Rebecca B. Kimmelfield
Associate
Dr. Rebecca Kimmelfield is a member of Foley’s Chemical, Biotech & Pharmaceutical Practice. She began her career at Foley as a summer associate in 2021 and 2022.
Prior to joining Foley Rebecca completed a PhD at The Ohio State University, during which she had the opportunity to participate in the I-Corps@Ohio program as well as intern at a biotech company.
Presentations and Publications
- Co-author, “FDA: The Effects of Loper on the Regulatory Agenda,” Health Care Law Today (August 1, 2024)
- Co-author, A Combined Metabolomics and Fluxomics Analysis Identifies Steps Limiting Oil Synthesis in Maize Embryos. Plant Physiology. (September 17, 2019)
FDA: The Effects of Loper on the Regulatory Agenda
The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency, including the U.S. Food & Drug Administration.
USPTO Publishes Drug Patent and Exclusivity Study Report
The U.S. Patent and Trademark Office in conjunction with the Food and Drug Administration, and in response to January and April 2022 letters from Senator Thom Tillis, has published a report examining the time from approval of a New Drug Application until the first generic launch for 25 drug products, including consideration of patent and regulatory exclusivities.
USPTO Issues Updated Guidance on Obviousness
For the first time in nearly 15 years, the U.S. Patent and Trademark Office has issued “Updated Guidance for Making a Proper Determination of Obviousness” under the U.S. Supreme Court’s ruling in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
USPTO Releases Guidance on Rule 132 Declarations
The U.S. Patent and Trademark Office (USPTO) has released new training materials on “Declaration practice under 37 CFR 1.132 (Rule 132).”
Time Has Run Out for China’s 15-Day Mailing Rule
As of January 20, 2024, applicants are no longer able to enjoy a 15-day grace period for most response deadlines pertaining to patent applications being pursued in the Chinese National Intellectual Property Administration.
A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for biosimilars.