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Womble Carlyle is a full-service business law firm that provides a wide-ranging array of services that life science companies need in order to be successful. Our clients are varied and cover the continuum from university spin-offs and venture capital-backed start-ups to Fortune 100 multi-national corporations.
Our Life Sciences Industry Group, a multi-disciplinary team, focuses primarily on three industry segments — pharmaceutical and animal health; biotechnology; and medical devices. We have national and multi-national clients who have chosen us based on our industry knowledge, and business and legal acumen. While we have more than 50 lawyers in the Life Sciences Industry Group who focus on this area, of our firm’s 500 lawyers, 330 of them have done work for our life sciences clients – reflecting the breadth and depth of our firm’s life sciences experience.
A number of our lawyers are M.S. and Ph.D. level scientists whose research and industry backgrounds provide a very helpful perspective when working with life science companies. Our lawyers’ understanding of the scientific foundation of such businesses enables them to provide more effective analysis and advice. In addition, since much of life sciences relates to health care providers or patients, our health regulatory knowledge assists life science companies in successfully navigating the multiple layers of applicable regulations and reimbursement rules. Finally, our lawyers have been instrumental in fostering the growth of life sciences businesses in the Southeast and regularly participate in and support key life science organizations.
In organizing our Life Sciences Industry Group, we have been guided by the challenges our life science clients face in the highly regulated and competitive marketplace. In our experience with pharmaceutical, biotechnology and medical device companies, we have observed that all three segments have one thing in common: the never-ending challenge of creating successful, safe, cost-effective and regulatory compliant products that provide the critical revenue streams that are the lifeblood of all successful life science companies—revenue streams that once created must be maintained and defended.
The sections that follow summarize our core legal service groups. The summaries identify many of the specific legal services we provide to our life science clients on a regular, recurring basis. Additionally, each core group summary lists some representative matters/cases. Because our clients cover the entire continuum from early-stage companies to large, established life science organizations, we treat each client situation as special and unique. Part of doing that entails developing a customized client service and communication plan whose overall goal is to serve you, the client, in ways that work best for you and your organization.
The corporate lawyers on our life science team have extensive experience in evaluating, structuring and negotiating complex business transactions, including technology transfers from universities, medical centers and private industry; venture capital financings; strategic research, development and commercialization arrangements between large pharmaceutical companies, biotech companies and major research universities; out-licensing and in-licensing agreements; clinical trials agreements; private placement; initial and follow-on public offerings; corporate spin-offs; and mergers and acquisitions. In collaboration with our health regulatory team, we help life science companies structure relationships with health care providers and patients that comply with the peculiarities of antikickback laws, self-referral laws, patient privacy and protection laws and the evolving world of electronic health information technology. We have represented growing life science companies in securing some of the largest venture capital financings in the country from leading domestic and international investors. We have assisted our life science clients in growing and entering new business lines through corporate partnerships and strategic licensing arrangements.
Womble Carlyle is widely recognized for its active securities law practice. We have served as counsel to a variety of issuers and regional and national securities underwriting firms in connection with initial and other public offerings of securities. In addition, we have significant experience in advising public companies and their directors, officers and affiliates regarding corporate governance matters and their obligations under the federal securities laws.
Any result the lawyer or law firm may have achieved on behalf of clients in other matters does not necessarily indicate similar results can be obtained for other clients.
The life science experience of our intellectual property lawyers extends to all aspects of domestic and foreign intellectual property law. Our lawyers provide detailed patent investigations and analyses in all technical areas, including providing opinions on questions of patentability, infringement, permissive design around, state-of-the-art, and due diligence studies. Other services provided to our life science clients include procurement of U.S. and foreign patents in all technical areas; trademark and copyright registrations; enforcement of intellectual property rights including patent, trademark and copyright litigation; licensing; negotiation and arbitration. Reports and opinions are provided on the registrability of trademarks, logos and designs, including trade dress protection. Additionally, general counseling is provided to our clients regarding confidentiality agreements, government research funding, university-industry relations, license agreements, corporate sponsored research projects, development agreements, joint ventures, due diligence strategies, and technology transfer agreements.
Our life science patent lawyers bring decades of combined field experience as engineers and scientists to their life science legal work. Our lawyers are experienced in preparing and prosecuting patent applications relating to complex pharmaceutical compounds, nucleic acids, proteins, peptides, antibodies, transgene technology, transgenic animals and plants, nucleic acid expression systems, and gene therapy.
Our life science team also includes a group of experienced intellectual property litigation lawyers who regularly represent life sciences companies across all sectors of the industry in a wide range of complex and financially significant disputes, including those detailed below.
Our antitrust, health care and commercial regulation lawyers regularly counsel and represent our life science clients in a wide variety of matters involving antitrust and trade regulation at the state, federal, and international levels. Members of this group regularly counsel clients and litigate cases involving federal and state antitrust laws, unfair and deceptive trade practices, business torts, advertising laws and regulations, unfair competition laws and trade libel. Our antitrust lawyers include attorneys who focus on issues affecting the development and sale of many life science companies' products and services — issues relating to clinical trials, laboratory testing, product pricing, and restrictions on Medicare and Medicaid reimbursement. Our regulatory team includes health care attorneys who regularly counsel clients on anti-kickback (fraud and abuse); physician self-referral; HIPAA and patient privacy; joint ventures and consulting agreements with physicians; and false claims act allegations by third-party reimbursement agencies. We also assist clients in planning long-term strategies to manage regulatory impacts and in establishing appropriate compliance programs.
Our lawyers have extensive experience at the Federal Trade Commission, Department of Justice and U.S. Attorneys Offices and represent our clients before federal, state and international tribunals. They have experience in litigating antitrust and business tort cases in federal and state courts throughout the country. We have served as general antitrust and/or regulatory counsel for Fortune 500 companies. Our lawyers have particular experience in distribution, marketing and advertising issues including Internet and e-business components and work closely with our Intellectual Property attorneys to provide comprehensive business strategy counsel to our life science clients.
Womble Carlyle's mass torts practice concentrates on the defense of complex product liability litigation. Our involvement ranges from acting as local counsel in specific cases to serving as national and regional coordinating counsel for companies involved in hundreds or thousands of lawsuits across the country. We have litigated cases in 49 states and our lawyers have worked extensively with defense counsel teams of in-house, local, regional and/or national counsel in defending mass tort litigation.
Many of our lawyers have handled the defense of putative national, statewide or local class actions, as well as cases pending in various Multi-District Litigation (MDL) proceedings in the federal courts, and analogous proceedings in state courts. Our lawyers are also experienced in defending our clients in arbitrations or mediations, which are becoming ever more common nationwide.
We have considerable experience and depth in defending various pharmaceutical product liability and related claims for our clients, including cases involving diet drugs, antidepressants, cholesterol-lowering drugs, migraine medication, analgesics and vaccines. One of our lawyers was recently named to the national trial team for product claims involving a cholesterol-lowering drug. We have defended pharma-ceutical product liability lawsuits both in the jurisdictions where we maintain offices and also in jurisdictions where we do not. Our experience includes active defense work, as well as work on global settlements.
We also have extensive experience in the relatively new and growing area of clinical trial litigation. Our lawyers successfully defended sponsors of clinical trials in several high profile actions filed in Georgia and North Carolina challenging the design (use of placebos and exclusionary criteria) and conduct of the trials. This particular experience not only makes us qualified to defend lawsuits arising directly out of clinical trials, but also enables our lawyers to bring additional experience to the defense of pharmaceutical and medical device claims where the conduct and the results of clinical trials may become significant factors. Womble Carlyle has significant experience in the area of medical device liability litigation, including areas of practice such as defibrillators/pacemakers, breast implants, pedicle screws and latex gloves.
We have been tasked by pharmaceutical and other clients to take a primary role in locating and developing medical experts for use in connection with product liability claims around the nation. Several of our lawyers focus on the process of finding and developing experts critical to the defense of product liability lawsuits, especially those involving complex medical causation issues. Also, we provide litigation support services in various ways that assist the defense of product liability claims, including: review and analysis of medical records, trial consulting, and document review and management. These services are often critical to the defense of life science claims. A noteworthy service is the firm’s Case Management Facility, a proprietary service that provides automated case management and reporting for mass tort litigation, enabling our clients’ national law firms, local counsel and in-house attorneys to perform efficiently as a virtual law firm.