PUBPAT News: Key HIV/AIDS Drug Patents To Be Reviewed By U.S. Patent Office

Date:  Wed, 2007-07-18

Dr. David E. Martin July 18, 2007

KEY HIV/AIDS DRUG PATENTS TO BE REVIEWED BY U.S. PATENT OFFICE: Prior Art Submitted by PUBPAT Raises Substantial Doubt Regarding Validity of Gilead Sciences Claims

New York, NY — July 18, 2007 — The Public Patent Foundation (“PUBPAT”) announced today that the U.S. Patent & Trademark Office has granted each of PUBPAT’s requests to review four key HIV/AIDS drug patents held by Gilead Sciences, Inc. (NASDAQ: GILD). The patents relate to the drug known generically as tenofovir disoproxil fumarate (TDF), a key weapon in the battle against HIV/AIDS. Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product.

Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans. The U.S. Food and Drug Administration will not allow anyone other than Gilead distribute TDF in the United States because Gilead claims the four challenged patents give them the exclusive right to do so.

“Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way,” said Dan Ravicher, PUBPAT’s Executive Director. “This includes Americans infected with HIV/AIDS, who are entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive.”

In its March filings challenging the patents, PUBPAT submitted prior art that the Patent Office did not review before granting the patents to the Foster City, California, biopharmaceutical giant. PUBPAT also described in detail how the prior art invalidates the patents. The Patent Office has now found that PUBPAT’s filings indeed raised “substantial questions” regarding the validity of each of the four Gilead Sciences patents. Having granted PUBPAT’s requests to review each of the patents, the Patent Office will now turn to deciding whether they deserve to exist or not.

“We are very pleased that the Patent Office has agreed with us that there are indeed significant questions about the validity of the Gilead patents on TDF,” said Ravicher. “This is a very strong first step towards ending the harm being caused to the public by Gilead’s use of those patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States.”

The Gilead Sciences TDF patents challenged by PUBPAT now being reviewed by the Patent Office are U.S. Patents No. 5,922,695, 5,935,946, 5,977,089 and 6,043,230. Gilead has applied for similar patents on TDF in other countries throughout the world, including India, where they have received fierce opposition by non-profit AIDS patient groups.

More information about the reexaminations of the four Gilead Sciences TDF patents challenged by PUBPAT, including copies of the official Office Actions issued by the Patent Office granting PUBPAT’s four requests for reexamination, can be found at http://www.pubpat.org/gileadhivaidsdrug.htm.