United Press International - October 16, 2001
Scott R. Burnell, UPI Science News

Allowing for what is known as "compulsory licensing," Schumer's proposal calls for requiring Bayer to relax its control on the patent for Cipro and allow other companies to make and sell generic copies of the antibiotic, which is the most widely prescribed anthrax treatment in the United States. This would expand the supply of the treatment and reduce the possibility of hoarding by consumers, Schumer said.

Bayer has the exclusive right to manufacture and distribute Cipro -- its top-selling medicine. Under its patent, the German company has the option of granting licenses to other companies to produce generic copies of Cipro, but it has not done so.

Speaking at a press conference, Schumer said the Department of Health and Human Services has the authority to buy generic Cipro in bulk for public health needs.

"If we increase the number of manufacturers producing Cipro, we're more likely to have enough on hand should we need it," Schumer said. "Knowing we have enough Cipro just in case would go a long way towards calming the public about potential shortages."

Bayer representatives would not comment Tuesday on Schumer's proposal, but the company committed to producing 200 million Cipro doses in the next three months, triple its normal output.

Bayer will reopen a facility and run its existing production lines 24/7 in order to meet the demand, said Mark Ryan, the company's senior vice president of corporate communications. The company will also fix its Cipro prices at pre-Sept. 11 levels, he said, and hopes the supply chain will follow that lead.

Schumer's office said the government currently has enough Cipro to treat approximately 2 million people for sixty days -- the length of time generally necessary to treat anthrax. Health and Human Services Department Secretary Tommy Thompson has requested an additional $643 million to purchase antibiotics including Cipro, but that would only cover the treatment of an additional 1.5 million people for sixty days, the office said.

Since generic drugs cost about half as much as brand name versions, going the generic route would provide the United States with about twice as much Cipro with the funds Thompson has requested, Schumer said. Buying directly from generic drug manufacturers might also force Bayer to drop prices for private buyers, such as like hospitals, looking to boost their Cipro stockpiles, he said.

Rep. Sherwood Boehlert, R-N.Y., chairman of the House Science Committee, said working around patent protections is problematic, but these extraordinary times could call for unusual measures.

"That's an intriguing possibility, and I'd like to talk to (Schumer) about it," Boehlert said. "First and foremost, we've got to be concerned with public health."

Several generic drug manufacturers, including Par Pharmaceuticals, Ranbaxy Pharmaceuticals, and Teva Pharmaceuticals, told Schumer they could produce enough Cipro to treat about 1 million people per month. Having multiple manufacturing points would also help ensure the drug's overall availability, Schumer said.

While the Federal Trade Commission studies the Cipro patent issue, the company would retain commercial rights to the drug even if his plan was put into operation, Schumer said. He asked the Food and Drug Administration to give five generic drug makers final approval to manufacture Cipro; failure to do so quickly could delay additional supplies of the drug for up to 6 months, he said.

Mary Kuhn, vice president of operations for Bayer Pharmaceuticals, said some pharmacies in New York City ran out of Cipro over the weekend, and the company arranged immediate additional shipments to compensate. Kuhn said Bayer will continue its increased Cipro production until demand goes down.

While any manufacture of generic Cipro is controlled under strictly enforced patent laws in North America and Europe, the rules -- if they exist -- are much more lenient in many other countries. In India, patent-holders have few legal protections, enabling the generic-medicine industry to thrive -- dozens of Indian companies currently copy Cipro.

Schumer's argument echoes the recent controversy over the availability of patented drugs used to prolong the lives of people with HIV and AIDS. Activists, citing urgent public health needs, have succeeded in pressuring many multinational corporations that produce such treatments to relax or abandon their patents in poor countries to allow for the manufacture of cheaper generic versions. The copies are then sold to state health agencies and distributed to patients who would otherwise not have access to the drugs.

Bayer's patent on ciprofloxacin -- the proper name for the drug -- expires in 2003, at which time generic producers will automatically have the right to produce generic versions.
011016
UP011006

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2001. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .