Jeremiah B. Frueauf is a director in Sterne Kessler’s Biotechnology & Chemical Practice Group. Jeremiah counsels domestic and international clients on patent procurement, product development and clearance strategies, and protection of complex worldwide patent portfolios. Jeremiah leverages his experience in numerous inter partes disputes, including district court litigation, PTAB litigation (inter partes reviews and post-grant reviews), and Section 337 investigations before the USITC to help patent owners and challengers craft and execute patent strategies that best align with their business needs.
Jeremiah counsels clients across the life sciences spectrum, from small and large molecule development, to bio-based products for the bioeconomy, to personalized medicine, molecular diagnostics, and biosensors. His clients span from early-stage start-ups and SMEs to multinational corporations, and he is frequently sought after to provide strategic advice to support clients’ product development—from conception to launch. Jeremiah practices primarily in the fields of small molecules, chemistry, next-generation sequencing and massive parallel sequencing technologies, immunology, immunotherapy, antibody technologies, microbiome-based technologies, synthetic biology, biologics, biotherapeutics, and drug delivery. He has extensive experience advising clients on freedom-to-operate and patentability issues, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments.
Jeremiah’s IP due diligence evaluation and counseling are critical to his clients’ businesses in the context of raising and investing growth capital, executing strategic partnerships and M&A transactions and going public. Representative recent matters in which he served as IP lead:
- Represented licensee company acquiring exclusive licenses and development rights for two small molecule assets in late clinical development for treatment of metabolic disorders, including type 2 diabetes, for deals valued at $20 million upfront and $513.8 million in milestones and $35 million upfront and $615 million in milestones.
- Represented company acquiring exclusive licenses and development rights for spin-out RNA therapeutics company jointly owned with patent owner for deal involving $37.5 million in transaction-related seed capital. Involved technology included RNA lipid delivery platform.
- Represented venture funds in $30 million Series B financing for biologic asset in clinical development for metastatic bladder cancer.
- Represented acquired company for dermatological therapeutic in mid-stage clinical development for deal valued at $229 million upfront and $618 million in milestones.
He is a contributing author of Patent Office Litigation, a two-volume set focused on the new contested proceedings under the America Invents Act published in 2012 by Thomson Reuters Westlaw. This book examines how the proceedings interact with other aspects of patent procurement and enforcement, and delivers practical analysis and advice. In particular, Jeremiah co-authored Chapter 6, entitled “The Patent Trial and Appeal Board (PTAB),” which is a comprehensive review of practice before the PTAB in inter partes proceedings.
Prior to joining Sterne Kessler, Jeremiah was a Biologist at the National Cancer Institute where he studied the molecular signaling pathways related to programmed cell death using various molecular, biochemical, and proteomic technologies. He also assisted in the administration of phase II clinical trials related to an ovarian cancer therapeutic.
Jeremiah's graduate work at Michigan State University as a member of the Starch Bio-Engineering Group focused on analysis of the structure/function relationships of the enzymes involved in starch and glycogen biosynthesis. His work included successful alteration of the catalytic activity and inhibitor specificities of these enzymes to affect the recombinant production of starch or glycogen molecules.
- Frueauf J. B., Ballicora M. A., and Preiss J. (2003) “ADP-glucose Pyrophosphorylase from Potato Tuber. Site-Directed Mutagenesis of Homologous Aspartic Acid Residues in the Small and Large Subunits” Plant J. 33: 503-11.
- Frueauf J. B., Ballicora M. A., and Preiss J. (2002) “Alteration of Inhibitor Selectivity by Site-Directed Mutagenesis of Arg294 in the ADP-glucose Pyrophosphorylase from Anabaena PCC 7120” Arch. Biochem. Biophys. 400: 208-14.
- Frueauf J. B., Ballicora M. A., and Preiss J. (2001) “Aspartate Residue 142 is Important for Catalysis by ADP-glucose Pyrophosphorylase from Escherichia coli”J. Biol. Chem. 276: 46319- 25.
- Ballicora M. A., Frueauf J. B., Fu Y. B., Schurmann P., and Preiss J. (2000) “Activation of the Potato Tuber ADP-glucose Pyrophosphorylase by Thioredoxin” J. Biol. Chem. 275: 1315-20.
Law Review Articles
- Jeremiah B. Frueauf, "A Comparison of Section 337 Decisions at the ITC and Parallel District Court Proceedings: The Commission's Decisions Affect Dispositions at the District Courts," Vol. XXII 337 Rep., ITC Trial Law. Ass'n, 4th Ann. Summer Associate Edition 31 (2006).
- Jeremiah B. Frueauf, Note, "Making Your Business Fly Above Section 183: Fair Skies Following Rabinowitz v. Commissioner," 59 Tax Law. 887 (2006).
- Bisnow, "Trending 40 Lawyers Under 40" (2016)
Jeremiah’s representative inter partes matters include:
- Eli Lilly and Company v. Teva Pharmaceuticals International GmbH et al, Nos. IPR2018-01711, -01712, -01710, -01422, -01423, -01424, -01425, -01426, -01427 (P.T.A.B. 2018) (Representing patent owner Teva Pharmaceuticals International GmbH in defense of 9 patents challenged in IPR proceedings).
- In Re: BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Nos. 2-14-md-02510; 2-13-cv-00954 (D. Utah 2013, 2014) (Represented patent challenger GeneDx, Inc. against University of Utah Research Foundation and Myriad Genetics in district court litigation and IPR challenges to 13 asserted patents related to BRCA1/2 sequence mutations).
- Merck Sharp & Dohme Corp. v. Ono Pharmaceutical Co., Ltd., Nos. IPR2016-01219, -01217, -01218, -01221 (P.T.A.B. 2016) (Represented patent owner Ono Pharmaceuticals Co., Ltd. in defense of 2 patents challenged via 4 IPR petitions).
- Butamax Advanced Biofuels LLC v. Gevo, Inc. (Represented patent owner Butamax Advanced Biofuels LLC in defense of several patents, as well as in challenge of several patents owned by Gevo, Inc., before the PTAB in inter partes and ex parte reexamination proceedings).