Charles Andres

WORK HISTORY

EDUCATION

SKILLS

ABOUT CHARLES ANDRES

Charles Andres, Ph.D, RAC, is an shareholder in the Washington, D.C, office of Greenberg Traurig. He focuses 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, and related business matters. His achievements include: Obtained patents and built patent portfolios which have sold for a cumulative total of approximately $4 billion. Drafted and prosecuted patents covering three FDA approved drugs. Orange Book listed multiple patents. Had Orange Book patents asserted against a generic pharmaceutical manufacturer. Filed multiple applications for patent term extension. Defended a generic pharmaceutical manufacturer in an Actavis reverse payment inquiry at the Federal Trade Commission. Represented a client at a U.S. Senate HELP Committee full hearing on electronic health records. Authored and reviewed numerous freedom-to-operate, invalidity, and non-infringement opinions, including opinions supporting Paragraph IV certification for ANDA filers under the Hatch-Waxman Act. Advised companies on the use of post-grant U.S. Patent and Trademark Office proceedings to achieve IP goals. Counseled companies on a broad spectrum of FDA related matters including: medical devices, laboratory developed tests (LDTs), dietary supplements, pharmaceuticals, biologics, off-label promotion, DESI drugs, combination drugs, combination drug and device submissions, rare disease vouchers, clinical trial primary and secondary endpoints, expedited approval pathways, FDA regulatory exclusivities, and labeling claims. Charlie spent a decade as a medicinal chemist and early-phase project co-chair at Bristol-Myers Squibb Company, where he won a Presidential Award, among other accolades. He holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.