J.D., with honors, The George Washington University Law School
M.S., Hood College
B.S., University of Maryland
Bar and Court Admissions
District of Columbia Bar
U.S. Court of Appeals for the Federal Circuit
U.S. Patent and Trademark Office
Rachel is experienced in representing companies in high-stakes patent infringement litigation, with a focus on Hatch-Waxman patent litigation. She also advises clients on a wide range of U.S. Food and Drug Administration (FDA) regulatory matters, including life cycle management issues such as market exclusivity periods, Orange Book patent listings, and patent term extensions.
- Represented clients in intellectual property disputes relating to a wide variety of technologies including pharmaceutical products, therapeutic antibodies, pharmacokinetic parameters, and new chemical entities.
- Performs validity, non-infringement, and freedom to operate analyses.
- Conducts intellectual property and FDA regulatory due diligence studies.
- Counsels clients on Orange Book patent listing strategies, bioequivalence standards, and Abbreviated New Drug Application (ANDA) and 505(b)(2) New Drug Application (NDA) strategies.
- Representative engagements include Takeda GmbH et al. v. Hetero USA Inc. et al., No. 15-3385 (D. N.J. filed May 15, 2015), Celgene Corp. et al. v. InnoPharma, Inc., No. 14-1188 (D. Del. filed Sep. 12, 2014), Otsuka Pharmaceutical, Co. Ltd. v. Torrent Pharmaceuticals Ltd., et al., Nos. 14-1078, 14-4671 (D.N.J. 2014), Command Tech., Inc. v. Lockheed Martin Corp. et al., No. 363431-V (Circuit Court for Montgomery County, MD filed May 21, 2012), Pfizer Inc. et al. v. Mylan Inc. et al., No. 10-3246 (D.N.J. filed June 24, 2010), and Golden Hour Data Systems, Inc. v. emsCharts, Inc., No. 06-381 (E.D. Tex. filed Sep. 19, 2006).
- Prepares and prosecutes patent applications in a number of fields.
- Patent Examiner, U.S. Patent and Trademark Office, Art Unit 1647 (2003-2005)
- American Bar Association (ABA)
- American Constitution Society (ACS)
- American Intellectual Property Law Association (AIPLA)
- Licensing Executives Society (LES)
News & Insights
- September 22, 2017 | Alert
- May 23, 2017 | AlertRachel K. Hunnicutt, Alexander B. Owczarczak
- May 15, 2017 | Webcast | Speaking EngagementThe Knowledge GroupRachel K. Hunnicutt, Speaker
- December 20, 2016 | AlertRachel K. Hunnicutt
- November 30, 2016 | Press Release
- June 11, 2015 | Press Release
- March 9, 2015 | Alexandria, VA | Speaking Engagement3D Printing and Innovative Medical Devices: Clarifying FDA Regulations & Identifying Strategies For SuccessQ1 Conferences' Medical Device and Diagnostic IP/Patent Strategy ConferenceRachel K. Hunnicutt, Speaker
- January 29, 2015 | Speaking EngagementMedical Device Manufacturers AssociationRachel K. Hunnicutt
- December 4, 2014 | Press Release
- November 14, 2014 | Press Release
- November 27, 2013 | Press Release
- October 29, 2013 | ArticleLaw360Scott A. Felder, Rachel K. Hunnicutt
- January 20, 2012 | ArticleFirst-Inventor-to-File, or First-to-Disclose?-Understanding the America Invents ActBloomberg BNA's Patent, Trademark & Copyright JournalScott A. Felder, Rachel K. Hunnicutt