HIV/AIDS Drug Maker's Patents Under Attack

A New York City public interest group yesterday challenged eight patents on the widely used HIV/AIDS drug ritonavir, a protease inhibitor. It wants the U.S. Patent and Trademark Office to hold a formal reexamination of a string of awards made between 1996 and 2008.  

The Public Patent Foundation (PubPat) claims that ritonavir’s maker, Abbott Laboratories of Abbott Park, Illinois, is attempting to maintain an improper monopoly. In extensive documents filed on 26 August, PubPat asks the Patent Office to declare the patents invalid because they fail to describe a new invention and are “causing significant public harm.” The ritonavir patents, PubPat says, inflate the cost of therapy for HIV/AIDS patients and restrict research on related drug possibilities.

PubPat’s director, Daniel Ravicher, argues that “fairness” is the issue. One of Abbott’s central patents (5,541,206), granted in 1996, is substantially the same as a patent the company received in 1992, according to Ravicher. That earlier one (5,142,056) expired in August 2009. Ravicher doesn’t dispute the original invention. But he says it is “greedy” to extend the patent on retonavir beyond the statutory limit of 17 years with slight formula modifications. PubPat makes similar arguments against all eight ritonavir patents. Ravicher also argues that they lack originality because the science in them was discussed in print before the patents were applied for. (PubPat is the same group that persuaded a New York federal court in March to invalidate Myriad Genetics’s patents on breast cancer genes.)

Abbott has been challenged before over HIV/AIDS therapy. PubPat points out that a group of consumers sued the company and tried to overturn its patents on a ritonavir product (Norvir) in 2003 after Abbott raised the price, boosting the cost to a patient from roughly $1.71 a day to $8.57 a day. Abbott fought the suit for years but agreed to settle in 2008, promising to distribute $10 million to patient support groups.

Abbott spokesperson Scott Stoffel said, “We're confident in the validity of our patents and expect they will be upheld.”