Case Study: IP Resulting From Research of Dr. Roberta Diaz Brinton
Dr. Roberta Diaz Brinton, Director of the Center for Innovation in Brain Science at the University of Arizona and Professor of Pharmacology and Neurology in the College of Medicine (Tucson), is a leading authority on the bioenergetic and regenerative systems of the brain. Her ground-breaking research has discovered that the neuro-steroid allopregnanolone can activate neural stem cells to grow new brain cells, restoring brain function lost during the progression of Alzheimer’s disease. Over the course of 12 years, with research conducted at multiple universities, Dr. Diaz Brinton made the initial discovery and patented her IP. Additional post-patent research uncovered the critical importance of specific dosing regimens as an integral part of the protocol effectiveness.
Dr. Diaz Brinton turned to Pabst Patent Group (PPG) after examiners at the USPTO repeatedly denied her applications for additional protections related to dosing regimens, citing her own work against her and prior protections as sufficient. PPG appealed the decision, arguing before the PTAB that examiners overlooked just how central the dosing regimen was to allopregnanolone’s efficacy. Without this additional knowledge, patients on allopregnanolone showed little improvement; but with the proper regimen, progress was stunning. PPG won the appeal, securing application approval on behalf of the client. This additional IP protection has been instrumental in receiving research funding for further Phase III development, and opens up future commercialization opportunities.
Dr. Diaz Brinton’s work is considered so groundbreaking in the treatment of Alzheimer’s disease that it has been picked up by the National Institutes of Health (NIH) for clinical trials. More than six million Americans are currently living with Alzheimer’s disease, and one in three seniors dies with Alzheimer’s or another form of dementia, according to the Alzheimer’s Association.