The life sciences industry plays a vital role in the health and welfare of every individual. It plays an equally important part in the health of the global and domestic economy — by some estimates, accounting for approximately 25 cents of every US dollar spent by consumers.
The life sciences industry team at Hunton & Williams LLP has extensive experience in all areas of law that affect participants in the life sciences industry. We have a long history of success representing clients whose products and services include the following:
- Animal drugs
- Biologics and biosimilars
- Diagnostic tools
- Dietary supplements
- Medical devices
- Pharmaceuticals, including drug delivery and formulation
- Tobacco products
The life sciences industry is broad and includes companies, research and development divisions of major corporations, and educational institutions focused on developing, manufacturing, and marketing products that address specific technologies and medical and health-related issues. At Hunton & Williams, our life sciences team has a broad view of the industry and the myriad legal, market and regulatory forces that play a role in business success. To help clients address these many issues, our core life sciences practitioners — and our clients — have direct access to the full resources of the firm's more than 750 lawyers worldwide.
We have also developed an extensive network of advisors that enables us to deliver practical, real-world solutions to clients whose operations, investments, and customer and vendor relationships extend around the world.
In addition to this broad industry perspective, and to better serve our clients’ unique needs, we draw on more than 70 highly skilled, life-sciences focused lawyers, each of whom has deep experience in specific areas of law and regulatory policy. Many of our lawyers also have extensive training in the scientific and technical disciplines that form the core of our clients' businesses. Members of our group hold doctorate, master’s and bachelor’s degrees in areas such as biology, chemistry, chemical engineering and electrical engineering. We are also home to numerous former patent examiners at the US Patent and Trademark Office, who apply their firsthand experience in helping clients navigate complex patent prosecution and dispute resolution processes.
The sophistication of our life sciences practice is a direct result of the knowledge and creativity of our individual lawyers. As thought leaders, our lawyers speak frequently at life sciences-related conferences, seminars and annual meetings. We regularly provide in-depth analysis of emerging regulatory and legal topics in journals and in the news media, and publish the annual Pharmaceutical, Chemical and Biotech Year in Review to help clients stay ahead of the business and technology curve.
Given the pace of change in today's economy, we also publish numerous blogs that allow clients to get timely information on emerging issues, legislation and market developments. Among others, the following blogs are of particular interest to members of the life sciences industry:
Clients, industry journals and ratings agencies alike name Hunton & Williams and our life sciences lawyers among the leading practitioners in the United States and abroad:
- In its annual guides to the leading US litigation firms, Benchmark Litigation and Benchmark Appellate, Euromoney Legal Media group has ranked Hunton & Williams among the top providers nationally, in the District of Columbia and in several states. The publications also recommend a number of our individual intellectual property litigators.
- Chambers USA, Chambers UK, Chambers Europe, Chambers Latin America, Chambers Asia and Chambers Global have named dozens of our practices and lawyers to the publications’ lists of the top providers worldwide, including numerous Band 1 rankings. Among other practices highlighted are our data privacy and security, health care, environmental, immigration, information technology, intellectual property, labor and employment, litigation, outsourcing and products liability teams.
- Managing IP, US News & World Report, The Legal 500 and Corporate Counsel have all recognized Hunton & Williams as a leading intellectual property team and as one of the nation's busiest patent practices.
Corporate Counseling. We advise clients on corporate and transactional issues that arise through the entire business lifecycle, from counseling startups and new initiatives on business formation, through negotiation of licensing agreements, technology transfers and portfolio management, to conducting due diligence related to mergers, acquisitions, divestitures, joint ventures, strategic alliances, leveraged buyouts, spinoffs, privatizations and other strategic programs.
Investigations and Compliance. We guide clients through a wide variety of investigations, settlements and post-settlement compliance activities related to law enforcement and regulatory proceedings deriving from the Federal Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, the Prescription Drug Marketing Act, the False Claims Act, the Stark physician self-referral statue, and current good manufacturing practice (cGMP) and quality system regulation (QSR) requirements. We negotiate deferred prosecution and non-prosecution agreements and represent firms subject to Corporate Integrity Agreements imposed by the US Department of Health and Human Services’ Office of the Inspector General. We design and help implement comprehensive compliance programs for pharmaceutical and medical device companies, including written policies and procedures, training programs, and the like. In addition, we leverage our agency and regulatory experience to help firms comply with state laws regulating the marketing of drugs and devices.
FDA Regulatory. Our experienced regulatory lawyers counsel clients on compliance with the full range of laws and regulatory policies that govern the life sciences industry. We assist clients in their dealings with the US Food and Drug Administration and other governmental agencies, including obtaining FDA approval or clearance of new pharmaceutical products and medical devices, clinical trial development and design, product labeling and manufacturing issues, and responses to recalls and warning letters. We have extensive experience with the legal and regulatory standards governing the development, commercialization and promotion of food, drugs, devices, cosmetics and dietary supplements, in accordance with FDA, Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), and US Department of Agriculture (USDA) requirements.
Intellectual Property. While patents are a core asset for life sciences companies, copyrights, trademarks, trade secrets and other proprietary information typically play a large role in the overall intellectual property portfolio of a business. We have significant experience helping clients achieve the maximum competitive advantage from their IP assets while helping them protect, defend and avoid infringing upon these rights. In addition to our patent prosecution practice, we have particular strength in areas such as advertising compliance, unfair competition, rights of publicity or privacy, trade secret protection and patent litigation.
Labor and Employment and Immigration Issues. Identifying, attracting and retaining highly experienced employees remains one of the greatest challenges facing life sciences companies today — as does compliance with the host of employment-related regulations imposed by US Immigration and Customs Enforcement (ICE), the Department of Labor (DOL), the Equal Employment Opportunity Commission (EEOC), the Occupational Safety and Health Administration (OSHA), the Department of Justice (DOJ), and the National Labor Relations Board (NLRB), among other agencies. Our labor and employment litigators have handled thousands of individual cases and class actions heard before state and federal courts in almost every state in the country.
Litigation. For life sciences companies, intellectual assets are the foundation of their business models. Allegations of wrongdoing must be addressed immediately and effectively, whether our client is seeking to prevent the further misuse of trade secrets, patents, copyrights, trademarks and other proprietary information, or to respond to action taken to prevent their rightful use of IP assets that have been obtained through licensing and other agreements. We also counsel clients in litigation arising from the Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Amendments) and in related life cycle management issues. Our experienced trial lawyers and litigators represent clients in a broad range of venues, from federal and state district and appellate courts across the country, to the PTO Board of Patent Appeals and Interferences and the International Trade Commission, to regulatory agencies of the European Union and Member States.
Patent Office Practice. Our patent practitioners in the firm’s Washington, Brussels and other offices worldwide have deep, firsthand experience with patent authorities in the United States, Europe and in countries around the world. We provide effective counsel in all aspects of patent creation, prosecution and defense, including administrative appeals, petitions and protests, ex parte reexaminations, inter partes reviews, reissues, priority disputes, European oppositions. We have helped clients secure thousands of patents in numerous technical areas, including pharmaceuticals, nutraceuticals, agriculture, chemistry, cosmetics, food products, biotechnology and medical devices.