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Charles Andres, Ph.D., RAC, is a shareholder in the Intellectual Property and Technology group and Health Care and FDA Practice groups. Charlie has designed and implemented IP strategy for companies from startups to venture backed and public companies, from inception through public offerings and exits.

Charlie represents investors and companies in IP related matters in financings in all stages. Charlie built patent portfolios and obtained patents protecting three FDA approved drugs (a tamper resistant opioid, an anti-cancer drug, and an MS drug) and many drug candidates currently in phase 1, 2, and 3 clinical trials. Charlie has deep experience in protecting novel and repurposed drugs, as well as devices for delivering these drugs. Charlie has built patent portfolios protecting diagnostic tests and kits and epigenetic diagnostic tests and kits.

As company counsel, Charlie has built, sold and partnered patents and patent portfolios valued, in aggregate, at over ten billion dollars. As investor counsel, Charlie cleared (for IP and FDA regulatory) investments in an aggregate approaching eleven billion dollars. Most recently, Charlie represented Miromatrix Medical for IP in its NASDAQ IPO.

Charlie has published over one-hundred legal and scientific publications, was a panelist or lecturer in over 50 events, is primary author on three U.S. Supreme Court amicus briefs, filed multiple patent term extension applications for therapeutics and medical devices, and facilitated the Orange Book listing of over fifteen patents. Charlie routinely advises on transactional matters including NDAs, common interest agreements, options, licenses, SRAs, MTAs, SPAs, and SEC Form S-1 disclosures. Charlie is regularly engaged to author “bet the company” IP opinions and memoranda.

Charlie is an IP facing attorney who sees and understands the bigger picture of what is necessary for companies to be successful and uses this knowledge to advance the interests of his clients.

Concentrations

  • Biotech
  • Digital health
  • Pharmaceuticals
  • Medical devices
  • Quantum computing in drug discovery
  • Patents
  • Diagnostics
  • Research tools
  • FDA
  • RNA therapeutics
  • Small molecule therapeutics
  • Peptide and protein therapeutics
  • Repurposed drugs
  • Drug delivery technologies
  • Transactional
  • Investor and company side diligences

Capabilities

Experience

  • Medicinal chemist and early phase project co-chair, Bristol-Myers Squibb Co.
    • Presidential Award recipient
  • CORe: Credential of Readiness, HBX / Harvard Business School
  • Regulatory Affairs Certification, U.S. Drugs and Devices

Recognition & Leadership

  • Listed, The Best Lawyers in America, “Ones to Watch,” Health Care Law, 2023
  • Listed, IAM magazine, "IAM Patent 1000," Prosecution, 2022
  • “Top Author – Life Sciences,” JD Supra Readers’ Choice Awards in 2016, 2019 & 2020
  • Listed, Who’s Who in America, 2019
  • Member, American Bar Association
  • Member, American Chemical Society
  • Member, Regulatory Affairs Professionals Society
  • Member, Food and Drug Law Institute
  • Technical and Regulatory Advisor, Fair Access Medicines
  • Mentor, Spark Factory at the Delaware Innovation Space
  • Mentor, Start Codon Cambridge Health Accelerator
  • Co-organizer, BioHealth Capital Region Annual Investor Conferences

Credentials

Education
  • J.D., Columbus School of Law, Catholic University of America
  • Post-doctoral Fellow with Professor A.I. Meyers, Colorado State University
  • Ph.D., Organic Chemistry, University of Virginia
  • B.S., Chemistry, cum laude, Hillsdale College
Admissions
  • District of Columbia
  • Virginia
  • U.S. Patent and Trademark Office