(CN) – A New Jersey-based drug company can’t claim a patent for an Alzheimer’s treatment because it failed to provide in vitro or animal test results, the Federal Circuit ruled.
Drug maker Janssen Pharmaceutica submitted a patent application for a treatment using galantamine, which inhibits the enzyme that breaks down acetylcholine, a neurotransmitter. Scientists have discovered that Alzheimer’s patients have reduced levels of acetylcholine.
Janssen sued to block generic drug companies from making and selling similar galantamine treatments, but the district court ruled that Janssen did not have a valid patent claim.
The Washington, D.C.-based federal appeals court affirmed.
It said the patent application failed to meet the enablement prong of patent validity, which states that anyone skilled in the art could make and use the patented method, or the test for utility, which shows how the method is useful.
Dr. Bonnie Davis, the method’s inventor, admitted that studies showing galantamine’s ability to reverse a certain type of amnesia in rats revealed nothing about its effectiveness in treating Alzheimer’s disease. The tests ignored nicotinic inhibitor damage, which plays a large part in the disease, the ruling states.
Dissenting Judge Arthur Gajarsa said the district court failed to make factual findings to support its rejection of the patent’s validity.
The district court focused on studies surrounding galantamine, and not the actual text of the patent, to find evidence of utility, Garjarsa noted.
He argued that the case should be remanded for further legal analysis.