- Email: [email protected]
Patent protection: a need for value-based patents
CORRESPONDENCE
the sex difference in coronary risk. Correspondingly, a study currently in process is investigating whether castration influences coronary mortality in a cohort of men. In our case-control study,5 we measured body fat (body-mass index and waist-to-hip ratio) in 22 patients with acute myocardial infarction younger than 41 years and 24 agematched and sex-matched controls. Body fat was also measured as total body fat percentage by means of a dualenergy X-ray absorptiometer (DEXA), and as the extent of intra-abdominal fat by means of an abdominal slice with a CT scanner. Women had a higher overall body fat percentage and a lower intra-abdominal adipose tissue area than did men. Half the men and none of the women had intra-abdominal obesity, with an intra-abdominal adipose tissue area greater than 135 cm2. In multiple regression analyses of the four fat variables, only the intra-abdominal adipose tissue area was significantly associated with risk factors such as systolic and diastolic blood pressure, and concentrations of fasting blood glucose concentration and HDL cholesterol. Thus intraabdominal adipose tissue could contribute to the sex difference in coronary risk. Other mechanisms—eg, psychological ones—could also contribute to the sex difference.4 Further studies should target these aspects, and might expand our knowledge of the pathogenesis of acute coronary syndromes and have consequences for public health and primary prevention. *Finn Edler von Eyben, Ejvind Mouridsen, Jan Holm, Paulius Montvilas, Georg Dimcevski Departments of *Internal Medicine (FEvE, EM), Clinical Chemistry (JH), Radiology (PM), and Clinical Physiology (GD), Herning Central Hospital, DK-7400 Herning, Denmark (e-mail: [email protected]) 1
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Roussouw JE. Hormones for coronary disease—full circle. Lancet 2002; 360: 1996–97. The ESPRIT team. Oestrogen therapy for prevention of reinfarction in postmenopausal women: a randomised placebo controlled trial. Lancet 2002; 360: 2001–08. Hansen EF, Andersen LT, von Eyben FE. Cigarette smoking and age at first acute myocardial infarction and effect of gender and extent of smoking. Am J Cardiol 1993; 71: 1439–41. Gertler MM, White PD. Coronary heart disease in young adults: a multidisciplinary approach. Cambridge MA: Harvard University Press, 1954. von Eyben FE, Mouridsen E, Holm J, Montvilas P, Dimcevski G. Glucose homoeostasis in young adults without diagnosis of diabetes mellitus. Lancet 2002; 360: 1978–79.
Patent protection: a need for value-based patents Sir—Your Sept 21 Editorial1 brings home the point that patent laws regarding drugs and pharmaceutical companies protect rich nations at the cost of poor ones. TRIPS (Trade-Related Aspects of Intellectual Property Rights) has set minimum standards of patent laws for the member nations of the World Trade Organization (WTO). Developed nations are understandably trying to protect their pharmaceutical industries through TRIPS, but they often ignore social dimensions, and their stand adversely affects the developing and underdeveloped nations of WTO. The major health problems faced by these nations relate to diseases such as diabetes mellitus, hypertension, coronary artery disease, and AIDS. If undue protection is provided to the drugs directed at such diseases, the result will be an increase in the health expenditure of individuals, insurance companies, and other health providers. In most developing countries, schemes for health insurance do not exist, so the expenditure would be born by the governments or the individuals. In our opinion, patent law must address three main issues. First is the issue of why protection should be granted for as long as 20 years. Why not amend the laws such that patent protection lasts for 5 years after the launch of the drug? Such an amendment would ensure that the financial interests of the company are protected, but also that the companies are unable to take undue advantage of such protection. The case of ciprofloxacin is an example.2 Second, other companies who want to manufacture and sell the patented drug should be required to obtain a licence by paying a royalty to the parent company. This process would not only ensure speedier recovery of the cost, but would also enable companies in developing countries to sell the drugs at affordable prices. Nobody disputes the fact that the inventor deserves to get a royalty, but that must not result in a monopoly. The audiovisual industry is a good example. Any company not involved in the invention of CDs or DVDs can manufacture these products by paying licensing fees. Why should pharmaceutical companies not do the same? Lastly, why not introduce a valuebased patent? The average cost for any drug to get to market level is US$500 million. Patent protection should be allowed until sales reach US$8– 10 billion. This limit will be reached
THE LANCET • Vol 361 • February 15, 2003 • www.thelancet.com
more quickly for drugs that are widely used—eg, antidiabetics and antihypertensives. The revenue should also include the licensing fee. These suggestions need to be looked into. Classification and changes in the TRIPS agreement to favour public needs rather than patent protection are urgently needed. Only with this approach, as your Editorial rightly states, will “Rich country Governments . . . have a genuine commitment to transform WTO from a rich man’s club to one that puts poverty reduction at the top of its agenda.” *H M Mardikar, N V Deshpande, Nikhil S Ghadyalpatil, Majusha Mardikar Spandan Heart Institute and Research Center, Dhantoli, Nagpur 440012, India (e-mail: [email protected]) 1 2
Editorial. Patently robbing the poor to serve the rich. Lancet 2002; 360: 885. Editorial. Patent protection versus public health. Lancet 2001; 358: 1563.
Physicians and patent law Sir—David Henry and Joel Lexchin (Nov 16, p 1590)1 illustrate many of the awesome problems of the pharmaceutical industry. They also illustrate the equally awesome problem of allowing physicians to feign legal expertise as pundits of patent law. Aside from numerous factual errors—eg, Henry and Lexchin write repeatedly about World Trade Organization “TRIPS agreements”, as if patent law were contained in a plurality of treaties, when actually only a single TRIPS agreement exists—the authors fail to differentiate between how pharmaceutical patents theoretically work, and how they actually work. The difference is not insignificant. First, although patents can theoretically create “monopoly selling power”, as Henry and Lexchin call it, they often fail to do so. A patent on (say) an antipsychotic medicine does not allow the patentee to monopolise the whole antipsychotic market. This is why different patented medicines for a single clinical indication often coexist and compete for market share. Second, when a new medicine is invented and patented, its patent rights are independent of its predecessors. Henry and Lexchin’s example of inventing esomeprazole as a successor to omeprazole does not “maintain”, “extend”, or “evergreen” the omeprazole patent as they say—but only establishes an esomeprazole patent. Clinicians may therefore freely prescribe generic omeprazole, or patented and brand-name
613
For personal use. Only reproduce with permission from The Lancet Publishing Group.
the sex difference in coronary risk. Correspondingly, a study currently in process is investigating whether castration influences coronary mortality in a cohort of men. In our case-control study,5 we measured body fat (body-mass index and waist-to-hip ratio) in 22 patients with acute myocardial infarction younger than 41 years and 24 agematched and sex-matched controls. Body fat was also measured as total body fat percentage by means of a dualenergy X-ray absorptiometer (DEXA), and as the extent of intra-abdominal fat by means of an abdominal slice with a CT scanner. Women had a higher overall body fat percentage and a lower intra-abdominal adipose tissue area than did men. Half the men and none of the women had intra-abdominal obesity, with an intra-abdominal adipose tissue area greater than 135 cm2. In multiple regression analyses of the four fat variables, only the intra-abdominal adipose tissue area was significantly associated with risk factors such as systolic and diastolic blood pressure, and concentrations of fasting blood glucose concentration and HDL cholesterol. Thus intraabdominal adipose tissue could contribute to the sex difference in coronary risk. Other mechanisms—eg, psychological ones—could also contribute to the sex difference.4 Further studies should target these aspects, and might expand our knowledge of the pathogenesis of acute coronary syndromes and have consequences for public health and primary prevention. *Finn Edler von Eyben, Ejvind Mouridsen, Jan Holm, Paulius Montvilas, Georg Dimcevski Departments of *Internal Medicine (FEvE, EM), Clinical Chemistry (JH), Radiology (PM), and Clinical Physiology (GD), Herning Central Hospital, DK-7400 Herning, Denmark (e-mail: [email protected]) 1
2
3
4
5
Roussouw JE. Hormones for coronary disease—full circle. Lancet 2002; 360: 1996–97. The ESPRIT team. Oestrogen therapy for prevention of reinfarction in postmenopausal women: a randomised placebo controlled trial. Lancet 2002; 360: 2001–08. Hansen EF, Andersen LT, von Eyben FE. Cigarette smoking and age at first acute myocardial infarction and effect of gender and extent of smoking. Am J Cardiol 1993; 71: 1439–41. Gertler MM, White PD. Coronary heart disease in young adults: a multidisciplinary approach. Cambridge MA: Harvard University Press, 1954. von Eyben FE, Mouridsen E, Holm J, Montvilas P, Dimcevski G. Glucose homoeostasis in young adults without diagnosis of diabetes mellitus. Lancet 2002; 360: 1978–79.
Patent protection: a need for value-based patents Sir—Your Sept 21 Editorial1 brings home the point that patent laws regarding drugs and pharmaceutical companies protect rich nations at the cost of poor ones. TRIPS (Trade-Related Aspects of Intellectual Property Rights) has set minimum standards of patent laws for the member nations of the World Trade Organization (WTO). Developed nations are understandably trying to protect their pharmaceutical industries through TRIPS, but they often ignore social dimensions, and their stand adversely affects the developing and underdeveloped nations of WTO. The major health problems faced by these nations relate to diseases such as diabetes mellitus, hypertension, coronary artery disease, and AIDS. If undue protection is provided to the drugs directed at such diseases, the result will be an increase in the health expenditure of individuals, insurance companies, and other health providers. In most developing countries, schemes for health insurance do not exist, so the expenditure would be born by the governments or the individuals. In our opinion, patent law must address three main issues. First is the issue of why protection should be granted for as long as 20 years. Why not amend the laws such that patent protection lasts for 5 years after the launch of the drug? Such an amendment would ensure that the financial interests of the company are protected, but also that the companies are unable to take undue advantage of such protection. The case of ciprofloxacin is an example.2 Second, other companies who want to manufacture and sell the patented drug should be required to obtain a licence by paying a royalty to the parent company. This process would not only ensure speedier recovery of the cost, but would also enable companies in developing countries to sell the drugs at affordable prices. Nobody disputes the fact that the inventor deserves to get a royalty, but that must not result in a monopoly. The audiovisual industry is a good example. Any company not involved in the invention of CDs or DVDs can manufacture these products by paying licensing fees. Why should pharmaceutical companies not do the same? Lastly, why not introduce a valuebased patent? The average cost for any drug to get to market level is US$500 million. Patent protection should be allowed until sales reach US$8– 10 billion. This limit will be reached
THE LANCET • Vol 361 • February 15, 2003 • www.thelancet.com
more quickly for drugs that are widely used—eg, antidiabetics and antihypertensives. The revenue should also include the licensing fee. These suggestions need to be looked into. Classification and changes in the TRIPS agreement to favour public needs rather than patent protection are urgently needed. Only with this approach, as your Editorial rightly states, will “Rich country Governments . . . have a genuine commitment to transform WTO from a rich man’s club to one that puts poverty reduction at the top of its agenda.” *H M Mardikar, N V Deshpande, Nikhil S Ghadyalpatil, Majusha Mardikar Spandan Heart Institute and Research Center, Dhantoli, Nagpur 440012, India (e-mail: [email protected]) 1 2
Editorial. Patently robbing the poor to serve the rich. Lancet 2002; 360: 885. Editorial. Patent protection versus public health. Lancet 2001; 358: 1563.
Physicians and patent law Sir—David Henry and Joel Lexchin (Nov 16, p 1590)1 illustrate many of the awesome problems of the pharmaceutical industry. They also illustrate the equally awesome problem of allowing physicians to feign legal expertise as pundits of patent law. Aside from numerous factual errors—eg, Henry and Lexchin write repeatedly about World Trade Organization “TRIPS agreements”, as if patent law were contained in a plurality of treaties, when actually only a single TRIPS agreement exists—the authors fail to differentiate between how pharmaceutical patents theoretically work, and how they actually work. The difference is not insignificant. First, although patents can theoretically create “monopoly selling power”, as Henry and Lexchin call it, they often fail to do so. A patent on (say) an antipsychotic medicine does not allow the patentee to monopolise the whole antipsychotic market. This is why different patented medicines for a single clinical indication often coexist and compete for market share. Second, when a new medicine is invented and patented, its patent rights are independent of its predecessors. Henry and Lexchin’s example of inventing esomeprazole as a successor to omeprazole does not “maintain”, “extend”, or “evergreen” the omeprazole patent as they say—but only establishes an esomeprazole patent. Clinicians may therefore freely prescribe generic omeprazole, or patented and brand-name
613
For personal use. Only reproduce with permission from The Lancet Publishing Group.