The quotes below are from a DePaul Law Review discussing factors affecting patents for antibiotics. I have no idea what Kempler has to wade through at short notice now, but I doubt it is simple. [Antibiotic resistance can result in longer illness and even death ifthere are no antibiotics that can target the bacteria that caused theinfection. 5 Antibiotic resistance comes at a high cost to society because antibiotic-resistant infections increase medical expenses and decrease productivity. 6 Faced with the serious repercussions ofantibiotic resistance, public health authorities encourage the conservation of existing antibiotics and the development of more novel antibiotics. 7 Conserving antibiotics involves limiting the use of antibioticsto situations in which they are absolutely necessary. This aims to delay the onset and spread of antibiotic resistance. 8 Developing novelantibiotics ensures that when existing antibiotics are no longer effective, new antibiotics that are capable of treating the resistant bacteriaare available. 9 However, conservation has not been successful, 10 andthe development of novel antibiotics continues to stagnate."]
[Many scientists and politicians believe that patent-based incentiveswould persuade drug developers to invest in antibiotic development.' 6This Comment argues that, contrary to these beliefs, the patent lawsystem further exacerbates the problem of antibiotic resistance. 17 Thepatent bargain between the inventor and society functions differentlyfor antibiotics than other inventions.18 Generally, the inherent usefulness of an invention is not altered by an inventor's incentive to exploitthe value of the invention while it is being protected by the patent. 19However, the exploitation of antibiotics leads to overuse of the antibiotic and can result in antibiotic resistance.20 In addition, from a publichealth perspective, the optimal use of antibiotics involves delaying theintroduction of new antibiotics until existing antibiotics are ineffective.21 This waiting period is incompatible with a patent structure thatgrants a limited monopoly to an inventor as soon as the inventor applies for a patent. 22]
[Many successful antibiotics were discovered by observing how otherorganisms, such as fungi, inhibit the growth of bacteria. 37 Antibioticsdiscovered from these natural sources are very effective against bacteria because the natural sources have been fighting bacteria for morethan two billion years.38 However, bacteria have been exposed to thebacteria-fighting properties of those natural sources for an equallylong period of time. ]
[Humans have accelerated this evolution by exposing bacteria to "thousands of metric tons of antibiotics ... used in patients andlivestock over the past half century.]
[While the need for novel classes of antibiotics is clear, drug developers increasingly choose to research chronic diseases and so-calledlifestyle diseases in lieu of developing novel antibiotics. Few novelantibiotics are being developed 53 because it has become increasinglyexpensive to research, develop, and obtain Food and Drug Administration (FDA) approval for novel drugs in general.54 In addition toincreased research and development costs, antibiotics are less likely tobe profitable than drugs that treat chronic diseases. 55 Unlike drugsfor chronic diseases, "antimicrobials are used for very short periodsand are used relatively infrequently. ' 56 Bacteria can quickly grow resistant to novel antibiotics and make the antibiotic all but useless, unlike drugs for chronic diseases, which do not become obsolete becauseof resistance. 57 Because it takes an average of eight years to introducea novel drug into the market 58 and an average of ten years to introduce an antibiotic into the market,59 the lack of novel antibiotics currently in development means that there will be a continuing shortageof antibiotics.60 Furthermore, the market for novel antibiotics issmall, especially in comparison to the market for drugs that treatchronic diseases. 61]
[The term of a U.S. patent, including patents for antibiotics, istwenty years from the date of the patent application. 64 Currently,there are three statutes that can extend the patent term for certaindrugs beyond the twenty-year statutory period or confer a period ofmarket exclusivity: the Hatch-Waxman Act, 65 the Orphan DrugAct,66 and the Best Pharmaceuticals for Children Act. 67 Recently,proposed legislation sought to extend the patent term for certain inventions that relate to bioterrorism and infectious disease outbreaks,68but those legislative bills were not enacted into law.]
[The Orphan Drug Act grants a seven-year period of market exclusivity and tax credits to the developer of a drug that treats a rare disease.76 The Act was deemed necessary because existing financialincentives were insufficient to encourage the development of drugsthat treat rare diseases. 77 This Act could be used to encourage thedevelopment of an antibiotic for relatively rare bacterial infections orantibiotic-resistant bacterial infections that affect fewer than 200,000.Likewise, the Act could encourage the development of antibioticswhen a developer cannot expect to recoup its investment. Unfortunately, few antibiotic developers have utilized this Act, which suggeststhat the Act does not adequately encourage research and development into novel antibiotics. 78]
[Patent law exacerbates the problems of antibiotic resistance for thefollowing reasons: (1) the patent bargain does not function effectivelywith respect to antibiotics, (2) the antibiotic developer has little incentive to minimize antibiotic resistance, and (3) the patent term itself isincompatible with the optimal use of antibiotics.]
[For some bacteria, such as extremely drug-resistant tuberculosis 131and vancomycin-resistant Enterococcus,132 few if any antibiotics areeffective.1 33 If a pharmaceutical company developed an antibiotic thatwas effective against these bacteria, it would be most beneficial from apublic health perspective to "save" the antibiotic for these infectionsand not to use it on bacteria that can be effectively treated by otherantibiotics. 134 However, the pharmaceutical company has no incentive to save the antibiotic for these extremely resistant infections. Ifthe antibiotic is effective against a wide spectrum of bacteria and if itis easy to administer and tolerate, the pharmaceutical company wouldprofit by promoting its extensive use. 1]
[Commentators, such as Eric Kades, have suggested that extendingthe patent term may encourage antibiotic conservation. 158 Kades believes that if antibiotic patents had longer terms, pharmaceutical companies would be likely to promote antibiotic conservation so that theantibiotic remains effective for a longer time.159 Kades assumes thatan antibiotic developer would "initially price the good higher than optimal, and will stretch out the useful life of the resource."'' 60 However,even if this assumption were true, a pharmaceutical company may bemore concerned with its short-term financial health than long-termfinancial possibilities, in which case it "might still be tempted to sellmore now rather than later. ' 161 Thus, even if a longer patent termcould result in a long-term financial benefit, that benefit may be insufficient to encourage conservation. Furthermore, bacteria can developresistance quickly, even if the antibiotic is carefully conserved. 162 Ifthe antibiotic becomes ineffective before the original patent term expires, the pharmaceutical company will not financially benefit fromeither the patent extension or the antibiotic's conservation.]
[Moreover, if a patent term extension would effectively promptpharmaceutical companies to develop novel antibiotics, there wouldbe many additional adverse effects. Generic pharmaceutical companies would be unable to sell generic versions of the patented drug during the patent term extension period. Without competition fromgeneric pharmaceutical companies, the antibiotic developer wouldcharge more for the patented drugs.' 70 Insurance companies wouldbear the additional costs of covering the expensive brand name drugsfor an extended period, and they would pass on the increased costs toconsumers via increased fees, deductibles, and co-pays. Ultimately,the public would pay the price for patent term extensions.]
[In 2007, Senator Bernie Sanders of Vermont proposed legislation toaward a cash reward to developers of a novel drug in lieu of the traditional monopoly patent right;226 this legislation is characterized as apatent prize system. 227 Patent prizes separate the financial reward fora successful drug from the market of the drug itself.2 28 The proposedlegislation would put 0.6% of the U.S. GDP-$80 billion in 2007-into a medical innovation fund.229 Drug developers would receive adiscretionary portion of the fund for a medical innovation.230 Thedrug would then enter the public domain so that it could be manufactured and sold by other companies at a marginal cost, which woulddecrease cost barriers to novel drugs. 231 Therefore, the drug developers would derive profit from the government prize, rather than marketsales.]
[Those in favor of patent prizes predict that the system would encourage antibiotic development without rewarding excessive antibiotic use. 235 Because the drug developer's profit would not be relatedto product sales, the developer would presumably have no incentive tomarket the drug or encourage its overuse. Antibiotics would only beused when needed, and antibiotic choice would be unaffected byprice. Ultimately, however, a patent prize system "would be undesirable for antibiotics. '236 Under a patent prize regime, all antibioticswould presumably cost about the same price: the price of manufacture. The low price for antibiotics would likely facilitate overuse.] Imagine how simple it would be if someone came up with a way to assure the old and new antibiotics could beat the bacteria resistance.
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