Senator Schumer Press release calling for use of 28 USC 1498 to authorize generic manufacture of oseltamivir (TN: Tamiflu)

Schumer’s October 16, 2005 press release

As Avian Flu Closes In On U.S., Schumer Calls For Immediate Action: Demands Suspension Of Tamiflu Patent So Vaccine Can Be Mass-Produced, Dramatically Increasing Supply

Tamiflu, the Only Effective Treatment of Bird Flu in Humans is in Short Supply; Roche, the Only Producer of the Drug, Refuses to License Others

Schumer Plan Allows Roche to Be Reimbursed, but Requires Compulsory License Because of Shortage

While just this week Avian Flu came even closer to New York with the first ever confirmed cases in Europe and as experts predict a shortage for Tamiflu, the only known effective treatment for Avian Flu in humans, U.S. Senator Charles E. Schumer called for the temporary suspension of the Tamiflu patent so that the drug can be mass produced. Schumers call comes on the heels of 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. Schumer has been a leader in getting consumers access to more affordable drugs. He authored the Generic drug law that brought lower cost prescription drugs to millions, it passed in 2003.

Under my plan, everybody wins: Americans get the treatments they need if a pandemic hits, generic manufacturers get paid for producing the drug, and Roche gets paid for doses it couldnt possibly produce on its own, Schumer said.

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 U.S. Department of Health and Human Services 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.”

In an effort to ensure that the United States doesnt face a deadly shortage of the drug today Senator Schumer called for compulsory licensing of Tamiflu. The Senators plan will compensate Roche for the extra drugs produced by other companies compensation Roche would not receive if no one was allowed to make extra doses of the drug. The problem, Schumer explained, is not the expense of the drug but rather the shortage of supply, which would immediately be rectified if other companies were able to produce it.

Schumer said today that he is calling on Roche to issue compulsory licenses within a month, if not he will do it with a legislative vehicle. Under the Senators proposal, the government will contract with a limited number of generic companies to produce just as much Tamiflu as is needed for stockpiling purposes. It will make two equivalent payments for each dose of drug produced: one to Roche for the use of its technology, and one to the generic company for completing the production.

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 it would take only a few months to get the capabilities up and running, and under a month if Roche cooperates voluntary. Companies in India and Taiwan are already prepared to begin production.

Schumer said that in order for any of the generic manufacturers to reach agreements with HHS, the United States 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.

“Although it seems unlikely that Roche would sue to prevent the United States from obtaining Tamiflu,” Schumer said, “if that happens, the generic manufacturers need to be protected. Otherwise, they can’t sell Tamiflu to the government and that puts us back to square one.”

The bird flu (knows as H5N1) has killed tens and maybe hundreds of millions of animals since it appeared in Asia in 1997 and has infected 120 people, killing half. The strain has been identified as a type A influenza virus which is both genetically versatile and able to elude a variety of defenses making it extraordinarily dangerous. This specific type of virus constantly changes as it replicates. Additionally H5N1 has never been a strain of flu before, so nobody has any form of immunity to this type of flu.

H5N1 can also swap genetic materials and merge. This reassortment process creates a new strain that differs from both the parent strains and as a result, no population has immunity to the new strain and no existing vaccines can protect them. According to the World Health Organization (WHO), H5N1 has a documented ability to cause severe disease in humans.

Even birds that survive the infection excrete the virus for at least 10 days, orally and in feces, thereby facilitating further spread at live poultry markets and by migratory birds. The spread of infection in birds increases the opportunities for direct infection of humans. If more humans become infected over time, the likelihood also increases that humans, if infected with both human and avian influenza strains, could serve as the mixing vessel for the emergence of a new strain with sufficient human genes to be easily transmitted from person to person. Such an event would mark the start of an influenza pandemic.

New York is a potential breeding ground for an influenza pandemic. With a population of over 8 million people and a population density of nearly 27,000 people per square mile, New York City could be easily devastated by an airborne disease like the avian flu. Once the bug jumps the species barrier, the large and dense population in the city would allow it to spread quickly and health authorities would have very little time to respond. New Yorks enormous tourist industry makes the city particularly vulnerable; in 2003 there were nearly 4 million international visitors, and 2004 brought even more to the city.

The bottom line is, once the avian flu develops in people it will get to New York in the blink of eye and we must prepare for the worst because if we dont once avian flu arrives we will be defenseless, said Schumer. By allowing other companies to produce this critical vaccine well be much better prepared should the Avian Flu come our way.

Schumer is also a cosponsor of the Pandemic Preparedness and Response Act of 2005 (S. 1821). The bill would:

” Prepare for a pandemic by finalizing, implementing, and funding pandemic preparedness and response plans.

” Improve surveillance and international partnerships so we may monitor the spread of avian influenza and detect the emergence of a flu strain with pandemic potential immediately.

” Protect Americans though the development, production, and distribution of an effective vaccine

” Plan ahead for a pandemic by stockpiling antivirals, vaccines, and other essential medications and supplies.

” Strengthen our public health infrastructure.

” Inform Americans by increasing awareness and education about pandemic flu.

According to the Wall Street Journal, scientists believe that flu pandemics occur in 25year cycles, the most recent pandemic was in 1968. In the past century there have been three flu pandemics, each triggered by genes in bird viruses. The 1918 pandemic left 40 million people dead, and between one and four million died in each the 1957 and 1968 milder flu pandemics. The common flu spreads through the air making it extraordinarily easy to pass from one person to another. If the avian flu mutates so that it can spread from person to person, a cough in an office or a sneeze in a subway car could have dire consequences. Avian flu symptoms in humans start off with a mild fever, joint pain and headaches and develops into fever and respiratory difficulty. As oxygen gets cut off from the brain, coma and death may follow. I refuse to stand by, fearing an impending public health disaster, Schumer said. The ability to create more of the only known, effective vaccine is a common sense solution.

Schumer was joined today by W. Ian Lipkin, MD; Director of the Greene Infectious Disease Laboratory at the Columbia University Medical Center Mailman School of Public Health and Dr. Anne Moscona a Professor of Pediatrics and Vice Chair for Research of Pediatrics at New York Weill Cornell Medical Center.