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Robert F. Shaffer

Partner
Head of Life Sciences Patent Litigation practice
A former client said Rob’s knowledge "is only rivaled by his responsiveness, personable nature, and high standard of integrity. I recommend Rob as intellectual property counsel without the slightest hesitation."
About

Rob Shaffer is a nationally recognized first-chair intellectual property (IP) trial lawyer with more than 25 years of experience handling complex patent litigation in high-stakes IP matters. Rob has represented leading pharmaceutical and medical device companies in major cases, including Hatch-Waxman disputes, International Trade Commission (ITC) actions, and complex commercial arbitrations. He also represents clients before the Patent Trial and Appeal Board of the United States Patent and Trademark Office.

Rob represents clients ranging from emerging startups to global industry leaders in matters involving significant IP assets. He has handled multibillion-dollar disputes involving pharmaceuticals, medical devices, consumer products, and software. Rob has led high-profile patent cases, with a particular concentration in life sciences.

Rob’s approach starts with a thorough understanding of each client’s business and objectives, both in the immediate matter and over the long term. With that foundation, he builds a strategy and leads the team carrying it out, whether at trial, in arbitration, or on appeal. His extensive trial experience, cross-examination skills, and strategic approach have contributed to successful outcomes in numerous matters. Clients describe Rob as approachable and collaborative, keeping stakeholders informed and engaged while guiding them through high-pressure litigation.

Rob’s practice also extends beyond the courtroom. He advises clients on building and managing IP portfolios and strategies, works on licensing and transactional matters, and counsels clients on legal positions, obligations, and risk management.

Bar admissionsDistrict of ColumbiaVirginia
CourtsUnited States Court of Appeals for the Federal CircuitSupreme Court of the United States
Rob’s 'outstanding winning record' in pharmaceutical and biotechnology litigation.
— The Legal 500 United States and IAM Patent 1000
Education
  • J.D., George Mason University
    magna cum laude
  • M.S., Medical College of Virginia at Virginia Commonwealth University
  • B.A., Georgetown University

EXPERIENCE

  • Lead counsel for a Taiwanese biotechnology and chemical manufacturing company in two confidential arbitrations relating to exclusive licenses and patent assignments for patents directed to treating a rare genetic disorder; secured a USD180 million settlement
  • Lead counsel for a molecular pharmaceutical research and development biotechnology company in an ITC action involving a recombinant protein product; secured a favorable finding of no infringement, subject to appeal
  • Lead counsel for a pharmaceutical company in litigation in the District of New Jersey involving patents covering the use of iron carbohydrate complexes; secured a favorable settlement following a successful related post-grant review proceeding
  • Co-lead counsel for two branded pharmaceutical companies in two Hatch-Waxman Act cases against generic companies regarding their attempts to obtain Food and Drug Administration approval for their respective Abbreviated New Drug Applications (ANDAs); secured a favorable settlement after a six-day bench trial with a generic entry date well past the expiration of the composition patents
  • Trial counsel for a leading medical device company in multiple district actions against direct competitors, resulting in an eight-figure damages award and subsequent settlement
  • Trial counsel for an international pharmaceutical company in ANDA litigation against multiple generic challengers involving diabetes treatments; the patent was held infringed and not invalid in the district court and further upheld in a parallel inter partes review proceeding
  • Lead counsel for a pharmaceutical company in an ITC investigation involving methods of manufacturing a cancer treatment drug; the matter was resolved through a confidential settlement

AWARDS AND RECOGNITION

The Legal 500 United States

  • Recommended, Healthcare: Life Sciences; Patents: Litigation (Full Coverage), 2026
  • Recommended, Trade Secrets (Litigation and Non-Contentious Matters), 2022 and 2024

IAM Patent 1000

  • Recommended, Litigation, 2025
  • Recognized, Leading Patent Litigator, 2022

LMG Life Sciences Awards

  • Shortlisted, DC Patent Litigator, 2026

Seminars

  • Presenter, Advanced Trade Secrets, Medical Device Manufacturing Association, September 2026
  • Presenter, Update at the Federal Circuit, Medical Device Manufacturing Association, September 2025

Media Mentions

Memberships and Affiliations

  • Member, District of Columbia Bar, Intellectual Property Section
  • Chair, District of Columbia Bar, Trade Secrets Section, 2004–2007
  • Member, District of Columbia Bar, Steering Committee, 2007–2010
  • Member, American Intellectual Property Law Association
  • Member, American Bar Association
  • Member, Virginia State Bar, Intellectual Property Section
  • Member, Intellectual Property Owners Association
  • Member, Federal Circuit Bar Association

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