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Concern about the rapid spread of antibiotic resistance among bacteria, including resistance to the strongest antibiotics used as a last resort, led the Infectious Diseases Society of America (IDSA) last year to issue a white paper entitled “Bad Bugs, No Drugs” that characterized the decline in new antibiotic discovery as a public health crisis. See www.idsociety.org/pa/IDSA_Paper4_final_web.pdf . According to IDSA’s July 2004 report, about 2 million people acquire bacterial infections in U.S. hospitals each year, and 90,000 die as a result. About 70% of those infections are resistant to at least one drug. The cost to U.S. society was estimated to be at least $4 billion annually. Against this backdrop, IDSA is concerned that the pipeline of new antibiotics is drying up. In the past 30 years, only two new classes of antibiotics have been introduced, and resistance to one class emerged even before the Food and Drug Administration (FDA) approved the antibiotic. In 2002-2003, not a single new antibiotic was approved. After extensive investigation, IDSA concluded that companies are losing interest in antibiotic research and development because antibiotics are not as profitable as drugs that treat chronic conditions. To reverse this trend, IDSA’s report outlined a plan to motivate companies to return to the anti-microbial business. The IDSA’s intellectual property recommendations included “wild card” patent extensions awarded to any drug company that successfully develops a new antibiotic to a targeted priority microbe. A company could extend a patent for any one of its approved drugs-even a nonantibiotic blockbuster drug-as long as the company commits to reinvesting a portion of the profits derived during the extension period into antibiotic research and development. For a blockbuster drug with billions of dollars a year in revenue, the wild-card extension could prove a substantial reward that would easily offset the investment required to develop a new antibiotic. IDSA’s other IP recommendations included allowing full day-for-day restoration of patent term lost to regulatory review and extending market exclusivity provisions similar to the pediatric or orphan-drug exclusivity provisions already in place. Other non-IP recommendations included tax incentives, liability protection and expedited or flexible FDA review for antibiotics. Some of IDSA’s proposed IP solutions for reinvigorating the antibiotic pipeline appear in H.R. 3154, the “Infectious Diseases Research and Development Act of 2005,” introduced on June 29 in the U.S. House of Representatives. Similar provisions appear in anti-bioterrorism legislation pending in the Senate: S. 3, “Protecting America in the War on Terror Act of 2005,” introduced on Jan. 24; and S. 975, “The Project BioShield II Act of 2005,” introduced on April 29. Generic manufacturers have vigorously opposed the IP provisions, particularly the wild-card patent extension, and at least one bill, S. 975, reportedly was modified in an attempt to pacify them. This article briefly explores the origin of patent-term extension and explains how wild-card patent-term extension provisions would be applied. The Hatch-Waxman Act Pharmaceutical companies have always relied on patent protection to allow them to recoup the major investment needed to discover and develop a new drug. Patent exclusivity allows pharmaceutical manufacturers to charge higher prices for a new drug until the patent expires and generic copies are allowed on the market. However, the regulatory review process for new drug approval often consumes much of the lifetime of patents relating to the drug. The concept of drug patent-term extension was originally introduced as part of a carefully crafted legislative compromise, the 1984 Hatch-Waxman Act, that was designed to lower the cost of drugs through generic competition while providing sufficient incentives to encourage pharmaceutical companies to invest in research and development of new drugs. Provisions that encourage early market entry of generics immediately after patent expiration have contributed in no small part to the strength of the generic- drug industry. To counterbalance these effects, the act provided for patent-term extensions that allow brand-name manufacturers to restore some of the patent term lost during the FDA review process. The measures to expedite generic approval included creation of a streamlined, “abbreviated” form of drug approval. Instead of duplicating the extensive clinical trials necessary to obtain drug approval, generic manufacturers can rely on the brand-name manufacturer’s clinical data to show safety and efficacy. Generic manufacturers need only show bioequivalence of the generic to the brand-name drug (in other words, that it is the same active ingredient and is delivered to the body at the same rate and extent). The Hatch-Waxman Act contained several other incentives for seeking early generic-drug approval, including freedom from patent infringement liability for activities related to drug approval, and a lucrative 180-day exclusivity period for the first generic manufacturer to apply for approval.

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