The patent on K-Dur 20 expires in September 2006. Schering-Plough intends to proceed with a vigorous defense of the administrative complaint. According to Bloomberg, Schering-Plough did not sell four of the licensed products and little of the fifth. Action follows settlements in other similar cases The FTC files an administrative complaint after determining that a violation has occurred and after failing to reach a settlement with the alleged violator.
Settlements are common.
System encourages problems Drug patent holders and generic drug makers are in a bind, which can be partly blamed on the Hatch-Waxman Act. The Act, passed in 1984, sought to balance laws that added years to existing drug patents to compensate for years taken up with testing and regulatory review, with encouraging cheaper generic drugs. The early filing and approval is important because a generic drug maker wants to have its drug ready to go the day of patent expiration, so as not to lose one single sale during the market-exclusivity period. In practice, Hatch-Waxman has encouraged generic drug development but also led to all sorts of strategic FDA filings, lawsuits over patent infringement, and settlements. Some have speculated that this kind of FTC enforcement might disappear with appointments in the Bush administration, because the Commission is currently 3-2 in favor of Democratic appointees.