The second circuit court in New York reviewed claims that Japan-based Takeda Pharmaceuticals delayed a competitor from releasing a generic version of Actos, a diabetes drug, Court House News reports.
Here's what you should know.
1. Several unions and municipalities that purchased the drugs for their employees brought the suit.
2. In a federal complaint, the union argues Takeda monopolized the market and then charged an inflated rate. .
3. Takeda's patent on Actos expired in February 2013, leading to a wealth of competitors attempting to enter the market.
4. Ten pharmaceutical companies tried to make an Actos generic. Takeda allegedly used false patent descriptions to force the generics to earn FDA approval. As they attempted to gain the approval, Takeda filed multiple patent infringement suits and forced the companies into a regulatory bottleneck process.
As one generic gains approval, it receives an exclusivity period of 180 days before another generic could enter the market.
5. Takeda settled three suits, and allowed the generics to release to market on Aug. 17, 2012. The other six companies had to wait until February 2013.
6. Israel-based Teva sought out regulatory approval through a different regulatory scheme, but ended up in the bottleneck with the other generics following an FDA announcement.
7. A court previously dismissed the original antitrust suit, but a second circuit judge reversed part of the ruling concerning Teva's market entry, because the pharmaceutical company required no knowledge of Takeda's patent descriptions.
The ruling said, "Teva’s application received preliminary approval from the FDA in 2006, and if Teva had been granted final approval, then it would not have been subject to the first-filers’ 180-day exclusivity period, and could have begun marketing generic Actos for non-patented uses."