David J. Augeri

Innovative Medicinal Chemistry director at Lexicon Pharma who led multidisciplinary teams of 12-16 PhD-level senior scientists pursue 3 INDs, has been credited with FDA-approved drug discoveries in diabetes and oncology, acquired a first-rate education in pharmaceutical IP and has served on nearly 20 cases in US Federal Court as an Expert Medicinal Chemistry Witness in pharmaceutical IP litigation. I have authored dozens of provisional and non-provisional patent applications and many of the sections contained within issued US Patents. I have provided testimony 3 times in the past 4 years. I have served on cases predicated on enablement and/or infringement complaints as well as obviousness as the central complaint in ANDAs (DPP4/GLP-1/SGLT2). These ANDAs derived from my core pharmaceutical expertise in diabetes drugs of the class DPP4 inhibitors and SGLT2 inhibitors. The GLP-1 agonists have rewritten the priorities in the incretin hormone arena. I conducted drug discovery/drug design research in oncology for 12 years first with the AbbVie NMR Research Group where we identified the lead molecule for the Venclexta bcl-2 inhibitor program. Over time my experience has extended to many of the most important oncology disease targets in the field including multiple myeloma, P32MAP Kinase, P53, BMP2, MMPs (Gel A/B), Kras, btk, EGFR, HER-2 and bcl-2 with the AbbVie NMR group - there, we discovered the lead acylsulfonamide chemotype for Venclexta (FDA2015). I observed the beginnings of antibody-drug conjugatges, used humanized monoclonal antibodies in ADC at AbbVie. Also, I watched new technologies evolve such as Heat Melt Extrusion (HME) and Amorphous Solid Dispersion technology (ASD). I then moved to BMS to discover the DPP4 inhibitor saxagliptin (FDA2009) for the treatment of T2DM. I published approx. 40 research articles in top journals like Nature, JACS and J Med Chem. I am also listed as an inventor on 60+ issued US Patents. I am quite thorough with the patents at issue in each case. I have prepared 20+ reports in a Chemical Reviews journal format for the US and Canadian Federal Court justices on either the drug or the drug class in preparation for the case. I review documents submitted for Discovery by the opposition, provide depositions and testimony and I prepare relevant questions for Discovery.

• Amgen Canada Inc. & Onyx Therapeutics Inc. v. Dr. Reddy's Laboratories Ltd., 2024
• Shionogi, Hoffmann-La Roche, and Genentech vs. Norwich Pharma., 2023
• Linagliptin vs. B.I., Canada., 2021-2023
• Merck. Canada ANDA., Expert regarding Januvia., 2021-2023
• University of Michigan., Expert regarding Genzyme sphingosine-1-phosphate and ceramide signaling., 2020-2021
• Expert Witness ANDA Trazodone., 2020-2021
• AstraZeneca, (saxagliptin ANDA; Mylan, expert for Onglyza), 2020-2022
• Empagliflozin-BI vs. Zydus., Expert regarding Jardiance., 2019
• BMS (saxagliptin ANDA, expert witness), 2018-2019
• Merck (sitagliptin ANDA, expert witness), 2018-2019
• Pharmacyclics v. Acerta., (BTK, acalabrutinib/ibrutinib expert consultant), 2014-2017

• N-AziridinylImines; Synthetic Methodology for the Efficient Construction of skipped 1,3-syn and skipped 1,3-anti deoxypolypropionate natural products, The 33rd IUPAC International Symposium on Macromolecules International Symposium on Organic Chemistry, 1990-07-09, Montreal, Canada.
• Discovery and Preclinical Profile of Saxagliptin (BMS-477118): A Highly Potent, Long-Acting, Orally Active Dipeptidyl Peptidase IV Inhibitor for the Treatment of Type 2 Diabetes, 2006-06-04, Hershey, Pennsylvania.
• Inhibition of S1P Lyase for the Treatment of Rheumatoid Arthritis, First Disclosures Session, The 239th American Chemical Society Meeting, 2010-03-21, San Francisco, California.
• Saxagliptin: A Rutgers Case Study, Part1 Dr. DJ Augeri, PhD, 2015-10-28, Piscataway, New Jersey, 08854.

–Structure / Fragment-Based Design of Acylsulfonamide as the lead bcl-2 inhibitor chemotype for Venclexta (FDA2015)

–Discovery of Saxagliptin, a DPP4-Inhibitor for diabetes.

–Published 40+ research articles in medicinal chemistry research

–Listed as Inventor on 60+ Issued US Patents

–Awarded funding for 5 NIH R01 grant proposals

–Awarded funding for DoD proposal on malaria drugs

–Awarded funding for NIH R21 research grant

–Supervised team of 12-16 PhD-level scientists

–Collaborated with team of UNC Chapel Hill Neuroscientists Prof. B. Roth MD/PhD and Prof. Ryan Gumpper PhD in the development of new CNS medicines.

• Member of the American Chemical Society Division of Medicinal Chemistry35 years +
• Member of the American Chemical Society Division of Organic Chemistry35 years +

a. Expert Witness and Expert Med Chem/Science Consultant– $600 per hour and $5000 retainer.

Should a case require many hours of work then I would likely negotiate to a lower hourly rate.  I require a $5000 retainer and a flat rate of $600/hour to be applied to the first ten hours of attorney/work product:

Attorney Work Product – $600 hourly

Depositions– $700 hourly

Testimony– $800 hourly

–A top priority is to read the complaint and carefully read the US Patent(s) cited in the complaint.

–The US and Canadian Federal Courts require a background report on drug/drug class in preparation for the case. The report is sort of a slightly shorter version than a review found in Accounts of Chemical Research.

–Read published papers on the drug/drug class and conduct search AS PER ATTORNEY’S instructions. I have performed many different searches, depending on what the attorneys asked for. The content of papers like this are seen in the report that I would write.

–If infringement is the focus of the complaint, then I have helped attorneys prepare for Markman Hearing to go over the claims.

–look at claims that will be covered by the Court for both infringement and enablement.

–work with attorneys to prepare for testimony, testimony for deposition or cross examination.

–Offer expert testimony for deposition or cross-examination.

b. Fee during Travel – Modified hourly rate of 50% - true, I could be in my office attending to other matters at the full rate. 

c. Airfare and hotels should be covered by law firm or client. I will invoice small expenses.