January 25, 2008
|The generic Truvada would look pretty different|
In what could be a major gain for millions of people living with HIV/AIDS in poor countries, the U.S. Patent & Trademark Office (USPTO) rejected four HIV/AIDS drug patents held by Gilead Sciences that relate to the antiretroviral tenofovir disproxil fumarate (TDF), known as tenofovir and marketed under the brand name Viread and as part of the Atripla and Truvada combos.
"No one can deny that tenofovir is a very helpful drug. But that doesn't mean there are merits to Gilead's patents," said Dan Ravicher, executive director of the Public Patent Foundation (PUBPAT), the small not-for-profit that challenged Gilead's patents. "To allow Gilead to have an undeserved monopoly decreases availability, increases price and otherwise restrains access to the drug."
For many of the 40 million people with HIV/AIDS worldwide who cannot afford brand-name antiretrovirals, access to generic drugs is literally life saving, and the use of older drugs that are no longer under patent has been critical to the massive scale-up in AIDS treatment during this millenium. The 2001 Doha Declaration, signed by 142 countries including the U.S, confirmed the right of poor countries to break drug patents and produce cheap generic drugs in the event of epidemics like HIV. Doha does not apply to second-generation drugs like tenofovir, however.
The USPTO's decision, which PUBPAT announced Wednesday, was a "non-final rejection," and Gilead will be given the chance to defend itself. Gilead spokesperson Amy Flood told the Update, "The U.S. Patent and Trademark Office's action is typical in the re-examination process. We now have the opportunity to address the Patent and Trademark Office's questions. We will vigorously defend each and every claim that supports our patent protection, and we remain confident in the outcome. The process of a challenge -- like the one from PUBPAT -- may take time, but we do not believe the exclusivity of any of our products is in jeopardy." PUBPAT expects two to five more years of litigation ahead.
Despite the David-and-Goliath nature of the battle, an April Supreme Court decision could put Gilead at a disadvantage. In KSR v. Teleflex, the court ruled that the rarely enforced 1952 "obvious test" stands. This means that for an invention to receive a patent, it must not only be proven to be new, but it cannot be patented if a "person having ordinary skill in the art" would consider it an obvious creation. During PUBPAT's appeal, the USPTO ruled that for four Gilead patents, that was not the case.
This leaves treatment activists fairly optimistic. "The odds of busting the patents are not that low," said James Love, director of the Consumer Project on Technology, who has challenged patents for HIV/AIDS drugs. Still, he cautioned not to expect a generic-Truvada coming out of the U.S. in the near future. "Even in the best of circumstances, the fact that you might win eventually doesn't mean you'll win in the short-term. And even if these patents don't survive, Gilead might have other patents."
And this is primed to be a worldwide battle, since each country has different patent laws as well as patents that are issued. Currently in India, not-for profit HIV/AIDS organizations are fighting Gilead's patents there. There has yet to be a decision. "Because of political reasons, the process to date has been extremely difficult," Ravicher said. "But we expect if a decision is made on merits, the challenges will win."