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.

Our relevant experience includes:

• Patent protection and intellectual property - our patent attorneys have degrees in Chemistry and Microbiology and are registered to practice before the U.S. Patent & Trademark Office
• Centers for Medicare and Medicaid Services (CMS-formerly HCFA) reimbursement for drugs, devices and services
• Testing and clinical trial requirements and procedures
• Privacy requirements under domestic and international laws and regulations
• Cosponsored and other 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. While we are often involved in cutting-edge policy and business issues, we are results driven and strive to devise domestic and international strategies and implementation plans that economically and efficiently accomplish our clients' objectives.

Together, we have:

• 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
• Negotiated a unique public-private partnership between a medical device manufacturer and a Department of Energy National Laboratory to redeploy cold-war nuclear technology for use in cancer treatment
• 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 that 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 biotechnology
• 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