Hatch Waxman Expert Witnesses

Cambridge, Massachusetts

Medical Devices, Intellectual Property - Patent litigation, Hatch Waxman, ANDA, Inhaler, Inhalation, Inhaled drug delivery, Drug delivery device, Intellectual property, Branded Pharmaceutical, Generic Pharmaceutical, Respiratory, Medical device, Device design, Device development, Trade secret, Asthma, COPD, Consulting expert, Hatch-Waxman, Expert Witness

Matthew Sarkar brings a rare combination of insider industry experience and expert witness credentials to Hatch-Waxman patent litigation involving inhaled drug delivery and respiratory device technology. As a co-founder of the device business acquired by Vectura plc — one of the UK's leading inhaled therapeutics companies — he led the development of novel inhalation devices from concept through clinical trials, and subsequently took strategic responsibility for Vectura's device IP portfolio, managing licensing, due diligence, and technology transfer across the respiratory sector. He is a named inventor on more than 20 granted patent families in medical and drug delivery technology, giving him direct, first-hand insight into the inventive process that is central to patent validity and infringement analysis. Mr Sarkar has provided expert analysis in Hatch-Waxman litigation involving inhaler technology, breath actuation, and dose counter mechanisms. His technical expertise spans the f...

Princeton, New Jersey

Chemistry & Chemicals, Pharmaceutical Research - Synthetic Organic/Medicinal Chemistry, ANDA Expert Witness, DPP4 SGLT2 ANDA, HatchWaxman, Obviousness, Enablement, Infringement, Invalidity, Paragraph IV, Patent IP and Litigation, Osimertinib EGFR, GLP-1 agonists, Sitagliptin, drug discov. and development, Dapagliflozin, venclexta bcl2, btk Ibutinib, Adagrasib KRASG12C, FLT3, POSITA

With over 10 years of experience as an expert witness at DJ Augeri Pharma Consulting LLC, I specialize in pharmaceutical patent litigation, specifically in the areas of synthetic organic and medicinal chemistry, drug discovery, and CMC/API process development. I provide critical support for legal clients, offering expert reports, prior art review, claims interpretation, and testimony in U.S. and Canadian courts. My work spans patent infringement, validity, obviousness, and enablement analyses, as well as consulting on ANDA/Hatch-Waxman litigation, with a focus on diabetes and oncology drugs. I am committed to advancing pharmaceutical innovation by combining my expertise in medicinal chemistry, structure–activity relationships, and drug development, from preclinical research to IND submissions. My technical contributions include designing alternative compounds, optimizing drug properties, and overseeing CMC facets of clinical development. I strive to provide high-quality, data-dri...