E. Hazard
Associate
Michael E. Hill
Associate
S. Ryan Hoffman
Associate
Angela Humphreys
Member
Brian R. Iverson
Member
Michael P. Kapellas
Associate
John E. Kelly
Member
Michael R. Kuffner
Member
Howard H. Lamar III
Member
Katherine S. Linsey
Associate
Richard F. Mattern
Member
Sarah B. Miller
Associate
Daniela J. O'Mara
Associate
J. Allen Overby
Member
R. Gregory Parker
Member
Janice Parmar
Associate
Tatjana Paterno
Member
Frank M. Pellegrino
Member
Robert K. Platt
Associate
Cynthia Y. Reisz
Member
Lisa S. Rivera
Member
Molly K. Ruberg
Associate
Sehrish Siddiqui
Member
Susan V. Sidwell
Member
Danielle M. Sloane
Member
Julia Tamulis
Associate
Oscar L. Thomas
Counsel
Ryan D. Thomas
Member
Nesrin Garan Tift
Member
Janelle D. Waack
Member
Julie C. Walker
Senior Corporate Attorney
Elizabeth S. Warren
Member
Brian K. Wilke
Associate
Price W. Wilson
Member
Abby Yi
Associate
Jessalyn H. Zeigler
Member

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