Healthy Skepticism Library item: 12579

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Publication type: news

U.S. Patent Office Rejects Key HIV/AIDS Drug Patents at PUBPAT Request: Government Finds Prior Art Submitted By PUBPAT Invalidates All of Gilead Sciences' Claims
PRNewswire 2008 Jan 23
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-23-2008/0004741641&EDATE=

Full text:

The Public Patent
Foundation (“PUBPAT”) announced today that the U.S. Patent & Trademark
Office has rejected four key HIV/AIDS drug patents held by Gilead Sciences
that 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 patents challenged by
PUBPAT and now rejected by the Patent Office 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 filings challenging the patents, PUBPAT submitted prior art that
Gilead had not disclosed to the Patent Office during the patent application
process that resulted in the patents being granted to the Foster City,
California, biopharmaceutical giant. PUBPAT also described in detail how
the prior art would have prohibited the patents from being issued in the
first place, had the Patent Office had been aware of it. The Patent Office
has now agreed with PUBPAT and found that each of the four Gilead Sciences
patents are undeserved. Although Gilead has the right to respond to the
Patent Office’s rejections of the patents, third party requests for
re-examination, like the ones filed by PUBPAT against the four Gilead TDF
patents, are successful in causing the reviewed patents to either be
revoked or changed more than two-thirds of the time.

“We are extremely pleased that the Patent Office has agreed with us
that Gilead’s TDF patents are invalid,” said Ravicher. “This means that we
are now well on the way towards ending the harm being caused to the public
by Gilead’s use of the patents to prevent anyone else from offering TDF to
HIV/AIDS patients in the United States.”

The Gilead Sciences TDF patents challenged by PUBPAT that have now been
rejected 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.