[Ip-health] U.S. Patent Office Rejects Key HIV/AIDS Drug Patents at PUBPAT Request

Daniel B. Ravicher ravicher@pubpat.org
Wed Jan 23 14:53:00 2008


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

New York, New York -- January 23, 2008 -- 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.

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 rejecting all of the claims
of each of the four patents, can be found at
http://www.pubpat.org/gileadhivaidsdrug.htm.

Contact:

Daniel Ravicher, Executive Director
Public Patent Foundation
(212) 796-0570
info@pubpat.org
http://www.pubpat.org

About the Public Patent Foundation

The Public Patent Foundation ("PUBPAT") is a not-for-profit legal
services organization working to protect the public from the harms
caused by the patent system, particularly the harms caused by undeserved
patents and unsound patent policy.  PUBPAT provides the general public
and those specific persons or businesses otherwise deprived of access to
the system governing patents, with representation, advocacy, and
education.  To be kept informed of PUBPAT News, subscribe to the PUBPAT
News List by sending an email with "subscribe" in the subject line to
news@pubpat.org. To be removed from the PUBPAT News List, send an email
with "unsubscribe" in the subject line to news@pubpat.org.

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