Government to pharma companies: stop registering sham patents to delay generics

Mike Masnick writes that the Federal Trade Commission has taken a dim view of sham patents registered by pharmaceutical companies to spook competitors eager to release generic drugs.

…despite enforcement against such abuse years ago, it seems that the FTC and the FDA have kinda let these things slip over the past few years. And Big Pharma has really taken advantage of that. Thankfully, it looks like the FTC is finally interested in cracking down on this practice again. In a new policy statement, it warns pharma companies that it's looking into the abuse of the Orange Book and sham patent inclusions.

The Orange Book is a registry of medicines under patent ('approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information.) and the abuse centers on fraudulent additions.

Brand drug manufacturers are responsible for ensuring their patents are properly listed. Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. When brand drug manufacturers abuse the regulatory processes set up by Congress to promote generic drug competition, the result may be to increase the cost of and reduce access to prescription drugs.

In the absense of enforcement, corporations are free to break the law. As Masnick puts it, "It seems the dumbest possible system is to assume that the Big Pharma companies will be honest in their Orange Book listings."