US patent office rejects Gilead Viread patents

US patent office rejects Gilead Viread patents

Wed Jan 23, 2008 3:46pm EST
By Deena Beasley

LOS ANGELES, Jan 23 (Reuters) – U.S. patent officials have rejected four patents on Gilead Sciences Inc’s (GILD.O: Quote, Profile, Research) AIDS drug Viread, but the ruling is not final and the company said on Wednesday it is confident that the patents will be upheld.

The nonprofit Public Patent Foundation had challenged the Viread patents last year. The group said it submitted evidence that the scientific knowledge on which the patents were based had existed before the U.S. Patent and Trademark Office granted the patents to Gilead.

Viread, or tenofovir disoproxil fumarate, is also sold as part of Gilead’s two-drug combination AIDS pill Truvada and as a component of the newer Atripla, which combines Truvada with Bristol-Myers Squibb Co’s (BMY.N: Quote, Profile, Research) Sustiva into a single pill.

Daniel Ravicher, executive director of the patent-challenging foundation, said there was no single source of the “prior art” the group says preceded Gilead’s claims. “It was generally known, ubiquitous knowledge,” he said.

The nonprofit group said Gilead now has the right to respond to the Patent Office’s decision, adding that third-party requests for reexamination, like the ones it has filed against the four Gilead patents, are successful in causing the reviewed patents to either be revoked or changed more than two-thirds of the time.

“This is a typical step in the reexamination process,” said Gilead spokeswoman Amy Flood. “The process may take some time, but we don’t believe the exclusivity of our product is in jeopardy.”

Morgan Stanley analyst Sapna Srivastava said invalidation of the patents “creates an overhang” for Gilead’s HIV franchise.

“While, with our limited knowledge, we strongly believe that Gilead will be able to defend its patents, the PTO rejection does create some uncertainty about Gilead’s core franchise. We expect it will take roughly three to four years to get a final binding decision on these patents,” the analyst said in a research note.

Ravicher said his group has challenged patents from company’s including Microsoft Corp (MSFT.O: Quote, Profile, Research), Pfizer Inc. (PFE.N: Quote, Profile, Research) and Monsanto (MON.N: Quote, Profile, Research) for technologies ranging from stem cells to Internet technologies.

Gilead’s shares fell about 20 cents to $44.00 in late-afternoon trading on Nasdaq. (Reporting by Deena Beasley; editing by Braden Reddall, Richard Chang, Gary Hill)

Four Gilead patents tentatively rejected

By Steve Johnson
Mercury News
Article Launched: 01/24/2008 03:35:22 AM PST

A federal agency has tentatively rejected four patents for one of Gilead Sciences’ key drugs for treating people afflicted with the AIDS virus.

The decision by the U.S. Patent and Trademark Office to initially nullify the patents as it re-examines them is considered common, several experts said. But if the agency later makes a final determination that the patents should be revoked, it could have serious consequences for Gilead.

The patents are for Viread, which is used in three HIV treatments that account for most of the Foster City biotechnology company’s sales. If they are revoked, other companies could seek permission from the U.S. Food and Drug Administration to sell competing versions of the drug.

The agency’s action was made public Wednesday by the Public Patent Foundation, a New York-based consumer advocacy group that filed a petition in March seeking to revoke the patents for the drug, also known generically as tenofovir.

The group contends Viread never should have been patented in the first place, because, unknown to the patent office at the time, it claims the technology used to make the drug had been publicly disclosed previously.

Gilead spokeswoman Amy Flood said it is common for the federal agency to tentatively rule patents invalid after it has been asked by a third party to re-examine them. But she stressed that the company expects the patents’ legitimacy to be reaffirmed.

“We will vigorously defend each and every claim that supports our patent protection, and we remain confident in the outcome,” she said.

Daniel Ravicher, the Public Patent Foundation’s executive director, acknowledged that only about 10 percent of the patents the agency re-examines based on third-party challenges are revoked. And even then, he noted, the patent holder can appeal the agency’s decision, a process that can stretch out for several years.

Nonetheless, the tentative ruling “is a pretty huge deal,” Ravicher said. “These are patents which are being used to create market exclusivity for critical technology. . . . The game isn’t over, but we’ve put several touchdowns on the board.”

Ravicher’s organization claims that Gilead has used the Viread patents to charge exorbitant prices for the drug, limiting public access to the treatment. Although retail prices vary widely, a 30-day supply of Viread can easily cost more than $1,000.

Although a previous challenge by Ravicher’s group got Columbia University to stop claiming a right to one of its biotechnology patents in 2004, he couldn’t recall any biotechnology company having a patent revoked.

Neither could Charles Van Horn, a partner in the law firm of Finnegan Henderson, who previously oversaw biotechnology intellectual-property challenges at the Patent and Trademark Office. But if a company lost a key patent, Van Horn added, “that could certainly result in a loss of significant value.”

Gilead sells Viread under that name and in combination with other drugs as Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company, which reported its earnings Wednesday. That accounted for 83 percent of Gilead’s 2007 product sales.

Overall, the company earned $1.6 billion in profit on $4.3 billion in revenue last year. Its stock price rose 61 cents Wednesday to $44.81.

Gilead patent case to help Indian firms

25 Jan 2008, 0027 hrs IST,Rupali Mukherjee,TNN

NEW DELHI: The US Patent & Trademark Office’s rejection of four patents held by Gilead Sciences on a key HIV drug Tenofovir, paves the way for a more affordable treatment for millions of patients suffering from AIDS.

The US patent office decision strengthens the pre-grant opposition filed in 2006 by Indian Network for People Living with HIV/AIDS (INP+) to several patent applications filed by Gilead on tenofovir disoproxil fumarate (TDF) in India, on the ground that they did not meet the country’s patentability standards.

For the domestic generic industry, the development encourages production of the drug in the country, and gives them opportunities to export to developing countries.

US public interest organization, Public Patent Foundation (PUBPAT) challenged the patents in the US patent office, saying that Gilead’s patent on TDF did not fulfil the criteria of novelty.

With this rejection, Gilead Sciences faces an uphill task to get a patent in India, and other developing countries. Legal experts say, Gilead will now have to share this information with the Indian patent office, which is in the process of examining patent applications on TDF by Gilead.

TDF is important for people suffering with AIDS as a first line treatment, and also for those who have developed resistance to first-line antiretroviral therapy. WHO treatment guidelines include TDF in first and second-line antiretroviral regimens.

INP+, which filed a pre-grant opposition in India is concerned that if patents on TDF are granted access to affordable generic versions of the drug will be affected. Patents granted on TDF by other countries denied people living with HIV/AIDS access to this important anti-retroviral. In fact, Brazil who has granted the patents on TDF has not been able to produce the generic version and has been forced to pay high prices to Gilead to provide the drug to its patients.

The lowest price that Gilead offers TDF (300 mg) in Brazil is $2766 per patient per year, which was nearly halved at $1400 after it threatened invoking a compulsory licence.

The cost of treatment would be one-seventh of that price, if an Indian generic such as Hetero Drugs, Cipla and Matrix offers the drug – at $195 per patient per year.

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