Skip to main content

Charles J. Andres is a registered patent attorney focused on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, transactional work, and related business matters. Charlie is experienced in drafting and prosecuting patent applications and developing high value patent portfolios in the U.S. and worldwide. He also has experience evaluating the claims of issued patents and has won cases before the Patent Trial and Appeal Board by brief and on oral argument, and has worked with foreign counsel to obtain favorable outcomes in European patent oppositions.

Charlie has drafted numerous freedom-to-operate, invalidity, and non-infringement opinions, including opinions supporting Paragraph IV certification for ANDA filers under the Hatch-Waxman Act. He has also advised companies on the use of post-grant U.S. Patent and Trademark Office proceedings to achieve IP goals. He routinely formulates end-to-end patent and FDA strategies for pharmaceutical companies. Charlie has advised clients in responding to complete response letters, obtaining RMAT, QIDP, and orphan designations, and gaining 510(k) clearances. He has transferred IND sponsorships and routinely files FOIA requests. He has counseled companies in the CBD and hemp spaces. Charlie has obtained patents and built patent portfolios covering three FDA approved drugs, as well as three drug candidates currently in phase I, phase II and phase III clinical trials. Charlie has filed multiple patent term extension applications, and has facilitated getting multiple patents Orange Book listed.

Charlie routinely advises on transactional matters including NDAs, common interest agreements, options, licenses, SRAs, MTAs, and SEC Form S-1 disclosures. Acting as investor counsel, Charlie’s diligence work has resulted in over $8B in investments. Charlie has built and sold patent portfolios and their associated companies for approximately $5B in aggregate. Charlie has co-counseled companies through acute public crises.

A trusted advisor, Charlie has been invited to speak at conferences and programs worldwide. In addition, he has co-authored over 100 legal publications and three Supreme Court amicus briefs.

Concentrations

  • Biotech
  • Digital health
  • Pharmaceuticals
  • Medical devices
  • Patents
  • Diagnostics
  • Research tools
  • FDA
  • Transactional
  • Investor and company side diligences

取扱分野

実績紹介

  • 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
  • Co-inventor with S. Gerritz, J.A. Tino, and W. Zhai, "Heterocyclic Compounds Useful as Growth Hormone Secretagogues," U.S. Patent No. 7,214,804, 2007

受賞歴・所属団体

  • Listed, Who’s Who in America, 2019
  • “Top Author – Life Sciences,” JD Supra Readers’ Choice Awards in 2016, 2019 & 2020
  • Member, American Bar Association
  • Member, American Chemical Society
  • Member, Regulatory Affairs Professionals Society
  • Member, Food and Drug Law Institute
  • Scientific Advisory Board, Predictive Technology Group
  • 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

学歴・資格・言語

学歴
  • 法務博士, 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
弁護士資格
  • コロンビア特別区
  • Virginia
  • U.S. Patent and Trademark Office