Gabe McCool has over 17 years of experience advising clients in the life science industry on intellectual property matters, particularly in the areas of patent preparation, prosecution, and strategic counseling. He has advised biopharmaceutical, biomedical device, pharmaceutical, contract manufacturing, and molecular diagnostic companies of all sizes and stages of growth, ranging from startup companies through global corporations. Gabe also has extensive experience counseling universities and research institutes on a range of patent matters. In addition, he has significant in-house experience at a global biopharmaceutical corporation as a seconded patent attorney where he developed patent portfolios covering FDA-approved biologics and pharmaceutical products.
Gabe's experience spans a wide range of biotechnology areas, including therapeutic antibodies and proteins, pharmaceuticals, stem cells, genome-editing technology, bioprocessing, gene therapy, medical diagnostics, vaccines, nucleic acid-based therapies, and biomedical devices.
In addition, he has substantial experience in conducting patentability studies, freedom-to-operate analyses, and due diligence, as well as providing legal opinions addressing patentability, clearance, and validity inquiries. He has also has experience with post-grant proceedings and interferences before the USPTO, as well as opposition proceedings before the European Patent Office. Gabe has also supported various litigations involving generic drug patent disputes arising under the Hatch-Waxman Act and has provided counseling on biosimilars and the Biologics Price Competition and Innovation Act.
Gabe’s doctoral research focused on understanding the genetic and biochemical basis of polyhydroxyalkanoate synthesis in bacteria and their application as bioplastics.
Gabe is a co-inventor on US Patent No. 6,835,820, which relates to his doctoral research. Gabe has also co-authored numerous scientific and legal publications and regularly moderates and/or presents on IP-related topics.