For more than half a century, we have provided hands-on guidance and innovative solutions to domestic and international antitrust problems. Our antitrust lawyers have significant experience counseling on the antitrust aspects of affiliations and mergers, acquisitions and joint ventures. In addition, we have frequently represented life sciences clients before the US Federal Trade Commission (FTC), the Department of Justice (DOJ) and state competition authorities.
Our lawyers support the timely, efficient and compliant launch of multinational clinical trials. These trials support marketing approval applications and meet post-marketing clinical investigation requirements around the world. We help pharmaceutical, biotechnology and medical device companies, hospitals, pharmacies, contract research organizations, and academic research institutions to conduct clinical trials in emerging jurisdictions of interest.
We provide assistance with a range of commercial and M&A transactions, frequently involving multiple jurisdictions. We provide integrated management of the commercial and regulatory issues inherent in transactions conducted by the life sciences industry.
We also have substantial experience helping startups to secure public and private financing, whether through venture capitalists or sources such as grants or partnership agreements.
Data Privacy and Cybersecurity
We help to develop workable privacy compliance programs and counsel on specific privacy and data protection issues that arise in connection with activities involving the processing, transfer and storage of personal data.
We have a depth of expertise in advising governments and public-private partnerships, including project sponsors and awarding authorities, on infrastructure projects, as well as acting for lenders and borrowers on project funding.
US Food and Drug Administration (FDA)
We provide insightful advice in all FDA-regulated areas, including prescription drugs, biologics, over-the-counter drugs, nutritional supplements, food, medical devices, cosmetics and tobacco. Our work spans a spectrum of matters, including advising on effective strategies to obtain approval to market a new product, assisting in determining which regulatory pathway to follow, assessing regulatory and business risks associated with a particular strategy, responding to and defending enforcement matters, initiating and participating in rulemakings, and counseling on public policy.
Fraud and Abuse and False Claims
We offer full range of services relating to fraud and abuse statutes and regulations, including the False Claims Act (FCA) and its qui tam (whistleblower) provisions, the Anti-Kickback Statute, the Self-Referral (Stark) Laws, and the Food, Drug and Cosmetic Act (FDCA). As many of our team served in senior positions in the DOJ, we have particular expertise in counseling clients on establishing and improving compliance programs and proactively addressing related issues. However, we are also well versed in handling complex civil, criminal and administrative matters for life sciences clients.
Intellectual Property and Technology
Our lawyers have the scientific and legal expertise to effectively acquire, defend and enforce IP rights in pharmaceuticals, medical devices, biotechnology and other life sciences areas. With a deep understanding of the interplay between the related science and technology, IP and the practical needs of your business, we can assist with comprehensive IP planning and management. In the patent area, our experienced scientist lawyers excel in procurement of patents world-wide and also provide counseling on patent portfolio management, due diligence on patent assets, freedom-to-operate and patent landscape assessments, and opinions on patent validity and infringement. When disputes arise, our team provides a breadth of dispute resolution services, including pre-suit, settlement, and litigation expertise, to address patent, trademark, copyright, trade secret and related antitrust matters, including Hatch-Waxman matters. Our lawyers are proficient in acquiring trademarks, counseling regarding trademark strategies, as well as policing and enforcing trademark rights. They also provide for registration and management of copyrights, counsel on the effective use of trade secret law to protect IP and handle post-grant proceedings before the Patent Trial and Appeal Board.
International Dispute Resolution (IDR)
Life sciences businesses working across borders need sophisticated IDR counsel when conflicts arise. This is the case in business transactions and contract disputes or disputes related to foreign patients. We are one of only a small number of legal practices able to serve the IDR needs of clients on a truly global basis, with long-established practice groups throughout the Americas, Europe and Asia Pacific.
Active engagement in cross-border and international life sciences transactions, often with the ability to bring extensive knowledge of local law to the documentation and implementation of our clients’ interests.
Labor and Employment
Practical guidance and assistance for life sciences clients. Legal matters range from employment litigation and risk management, to discrimination and harassment, and executive agreements. We also advise on the sponsorship and employment of foreign nationals throughout the world.
Legislative Advocacy and Regulatory Policy
Nationally recognized for our advocacy and regulatory knowledge, we have strong ties to leading policymakers and an impressive track record of success. Part of this reputation can be attributed to our long-standing working relationships with members of Congress and senior staff on each of the House and Senate health-related committees, as well as congressional leadership. These relationships often enable us to achieve clients’ desired changes to statutory and committee report language – and are useful in preventing unintended or adverse consequences. Members of our team regularly participate in the development of legislation and are consulted as a resource for policy analysis.
Litigation (Business, Government Investigations, Product Liability, Life Sciences)
With an exceptional combination of litigation and life sciences capabilities, we resolve multifaceted legal matters efficiently. We counsel and defend clients faced with pending and threatened litigation and governmental investigations stemming from sweeping regulatory reform and significant advancements in science and technologies. We can represent you in state and federal courts through jury and bench trials, in administrative procedures and hearings, and through the appellate process. Our experience spans a variety of lawsuits, including complex, bet-the-company litigation. We advise on liability and risk mitigation options related to corporate agreements, as well as on precedent-setting issues and rules shaping the industry.
We represent developers, contractors, major utilities, commercial lenders and financing institutions, governments, and governmental agencies in real estate matters in the life sciences sector. This includes property acquisitions, planning, construction and project funding. Our lawyers can share the benefit of their broad experience, having participated in all phases of the real estate development process, from both business and legal perspectives. We are familiar with all regulatory matters and environmental concerns that you may confront.
We provide expert advice on every facet of regulatory compliance, from new product inception to international distribution. Lawyers in all our offices around the world regularly handle the regulatory issues inherent in bringing life sciences products to market.
We work closely with regulatory agencies including the US FDA, DOJ, Department of Commerce, FTC, Consumer Product Safety Commission, Environmental Protection Agency and Department of Agriculture.
In Europe, our lawyers monitor EU regulations to assess their likely impact on our clients’ business. We regularly coordinate with the European Medicines Agency, the European Commission and national regulatory authorities to stay abreast of developments and help our clients navigate the regulatory compliance process.
Taxation and Benefits
We provide pragmatic advice on tax exemption matters, community benefit and the new IRC §501(r) requirements, unrelated business taxable income, reorganization and diversification, physician recruitment programs, charitable giving vehicles, and audits and appeals. We can also provide insights into any employee benefits and pension scheme matters in the countries in which you are investing for growth.