Pharmaceuticals, Biotechnology, Bioinformatics & Medical Devices
With its powerful combination of food and drug, intellectual property and health care regulatory practices, and drawing on the experience of lawyers in its corporate finance, litigation and other practice areas, Buchanan represents its life sciences clients with a multi-disciplinary team to handle the regulatory, financial and commercial needs of established and emerging companies, research institutions, and investors in the pharmaceutical, biotechnology, bioinformatics, medical device, biological product, tissue and cellular product, combination product, animal drug, chemical, food and cosmetic industries (which we refer to as "life sciences".).
Our team includes many members who have held senior agency and congressional positions, as well as members with advanced scientific backgrounds. This affords us — and ultimately our clients — a working knowledge of the policies, practices and procedures that govern regulatory decision-making in such agencies as the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the U.S. Patent and Trademark Office (PTO), the Securities and Exchange Commission (SEC) and the U.S. Department of Justice (DOJ).
We assist life sciences producers at each phase of the product growth life-cycle with comprehensive and strategic services including:
- U.S. Food and Drug Administration (FDA) and regulatory compliance and strategy
- Post-approval marketing compliance and reimbursement strategy
- Patent and Trademark Protection and Defense
- Health Care: Regulatory, Transactions, Litigation
- Federal and Pennsylvania Government Relations
- Licensing, Collaboration and Strategic Alliances
- Technology Transfer
- Capital Formation and Corporate Finance
- White-Collar Defense and Investigations
- Products Liability
FDA and Regulatory Strategy
Buchanan's Food and Drug Practice is dedicated to providing its national and international clients with comprehensive legal counseling to develop and market products regulated by the FDA. Several of our attorneys have held senior legal and policy-making positions within the FDA, and others have worked for drug companies and research institutes as scientists or legal counsel. Few law firms can match the level of substantive FDA, scientific and industry experience that Buchanan offers to its clients.
Our Food and Drug Practice provides strategic and comprehensive regulatory advice and representation to businesses and individuals throughout the financing, development, application review, manufacturing and marketing phases of the product life-cycle. Our attorneys assist clients in developing and maintaining effective clinical trial programs, and in meeting all regulatory criteria and requirements for the approval and pre-market clearance of products regulated by the FDA. In addition, based on the compliance, enforcement and prosecutorial experience of our FDA attorneys, we provide our clients effective strategies and solutions to regulatory compliance and enforcement issues pertaining to clinical trials and the manufacture, marketing, and distribution of products regulated by the FDA. Our attorneys assist clients in developing and maintaining successful and cost-effective internal compliance programs, as well as operating procedures to meet all current good manufacturing practice requirements of the FDA.
Biotechnology
We represent biotechnology, pharmaceutical, and medical device companies from earliest formation to most advanced. Our clients are engaged in international product development, testing, and marketing. Our experience has shown that a multi-track approach is effective and efficient way to deliver the legal services to needed to position clients in these related industries. in the global marketplace. by assisting them in both U.S. and European regulatory approvals, intellectual property protection and by helping them to secure financing and commercial opportunities both in the United States and abroad.
We provide traditional representation as well as counseling on business needs. We help identify strategic partners, negotiate transactions and craft agreements that address the intricacies of the industry.
The firm's lawyers have experience in the following technical fields:
- Medical and diagnostic equipment
- Microbiology and Immunology
- Hybridization processes involving agricultural crops
- Genetic research and engineering
- Pharmaceuticals, ethical drugs and drug-delivery systems
- Robotics
- Ultrasound devices
Buchanan's biotechnology lawyers have comprehensive capabilities to meet the needs of biotechnology clients in six core areas:
- Capital formation and corporate finance
- U.S. Food and Drug Administration (FDA) and regulatory strategy
- Intellectual property and patent prosecution
- Licensing, collaboration and strategic alliances
- Government relations
- Medical coverage and reimbursement
Intellectual Property
The firm's Intellectual Property (IP) Practice offers clients depth and capacity few other law firms can match. Many of our IP professionals are former examiners at the PTO. Many possess masters and doctorate degrees in the disciplines of biochemistry, biology, chemistry, electronics, genetics, mechanics, molecular biology and software design. In the patent field alone, more than 1,100 patents are issued annually by the PTO to Buchanan clients. More than 300 foreign patents are issued each year to our clients, as well.
Buchanan's involvement in patent issues extends well beyond application preparation and prosecution. Infringement and ownership of patents and trademarks frequently are contested by various parties. These conflicts may pit corporation against corporation, inventor against corporation or employer against employee. Representing both plaintiffs and defendants, in both domestic and international venues, the firm's lawyers are broadly experienced in the litigation of patent-related issues. Buchanan clients rely on the firm's practical and prepared approach to matters of patent and trademark infringement. Our approach reflects recognition that clients' very ability to compete may be determined by the outcome of the litigation process.
In addition, the firm has conducted due diligence for corporate transactions in the IP area, and its lawyers have litigated extensively in patent and Hatch-Waxman litigation.
Health Care
As pioneers in the health care legal industry, the attorneys in our Health Care Practice have a long history of helping clients navigate the complexities of the increasingly regulated life sciences industry. They have significant practical experience assisting clients in such areas as obtaining Medicare coverage and reimbursement for their products, and providing advice regarding clinical research trials, conflicts of interest, patient rights/HIPAA and the Medicare Part D program.
Additionally, the recent increase in government investigations and enforcement efforts has resulted in a particularly challenging time for life sciences companies. Drawing on their experience representing hospitals and other providers over the years in similar investigations by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services and other federal and state enforcement agencies, our attorneys are prepared to assist life science companies in analyzing potential claims under the False Claims Act, the Anti-Kickback Statute, the Stark laws and other areas of increasing governmental interest in the life sciences industry. They also have significant experience helping clients design and implement effective compliance plans to minimize undue legal and financial risk in these areas.
Government Relations — Federal and State
Buchanan actively represents the interests of its life science clients before Congress and the agencies of the federal and state government on a variety of legislative, regulatory and appropriations matters. While federal and state agencies annually allocate billions of dollars to life science programs, it can often be difficult for companies with limited resources to navigate their way through these various government labyrinths. Buchanan's Government Relations group assists life science companies in planning government appropriations strategies, preparing funding requests and designing collaborations with the government — from finding avenues for publicly funded cooperative research to in-licensing government-owned technology. In conjunction with other members of the firm's practices, the Government Relations group also routinely advocates on behalf of life science companies with regard to proposed legislation before Congress and the adoption and interpretation of regulatory requirements, as well as in raising governmental awareness about areas of special concern to the life sciences industry.
Licensing, Collaboration & Strategic Alliances
Licensing, collaborations and strategic alliances are three key commercial vehicles used by life sciences enterprises to unlock the value in their intellectual property. There are numerous commercial models used in this industry. Because of the increasing costs of research and development, collaborations, often with universities or multinational corporations, and strategic alliances have become useful catalysts to share risk and get new ideas to market.
Buchanan lawyers craft and negotiate various contractual agreements tailored to the pharmaceutical, biotech and device industries. These include clinical trial agreements, manufacturing and supply agreements, drug and device development agreements, and master services agreements with contract research organizations.
Capital Formation & Corporate Finance
Buchanan handles billions of dollars in transactions every year. We structure and negotiate sophisticated transactions involving equity and debt offerings, public and private capital formation, private placements, mergers and acquisitions, venture finance transactions. We also provide corporate governance and regulatory compliance counsel. In addition to these transactional services, we work closely with other practices to address issues that require specialized experience.
Our lawyers structure, negotiate, document and complete transactions essential to accomplishing both the operational and strategic objectives of their clients. The firm's services in this area span the full range of public and private capital formation, initial public offerings, mergers and acquisitions and corporate governance, both in the U.S. and in Europe.
We frequently bring our knowledge and judgment to the design and negotiation of private placements, ranging from initial "angel" rounds of financing to venture capital investments, mezzanine financings and Rule 144A private placements. Our ongoing experience in this area provides our clients with the advantage of being able to gauge market expectations, internal structuring pitfalls and overall risk from the points of view of both issuer as well as investor.
White-Collar Defense and Investigations
The attorneys in our White-Collar Defense and Investigations Practice include former assistant U.S. attorneys, DOJ trial lawyers, FBI agents, SEC officials and state and local prosecutors. In addition to having experience on both sides of the courtroom, members of our group include former criminal law professors at nationally known law schools. Our attorneys have successfully defended corporate and individual clients under investigation for or charged with alleged violations of a wide variety of federal and state offenses, including Medicare/Medicaid fraud, qui tam/whistleblower claims, antitrust, securities, RICO, extortion, foreign corrupt practices, bid-rigging, embezzlement, money laundering and HIPAA, to name a few. Additionally, our team has represented clients involved in parallel or subsequent civil proceedings, and has experience with the ramifications of Fifth Amendment invocations in civil cases.
Products Liability
Whether a life sciences client faces a challenge to an allegedly defective product, a class action or a coordinated series of filings throughout many jurisdictions, Buchanan's Products Liability Practice offers substantive legal knowledge and the ability to quickly marshal an experienced legal defense team. Our litigators partner with clients to learn about the product in question and meet with experts to learn the alleged issues associated with the product and the epidemiology and other scientific support involved in mounting a successful defense.
Lawyers in our Products Liability Practice are commercial litigators who bring with them a practical understanding of the demands of the business world in which our life sciences clients operate. These cases do not exist in a vacuum, and our attorneys understand that in personal injury and products liability litigation, a single adverse judgment can have disastrous short- and long-term consequences to our clients. Our Products Liability Practice represents regional, national and international clients that manufacture and/or distribute a diverse cross-section of life science products, including biomedical, medical device, pharmaceutical and chemical products.