It's never good news when the U.S. Patent Office rejects your patent, but at least it's not the final word--yet. Yesterday, Gilead Sciences saw its four key patents on its anti-HIV med Viread (tenofovir disoproxil fumarate, also found in the Atripla combo pill [1]) declared invalid. Apparently, other people publicized the necessary technology before Gilead applied for its patent, and if the patent office had known about that prior work, the patents would never have been issued in the first place.
However--and this is a big however--the company can now try to prove that its work is original enough to qualify for the patents. "We now have the opportunity to address the PTO's questions," a Gilead spokesperson told Pharmalot. "[W]e do not believe the exclusivity of any of our products is in jeopardy."
Of course not. But the Public Patent Foundation, which challenged Gilead's patents on behalf of HIV/AIDS patients, says it's convinced otherwise. PubPat says requests for re-examination like the one it filed against Gilead cause the patents in question to be revoked or changed more than two-thirds of the time. "This means that we are now well on the way" toward getting cheaper generic versions of Viread to patients, the foundation's executive director said in a statement. But upon questioning by the Mercury News, he admitted that re-examined patents are revoked only 10 percent of the time.
As bureaucracy moves slowly, and Gilead retains patent protection until the patent office issues a final decision and through appeal, Viread and Atripla are safe for some time. And that's a good thing for Gilead, because its TDF-containing meds accounted for 83 percent of its $4.3 billion in 2007 sales.
- see the release [2] from the Public Patent Foundation
- read the The Mercury News report [3]
- here's an item [4] from Pharmalot
Related Articles:
Standards on biotech patents get tougher. Report [5]
Viread data points to role in HIV prevention. Report [6]
Viread program mired in controversy. Report [7]
Links:
[1] http://www.fiercebiotech.com/story/spotlight-fda-oks-three-in-one-aids-drug/2006-07-13
[2] http://www.fiercebiotech.com/press-releases/u-s-patent-office-rejects-key-hiv-aids-drug-patents-pubpat-request
[3] http://www.mercurynews.com/business/ci_8057299?nclick_check=1
[4] http://www.pharmalot.com/2008/01/gilead-hiv-patents-rejected-by-uspto/
[5] http://www.fiercebiotech.com/story/standards-on-biotech-patents-get-tougher/2006-09-26
[6] http://www.biospace.com/news_story.aspx?NewsEntityId=61010
[7] http://www.fiercebiotech.com/story/spotlight-viread-program-mired-in-controversy/2006-06-30