WASHINGTONPresident Bush has proposed policy changes to restrict the ability of drug companies to extend their patents past their expiration date. Mr. Bush said current federal laws and regulations try to balance the goals of innovation and accessibility.
New drugs have an average of 11 years patent protection before generic versions can be offered. However, companies can extend patent protection by seeking an automatic stay of expiration, which freezes the status quo until the legal questions are answered. Such stays are often based on items as seemingly trivial as the color of a bottle or a combination of ingredients unrelated to the product’s efficacy, the President said.
The FDA will issue a proposed rule that will permit only one automatic stay per generic drug application. Some patents, including those on packaging, will no longer be entitled to protections such as the 30-month automatic stay.