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Life Sciences and Biotechnology
Businesses in the life sciences industry traverse new frontiers daily. Whether pioneering lifesaving developments or exploring novel technology-sharing agreements, industry participants need legal counsel experienced in protecting and leveraging their assets, especially when there are few precedents to follow. Each day, lawyers in Duane Morris' Life Sciences and Biotechnology Group work with legal issues at the crossroads of science and business.
The clients we represent are as diverse as the products they discover, develop and commercialize. Life sciences entities in all stages of development, from start-ups seeking an initial capital investment to multinational, publicly traded companies, including pharmaceutical companies, biotechnology companies, medical device manufacturers, academic research institutions, university technology transfer offices and clinical laboratories, turn to Duane Morris as their legal counsel. Similarly, we represent our clients at all stages of their products' lives, from discovery through development, clinical testing, marketing and sales. Our clients' underlying science platforms encompass a broad range of technologies, including monoclonal antibody-based diagnostic and therapeutic applications, in vivo diagnostic imaging applications, proteins, genomics, drug delivery, combinatorial chemistry and bioinformatics.
Our Life Sciences and Biotechnology Group includes lawyers from several of our firm's practice groups to offer clients a full panoply of legal services–including intellectual property counsel, securities counsel in connection with private and public equity funding, international trade and tax advice, labor and employment guidance, dispute resolution and litigation services–provided within the framework of their business to address each client's specific needs.
With each client, we emphasize the need to understand the client's science so we are better positioned to advise on how to achieve the client's goals. Our lawyers know what questions to ask to guide each client to focus on its goals. Clients value the fact that we deliver our answers in their language, not "legalese." We make every effort to distill our advice to highlight the ramifications of each course of action.
Our life sciences clients have access to a team of life sciences lawyers with a combination of industry experience that includes lawyers who:
- Served as general counsel for a leading, publicly traded biotechnology company that, during his tenure, entered into its first strategic alliance, generating $100 million of research and development funding for the company.
- Are licensed as registered pharmacists.
- Previously worked in genetics laboratories.
- Achieved advanced degrees in biology, biochemistry and molecular and developmental genetics.
- Advised on several strategic alliances resulting in millions of dollars of research and development funding.
This in-depth, hands-on experience means that Duane Morris' life sciences clients can receive legal counsel from lawyers who have devoted years to learning and understanding the industry in which the clients operate their businesses.
Corporate: Business Growth and Operations
Nowhere does Duane Morris' extensive life sciences experience become more obvious than in our counsel to clients on the formation and growth of their business and operations. We have guided clients from the protection of initial discoveries all the way through million-dollar strategic alliances. Our services include:
- Acquisitions, strategic alliances and collaborations
- Assistance with raising and documenting private and public capital, including angel financings, venture capital financings and public offerings
- License agreements for proprietary biological materials, know-how and patent rights
- Product research and development agreements
- Clinical trial agreements
- Manufacturing and supply agreements
- Marketing and distribution agreements
- Research and consulting agreements
- Technology transfer agreements
Beyond seeking assistance with initial research and development relationships, clients turn to the firm for its counsel on leveraging their technology, whether through raising capital, gaining access to manufacturing capabilities, marketing and distribution channels or establishing single or multiproduct strategic alliance relationships.
Our life sciences lawyers have successfully represented clients in the negotiation of agreements with Eli Lilly and Company, The Wellcome Foundation, Burroughs Wellcome, Genentech, Inc., Warner Lambert, Abbott Laboratories, SmithKline, Johnson & Johnson, F. Hoffman-La Roche and Bayer Corporation.
From the outset, protection of discoveries and inventions, and the related intellectual property rights, is of paramount importance to the client's overall success. Duane Morris' Life Sciences Group regularly advises clients on the patent, copyright and trade secret protection of their materials and intellectual property, including preparing agreements for employees and consultants to maintain the confidentiality of the client's proprietary technology and to assign inventions to the client; reviewing third party patent portfolios in connection with licensing arrangements; providing clearance opinions; rendering patentability, validity and infringement opinions; and preparing patent applications. Our intellectual property lawyers with biology, chemistry and biochemistry degrees and relevant industry experience work closely with clients to establish strategies and contractual arrangements to capitalize on and protect their developments. Our lawyers also assist clients to establish company-wide intellectual property enforcement programs and guidelines, and training to avoid infringement.
Clients rely on the firm to defend their intellectual property not only through patent and trademark prosecution, but also through infringement litigation and patent interference proceedings. During the past several years, the firm has represented three of the world's largest biotechnology companies in significant patent litigation. The firm advised Amgen in its patent infringement litigation against Transkaryotic Therapies (TKT) in a case before the Court of Appeals for the Federal Circuit. The firm also represented Genentech in a number of patent infringement cases concerning two of its most important products, tissue plasminogen activator (known as t-PA, used to treat heart attack patients) and human growth hormone.
In each case, in consultation with the client, our lawyers first establish a litigation strategy and outline the plan to pursue the strategy. While the objective is often dispute prevention, we work with clients to determine when they should utilize proactive strategies – litigation, arbitration or mediation – and advise them on the risks and likelihood of success with each course of action.
Products Liability Litigation
Life sciences clients–ranging from international pharmaceutical companies to manufacturers of medical and orthopedic devices–are able to draw on Duane Morris' trial teams to defend them against products liability claims in both federal and state courts. The firm has served as counsel to an international pharmaceutical company in the defense of all of its HIV/hemophilia product liability litigation in the state of New Jersey. Our lawyers provide clients with counsel experienced in products liability and toxic tort law, including advice regarding the imposition of "market share liability," the use of class actions in mass tort litigation, liability for products sent to licensed waste disposal facilities and problems arising from the acquisition of another company. We also regularly represent clients with regard to a broad spectrum of injuries alleged to have been caused by their products.
In numerous cases, Duane Morris' experience has enabled it to guide its clients to the negotiation of satisfactory settlements, avoiding extensive additional discovery and trial expenses and risk. The firm's trial lawyers have served as outside counsel to the attorneys general of Pennsylvania and New Jersey in separate products liability litigation.
Regulatory and Compliance Services
Companies in the life sciences industry must conform their business practices to a wide array of legislation and regulations promulgated by federal, state and local legislative bodies and government agencies. We regularly represent our clients' interests before government agencies. We also assist in drafting and implementing training programs, personnel policies and handbooks with the goal of achieving legal compliance and avoiding litigation. We regularly advise clients on environmental law matters. For example, we have represented a leading pharmaceutical company during an EPA criminal investigation regarding violations of the Clean Air Act. We have also represented clients with respect to FDA and FTC compliance on issues regarding the storage, handling and record keeping for prescription pharmaceuticals, orphan drugs and advertising and label requirements.
International Trade and Customs
Life sciences companies engaged in the import or export of goods face numerous regulatory issues that can have a significant impact on their bottom lines. Our goal is to help each client's product make it through a country's gateway and, once inside, pass regulatory muster.
We 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. We also advise and guide clients on the customs implications of joint research and development agreements and the implications of shelf-life testing agreements on customs duty valuation of products.
One of our primary tools is a custom compliance program created for each client to manage their international trade activities and mitigate potential problems. For example, the firm recently designed and implemented a compliance program for a $3.2 billion Asian company that resulted in a 98 percent mitigation of fines and penalties in a pending trade investigation. We routinely undertake full audits for clients to assess the extent of their exposure to tariffs and other duties and proactively reduce them.
Life sciences companies transacting cross-border business find themselves subjected to a wide array of tax regimes. They require the counsel of tax lawyers who not only understand their business objectives, but who also can create a comprehensive plan that coordinates the tax requirements of every jurisdiction where they operate for the purpose of reducing the company's worldwide effective tax rate. Our tax lawyers make efficient and effective use of tax treaties, tax havens and low-tax jurisdictions to favorably impact each client's tax exposure. We strategically utilize transfer pricing and related party transactions, as well as employ holding companies, to pursue each client's objectives. We also guide clients on the avoidance of anti-deferral tax rules, such as the controlled foreign corporation and passive foreign investment company regimes.
As a full service law firm with offices in major U.S. markets, as well as in London, Duane Morris offers life sciences clients a complete range of legal services, including, in addition to those detailed above, counsel on corporate governance matters; mergers and acquisitions; employment matters, including employee and executive benefits; federal, state and local tax issues; immigration matters and real estate matters. Through the coordination of the Life Sciences Group, clients tap into the extensive resources across the firm's practices and offices.