From early-stage biotech and medical device innovators to Fortune 500 pharmaceutical manufacturers, Loeb & Loeb serves as a trusted legal and business adviser to clients throughout the life sciences industry. Our interdisciplinary team of counselors and litigators has decades of experience representing life sciences companies across all value-added aspects of their business, offering a diverse range of transactional, regulatory, investigation and dispute resolution services. We combine deep industry knowledge with multifaceted expertise to help our life sciences clients find venture funding and access the capital markets, protect and enforce their intellectual property, resolve federal and state law compliance matters, navigate the regulatory pathway and commercialize and distribute their products, and address a broad cross- section of ancillary issues to advance their business objectives.
We recognize the demands of research, development, regulatory approval, strategic alliances and commercialization, and our cohesive team of attorneys and professionals works seamlessly to address our clients’ needs at every phase of the growth cycle, including through the following core areas of service:
Regulatory and Compliance
We advise life sciences companies on a variety of regulatory and compliance issues related to the approval, distribution and commercialization, including marketing and promotion, of FDA-regulated products. Our team provides counsel on federal and state laws and industry standards; helps clients craft and implement compliance policies and programs; reviews product advertising, labeling and promotions; performs audits and risk assessments; and conducts compliance training. We have extensive experience advising on technology-specific regulatory concerns and health information privacy and data security considerations and compliance. Our team also has significant experience counseling life sciences companies on the implementation of corporate integrity agreements.
Loeb & Loeb’s patent attorneys and patent litigators combine in-depth technical expertise and industry knowledge with deep experience in all areas of intellectual property law to help our life sciences clients protect, enforce and leverage their valuable innovations. Our patent litigators represent innovative pharmaceutical companies in Hatch-Waxman litigation and proceedings before the USPTO’s Patent Trial and Appeal Board. Our capabilities extend to dispute and strategic counseling involving compound, formulation, diagnostic, method-of-treatment and medical device patents, as well as developing strategies to protect biotech products under the recently passed Biologics Price Competition and Innovation Act. Innovators at multinational, emerging growth and midsized companies rely on our team to assess, manage and prosecute their patent portfolios to fully realize the value of their intellectual property through direct commercialization and licensing, all aimed at mining the full patent life cycle and exploiting awarded exclusivities. We also offer representation in the areas of trademark and trade secret protection.
Litigation and Investigations
We represent life sciences clients in all manner of federal and state litigation, corporate investigations, and regulatory and criminal enforcement matters. With our knowledge of the industry, the regulatory environment, and current enforcement trends, we are well- positioned to help clients navigate the unique legal and business challenges they face in regulatory and criminal investigations and related civil litigation. Our team has significant experience helping clients manage cross-border risk at all stages, from commercializing products abroad to maintaining an established presence in markets around the globe. Our work in the cross-border context includes all aspects of compliance counseling, litigation and investigations related to the Foreign Corrupt Practices Act, the UK Bribery Act and various U.S. trade sanction regulations.
Capital Raising and Corporate Transactions
Our transactional attorneys are well-versed in the strategic considerations impacting the pharmaceutical, biotechnology and medical device sectors. We regularly represent both life sciences companies and their investors in an array of financing arrangements, including venture capital investments for early-stage companies, initial and secondary public offerings, private placements of debt and equity securities, and PIPE transactions. We also provide counsel in mergers and acquisitions, joint ventures, and strategic business collaborations, as well as licensing and distribution agreements and other general commercial transactions.
Addressing Our Clients’ Needs at Every Stage
In addition to sophisticated and industry-focused legal counsel related to product development and commercialization, many of our life sciences clients rely on us for representation in matters related to real estate, outsourcing, tax planning and structuring, and other issues critical to their operations. With a fully integrated life sciences industry team and the resources of a nationally prominent, multiservice law firm, we are able to anticipate and address our clients’ needs at every stage and are committed to adding value in every matter we handle. For more information about our interdisciplinary life sciences team, please contact Scott S. Liebman, Fran M. Stoller or Mark E. Waddell.