Life Sciences, Biotech, Medical Devices, Pharmaceuticals and Biologics
Duane Morris attorneys understand the issues faced by innovators in the life sciences, biotech, medical devices, pharmaceuticals and biologics industries: from the science and technology, to the business realities, to potential legal challenges. We know because we have been there. Many of our attorneys have been in-house counsel at health and life sciences companies and/or have worked as scientists in research laboratories. Our lawyers have decades of experience guiding clients from startups to publicly traded companies, as well as academic and research institutions, working in a broad range of technologies at all stages of the product life cycle, from discovery through clinical development and commercialization.
Duane Morris and its individual attorneys have received numerous accolades, including being named one of the top global legal advisors for biotechnology and pharmaceutical licensing transactions, being recognized as one of the most prominent Intellectual Property practices in the United States and winning statewide and international client service awards.
Corporate Startups and Financing Transactions
Duane Morris attorneys have been involved in the initial formation of some of the most successful companies in the life sciences industry and have assisted dozens of companies raise an aggregate of over $500 million in private transactions, including from angel investors, venture capital funds, corporate venture arms, and public offerings. Duane Morris welcomes representation of early-stage companies and frequently partners with them by extending substantial fee-deferral arrangements to foster innovation and support promising entrepreneurs. Duane Morris also works tirelessly to introduce our early-stage clients and entrepreneurs to prospective investors and strategic partners through our vast network of connections and a variety of programs and events.
Collaborations and Licensing
Our group has extensive experience in representing health and life sciences companies and academic institutions with critical partnering, licensing, joint venture and other collaboration transactions. For example, Duane Morris has been recognized as one of the top legal advisors worldwide in biotechnology and pharmaceutical licensing deals.
Mergers and Acquisitions
Duane Morris has represented health and life sciences industry companies in mergers and acquisitions and related aspects of M&A. Corporate attorneys throughout Duane Morris are experienced in developing and implementing creative strategies to help maximize value and position emerging and mid-market companies as advantageously as possible to meet their immediate needs and long-term business goals.
Patent Prosecution and Maintenance and IP Due Diligence
The Intellectual Property practice at Duane Morris is recognized as one of the most prominent IP practices in the United States by national publications including U.S. News & World Report. Duane Morris’ IP attorneys provide counsel on the most effective methods of establishing and developing IP holdings. Our attorneys understand that a thorough and accurate IP asset due diligence review is essential to help companies protect their IP rights and realize the most value from their assets. Duane Morris’ due diligence can help reduce risk and identify opportunities for our health and life sciences clients.
Regulatory and Compliance
We regularly represent our clients' interests before government agencies such as FDA, DEA, CMS and the FTC. Depending on where a client stands in its lifecycle, we counsel on regulatory strategies, assist with clinical study issues and advise on marketing submissions issues. For firms with marketed products, we help ensure compliance with the myriad of regulatory requirements impacting operations and marketing, including review of marketing materials (real and virtual) and responding to agency enforcement actions ranging from Warning Letters to criminal prosecutions. For all clients, we also engage in training and procedures development to enhance regulatory compliance and reduce the potential for adverse agency actions.
Health and life sciences clients draw on Duane Morris’ trial teams to defend them against patent infringement and products liability claims. Our lawyers provide clients with counsel experienced in patent infringement, products liability and toxic tort law, including the use of class actions in mass tort litigation, and problems arising from the acquisition of another company.
Clinical Trials, Manufacturing, Distribution and Other Life Sciences Agreements
Duane Morris attorneys have significant experience in drafting, negotiating and advising clients in connection with a variety of agreements and other documentation relating to U.S. and pre-clinical and sponsored research, global clinical trials, manufacturing activities, distribution arrangements and various other matters unique to the health and life sciences industry.
Trademarks, Copyrights, Trade Secrets and Unfair Competition
Duane Morris’ full-service Trademark, Copyright, Entertainment and Advertising practice has earned rankings and recognition from a number of publications, including Managing Intellectual Property and World Trademark Review. Our IP lawyers work with health and life sciences clients, filing and maintaining applications to register trademarks, current trademark registrations and copyrights each year in the U.S. and throughout the world. We also handle an array of disputes related to trademarks, copyrights, trade secrets and unfair competition claims.
International Trade, Customs and Taxation
Health and life sciences companies engaged in the import or export of goods face numerous regulatory issues and Duane Morris routinely assist clients regarding presentations to U.S. Customs relating to royalty and license agreements and dutiable value of goods; transfer pricing; tariff classification of products; country of origin issues; and interdiction of unauthorized shipments of products produced in non-FDA-certified foreign facilities.
For Additional Information
For additional information, please contact Dana J. Ash, Frederick R. Ball, Patrick C. Gallagher, Ph.D., Jonathan Lourie, Vicki G. Norton, Ph.D., Sandra G. Stoneman, or any of the group members referenced in the Attorney Listing.
Duane Morris attorneys understand the issues that innovators in the life sciences industry face from every angle: from the science and technology to the business realities and potential legal challenges. We know because we have been there. Many of our life science attorneys have been in-house counsel at life sciences companies and/or have worked as scientists in research laboratories. Our lawyers have decades of experience guiding life sciences clients from startups to publicly traded companies, as well as academic and research institutions, working in a broad range of technologies, including biologic drugs, pharmaceuticals, biotechnology, immuno-oncology, regenerative medicine, gene editing, precision medicine and diagnostics, medical devices and veterinary medicine at all stages of the product life cycle, from discovery through clinical development and commercialization.
The Duane Morris Life Sciences IP group and its individual attorneys have received numerous accolades, including being named one of the top global legal advisors for biotechnology and pharmaceutical licensing transactions, being recognized as one of the most prominent intellectual property practices in the United States, and winning statewide and international client service awards.
Patent Prosecution, Life Cycle Management and Strategic Counseling
The Intellectual Property practice at Duane Morris is recognized as one of the most prominent IP practices in the United States by national publications including U.S. News & World Report. Duane Morris’ IP attorneys provide counsel on the most effective methods of establishing and developing IP holdings. Our attorneys understand that a thorough and accurate IP asset due diligence review to align IP strategy with business goals is essential to help companies protect their IP rights, maximize their patent term and realize the most value from their assets.
IP Due Diligence
Duane Morris’ Life Science IP team has assisted clients with due diligence, from product design to product launch, from venture financings to at-the-marketing offerings, and in connection to mergers and acquisitions. Duane Morris' due diligence can help reduce risk and identify opportunities for our life sciences clients.
Duane Morris’ Life Science IP group has handled all aspects of litigation and PTAB proceedings involving cutting-edge gene editing, diagnostic and precision medicine technologies, and therapeutic technologies.