The accelerating pace of life science and biotechnological discovery are bringing unprecedented and rapid change to every aspect of our lives including the medical treatment we receive, the foods we eat and the environment in which we live. The resulting public policy and legal questions and issues involve multiple disciplines and require anticipation and creative solutions.

Powell Goldstein's robust practice involves all of the disciplines necessary to serve the multilevel needs of inventors, companies, investors and institutions involved in life sciences and biotechnology.

Our life sciences and biotechnology team includes a principal author of the Patent Office examination guidelines for biotechnology patents, a former Principal Examiner for biotechnology patents and attorneys who have worked in the Congress, the White House, various Executive Branch agencies, federal prosecutors' offices and the World Health Organization.

Relevant Experience:

• Patent protection and intellectual property - our patent attorneys have degrees in Chemical Engineering, Chemistry and Biochemistry and are registered to practice before the U.S. Patent and Trademark Office
• Centers for Medicare and Medicaid Services (CMS-formerly HCFA) reimbursement for drugs, devices and services
• FDA procedures and protocols
• Testing and clinical trial requirements and procedures
• Privacy requirements under domestic and international laws and regulations
• Research and development agreements
• Federal grant, supply schedule and contracting
• Federal and state compliance and investigation matters
• Business financing and structuring
• International trade and market rights
• Legislative and public policy matters

Our clients include inventors; pharmaceutical, diagnostic and biotechnology companies, medical device manufacturers, medical equipment and service suppliers, national and regional trade associations, financial institutions, venture capital companies and government contractors.

We are results driven and deeply involved in helping our domestic and international clients with cutting-edge policy and business issues.  Our clients tell us that we go Above & Beyond^{sm _to} devise strategies and implementation plans that help them achieve their business goals.

Representative Matters:

• Introduced our clients to potential new customers both in the U.S. and abroad and assisted clients in meeting the political and regulatory challenges of bringing new medical products, technologies and services to market and securing coverage by various payers
• Assisted a biotech start-up in structuring a strategic alliance and licensing agreement to develop and commercialize a new class of antibiotics
• Structured exclusive and nonexclusive distribution agreements for medical devices
• Negotiated licensing arrangements for the commercialization of university-developed intellectual property
• Represented private industry sponsors of university research projects and government CRADA
• Navigated federal and state regulations restricting access to individually identifiable health information to foster human research and population-based research
• Advised on various research issues: represented teaching/research hospitals in reorganizing their operations, including practice plans and research programs, and represented providers in administering research and clinical trials, including administration and operations of IRBs and sponsorship contracts
• Represented investigators in assuring drug clinical trials complied with regulatory requirements
• Conducted "due diligence" for companies and individuals interested in investing in medical products and technologies by identifying and satisfying potential regulatory and coverage hurdles, identifying potential fraud and abuse exposure and quantifying the likelihood of success
• Advised start-up and developing companies considering private offerings and/or initial public offerings (IPOs) on issues that would attract investors; represented a leading venture capital fund investing in genomics
• Built broad-based coalitions to serve our client's objectives by leveraging client resources, establishing grassroots support and forming alliances with patient advocacy groups, professional associations and industry groups
• Provided procedural and strategic advice on obtaining and performing pharmaceutical, medical and surgical supply contracts with the DoD and the VA
• Developed and implemented efforts to obtain new, unique HCPCS coding and CPT coding for new medical products, technologies and professional services
• Advised and represented clients on fraud and abuse issues, including compliance, alleged overpayments, white collar crime defense, Justice Department investigations, Medicare audits, Health and Human Services Office of Inspector General investigations and compliance plans
• Advised landlords and tenants on environmental issues, zoning and hazardous materials land use ordinances
• Helped resolve compliance issues surrounding hazardous materials zoning regulations