A lawsuit about an insomnia medication has kept lawyers awake at night for the last five years. Who would have thought?
Tyco Healthcare manufactures Restoril, an insomnia medication. The patent covers formulations of Restoril with a particular surface area. Its competitor, Mutual Pharmaceutical, wanted to make a generic version of Restoril with a larger surface area. Tyco sued for patent infringement, but a district court agreed with Mutual, finding that a generic version of Restoril with a larger surface area couldn't possibly infringe on Tyco's patent. It also ultimately invalidated Tyco's patent, which it acquired from another company, as being prior art.
After that lawsuit didn't work, Tyco filed a citizen petition with the FDA, urging it to reconsider its guidelines for generic makers of Restoril -- and conveniently, those guidelines suggested that the same larger surface area that Mutual wanted to manufacture shouldn't be approved for use. For safety, you know. The FDA denied the petition, which "reli[ed] entirely on uncorroborated generalities and theoretical speculation." Mutual then counterclaimed that Tyco was engaging in "sham" litigation and antitrust behavior to keep Mutual from selling generic Restoril.