Understanding Patents on Pharmaceuticals Patents
are a policy tool used to encourage innovation and the diffusion of
knowledge. Patents provide an incentive
for inventors both to invest in creating new useful knowledge, and to make that
knowledge public. A patent grants to
the patentee[1] the right to
control the use of an invention for a period of time, generally 20 years. The patentee can license the use of the
invention to others, or produce and sell the invention without competition.[2] The patent is an incentive and reward
because it ensures that the patentee will be able to benefit from any
commercial opportunities that derive from the invention. At the end of the patent period the
invention is no longer protected and can be used by anyone. The need for patent protection in order to encourage the creation of new pharmaceutical products is clear.[3] Pharmaceuticals are expensive to invent but cheap to copy and manufacture. Estimates of the cost of developing a new drug vary between $200 million and $900 million.[4] Even at $200 million, drug development requires the expenditure of a massive amount of capital. In contrast, producing copies of a drug that already exists is a relatively inexpensive exercise. Without patents (or some other sort of protection) every drug, would be copied by rival companies, that did not have to spend millions on drug development, and price competition would make it impossible to recoup the research investment. Without patent protection companies would be unwilling to invest the hundreds of millions of dollars necessary to invent new drugs. While patents do encourage innovation they also have a cost. Generally, the price of an item under monopoly is higher than it would be under conditions of competition. This means that some people who could afford the item under conditions of competition are unable to afford the item when sold at a higher, monopoly price. Economists refer to the lost sales as dead weight loss. If it is a life saving drug that is under patent protection, and the patent monopoly causes a dead weight loss, patent protection poses a serious ethical dilemma, between encouraging innovation that will help people in the future, and the current health of individuals in need of medicines that have already been invented.[5] In the case of some drugs, in particular drugs to treat HIV/AIDS, patent protection has had the effect of limiting access.[6] In developed nations, governmental programs for the poor generally ensure that people will have access to the medicines they need. This means that in developed nations there is generally no dead weight loss due to patented pharmaceuticals. In poor nations, however, the prices charged by pharmaceutical companies may cause dead weight loss. The government in many developing countries cannot afford to provide drugs for people who cannot pay. Most households in developing countries pay for their own medicines.[7] It is important to note that patents are not the only or even primary cause of limited access to essential medicines in poor countries. While there is a potential for dead weight loss, many people in poor countries cannot afford life saving drugs even if they were sold for the same price that they cost to produce.[8] In addition, regulatory and institutional barriers play important roles in limiting access to medicines in developing countries. For example, in India drug patents have been largely non-existent for the past 30 years, yet over 70% of the population still lack access to needed pharmaceuticals.[9] What high in-patent prices do for pharmaceuticals is place them even further out of reach for many of the world’s poor. This makes the job of governments and organizations mobilizing resources to provide access to medicines more difficult than it would otherwise be.
[1] The patentee is the entity (person, company or institution) who owns the patent. [2] Correa, Carlos. “Integrating Public Health Concerns into Patent Legislation in Developing Countries.” South Centre, Geneva, Switzerland, 2001, p. 2. [3] Patents are not the only policy tool that can be used to encourage the production of pharmaceuticals, tax incentives, grants of market exclusivity outside of the patent system, research grants can all encourage the development of pharmaceuticals. Patents remain the dominant policy tool used to encourage innovation and it is widely accepted that patents on pharmaceuticals are a precondition for industry research. There are, however, areas of medical science and drug development where patents may stifle innovation. This issue has been intensely debated in the context of genomics. See for example Caskey, Thomas. “Gene Patents – A Time to Balance Incentives,” 14 Trends in Biotechnology 298-302, (1996). See also Bar-Shalom, Avital & Robert Cook-Degan. “Patents and Innovation in Cancer Therapeutics: Lessons from CellPro,” 80(4) The Milbank Quarterly 637, (2002) for a case study detailing the potential of overbroad and inflexible patents to restrict innovation. See also the Canacan Foundation website for details of ongoing litigation seeking to challenge patents arising from research done with donated human tissue at www.canavanfoundation.org, see the first judgement in the case at Greenberg v. Miami Children’s Hospital Research Institute, Inc. 264 F.Supp.2d 1064, S.D. Fla., 2003. [4] See DiMasi, JA, et al. “The Price of Innovation: New Estimates of Drug Development Costs”, Journal of Health Economics, 22(2), 151-185. 2003 for the $900 million estimate. See Public Citizen, “America’s Other Drug Problem: A Briefing Book on the Rx Drug Debate.” Public Citizen, 2002, Washington, DC for the lower $200 million estimate. [5] The presence or absence of a patent alone does not determine drug pricing or profitability. The price of a patented pharmaceutical is highly dependant on the degree of clinical benefit the drug provides over existing treatment options and the number of other drugs that treat the same condition. See Schweitzer, Stuart. “Pharmaceutical Economics and Policy.” Oxford University Press, New York, 1997, p. 102. [6] Until recently the price of pharmaceuticals in South Africa was significantly higher than lowest available generic prices due in large part to patent protection. Treatment Action Campaign. “The Competition Commission Complaint: Questions and Answers.” TAC website, accessed 2003:08:05, http://www.tac.org.za/Documents/DrugCompaniesCC/QuestionsAndAnswers.pdf [7] Balasubramaniam, Kumariah. “Access to Medicines: Patents, Prices and Public Policy – Consumer Perspectives,” in Global Intellectual Property Rights: Knowledge, Access and Development, eds. Peter Drahos & Ruth Mayne, Palgrave MacMillan, 2002. [8] See Chapter 1 page 7 (including footnote 30). [9] See Lanjouw, JO. “The Introduction of Pharmaceutical Patents in India: ‘Heartless Exploitation of the Poor and Suffering’?,” NBER Working Paper NBER No. 6366, p. 30. 1997 available at http://www.cgdev.org/nv/lanjouw_drugs.pdf
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