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Health Care & Life Sciences
Pillsbury's Health Care & Life Sciences practice is nationally ranked by 2009 Chambers USA, a leading independent guide that interviews clients to compile its rankings.
Clients from all major sectors of the health care industry rely on Pillsbury’s Health Care & Life Sciences team for legal advice and strategic counsel. Our lawyers are as diverse as the industry itself, combining backgrounds in medical science with public service at federal regulatory agencies. The team is distinguished by its depth in the array of legal disciplines touching the health care industry—from intellectual property to tax; corporate governance to labor law; and government relations to litigation.
Pillsbury’s life sciences team is comprised of lawyers and senior advisors with years of experience and industry-specific credentials in health care-related fields like biopharmaceuticals and bioinformatics, and areas like agriculture and biotechnology techniques and tools. Our lawyers have PhDs and other advanced degrees in cellular biology, biochemistry, molecular biology, chemical engineering and physics, and include former judicial law clerks from the Court of Appeals for the Federal Circuit and examiners from the U.S. Patent and Trademark Office.
The firm’s experience spans the range of the life sciences, including pharmacogenomics, bioinformatics (such as data analysis, storage, display, and interactive platforms), stem cell technologies, transgenic animals, gene therapy, diagnostics, receptor-ligand interactions, immunomodulators, and genetically modified foods. Our combined technical, business, and legal skills enable us to promote the strategic intellectual property objectives of our clients.
Pillsbury helps our clients capitalize on their intellectual property assets by preparing and prosecuting patent applications worldwide, evaluating the external patent landscape and competitors’ IP positions, identifying appropriate partners for specific technology development, conducting complex patent invalidity, infringement, due diligence and freedom-to-operate studies and analyses, and representing our clients’ interests in District Court, International Trade Commission and U.S. Patent and Trademark Office actions and proceedings.
Our life sciences team assists promising startups, publicly held multinational corporations, research institutions, and government agencies, to protect and leverage intellectual property; raise capital; structure mergers, acquisitions, strategic alliances, joint ventures and spin-offs; navigate legislative and regulatory issues; and develop, lease and acquire R&D and laboratory facilities. We also help our clients enter the capital markets and consult on corporate governance and SEC compliance issues facing public companies.
Our life sciences litigators follow the complex issues facing this industry today, and have extensive experience in courts and in arbitrations, protecting clients’ rights in disputes regarding activities and demands of competitors, licensors and licensees, collaborators, inventors, shareholders, consumer classes and regulatory organizations.
Just as our life sciences-focused lawyers help clients with cutting-edge issues of science and intellectual property, the health care-focused side of the team keeps clients abreast of legislative, regulatory, enforcement, and market developments to provide up-to-the-minute advice as well as long-term strategic counsel. We are also thoroughly familiar with the fundamental business concepts that affect all aspects of health care organizations – from leasing and employment to technology and environmental issues – which informs our advice to clients on how to take advantage of the right opportunities to improve the quality of care while keeping costs down.
Our attorneys advise health care entities (including managed care companies, hospitals, medical groups, bio-technology companies, insurance companies, pharmacy benefit managers, vision centers, ambulatory centers and other facilities) on legal issues specific to the health care industry. We also provide counsel on all aspects of health law ranging from fraud and abuse and corporate practice of medicine to government regulation. We offer guidance to insurance carriers and employers on health benefit plans, and we work closely with our Employment & Labor and ERISA groups on employer’s health plan managed care issues.
In addition, our attorneys routinely advise on the laws relating to tax-exempt institutions. We also advise clients on management and expenditure of endowment and restricted funds, and government investigations into such funds.
Pillsbury is committed to working with developing companies involved in health care delivery through products such as medical devices or computer software, as well as companies involved with diagnostic and therapeutic medical technology and biotechnology. We have participated in public offerings of numerous major health care companies, representing both issuers and underwriters.
In regards to health care litigation, our attorneys provide clients with representation in administrative proceedings and in federal, state and bankruptcy courts. We also provide experienced counsel in alternative dispute resolution options, such as mediation and arbitration.
Other representative areas in which we serve clients include:
Pillsbury uses its substantial experience and well-developed government and private sector contacts to closely monitor legislative, regulatory and market trends that shape the health care industry, alerting clients to developments that affect their businesses and mission. We are able to analyze these trends and developments quickly and concisely, determine their legal and market significance, and help our clients develop and adjust their short and long term strategic and business plans and corporate structures accordingly.
Through effective advocacy, clients can influence the decision-making process and advance their business interests. Our role is to create a strategy tailored to achieve our clients’ specific objectives, which commonly involves advocating our clients’ positions directly to members of Congress and their staffs and to members of the Executive Branch, including the Centers for Medicare and Medicaid Services (CMS).
We have the technical skills, experience and relationships to mobilize the many forces in Washington, DC, to achieve our clients’ objectives. The group’s collective base of experience, excellent working relationships with government officials at all points on the political spectrum, and access to more than a dozen other Pillsbury lawyers and government relations advisors who routinely represent clients in various federal and state legislative, regulatory and agency forums, enable it to respond to clients’ government relations matters rapidly, efficiently and cost effectively.
Technology Transactions in Health Care
Our health care attorneys, working together with the firm’s preeminent technology and outsourcing group, have worked with numerous clients on the technology and privacy issues associated with electronic medical records and clinical information systems, and other cutting-edge issues including open source software, web-based personal medical records systems and other new technologies. Our health care lawyers bring their knowledgeable HIPAA privacy and security and other health law regulatory matters to assist our technology lawyers in negotiating software solutions for the firm’s health care clients.
Our extensive experience in all aspects of health care antitrust matters has led many respected trade and professional associations, as well as individual health plans, hospitals, and physician groups to seek our advice. Our lawyers have appeared on behalf of clients before the U.S. Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice.
Hospitals and Health Care Systems
Throughout a variety of regulatory and transactional matters, we have advised community and specialty hospitals, as well as academic medical centers, teaching hospitals, and faculty practice plans. We have structured affiliations among the hospitals, faculty practices, and medical schools. Our lawyers work with in-house counsel, compliance officers, and privacy officers, as well as presidents, CEOs and other senior officers, on the myriad of health care compliance issues facing hospitals. The firm counsels on the development of compliance plans and provides advice on Medicare and Medicaid billing issues, HIPAA, EMTALA (patient dumping), and Fraud and Abuse, including the Anti-kickback and Stark Laws. We represent hospitals on matters such as analysis and proposed revisions to medical staff bylaws, peer review issues, credentialing, and physician disciplinary actions.
Pillsbury advises hospitals on joint ventures and other arrangements with physicians and other entities. Our lawyers structure and negotiate agreements between hospitals and physicians that comply with IRS regulations applicable to non-profit organizations. We assist in the organization of successful equity joint ventures, medical practice acquisitions, and other creative arrangements.
For academic medical centers and teaching hospitals participating in clinical research sponsored by the government and pharmaceutical companies, we provide advice on intellectual property issues, patient consent issues, human subject protection, use of medical information for research, resolution of financial and other conflicts of interest, and on reporting of adverse events. We have also assisted academic medical centers and teaching hospitals and their Institutional Review Boards in developing policies and procedures for compliance with federal regulations involving research, including FDA regulations, and conducting internal investigations involving alleged scientific misconduct.
Intellectual Property Assistance for Health Care Organizations
Our lawyers help develop intellectual property (IP) strategies and programs to identify key IP assets and protect them with programs tailored to each client's unique size, research and development budget, and competitive market requirements. When necessary, Pillsbury also provides efficient, results-oriented litigation and dispute resolution.
Over the years, our lawyers have handled more than 300 technology and intellectual property initiatives, through activities such as preparing and prosecuting patent applications worldwide, evaluating the external patent landscape and competitors’ IP positions, identifying appropriate partners for specific technology development, conducting complex patent invalidity, infringement, due diligence and freedom-to-operate studies and analyses, and representing our clients’ interests in District Court, International Trade Commission and U.S. Patent and Trademark Office actions and proceedings.
Implementation of managed care systems requires complex contractual and financial relationships, compliance with statutory and regulatory requirements and case law, and an awareness of marketplace norms and trends. With the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pillsbury has been and continues to advise its managed care and health care clients on how this historic legislation will affect their businesses. For example, we have had extensive contact and discussions with representatives of the Centers for Medicare and Medicaid Services (CMS) and other agencies within the Department of Health and Human Services on new and proposed regulations implementing MMA.
We understand the business objectives and complexities of managed care and have experience setting up managed care entities and systems. The firm represents both payors and providers on matters that include: developing and negotiating managed care contracts; working with payors to ensure compliance with regulations such as state insurance company laws, HMO laws and ERISA; working with providers to ensure compliance with applicable licensure requirements, proper accreditation or credentialing in accordance with industry standards, and appropriate utilization management activities; working with managed care organizations to ensure compliance with the unique operational requirements of the Medicare and Medicaid managed care programs, including the new Medicare Advantage program; and developing government relations strategies to assist our clients in realizing the benefits of MMA and the other programs administered by CMS.
We also work with managed care organizations to assure their systems include the following attributes: adequate provider panels in terms of quality and geographical and specialty scope; risk assessment; loss prevention; quality assurance and control; and compliance with applicable solvency requirements.
The firm counsels insurance companies and third-party administrators on a broad spectrum of regulatory issues (including fraud and abuse counseling and privacy and administrative simplification requirements). In addition, we assist insurers with the full range of corporate transactions (including data technology outsourcing) and provide guidance in connection with licensing and other compliance issues. We also offer advice in the area of Medicare Secondary Payer requirements.
Nuclear Medicine Programs
Our team represents a broad spectrum of entities licensed by the NRC or the States to use nuclear byproduct materials for medical purposes, including hospitals, clinics, and physician groups, on a range of regulatory issues. Our attorneys played a pivotal role in implementing and auditing compliance with recently revised NRC regulations covering use of nuclear by-product material in medical research, diagnosis, and treatment. We also assist our medical clients in connection with NRC investigations, potential enforcement actions by the agency, and in the handling of employee concerns and "whistleblower" claims.
Real Estate and Land Use for Health Care Organizations
We apply our strength and experience in real estate on behalf of hospitals, laboratories, and other health care clients. For more than 25 years, our real estate lawyers have served domestic and foreign owners, investors, lenders and borrowers on all manner of real estate transactions. We represent our clients in financing; acquisition, development, and construction transactions; land use and zoning issues; many different types of leases; and real estate management and facilities operation. We prepare purchase agreements and sale and leasing agreements, handle project financing, and secure the necessary zoning and land use approvals. We are also active in representing governmental and private research agencies and organizations. For example, we serve as transactional counsel for the National Institutes of Health, the major government health and research agency, in procuring, developing, and constructing billions of dollars of world-class laboratory, clinical, and other space.