Alzheimer's Patent Battle May be Brewing
Nova Molecular’s plans to run an Alzheimer’s diagnostic service could infringe on an exclusive worldwide licensed granted to Athena Neuroscience.
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Drug companies involved in Alzheimer's disease research are a little fed up with FDA. Some, like Wyeth, believe the agency should put Alzheimer's research higher up on its priority list and allow the use of surrogate endpoints for clinical trials. But FDA says that no validated surrogate exists for Alzheimer's, and until it has hard data from products in development, it is loath to recommend one. A recent reorganization of the agency's neurology group may provide an opening to press home those arguments.
Pfizer was heavily invested in immuno-oncology combinations five years ago, but following setbacks, the pipeline has shifted considerably, shaped partly by the acquisition of Array.
The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.