Federal Circuit - The FindLaw Federal Circuit Court of Appeals Opinion Summaries Blog

Personalized Medicine Gets a Booster Shot From Patent Court

When new drugs come on the market, the warnings about side effects can seriously dampen the advertised benefits.

Personalized medicine through genetic testing holds the promise of changing all that. Designed to reduce adverse side effects on an individual basis, it seeks customized solutions for all kinds of ailments.

In Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, a federal appeals court affirmed the validity of a patent for treating schizophrenia based on such genetic testing. Industry watchers say it could help solve problems before they begin.

Dosage Regimen

However, there was a problem between Vanda Pharmaceuticals and West-Ward Pharmaceuticals. They both claimed patent rights to a process for administering the antipsychotic drug Iloperidone.

In patients with poor metabolism, the drug will stay in their system longer and heighten the risk of side effects. A personalized process involves a dosage regimen based on a patient's genotype.

"At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome," the Federal Circuit Court of Appeals said.

The appeals court affirmed a trial court decision, which enjoined West-Ward from manufacturing, using or selling the disputed product until Vanda's patent expires in 2027.

"Law of Nature"

It was a close call for personalized medicine, however. Chief Judge Proust said the claims were unpatentable based on the "law of nature" under Mayo Collaborative Services v. Prometheus Laboratories, Inc.

"This is no more than an optimization of an existing treatment of schizophrenia," he wrote.

Commenting on the decision, JDSupra said it was "an interesting case to keep in mind" when considering the patentability of personalized medicine in the future.

"The holding here highlights the importance of effective claim drafting to present your patent application in such a manner that conveys subject matter eligibility to the USPTO and the courts," the online journal said.

Related Resources: