Life Sciences Industry Group

• Pharmaceutical/Animal Health
• Biotechnology
• Medical Devices

Our Firm | Our Approach | Corporate and Securities | Intellectual Property | Antitrust and Regulatory | Product Liability Litigation | Representative Clients

Our Firm
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.

Our Approach
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 Life Cycle Model depicted here is a graphic representation of the basic process that most life science companies are continually attempting to manage.

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.

Our Capabilities and Experience

Corporate and Securities
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.

Representative Matters:

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.

• Represented a biopharmaceutical company developing drugs to treat central nervous system disorders in a partial spin-off from its parent company, in closing of its initial venture capital financing and in multiple closings involving the sale of its Series C Preferred Stock to leading life science investors. Also served as counsel in structuring collaborative research and development agreements with other pharmaceutical companies and in its initial public offering.
• Regularly serve as counsel to a leading academic research medical center in the negotiation and preparation of license agreements and sponsored research agreements and in the creation of new start-up businesses formed to commercialize technologies invented at the academic research medical center.
• Represented a company engaged in developing antibodies to treat cancer and autoimmune disorders in its Series A financing and in general corporate, corporate finance and intellectual property matters.
• Represented a major international pharmaceutical corporation in the sale of a pharmaceutical manufacturing facility with related supply agreement for products with an aggregate supply price of more than $500 million. Also completed related technology transfer issues.
• Represented a pharmaceutical distributing company in four separate acquisitions of proprietary pharmaceutical delivery technologies.
• Served as counsel to three early and late stage life science venture capital funds in fund formation and portfolio investment activities.
• Regularly serve as counsel to an international biotechnology company and its affiliates in the negotiation and preparation of license agreements and distribution agreements.
• Represented numerous start-up life science companies formed to commercialize technologies developed at leading research universities from around the country.

Intellectual Property
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.

Representative Matters:

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.

• Successfully represented a biotech company in patent litigation involving a method of use of test kits for in vitro manually formatted immunodiagnostic assays.
• Successfully represented a patent holder in a dispute involving the chemical oxidation of drug metabolites.
• Successfully represented a pharmaceutical company in litigation against a university research center involving ownership of triptorelin and somatostatin patents.
• Successfully represented a plaintiff company in a dispute in which our client claimed the defendants misappropriated the rights to a genetic construct that rendered corn immune to herbicide. The claims were tried over three years to three separate juries. The juries negated the defendants’ license and awarded our client more than $60 million in damages.
• Successfully represented the same plaintiff in the second of the trilogy of cases described above. Our client sought damages for patent infringement, while defendants sought a determination of patent invalidity due to alleged inequitable conduct. The jury found in our client’s favor on all counts, and a pre-determined royalty was paid.
• Successfully represented the same company in the third trial which resolved our client’s request that its scientists be added to defendants’ patents on a particular chemical product. An advisory jury answered all issues in the plaintiff’s favor.
• Currently representing an agriscience company in patent litigation regarding alleged infringement of the company’s patents on genetic constructs.
• Currently representing a pharmaceutical company in patent litigation against a competitor regarding semi-automation of screening and review of cervical slides.
• Currently representing a major international pharmaceutical corporation in patent litigation.

Antitrust and Regulatory
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.

Representative Matters:

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.

• Successfully represented a pharmaceutical company in a state court conspiracy and antitrust class action concerning drug pricing.
• Successfully represented a pharmaceutical corporation and its predecessors in various matters concerning disputes with joint ventures, managed care companies, business line acquirers, vendors and others regarding claims of fraud, unfair trade practices, breach of contract and violation of trade secret protections.
• Successfully represented two life science companies in litigation concerning termination of senior executives.
• Successfully represented a major pharmaceutical company in pursuing claims of theft of trade secrets, licensing violations, and contract enforcement.
• Successfully represented a pharmaceutical company in securities fraud cases.
• Represented a healthcare products company in defending claims of alleged monopoly action, as well as claims for fraud, breach of contract, trade dress infringement, and other claims. Directed verdict granted to defendant.
• Represented an agribusiness company in an alleged nationwide class action in which plaintiffs alleged claims of price-fixing. Defendants successfully defeated class certification, a determination that was affirmed by the panel and en banc by the U.S. Court of Appeals.

Product Liability Litigation
Womble Carlyle's product liability 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." 

Representative Matters:

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.

• Successfully represented a major pharmaceutical company in the defense of more than 1,000 diet drug lawsuits. Obtained more than 250 dismissals or settlements prior to national settlement of the cases.
• Currently handling a significant number of “phen-fen” cases during the intermediate- and back-end opt-outs phase, serving as local counsel for North Carolina cases, while assisting local counsel in other states that include Georgia, Minnesota, Mississippi, New Jersey, New York and Pennsylvania. Representation has included document production, discovery depositions, expert witness retention and preparation, and trial preparation.
• Successfully represented both drug manufacturers and drug retailers in defense of various PPA (cold remedy) lawsuits.
• Successfully represented a pharmaceutical company in defending a personal injuries claim alleged as a result of a clinical trial for a psoriasis drug. The case was brought by a national plaintiffs’ counsel firm, and it challenged the safety, scope and ethics of the clinical trial, and sought to establish a fiduciary duty between the sponsor and the participants. We obtained dismissal of fiduciary duty claims (reported nationally as leading case on the issue).
• Successfully represented a large pharmaceutical company in more than 60 personal injury cases involving thimerosol (compound used in vaccines) including putative national class action, cerivastatin (cholesterol), paroxetine (anti-depressant), sumatriptan (migraine), and PPA (cold remedies).
• Successfully represented a major pharmaceutical company in FDA regulatory and state and federal criminal investigations of clinical trials and assisted with media appearances by company executives on national TV (CBS’ 48 Hours).
• Successfully represented a pharmaceutical company in several lawsuits in state and federal court arising from nationally-publicized clinical trials investigations and prosecutions. Individual cases included claims for more than $100 million each and class action cases included claims for $1.5 billion against the sponsor, clinical research organization (CRO), institution and principal investigators. Lawsuits included claims for civil RICO, fraud, conspiracy, battery, unjust enrichment and wholesale challenges to human experimentation in clinical trials, and studies involved included investigational drugs for the treatment of alzheimers and schizophrenia.
• Member of a national trial team in cerivastatin litigation.

Representative Life Science Clients
Banner Pharmacaps
Bayer CropScience
CryoLife, Inc.
Duke University Health System
Eisai Inc.
GlaxoSmithKline
Innogenetics NV
Medtronic, Inc.
Merck & Co., Inc.
Novartis Pharmaceuticals Corporation
POZEN Inc.
Reddy US Therapeutics, Inc.
RTI International
Solvay Pharmaceuticals, Inc.
Syngenta Biotechnology Inc.
Syngenta Crop Protection, LLC
Talecris Bioptherapeutics
Targacept, Inc.
TransTech Pharma, Inc.
TriPath Imaging, Inc.
Wake Forest University Health Sciences