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