Wild-card patent extensions as a means to incentivize research and development of antibiotics

Journal of Law, Medicine and Ethics

Volumn 37, Issue 2, 2009, Pages 240-246

  Sonderholm, Jorn ^a  

^a GEORGETOWN UNIVERSITY   (United States)

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[No Author keywords available]

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EID: 67650227611     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2009.00368.x     Document Type: Article

References (43)

1. A significant number of Americans die each year from a resistant form of staphylococcus aureus. See L. Tanner Staph Fatalities May Exceed AIDS Deaths available at http://www.newsvine.com/news/2007/10/16/1029203-staph-fatalities- may-exceed-aids-deaths (last visited April 27, 2009). Moreover, the WHO estimates that 1.6 million deaths resulted from tuberculosis in 2005. Both the highest number of deaths and the highest mortality per capita are in the Africa region. A particularly dangerous form of tuberculosis is multidrug-resistant tuberculosis. See WHO Fact sheet No. 104, Tuberculosis, Revised March 2007, available at http://www.who.int/mediacentre/factsheets/fs104/en/ (last visited April 16, 2009).
2. K. Outterson, J. B. Samora, and K. Keller-Cuda Will Longer Antimicrobial Patents Improve Global Public Health The Lancet Infectious Diseases 7, no. 8 (2007 559 566, at 559. (Pubitemid 47079152)
3. For a discussion of these pull-mechanisms, see the following, for example : J. Love Would Cash Prizes Promote Cheap Drugs New Scientist Magazine, November 12, 2007, at 24 25 Infectious Diseases Society of America (IDSA), Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates a Public Health Crisis Brews, 2004; B. Spellberg, "Antibiotic Resistance and Antibiotic Development," The Lancet Infectious Diseases 8, no. 4 (2008): 211-212; B. Spellberg, R. Guidos, D. Gilbert, J. Bradley, H. W. Boucher, W. M. Scheld, J. G. Bartlett, and J. Edwards, "The Epidemic of Antibiotic-Resistant Infections: A Call to Action for the Medical Community from the Infectious Diseases Society of America," Clinical Infectious Diseases-Chicago 46, no. 2 (2008): 155; C. Nathan, "Antibiotics at the Crossroads," Nature 431, no. 7011 (2004): 899-902; C. Nathan and F. M. Goldberg, "Outlook: The Profit Problem in Antibiotic R&D," Nature Reviews Drug Discovery 4, no. 11 (2005): 887-891; T. Pogge, "Human Rights and Global Health: A Research Program," Metaphilosophy 36, nos. 1-2 (2005): 182-209; E. Power, "Impact of Antibiotic Restrictions: The Pharmaceutical Perspective," Clinical Microbiology and Infection 12, no. s5 (2006): 25-34; J. Love and T. Hubbard, "The Big Idea: Prizes to Stimulate R&D for New Medicines," Chicago Kent-Law Review 82, no. 3 (2007): 1519-1554; M. Kremer and R. Glennerster, Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases (Princeton: Princeton University Press, 2004); J. E. Stiglitz, "Scrooge and Intellectual Property Rights," BMJ 333, no. 7582 (2006): 1279; Outterson et al., supra note 2; K. Outterson, "Antibiotic Resistance and Antibiotic Development - Author's Reply," The Lancet Infectious Diseases 8, no. 4 (2008): 212-214.
4. See IDSA, supra note 3, at 14.
5. APUA, Urgent Federal Action Needed to Fill Antibiotic Pipeline and Curb Antibiotic Misuse, Press Release, June 24, 2008 (cited September 2, 2008), available at http://www.tufts.edu/med/apua/public-policy/statement-6-24-08.pdf (last visited April 16, 2009).
6. See Nathan, supra note 3, at 900.
7. B. Spellberg, J. H. Powers, E. P. Brass, L. G. Miller, and J. E. Edwards, Jr. Trends in Antimicrobial Drug Development: Implications for the Future Clinical Infectious Diseases 38, no. 9 (2004 1279 1286, at 1279. (Pubitemid 38608571)
8. See Spellberg et al., supra note 3, at 155.
9. D. J. Payne, M. N. Gwynn, D. J. Holmes, and D. L. Pompliano Drugs for Bad Bugs: Confronting the Challenges of Antibacterial Discovery Nature Reviews Drug Discovery 6, no. 1 (2007 29 40, at 39. (Pubitemid 46020284)
10. G. H. Talbot, J. Bradley, J. E. Edwards, D. Gilbert, M. Scheld, and J. G. Bartlett Bad Bugs Need Drugs: An Opdate on the Development Pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America Clinical Infectious Diseases 42, no. 5 (March 2006 657 668, at 657. In contrast to these estimates, Outterson, Samora, and Keller-Cuda (supra note 2, at 559) claim that when it comes to the pipeline for antimicrobial R&D, the glass is half-full rather than half-empty (this is disputed by Spellberg [supra note 3, at 211] who characterizes the glass as running ever closer to being empty). Power (supra note 3, at 30) states that overall, the pharmaceutical industry has responded to medical need despite various regulatory and market barriers, and Levy and Marshall state that the need for new antibiotics is being addressed by small companies that devote full attention to this goal. See S. B. Levy and B. Marshall, "Antibacterial Resistance Worldwide: Causes, Challenges and Responses," Nature Medicine 10, no. 12, Supplement (2004): S122-S129, at S127. (Pubitemid 43271379)
11. T. M. Jones, Transferable Intellectual Property Rights (TIPR) to Incentivise R&D for Neglected Diseases, Commission on Intellectual Property Rights, Innovation and Public Health e-Forum 2004 (cited July 17, 2008), available at http://lists.essential.org/pipermail/ip-health/2004-December/ 007225.html (last visited April 16, 2009).
12. The Infectious Diseases Research and Development Act (HR 3154), introduced to the U.S. Congress in July of 2005 by Congresswoman Barbara Cubin, recommends implementation of wild-card patent extensions for up to two years. The Project Bioshield II Act (S 975), introduced to the U.S. Congress in April of 2005 by Senators Lieberman, Hatch and Brownback, also recommends implementation of wild-card patent extensions for up to two years. Models involving five-year wild-card patent extensions have also been discussed (see M. Moran, Fast Track Options as a Fundraising Mechanism to Support R&D into Neglected Diseases: Pharmaceutical R&D Policy Project, London School of Economics, 2005).
13. See Drugs.com Top 200 Drugs for 2007 by Sales available at http://www.drugs.com/top200.html last visited April 16, 2009).
14. The assumption that annual sales of a patented drug stay constant throughout the duration of the patent is controversial. 2002 world-wide sales of Lipitor were up 20% from the year before. 2002 world-wide sales of Zocor (Merck) were up 13% from the year before. 2002 world-wide sales of Losec/Prilosec (AstraZeneca) were down 19% compared to the previous year. For more sales data on leading products in 2002 global pharmaceutical sales, see table from IMS World Review 2003, available at http://www.imshealth.com/ims/ portal/front/articleC/0,2777,6599-3665-41336931,00.html (last visited July 17, 2008).
15. See Spellberg et al., supra note 3, at 161.
16. Id.
17. See Power, supra note 3, at 30.
18. See Outterson, Samora, and Keller-Cuda, supra note 2, at 561; Outterson, supra note 3, at 212.
19. This 2001 estimate of the cost of a new drug is put forward by The Tufts Center for the Study of Drug Development. See http://csdd.tufts.edu/NewsEvents/ RecentNews.asp?newsid=6 (last visited April 16, 2009). It should here be noted that another estimate puts the price of new drug at 1.7 billion. See J. Gilbert, P. Henske, and A. Singh Rebuilding Big Pharma's Business Model In Vivo: The Business & Medicine Report 21, no. 10 (2003 73 80. This number is cited by the U.S. Department of Health and Human Services(see FDA, Challenge and Opportunity on the Critical Path to New Medical Products, U.S. Department of Health and Human Services Food and Drug Administration, 2005, at 3.) If the price for a new drug is this high, then some of the sting is taken out of the cost-effectiveness objection.
20. See Outterson, Samora, and Keller-Cuda, supra note 2, at 561.
21. This number is arrived at by dividing Outterson and colleagues' $8.7 billion estimate by four.
22. B. Spellberg, L. G. Miller, M. N. Kuo, J. Bradley, W. M. Scheld, and J. E. Edwards Societal Costs Versus Savings from Wild-Card Patent Extension Legislation to Spur Critically Needed Antibiotic Development Infection 35, no. 3 (2007 167 174. (Pubitemid 46932331)
23. Sales data obtained from Outterson, Samora, and Keller-Cuda, supra note 2, at 561.
24. In private correspondence, Eddie Power (Global Medical Director, Clinical Research, Cubist Pharmaceuticals) suggested that the profit benchmark that big pharma sets for continued R&D on a product is around $500 million.
25. This number is arrived at by adding Outterson and colleagues' estimate of the cost of a new antibiotic to Spellberg's cost-estimate and dividing this number by two and then detracting 3/4 from it.
26. See Outterson, supra note 3, at 213.
27. See Spellberg et al., supra note 22.
28. The annual societal cost of $2.7 billion is an estimate of Spellberg et al., supra note 22, at 170.
29. See Spellberg et al., supra note 22.
30. See Outterson, Samora, and Keller-Cuda, supra note 22, at 562.
31. See Power, supra note 3, at 32.
32. See Nathan and Goldberg, supra note at 888.
33. This worry has been suggested to me by Susan Foster from the Alliance for the Prudent Use of Antibiotics (APUA).
34. See Spellberg et al., supra note 22, at 168.
35. Currently, there is a whole family of statin drugs similar to Pfizer's Lipitor. There are also therapeutic alternatives to the patented drug Nexium (the second best-selling drug in the U.S. in 2007). These alternatives include Protonix (pantoprazole), Prevacid (lansoprazole), and AcipHex (rabeprazole). The third best-selling drug in the U.S. in 2007 was Advair Diskus (GlazoSmithKline). Albuterol is a therapeutic alternative to this drug.
36. See Power, supra note 3, at 32.
37. Lower-than-normal profits only means profits that are smaller than the profits that pharmaceutical companies in general aim for and set as benchmarks when they make decisions about whether to discontinue R&D on a product in their pipeline. It is here worth observing that GlaxoSmithKline (GSK) in recent years has terminated further development on a number of promising early-stage antimicrobial leads because of lack-of-profit concerns. A recurring reason for the termination of work on promising antimicrobial leads was that the bacterial spectra of these leads were very limited. GSK was not interested in developing narrow-spectrum agents but was, for economic reasons, looking for broad-spectrum agents (see Payne et al., supra note 9, at 32).
38. This is the principle of moral obligation that Power appeals to in his thoughts about the ethical responsibility of pharmaceutical companies.
39. It is here assumed that the man can swim and that by attempting to save the boy, the man does not jeopardize the life of others.
40. I. Maitland Priceless Goods: How Should Life-Saving Drugs Be Priced Business Ethics Quarterly 12, no. 4 (2002 451 80, at 460.
41. For an interesting discussion of the duty to rescue in the context of global intellectual property rights in medicine, see Global Pharmaceutical Markets by Kevin Outterson and Donald W. Light (Forthcoming in H. Kuhse and P. Singer, eds., A Companion To Bioethics, 2008, 2nd ed.).
42. See IDSA report, supra note 3.
43. See Spellberg et al., supra note 3, at 161.