Biologics & Biosimilars

The development of biologic therapeutics has entered a new age of competition following passage of a biosimilar law in the United States. The law is known as the Biologics Competition and Innovation Act, or "BPCIA." To give your company the best advantage in this market you need advice and counsel from professionals who know your industry. Professionals who give straightforward strategic and legal advice founded in real world experience. That’s the Mintz Levin team.

Mintz Levin has built up a world class reputation in the Life Sciences space, with significant emphasis on biotechnology. Our attorneys understand the playing field and the players in the biologics and biosimilars space. We know and have navigated our clients through the complicated pathways to success through which your company and products must pass – FDA regulatory, transactional, and innovation protection.

Quick Facts

  • 40+ years in the life sciences industry
  • Integrated intellectual property, regulatory, litigation, and corporate practice
  • Clients include public and private multinational corporations, hospitals, research centers, universities, early-stage-and mid-stage companies, investment funds, and individual inventors
  • More than 20 professionals of the practice have PhDs in fields valuable to biologics companies:
    • Biochemistry
    • Biomedical Sciences
    • Cell Biology
    • Chemistry
    • Immunology
    • Microbiology
    • Molecular Biology
    • Neurobiology
    • Organic Chemistry

Rankings & Recognitions

  • "Law Firm of the Year (Biotechnology) – North America" by Global 100 (2016)
  • National Tier 1 ranking for Biotechnology Law — U.S. News & World Report and Best Lawyers "Best Law Firms" (2014)
  • Ranked as "Law firm of the Year (Biotechnology) – North America" by M&A Today Global Awards (2014)
  • "Licensing and Collaborations Firm of the Year" by LMG Life Sciences (2013)

Areas of Focus

  • Patent Prosecution
  • Patent Litigation
  • Corporate Counseling
  • FDA Regulatory and Legal Strategy
  • Health Care Regulatory and Reimbursement
  • Transactions and Licensing
  • Products Liability Counseling and Litigation

Experience

  • Perform market landscape or "white space" analysis, which entails freedom-to-operate opinions and design-around counseling.
  • Provide strategic multi-jurisdictional patent portfolio development advice as approach to patenting in the US and in Europe are quite different in the biologics space.
  • Conduct range of technology-specific transactions such as in-licensing and out-licensing of cell lines.
  • Successfully represented biopharma clients in patent litigations involving recombinant erythropoietin (EPO), recombinant tissue plasminogen activator (TPA) derivative Reteplase®, and recombinant human growth hormone (HGH).
  • Represented an underwriter in the due diligence of a biologics company seeking entry to the public markets through an Initial Public Offering
  • Provide strategic business counseling at a macroeconomic level to determine the best market for access to financing for companies at cutting-edge of industry.
  • Track State pharmacy laws and administrative policies related to biosimilar substitution.
  • Draft comments for various clients on FDA guidance and policy positions and advise strategically on actions to take based on such FDA guidance.
  • Represent PBMs and pharmacy clients in contract negotiations with pharmaceutical manufacturers and provide insights into regulation and requirements around rebates, approved drug lists, and others.
  • Advise clients regarding ongoing activities and how they may potentially intersect one another under the legal framework for biosimilar biological products.
  • Provide advice and recommend action on securing reimbursement from Medicaid, Medicare, and other insurers.
  • Research and provide guidance on issues such as whether biologics need to be listed on formularies.
  • Structure transactions in markets most amenable to advances in the biologics/biosimilars space, including Korea and Egypt.
  • Give companies patent advice and counsel related to cell lines, cell culture media, chromatography, and other technologies used in the drug development process