Guiding you through a competitive marketplace
In today’s global life sciences marketplace, our clients work hard to develop and introduce new products and technologies. However, we understand that competitive, regulatory and litigation challenges can arise at any point; and our lawyers are ready to help your organization overcome these obstacles. From initial conception to commercial viability, from market success to expansion, we provide our clients with strategic and practical legal advice.
Our professionals are former scientists, engineers, researchers, physicians, and political advisors. With these backgrounds and experiences, we bring diversity and depth of knowledge to our clients, which include manufacturers of medical devices, biotech or pharmaceutical products, leading research institutions and major industry advocacy organizations.
To stay current on industry issues and advances, we also actively participate in various associations, including the Biotechnology Industry Organization, the Massachusetts Biotech Council, MassMedic, the American Chemical Society, the New England Healthcare Institute, the American Association for the Advancement of Science, Licensing Executives Society, Association of University Technology Managers, Massachusetts Hospital Association and the MIT Enterprise Forum.
We can help you with all types of matters, including:
- Life sciences matters
- Protection and enforcement of intellectual property
- Corporate finance and partnering arrangements
- Regulatory and government strategies
- Product liability defense
Patent Litigation, Prosecution and Strategy
We work with our clients to develop and execute patent strategies covering a wide range of technologies, including recombinant DNA, monoclonal antibodies, medical devices and diagnostics, and novel business methods.
We work with our clients’ in-house scientists and patent specialists, as well as relying on our own scientific, medical and engineering backgrounds to bring innovative solutions to our clients. Our lawyers develop strong patent portfolios; draft infringement, validity and patentability opinions; and perform patent due diligence in connection with public or private financings, acquisitions and joint ventures. If patent disputes arise, our litigators have extensive trial experience, as well as technical and scientific knowledge. In all of our work, our aim is to provide our clients with maximum marketplace advantage.
Foley Hoag’s litigators have successfully represented life sciences clients in complex patent and trade secret litigation throughout the world. For example, we were victorious as counsel to Johns Hopkins University, Baxter Healthcare Corporation, and Becton Dickinson and Company in a closely watched biotechnology patent litigation against CellPro, Inc. Our clients successfully enforced monoclonal antibody and stem cell technology patents, as a result.
Corporate Finance and Securities
We counsel our life sciences company clients in all aspects of their founding, financing, growth and development. Our lawyers provide services to our clients covering corporate organization and structuring, intellectual property acquisitions and protection, technology development and joint ventures, licensing and distribution, executive compensation, raising capital and other private debt and equity financings, initial public offerings and follow-on offerings, and mergers and acquisitions.
Frequently we structure creative partnering arrangements for our clients that are unique to the biotechnology, pharmaceutical, and medical device sectors.
Mergers, Acquisitions and Strategic Alliances
Foley Hoag represents both acquirers and target companies, providing comprehensive counseling for negotiated transactions. We assist our clients with purchases and sales of public and private corporations, asset sales, divisional and product line acquisitions and divestitures, management buy-outs, corporate restructurings, leveraged acquisitions and related acquisition financings.
For our clients seeking strategic alliances, we handle transactions ranging from simple license agreements to complex, multi-party, international joint ventures. When appropriate, we prepare research agreements between life science companies and other companies, universities or not-for-profit institutions in the United States and internationally.
Food and Drug Administration and Reimbursement
Federal funding is at the core of nearly one-half of the nation’s health care expenditures. Our lawyers know how to obtain appropriate coverage and payment for a wide range of health care products and services—despite a shifting policy landscape.
We regularly represent our clients before the Centers for Medicare & Medicaid Services (CMS). We also advise companies regulated by the Food and Drug Administration (FDA). Within the context of these efforts, we often work with senior agency managers, congressional staff and members of Congress. As a result, we play key roles in the enactment of laws and the implementation of regulations and policies affecting product development schedules, regulatory compliance, and timely product approvals.
Government Strategies
Our lawyers know the legislative and regulatory process well, having worked on such key legislation as the:
- Medicare Prescription Drug, Improvement and Modernization Act of 2003
- 1997 Food and Drug Administration Reform Law
- Orphan Drug Act and the Health Insurance Portability and Accountability Act of 1996
- Changes to Medicare and Medicaid law
We have worked on legislation and analyzed legislative proposals for our clients, worked with members of Congress and their staffs to prepare congressional testimony and counseled our clients in connection with committee and subcommittee hearings. We also advise industry trade associations regarding the reauthorization of the Prescription Drug User Fee Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act.
Venture Capital and Emerging Enterprises
Foley Hoag lawyers represent venture capital investors in transactions ranging from small seed rounds to larger later-stage investments. We provide cutting-edge advice on all aspects of these transactions. We also advise our clients on all matters important to their investments, such as protection of intellectual property, employment issues, duties of investor appointed directors, and issues related to the sale or other disposition of portfolio companies. Because our lawyers have such a wide range of experience, we often act as general counsel to emerging life sciences companies.
Product Liability and Complex Tort
We also defend our life sciences company clients against product liability and complex tort claims throughout the country, working closely with their in-house physicians, scientists and engineers. Our firm represents both Fortune 100 and smaller manufacturers; and we handle both individual cases and mass torts needing coordinating counsel.
LIFE SCIENCES GOVERNMENT STRATEGIES
At Foley Hoag, our Government Strategies lawyers have extensive experience in the development and implementation of legislation and regulations affecting the biotechnology, pharmaceutical, medical device and healthcare provider industries.
We understand that the regulatory environment can pose significant burdens to our life sciences clients. However, we believe that intelligent strategic advocacy in Congress and before federal regulatory agencies can open up new markets and opportunities for innovative products. Our lawyers work directly with congressional staff and federal agencies, including the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), on a variety of matters relating to the life sciences.
Legislative
Our Government Strategies lawyers provide our clients with comprehensive legislative advice and advocacy. Several of our lawyers worked on key pieces of health legislation while working as congressional staff members. These include the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), the 1997 Food and Drug Administration reform law, the Orphan Drug Act, and the Health Insurance Portability and Accountability Act of 1996, as well as legislation involving specific changes to Medicare and Medicaid law.
Drawing upon this experience, Foley Hoag provides legal and legislative counsel to our individual and corporate clients regarding a wide range of legislative matters. We assist clients in the preparation of draft legislation, analyze legislative proposals, work closely with members of Congress and their staffs, prepare congressional testimony, and advise clients in connection with committee and subcommittee hearings.
Our Government Strategies lawyers have been involved in every major piece of legislation affecting the pharmaceutical, medical device and biotech industries over the past several years.
Lawyers in our legislative group have:
- Represented leading pharmaceutical and biotech companies in connection with the enactment of the MMA.
- Advocated on behalf of a national civil rights organization to assure the timely reauthorization of the Ryan White CARE Act, the largest publicly funded program dedicated to providing people with HIV/AIDS in the United States with a wide range of community-based health and support services.
- Advised industry trade associations in connection with the reauthorization of the Prescription Drug User Free Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act.
Coverage and Reimbursement
Federal programs such as Medicare and Medicaid finance nearly one-half of the nation’s health expenditures, and are the primary models for private-sector medical coverage and reimbursement. It is critical that companies obtain the full coverage and payment allowed under these programs for biotechnology and pharmaceutical products, medical devices, and related health products and services. To do so, however, health care companies must navigate a myriad of frequently shifting coverage, reimbursement, coding and billing policies.
Foley Hoag lawyers have extensive experience with obtaining appropriate coverage and payment for a wide range of health care products and services. Our government strategies lawyers represent clients before CMS, and regularly participate in legislative, regulatory and administrative processes affecting CMS programs and policies.
Foley Hoag has developed particular expertise in securing appropriate payment from public and private payers for innovative products and therapies that might otherwise receive inadequate payment.
The lawyers in our coverage and reimbursement group have:
- Advised a coalition of leading academic medical centers and medical device manufacturers in the development of one of the first data registries under CMS’s Coverage with Evidence Development policy.
- Represented a leading cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for an anti-cancer therapy for renal cell carcinoma and melanoma.
- Worked successfully with CMS to expand coverage of a previously non-covered therapy for the treatment of age-related macular degeneration.
- Successfully argued for unique coding and payment for single-source drugs.
- Advised a genomic test company on lab billing and payment rules.
Food and Drug Administration
Our Government Strategies lawyers provide regulatory and legislative advice to leading biotechnology, pharmaceutical, medical device and healthcare companies regulated by the Food and Drug Administration (FDA). Foley Hoag lawyers have played key roles in the enactment of landmark laws and the implementation of critical regulations and policies affecting product development schedules, regulatory compliance and timely product approvals. We work with senior agency managers, congressional staff and members of Congress to shape agency interpretations, clarify regulatory guidance, challenge adverse decisions and enact legislation.
Foley Hoag lawyers served as senior congressional staff during the enactment of nearly every major food and drug law over the past two decades. These include:
- Amendments to the Orphan Drug Act
- Prescription Drug User Fee Act of 1992 and its subsequent reauthorizations
- Safe Medical Devices Act of 1990
- Nutrition Labeling and Education Act of 1990
- Dietary Supplements Health and Education Act of 1994
- Health Insurance Portability and Accountability Act of 1996
- Food and Drug Administration Modernization Act of 1997
- Best Pharmaceuticals for Children Act
- Public, Health, Security and Bioterrorism Preparedness and Response Act
- Medical Device User Fee and Modernization Act of 2002
The lawyers in our food and drug group have:
- Engaged the FDA and Congress, on behalf of a national coalition of innovative medical technology companies, regarding the appropriate regulation of break through genetic and molecular diagnostic tests.
- Devised a strategy to persuade an FDA review division to accept a medical technology company’s proposed development plan, after the company had reached an impasse with the review division over its data requirements.
- Represented a company regarding combination product issues with respect to a medicinal product used in conjunction with a medical device, which was subject to the Medical Devices Directive.
Bioterrorism and Pandemic Preparedness
Since 2001, Foley Hoag lawyers have played a leading role in the enactment of the bioterrorism and biosecurity preparedness legislation. The creation of the Biomedical Advanced Research and Development Authority (BARDA), in December 2006, has generated enormous opportunities for early-stage life sciences companies.
BARDA revitalizes the federal government’s efforts to support and fund the development of medical countermeasures critical to protecting the nation against bioterrorism and pandemic health threats. BARDA will inject more than $1 billion into the research, development and procurement of vaccines, antivirals and diagnostics. It will also enable vital new forms of coordination between the government and life sciences innovators. Foley Hoag lawyers assist life sciences innovators in navigating the complex process of obtaining and managing high-value BARDA contracts.
Lawyers in our biosecurity group have:
- Provided strategic counsel to a coalition of leading venture capitalists in support of Congress’ passage of the All-Hazards Preparedness Act, creating BARDA.
- Advised an innovative early-stage company on obtaining a $102 million contract with the U.S. Department of Health and Human Services to develop an influenza neuraminidase inhibitor for the treatment of pandemic influenza.
