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. Patent and Trademark Office
Rachel 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, Paragraph IV litigation, and patent term extensions. In addition, Rachel has extensive experience in all phases of Hatch-Waxman patent litigation.
- Rachel has represented clients in intellectual property disputes relating to a wide variety of technologies including pharmaceutical products, therapeutic antibodies, drug release rates, 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), and 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 Intellectual Property Law Association (AIPLA)
News & Insights
- 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 ConferenceSonali P. Gunawardhana, Speaker, Rachel K. Hunnicutt, Speaker
- January 29, 2015 | Speaking EngagementMedical Device Manufacturers AssociationSonali P. Gunawardhana, Rachel 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