Pharmacy Times

TAMIFLU:WILL THE PATENT BE BROKEN?

Author: Michelle Whelan

Concerns over the avian influenza A (H5N1) virus have thrust generic drugs into the spotlight as a potential saving grace against the possibility of a worldwide human pandemic. Roche Holding AG, the maker of Tamiflu (oseltamivir), the only known treatment for the virus, has now committed to meeting with generic drug makers and other nations in an effort to increase the supply of the drug.

With both media and government attention focused on possible shortages of Tamiflu, Roche has come under bitter attack, accused of putting profits and patent protection ahead of public health. As governments around the world begin stockpiling Tamiflu, the company may not be able to meet the increased demand for the drug on its own. Although the company has vowed to increase its own production of the drug, Roche also agrees that outside help will be needed to build up preventive stocks in response to the worldwide "bird flu" scare.

The Generic Pharmaceutical Association (GPhA) lauded the drug company's recent move. "Roche's decision to license Tamiflu is a positive step in the right direction," said GPhA spokeswoman Andrea Hofelich. "Generic manufacturers are ready to help the federal government to prepare for the avian flu in any way that they can."

Roche's decision came after Senator Charles Schumer (D, NY) repeatedly called for the branded drug maker to license the avian flu treatment to other drug companies to help increase production. Patent laws around the world, including the United States, allow governments to cancel patents during emergencies and either buy generics or force patent holders to license their formulas to rivals.

Roche, which holds the exclusive patent on Tamiflu until 2016, stressed that it is working with governments and other companies to increase production of the drug. The company says it has received requests for licensing agreements from over 100 companies and governments, and that most talks were still in the early stages.

The drug company has agreed to allow several countries that are most threatened by the avian virus to produce their own versions of the medicine. Thailand and the Philippines, which do not have patent protection for Tamiflu, are free to begin production of Tamiflu to meet the demands of national stockpiling. Indonesia, which has had 12 confirmed cases of human infection of bird flu, has also been granted Roche's blessing to produce the drug, and may do so within the next 3 to 5 months. No specific drug companies have been named at press time.

Taiwan, where Tamiflu does have a patent, has stated it will produce it under compulsory license if its supplies run low. Tamiflu has a patent pending in India, and in China, the Shanghai Pharmaceutical Group is negotiating with Roche regarding producing the drug in that country as well, where the patent is protected.

Roche is considering working with Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories, and Ranbaxy Laboratories to potentially produce more Tamiflu. It agreed to sublicense the production of Tamiflu to those generic drug makers that can produce it in quantities large enough to help meet the anticipated demand in the event of a flu outbreak. The determination as to which generic drug makers get licensed to produce the drug, however, will be made in cooperation with the US government and other governments around the world.

"Roche has graciously stepped up to the plate, and has essentially agreed to share its technology and the rights to manufacture this drug with other companies [that] are willing to help out," said Schumer. The senator noted that he asked Roche not to break the patent on Tamiflu, but to meet an emergency need for quantities of the drug that Roche itself could not do alone.

Not Everyone Agrees with Roche

Pharmaceutical Research and Manufacturers of America president and chief executive officer Billy Tauzin argued, however, that public health officials should not impose compulsory licenses on avian flu medicines. He contends that the action takes away incentives for other drug makers to undertake the difficult and costly work of searching for new vaccines or antivirals to treat the avian flu virus.

"The work being done by America's pharmaceutical research companies is the greatest hope of finding additional treatments and a vaccine for avian flu, and policy measures should be developed to encourage these efforts, not discourage them," said Tauzin. "The protection of intellectual property around the world is key to the search for new medicines, and undermining those rights at a time when companies are being urged to invest more capital in research and development just doesn't make common sense or economic sense."

Generic companies are also taking issue with Roche's claims that a high-quality version of the drug cannot be produced in less than 3 years. Although scientists in Taiwan and India claim to have successfully duplicated Tamiflu, Roche asserts that these are only small laboratory samples, and that making a quality product on a commercial scale would still take several years. This lengthy process includes getting regulatory approval and obtaining significant quantities of the raw material used to produce the drug.

What Can Be Done Right Now?

Outside of political forums and corporate boardrooms, pharmacists are dealing with the issue on a much more personal level. As the potential threat of the bird flu reaching American soil has citizens on heightened alert, pharmacists can help alleviate their patients' fears by serving as a calming force in the community.

"The best protection is to encourage your patients to get vaccinated against the [regular] flu, and stay up to date on your own influenza vaccination," said Mitchel Rothholz, RPh, director of professional practice for the American Pharmacists Association. "It does the community no good if a pharmacist is out with the flu, or is a vector for the flu."

Rothholz noted that this year's flu shot does not fight against the avian flu, but he said that it will help protect patients from getting influenza this winter season, which is more of an immediate threat than contracting the bird flu.

"Encourage people to wash their hands," said Rothholz. "Tell pharmacy patients, if they are sick, to stay home. These are things that we as pharmacists can help patients understand."

Rothholz said pharmacists also need to tell concerned patients walking up to the counter with questions about Tamiflu that there is no need to buy large quantities of the drug. "Pharmacists need to tell people they don't need to stockpile," he said. "They also need to tell people to not indiscriminately take the drug, since the development of a resistant strain could be a concern. When we use this product, we want to make sure it is effective."

Ms. Whelan is a freelance writer based in Teaneck, NJ.