Cipro ‘Saga’ Reveals How Drug Firms Protect Profits At Expense of Public, USA Today Editorial Says

The recent deal between Cipro manufacturer Bayer AG and the government to provide the anthrax antibiotic at a "hefty 46% discount" shows how drug companies have "perverted the patent system" to increase "guaranteed profits," a USA Today editorial states. With a push in Congress to revoke Cipro's patent and allow generic production because of the recent anthrax cases, the editorial says that the deal "raises questions" about why such an arrangement was even necessary. In 1997, Bayer agreed to pay generic-drug maker Barr Laboratories $28 million a year until 2003, when Cipro's patent expires, in exchange for dropping a challenge to the drug's patent. While the Federal Trade Commission is looking at that deal, which "sounds suspiciously like a payoff to avoid competition," the editorial notes that brand-name drug manufacturers are using many similar practices to "prolong the lucrative patent protection" on their products. The editorial notes that some brand-name drug makers file "citizen petitions" to challenge generic competition. Although such challenges "almost never succeed," they "trigge[r]" an FDA review and prevent generic competitors from entering the market until the review is completed. The editorial notes that some drug companies also file for a new patent for a drug based on new uses for that treatment, which "triggers a 30-month delay, while disputes over the new patent are settled." Now, drug companies are using two new laws to extend patents; one provides a half-year extension in exchange for conducting pediatric clinical trials and another extends patents when the FDA approves label changes. Although patents are designed to "encourage innovation" and reward "substantial investment costs," the editorial says that the system has been manipulated to delay generic competition at an "enormous" cost to consumers. The editorial concludes: "Trying to squeeze out extra profits is not a surprising business tactic. Doing so by abusing the patent system, however, is an affront to consumers who pay higher bills, and to the public, which could suffer the consequences in a public health crisis" (USA Today, 10/29).

Patents Foster Innovation
In an accompanying counterpoint opinion piece, Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, writes that the patent system "works well" and "ensures" that companies will develop "breakthrough medicines." Even though drug makers are "doing everything they can" to respond to the anthrax scare, Holmer writes that the system is being "attacked by some who are using the current crisis to push their agenda of weakening intellectual property protection." Although generic-drug companies are providing an "important service," Holmer says that the public "can't count on them to develop the medicines we need in the future, to deal with bioterrorism or to meet the needs of our aging population." Holmer concludes, "That's why we need strong patent protection: to give research-based companies the incentives to invest the average $500 million needed to discover and develop each new medicine" (Holmer, USA Today, 10/29). For comprehensive public health information from the CDC on anthrax and other bioterrorism issues, please visit www.bt.cdc.gov.