Rob Shaffer is a nationally recognized first-chair IP trial lawyer with extensive experience handling complex patent litigation in the most important intellectual property matters. For more than 20 years, Rob has represented some of the world’s most innovative pharmaceutical and medical device companies in dozens of 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 (PTAB) of the US Patent and Trademark Office (USPTO).
Rob advises clients through every step of patent litigation—from pre-trial counseling to leading trial teams, and through appeal. Along with his life sciences work, Rob also represents clients in other technologies, including consumer electronics, software, and gaming companies in patent matters.
Complementing his trial work, Rob advises clients on their patent strategies, including strategic portfolio management, licensing and transactional activities, and IP due diligence.
Rob has been recognized as a leading patent litigator by both the Legal 500 (2022) and IAM Patent 1000 (2022), which noted his “outstanding winning record” in pharmaceutical and biotechnology litigation.
Get to Know Rob
Get to Know Rob
- 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 that is often fatal if untreated; secured a US$180 million settlement
- Lead counsel for a molecular pharmaceutical research and development biotechnology company in an ITC action involving 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 for the treatment of iron deficiency diseases; the case resulted in 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 FDA approval for their respective ANDAs directed to generic copies of a drug used to treat iron deficiency anemia; after a six-day bench trial, the cases resulted in a favorable settlement 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 representing an international pharmaceutical company ANDA litigation against multiple generic challengers involving diabetes treatments; patent was held infringed and not invalid in the district court and further upheld in a parallel inter partes review (IPR) proceeding
- Lead counsel for a leading pharmaceutical company in an ITC investigation involving methods of manufacturing a cancer treatment drug; matter resolved through world-wide confidential settlement
Admissions
Bar Admissions
- District of Columbia
- Virginia
Court Admissions
- US Court of Appeals, Federal Circuit
- Supreme Court of the United States
Education
- George Mason University, J.D.: magna cum laude
- Virginia Commonwealth University, M.S.: Physiology/Biophysics
- Georgetown University, B.A., History
Honors & Awards
- Recognized by the Legal 500 US as a leading patent litigator (2022)
- Recognized by IAM Patent 1000 as a leading patent litigator (2022)
Professional Activities
Memberships
- District of Columbia Bar (Intellectual Property Section), Chair of Trade Secrets Section, 2004-2007; Steering Committee, 2007-2010
- American Intellectual Property Law Association
- American Bar Association
- Virginia State Bar (Intellectual Property Section)
- Intellectual Property Owners Association
- Federal Circuit Bar Association
Author
- “Section 101 Decisions Clarify 'Clear And Convincing Evidence,” Law360 (March 13, 2018)
Speaker
- “Keep it Secret, Keep it Safe: Leveraging Trade Secrets to Complement IP Protection and Enforcement Strategies,” BIO IP Counsel’s Committee Conference (Nov. 14, 2022)
- “Maximizing and Leveraging IP in the Life Sciences,” Webinar (Nov. 10, 2022)
- “Protecting and Managing Trade Secrets in the Medical Device Industry,” MDMA Member-Only Webinar (Oct. 5, 2022)
- “Section 101 Patent Eligibility: The Good, The Bad, and The Ugly,” BIO IP Counsel’s Committee Conference (Nov. 18-19, 2019)
- “Patent Strategies for Drug-Device Combination Products,” Medical Device Manufacturers Association (MDMA) Patent Law Roundtable (Nov. 12, 2019)
- Paragraph IV Disputes Master Symposium, American Conference Institute (Chicago, Illinois, Oct. 1-3, 2018)