Watson Pharmaceuticals ($WPI) has been vindicated in its fight for the right to sell an Actos generic. A U.S. judge ordered FDA to approve Watson's version of the Takeda Pharmaceutical diabetes drug, slapping aside the agency's move to bar Watson during the first six months of generic availability.
The story starts years ago, when Watson and its rival generics makers Mylan ($MYL) and Ranbaxy Laboratories settled its long-running patent dispute with Takeda. The Japanese drugmaker agreed to allow the three companies to launch Actos copies on Aug. 17, 2012, Bloomberg reports.
So far, so good. But in August, FDA told Watson that it decided to give "another filer or filers a period of 180-day exclusivity." That 6-month hold on the market is highly sought after by generics makers, because price competition kicks in as soon as multiple copies become available.
Watson sued. Mylan and Ranbaxy launched. And Watson argued in court documents that FDA "failed to provide any explanation or basis for its determination," Bloomberg says, and claimed that the agency's decision was "arbitrary, capricious and contrary to law."
Apparently, Judge Amy Berman Jackson was none too please with FDA's handling of the matter. She ordered FDA to usher Watson's product onto the market. Her written opinion is under wraps, at least for now.
- read the Bloomberg coverage
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