KEY HIV/AIDS DRUG PATENTS CHALLENGED BY PUBPAT: New Prior Art Proves Eight Abbott Laboratories Patents on Ritonavir are UndeservedNew York, NY -- August 10, 2010 -- The Public Patent Foundation (PUBPAT) announced today that it has formally asked the United States Patent and Trademark Office to reexamine eight patents held by Abbott Laboratories (NYSE: ABT) relating to the critical HIV/AIDS drug ritonavir, which is marketed by the Chicago, Illinois pharmaceutical giant under the name brand Norvir.
In its requests, PUBPAT submitted previously unforeseen prior art proving that the patents should not have been granted. PUBPAT also cited recent Federal Circuit case law that supports its detailed arguments for nullification of the eight patents.
The challenged patents, U.S. Patents Nos. 5,541,206, 5,635,523, 5,648,497, 5,674,882, 6,037,157, 6,703,403, 7,148,359, and 7,364,752, are the eight patents listed in the FDA's Orange Book for the 100mg ritonavir tablet approved on February 10, 2010. This tablet is heat stable and does not need to be refrigerated like prior versions of the drug, making it much more convenient for patients.
Among a class of drugs called protease inhibitors, ritonavir was originally developed for its antiviral properties in the treatment of HIV infection and AIDS. However, it is now more widely used for its ability to enhance the efficacy of other protease inhibitors by inhibiting the enzyme that breaks down those drugs. It thus remains a critical drug for HIV/AIDS treatment.
This is not the first time Abbott's popular HIV/AIDS drug has caused controversy. In December 2003, Abbott raised the price of its Norvir brand version of ritonavir from $1.71 a day to $8.57 a day. In response, a consumer group petitioned the NIH to override the then existing patents on ritonavir, because the research underlying those patents had been paid for by government tax-payer funds. Abbott settled a class action antitrust lawsuit regarding the Norvir price raise for $10 million in 2009.
Today over 30 million people worldwide are infected with HIV/AIDS, including more than one million Americans. "Abbott is using these eight patents to prevent anyone else from offering ritonavir to HIV/AIDS patients in the United States," said Dan Ravicher, PUBPAT's Executive Director. "Since the patents are undeserved, they are illegal barriers to the medical treatment that American HIV and AIDS patients need and deserve."
The U.S. Food and Drug Administration will not allow anyone other than Abbott to distribute ritonavir in the United States because Abbott claims the exclusive right to do so via its patents. If PUBPAT's request is granted and the United States Patent and Trademark Office agrees with PUBPAT that the challenged patents are invalid, Abbott will lose the legal right to prevent anyone else from making, using, or selling the subject matter of those patents.
The Requests for Reexamination filed by PUBPAT against the eight ritonavir patents held by Abbott Laboratories can be found at PUBPAT > Ritonavir HIV/AIDS Drug Patents.