Companies in the life sciences arena face unique challenges: complex domestic and foreign regulations, volatile capital and commercial market trends, and paradigm-shattering scientific advances. Many emerging life sciences clients tend to be growth- and risk-oriented, often with tight cash positions. They require lawyers who are responsive, committed, and focused, as well as value- and solutions-driven. K&L Gates’ life sciences lawyers have a keen sensitivity to these issues. The strength and breadth of the group — across legal practice areas, geographical regions, and life sciences industries — continually expose the lawyers to new information, while the group’s shared commitment enables rapid information dissemination.
K&L Gates’ Life Sciences team is an international network of more than 115 lawyers experienced in solving the complex legal and regulatory issues facing pharmaceutical, biotechnology, health care, and medical device companies around the world. Our team practices in areas as diverse as intellectual property, corporate and securities, regulatory compliance, litigation, employment and executive compensation, environmental, real estate, and tax law. Our life sciences lawyers possess an impressive complement of pharmaceutical, diagnostic, and medical device-related business experience and a deep technical background in molecular and cell biology. The Life Sciences practice represents a variety of clients, from private equity and venture capital funds, to angel investors, biotechnology start-ups, medical device companies, and academic and research institutions. Our capabilities span the entire spectrum of legal needs of life sciences companies, allowing us to provide integrated advice that result in efficiencies of both cost and precious management time. Our core teams include strategic alliances, licensing, and intellectual property; corporate and transactional; FDA and other regulatory issues; litigation and insurance coverage; and privacy, information management, and data protection.
We understand the need for a close working relationship with our clients' management and scientific teams at all stages of research, development, and marketing of their products and services. Many of our patent lawyers have worked in clinical and research laboratories, hospitals, or in life sciences companies and have an appreciation of the business dynamics that must be considered when developing workable solutions to complex legal issues.
Trademarks and CopyrightsK&L Gates also has a sophisticated trademarks and copyrights practice to assist our life sciences clients in establishing and protecting their brands in the marketplace. K&L Gates advises clients in many aspects of trademark practice, from clearance, registration, and transactions to enforcement, on a worldwide basis. Our trademark lawyers have experience in the protection and registration of thousands of trademarks, service marks, and certification marks worldwide. The firm manages the worldwide trademark portfolio for a number of the world's largest pharmaceutical companies, monitoring and overseeing the protection and enforcement internationally of those clients' trademark rights.
For life sciences companies at the formative stage, the raising of capital is of primary concern. We are often called upon to help identify sources of capital and to structure appropriate financing arrangements. We have extensive experience in representing emerging and developing enterprises that require equity investments to grow their businesses. We help negotiate, structure, and document venture capital and "angel" investments with the goal of achieving a marriage of the interests of the life sciences business, its management, and its investors. We also have broad experience in advising on the formation of venture capital funds specializing in life sciences portfolio companies. We maintain a proprietary database of financing leads in the venture capital community to help our clients identify potential sources of capital. As the enterprise grows, we help guide our clients through additional financings, initial public offerings, and mergers and acquisitions.
Mergers and AcquisitionsMany life sciences companies grow through mergers and acquisitions. K&L Gates represents both publicly traded and privately held life sciences companies in a wide variety of M&A transactions, including stock and asset acquisitions, traditional mergers, tender offers, leveraged buyouts, spin-offs, spinouts, and recapitalizations. Such transactions often require a careful analysis of tax, securities, intellectual property, and employment issues. We pride ourselves in providing the depth and breadth of experience and knowledge necessary to help achieve our clients' goals.
SecuritiesWe often assist our life sciences clients in raising private capital and in accessing the public markets. We have an excellent understanding of market practices and extensive experience in advising life sciences companies through the public offering process, including preparation of admission documents, registration statements and prospectuses, negotiation of underwriting and placement terms, and preparation of listing applications with respect to exchanges in the United States and in key international financial centers. We have more clients listed on AIM, the growth market of the London Stock Exchange, than any other U.S. law firm. The firm has advised on more than 30 AIM IPOs since 2004, including the largest life sciences AIM listing to date. K&L Gates' lawyers have also assisted the London Stock Exchange in the establishment of new rules and guidance relating to the new AIM Regulation S electronic trading mechanism (SIS).
Our lawyers regularly advise our publicly traded life sciences clients on continuing disclosure and compliance issues under securities laws. For example, our public company clients call upon us for advice as to insider trading, selective disclosure, option and other equity-based compensation plans, spin-offs, public-to-private transactions, poison pill and other anti-takeover devices, tender offers, proxy contests, and corporate restructurings. Our Securities Enforcement practice is a resource our clients value if compliance is ever called into question.
Strategic Alliances and LicensingLife sciences companies increasingly require global experience in negotiating the complex licensing and collaboration agreements common to bring therapeutics, diagnostics, and devices from the laboratory to the market. We have structured some of the largest and most sophisticated drug development deals in the world. We negotiate technology transfers, research and development licenses, joint ventures, and marketing, supply, and distribution deals for clients of all sizes in every industry in the life sciences sector. We have particular experience in alternative financing arrangements for drug development projects, including securitization of future royalty interests. We bring an abundance of experience to these endeavors, as well as to counseling on the operational and financial challenges both big and small companies face on the long road to product approval. In the post-approval phase we negotiate co-promotion and co-distribution partnerships, and with our regulatory team, we counsel on marketing strategies across the globe.
Clinical TrialsOne of the fastest growth areas in the life sciences industry is providing clinical trial and regulatory support to drug, diagnostic, and medical device companies, be they large pharmaceutical companies or emerging start-ups. The firm has much experience in representing Contract Research Organizations (CROs), university hospitals, site management organizations, and other service providers in this rapidly evolving field. Examples of our work include advising on clinical research, investigator, and contract manufacturing agreements; helping to prepare new drug applications; assisting in labeling and advertising questions; reviewing and formulating compliance plans; managing global data transfers; and counseling on strategic combinations and financings.
With the regulatory group, we develop strategies for advancing drug applications and resolving regulatory challenges. Because clinical trials are increasingly multi-country, our world-wide network of practitioners can aid large and small companies alike in obtaining services for distant trial sites.
Health CareOur Health Care practice is as diverse as our clients' needs. We represent public and independent universities, medical centers, and other scientific entities on matters ranging from funding and the commercialization of research in the life sciences to physician recruitment and credentialing, fraud and abuse, and Medicare/Medicaid coverage. In addition to a substantial transactional and corporate practice, in the United States, we advise life sciences clients in interpreting and complying with legislative and regulatory developments on the federal and state level, often appearing before Centers for Medicare and Medicaid Services (CMS - formerly HCFA) and other administrative entities that administer these requirements. Our health care clients include health care systems; tertiary, community, and specialty hospitals; managed care organizations; pharmacies and pharmacists; freestanding diagnostic and treatment facilities; private physician groups; behavioral health providers; nursing and assisted living facilities; and a variety of other ventures and entities in the health care industry.
TaxThe firm's tax lawyers advise life sciences clients in virtually every area of tax law likely to be encountered in their pursuit of business and financial objectives. Our multidisciplinary approach to tax practice helps our clients achieve their objectives and structure their activities in a manner that will maximize their overall tax benefits in the most efficient and cost-effective way possible. Among our life sciences clients, tax-exempt academic, health care, and research institutions rely heavily upon our advice in order to remain compliant with tax laws while exploring technology transfer and commercialization opportunities.
Technology Transfer — Academic and Research InstitutionsK&L Gates represents technology companies who sponsor research at or acquire technology from major universities, research institutions, and national laboratories with large intellectual property portfolios. K&L Gates also represents major universities and research institutions in connection with:
Real EstateThe availability of real estate suitable to biotechnology, pharmaceutical, or health care enterprises and the zoning and other regulatory issues affecting occupancy and use of such real estate are crucial business considerations. Our life sciences clients call upon us to help solve the entire spectrum of their real estate-based legal needs, from ground-up development and construction, to leasing and acquisitions, to asset-based financing, to tax advice and entity structuring. The knowledge of real estate issues we bring to life sciences clients is enhanced by the breadth of the rest of our real estate client base, which includes national, regional, and international commercial developers’ and retailers’ financial institutions; institutional and private investors; assisted living and other retirement facilities; mortgage banking/consumer finance companies; health care concerns; real estate brokers and property managers; railroad and other transportation companies; developers of natural gas, oil, and mineral properties; public utilities and other energy suppliers; governmental agencies; and other property owners ranging in size from sole proprietors to large multi-national companies.
Intellectual Property Litigation The primary assets of a life sciences company are its intellectual property. Our more than 175 lawyer-strong team of IP litigators is skilled in understanding our life sciences clients' particular IP and business needs, translating science into the language of courts and juries, and resolving cases through litigation, settlement, and trial. The experience gained in defending more than 175 class action lawsuits enables our lawyers to obtain or respond quickly to claims for preliminary injunctions, to try complex cases and handle appeals, and to resolve disputes in ADR proceedings worldwide.
Our IP litigators take full advantage of the broad range of substantive technical knowledge and automated litigation support systems within the firm, including their own technology and industry experience, our deep bench of Ph.D.s and industry-experienced lawyers, and our cutting edge e-DAT electronic evidence and discovery group.
Product Liability Litigation Our lawyers have defended a variety of product liability cases at trial and appellate levels in state and federal courts across the United States for pharmaceutical companies, medical device manufacturers, and diagnostic laboratories and have had significant success in obtaining dismissals or summary judgments for our clients before trial. Our lawyers have been involved in a number of high-profile cases in this area of litigation, and we are accustomed in such situations to acting as a media liaison for our clients.
In addition to defending individual cases, K&L Gates has coordinated the nationwide defense of certain of our life sciences clients--who include some of the largest pharmaceutical companies in the world--in class action suits involving product liability allegations: developing medical defenses, coordinating discovery responses, and supervising local counsel. In this area, the firm’s significant litigation resources are enhanced by its network of offices across the United States and the United Kingdom.
Insurance Coverage K&L Gates is also recognized for its insurance coverage practice. We have assisted life science clients in obtaining insurance coverage under their policies in cases where insurers have initially denied coverage or where there is a reservation of rights.
Other Litigation We have teams of lawyers who routinely represent life sciences clients in the litigation of other issues requiring specific, focused experience: protection of intellectual property rights against infringement; resolution of employment and labor disputes; defense against environmental claims; federal and state securities law compliance matters; and general business litigation, to name a few.
Expert Witnesses—Daubert Challenges We are experienced in all aspects of the involvement of expert witnesses in cases involving our life sciences clients, from maintaining contacts with a broad range of experts to handling Daubert challenges against the admissibility of expert testimony in state and federal courts.
Alternative Dispute Resolution; Settlements Where litigation is not the most desirable vehicle for settling a dispute, or where there is a contractual obligation to seek arbitration or mediation, we are practiced in the use of alternative dispute resolution forums. Where a good settlement is in our life sciences client’s best interest, our lawyers draw on experience in negotiating settlements, including joint tortfeasor releases and structured settlements.
Regulatory The life sciences sector is one of the most highly regulated industries in the world, and these regulations pervade all aspects of the development and marketing of life sciences products. K&L Gates has years of regulatory experience, particularly in the areas of food and drug, health, and environmental law. We also have experience in the crosscutting areas regulated by the United States Department of Agriculture (USDA) (food and agriculture products); the Drug Enforcement Administration (DEA) (controlled substances); the Bureau of Alcohol, Tobacco, and Firearms (ATF) (wine, beer, and spirits); the Consumer Product Safety Commission (CPSC) (product safety); the U.S. Department of Health and Human Services (HHS) (Medicare, Medicaid, and HIPAA privacy); the National Institutes of Health (NIH) (guidelines for research involving recombinant DNA and cooperative research agreements); the Federal Trade Commission (FTC) (advertising and antitrust); the Department of Transportation (DOT) (interstate transport); and the U.S. Customs Service (import/export), as well as a variety of state, local, and international authorities.
Because of the depth and breadth of our regulatory practice, K&L Gates is well positioned to help life sciences clients navigate the overlapping, and sometimes conflicting, regulatory requirements confronting them. Rather than focusing on isolated legal questions, we bring our knowledge of related regulatory agencies to bear as we develop regulatory strategies and focus on the single goal of helping clients achieve their business objectives. This interdisciplinary approach is further enhanced by the experience that many of our lawyers have in pharmacy, physics, engineering, biology, and nursing, as well as professional experience in government, trade, and legal associations, and in corporate legal, quality, and regulatory positions.
Food & Drug Our Food & Drug practice advises life sciences clients on all regulatory issues related to research, development, testing, approval, marketing, and post-marketing of pharmaceuticals, medical devices, foods, dietary supplements, biologics, veterinary products, and other FDA-regulated products. Whether it is advice on effective strategies to obtain approval to market a new product, assistance in determining which regulatory pathway to follow, assessing regulatory and business risks associated with a particular strategy, preparing submissions to the FDA, advising on due diligence matters, or responding to an enforcement matter, we have experienced lawyers who can provide sound, pragmatic advice. We also represent a substantial number of companies on the requirements governing food products developed from biotechnology, biotechnology-derived human and animal drugs/biologics, and diagnostic medical device products. Our clients are large and small, U.S. and foreign, emerging and mature.
Environmental and Natural Resources Our Environment and Natural Resources practice is comprehensive and international in scope, with lawyers located across the firm’s offices who are dedicated to developing creative and cost-effective solutions to environmental challenges confronting our life sciences clients. We help clients prepare environmental assessments, interpret EPA requirements for microbial products of biotechnology and plant-incorporated pesticides, respond to case-specific regulatory challenges, and keep manufacturing facilities in compliance with clean air, clean water, waste disposal, toxic substance, and other state and federal environmental laws. Our lawyers have also been active in helping clients frame and implement company-wide training programs, auditing procedures, corrective action plans, and environmental management systems and in assisting with the environmental aspects of due diligence investigations for purchasers, sellers, and investors.
Privacy, Information Management, and Data Protection Our Privacy, Information Management, and Data Protection practice is at the forefront of this dynamic and rapidly changing area of the law. We help our clients to ensure the integrity, reliability, legitimacy, and security of their information assets. Life sciences clients have a particularly difficult burden due to the patchwork of national and international laws governing storage, protection, and disclosure of individual patient health data. Along with traditional privacy issues, we help clients in the United States evaluate their responsibility under HIPAA, analyze HIPAA preemption and the continuing application of state confidentiality laws, and develop privacy compliance programs for clinical investigators and sponsors of clinical investigations, health care plans, and health care providers. In the U.K., we advise on data protection compliance strategies, audits, and all aspects of ensuring legitimate data processing. Throughout our European offices, we advise on country-specific data regimes as well as general applicability of the European Data Directive, forming data protection compliance and audit strategies, and counseling on legitimate data processing and transfer.
Other Regulatory Compliance Issues Our interdisciplinary Life Sciences group recognizes that regulatory concerns extend beyond the research, testing, and approval of a product. Once a product enters the marketplace, compliance and enforcement issues remain paramount. Our lawyers are ready to assist clients to develop cost-effective strategies for addressing the interplay of domestic and international laws, the Lanham Act, and the developing law on Internet advertising and electronic commerce. We are also experienced in negotiating with administrative agencies to resolve disputes, and, when resolution is not possible administratively, will represent clients in litigation and before administrative and regulatory agencies and governments.