Life Sciences Litigation
- Holland & Knight's Life Sciences Litigation Team represents manufacturers of pharmaceutical, biopharmaceutical and biotechnology products, as well as medical device companies, in government enforcement actions, commercial litigation, internal investigations and regulatory compliance matters.
- We understand the critical importance to life sciences companies of protecting their valuable patents, trademarks, trade secrets and other intellectual property assets in an industry marked by rapid innovation.
- Our life sciences litigators have significant experience representing clients that face allegations of False Claims Act violations brought by the federal government or individual whistleblowers.
Overview
Litigation within the life sciences industry is often complex and multifaceted, reflecting the sector's distinct blend of scientific innovation, regulatory scrutiny and commercial competition. Holland & Knight's Life Sciences Litigation Team represents manufacturers of pharmaceutical, biopharmaceutical and biotechnology products, medical device companies, pharmacy benefit managers (PBMs), laboratory companies and pharmacies in government enforcement actions, commercial litigation, internal investigations and regulatory compliance matters.
Intellectual Property Disputes
Recognizing the rapid pace of innovation in the development of new products and therapies, Holland & Knight's Life Sciences Litigation Team understands the critical importance of protecting valuable patents, trademarks, trade secrets and other intellectual property (IP) assets. Our attorneys defend life sciences clients against allegations and acts of patent infringement, and we have in-depth experience handling disputes over research and development agreements, licensing arrangements, collaboration agreements, supply contracts, breach of contract, and royalties or payments. Our recent experience includes the successful defense of a life sciences client against claims of breach of supply and licensing agreement.
False Claims Act and Government Enforcement Actions
The life sciences industry operates under strict regulatory frameworks established and enforced by the U.S. Food and Drug Administration (FDA), U.S. Drug Enforcement Administration (DEA), U.S. Department of Justice (DOJ), FBI and other government agencies. Our life sciences litigators have significant experience representing clients that face allegations of False Claims Act (FCA) violations brought by the federal government or individual whistleblowers. We have successfully defended pharmaceutical, biotechnology, medical device companies, specialty pharmacies, infusion centers and PBMs in FCA qui tam matters. Additionally, our attorneys are frequently engaged to conduct internal investigations related to FCA concerns, the federal Anti-Kickback Statute (AKS), sales and marketing practices, and a variety of other issues.
Our attorneys assist pharmaceutical manufacturers in the design of patient and provider assistance programs to help ensure compliance with anti-kickback and beneficiary inducement laws and regulations. Lawyers on our Life Sciences Litigation Team also have represented a pharmacy company against allegations of improper kickbacks, a global medical device company in DEA investigations and a generic drug manufacturer in qui tam litigation as well as in related DOJ allegations of FCA violations.
Product Liability Claims
Product liability lawsuits can be particularly significant in the life sciences industry, where products such as pharmaceuticals, medical devices and biologics are used to diagnose, treat or prevent diseases. Holland & Knight's Life Science Litigation Team has extensive experience representing clients confronted by allegations of defective products, inadequate warnings or instructions, failure to meet regulatory standards and other claims. We handle multidistrict litigation (MDL) and mass torts, and our life sciences litigators regularly address scientific, medical and regulatory issues in product liability cases.