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FOR IMMEDIATE RELEASE: October 18, 2005

SCHUMER DEMANDS ROCHE LICENSE TAMIFLU PRODUCTION TO 5 U.S. COMPANIES IN NEXT 30 DAYS TO FILL ORDERS OF BIRD FLU TREATMENT

Roche Says They’re Negotiating, but There is No Evidence – Senator Calls on 1st Company to Be Licensed in 2 Weeks

Today, Roche Says Production is the Biggest Hurdle -- Yesterday, Roche Said Production by Other Companies Not Possible – Other Drug Companies Say They Can Do it

U.S. Senator Charles E. Schumer sent another letter to Roche today demanding that they license production for Tamiflu to five U.S. drug companies in the next 30 days. Tamiflu is the only known effective treatment for the deadly avian flu virus and Roche holds the patent so that the drug can be mass produced but has not licensed it to other companies, which would dramatically increase production. As worldwide concern that this particular strain may soon develop into a deadly pathogen in humans and cause a horrible epidemic in the United States and throughout the world with little ability to treat it, it is imperative that Roche dramatically increase production capability by licensing the patent to other drug makers. Schumer outlined a plan this week for Roche to voluntarily suspend their patent so that other companies can begin to produce the Tamiflu drug. So far, the company has not responded to Schumer’s letters, but has previously denied that other drug companies could produce the drug.

Schumer stated, “Roche must engage in an active campaign to license Tamiflu production to 5 U.S. drug companies in the next 30 days. Roche is putting their own interests ahead of world health. They should not be slow-walking this process when we have a potential pandemic that could occur at anytime.”

“Yesterday Roche said production by other drug companies was impossible, today they are saying that production capacity is key. If they don’t begin to actually license the patent for Tamiflu to dramatically increase worldwide production, I am going to pursue a legislative remedy a month from today,” Schumer said.

Schumer has long been a leader in getting consumers access to more affordable drugs and co-authored with Sen. John McCain the 2003 Generic drug law that brought lower cost prescription drugs to millions. Also, after the Anthrax mail attacks on the U.S. Capitol and other places around the country in 2001, Schumer called on the Department of Health and Human Services (HHS) to contract with generic companies to produce Cipro, a drug prescribed to those who were in the vicinity of the deadly substance. Cipro made by Bayer, was in short supply and prohibitively expensive at a cost of $400 per patient, almost twice the cost of manufacturing the drug. After much public prodding and despite claims that they could not significantly increase production, Bayer tripled production and lowered its price.

Roche currently holds the patent for Tamiflu – the brand name version of oseltamivir and the only effective known treatment for the Bird Flu – through 2016. As the drug's sole patent holder, Roche is limited to producing as much Tamiflu as its manufacturing plants can handle. Many more countries want to stockpile Tamiflu than Roche is able to supply, and the United States is currently far down on the waiting list. If pandemic flu was to happen this flu season, many countries, including the U.S., would be left with no recourse for treatment. Roche has refused to license its product to other companies in order to ease the bottleneck and make sure that each country has enough Tamiflu on hand in case pandemic flu breaks out.

Infectious disease experts advise that each country have enough Tamiflu on hand for 40% - 50% of its population. That would require the U.S. to stockpile enough of the drug for over 100 million people, yet HHS Secretary Michael Leavitt has called for a supply for only 20 million, and the U.S. has only enough pills right now to treat 2.3 million. Experts say that just over 2 million treatments will barely cover the military and emergency workers, who represent about 1% of the population. Roche has said that producing enough pills to treat 20 million people – let alone the 100 million treatments we actually need – will take years.

"If we increase the number of manufacturers producing Tamiflu, we can protect many more Americans should a pandemic hit," Schumer said. "Knowing we have enough Tamiflu, just in case, would go a long way towards calming the public about potential shortages and hopefully dissuade people from buying, stockpiling or even taking a drug they currently don't need."

Though Roche has said it would take any generic company at least three years to ramp up to make the drug, experts in the generic drug industry disagree. Several U.S.-based companies are already interested and believe their existing manufacturing plants can be ready to produce the drug long before Roche can build more of its own. Companies in India, Taiwan and Thailand are prepared to produce the drug.

Schumer said that in order for any of the generic manufacturers to reach agreements with HHS, the U.S. would have to agree not to seek indemnification from the generic drug manufacturers if Roche successfully sued, and would also have to agree to indemnify the manufacturers in the event Roche successfully sued them for patent infringement. Federal law permits the United States to purchase products from manufacturers other than the patent holder, but says that the government could be liable for the patent holder's recovery of "reasonable and entire compensation for such use and manufacture." 28 U.S.C. §1498. No injunction preventing the generic manufacturers from producing oseltamivir and selling it to the government is available under §1498.

Schumer’s letter to Roche is attached.

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