IPR+Neg+-+Innovation+DA

A. Unique/Link – pharmaceutical R&D in the U.S. is at an all time high due to high intellectual property protection Wesley A. Cann, Professor Emeritus of Business Law, University of Connecticut, Fall 2004, “On the Relationship Between Intellectual Property Rights and the Need of Less-Developed Countries for Access to Pharmaceuticals: Creating a Legal Duty to Supply Under a Theory of Progressive Global Constitutionalism,” University of Pennsylvania Journal of International Economic Law, Lexis, [IK]

According to the Pharmaceutical Research and Manufacturers of America ("PhRMA"), R&D is "the key to pharmaceutical innovation." n203 The pharmaceutical industry is the most research-intensive major industry in the United States, and PhRMA member companies invested an estimated $ 33.2 billion in R&D in 2003 as compared to slightly less than $ 2 billion in 1980. n204 This $ 33.2 billion figure represented a 7.1% increase in R&D expenditures over the previous year n205 and an estimated 15.6% of total sales. n206 In the pharmaceutical industry, R&D is a "long, risky and expensive" process, with the average cost of developing a new drug now exceeding $ 800 million compared to only $ 231 million in 1987. n207 It is also estimated that it takes ten to fifteen years to develop a drug from the laboratory to Food and Drug Administration ("FDA") approval, with an average time period of 14.2 years during the 1990s. n208 Researching more complex, chronic, and degenerative diseases, complying with more demanding developmental requirements, and handling longer clinical trials with more participating patients all increase the cost of both capital and R&D. n209 [*792] Nevertheless, the average period of effective patent life in the pharmaceutical industry has been substantially shorter than that of other industries. For example, new medicines introduced in the early to mid-1990s have had an effective patent life (even with patent term restoration) of eleven to twelve years compared to the 18.5 year patent life in industries that do not receive regulatory approval before bringing a product to market. n210 These substantial investments of both time and money must also be viewed in light of the high failure rates that are involved in pharmaceutical R&D. For example, only 250 of 5,000 - 10,000 screened compounds actually enter preclinical testing and only five of those go on to clinical testing. n211 Only one of these is ultimately approved by the FDA as a new medicine n212 and it is often seven to nine years into the process before a company knows whether a drug will prove successful. n213 In light of these failure rates which are highest when researching complex diseases about which little is known, n214 pharmaceutical companies "must rely on a limited number of highly successful products to finance their continuing R&D." n215 Accordingly, it can be strongly argued that intellectual property protection must be granted for those research efforts that ultimately prove successful. Such protection diminishes some of the risks associated with R&D and thereby encourages private investment in innovative activities. Without potential reward, incentives [*793] for investing private capital would be substantially lacking. n216 Additionally, a credible argument can be made that in light of the disproportionately high level of both investment and risk - as well as the tremendous social benefits resulting from the introduction of an important new medicine - society should err on the side of "over-incenting" R&D in the pharmaceutical industry. n217 The need to preserve incentive has given rise to a number of allegations regarding the "rampant" and often "unfettered" piracy of intellectual property in many developing countries n218 that result in billions of dollars in losses to a variety of American industries. n219 In specific regard to the pharmaceutical industry, Corbett has indicated that patented drugs are "particularly vulnerable" to piracy since generic versions can be produced by using methods disclosed "in the patent itself or ... [through] the development of alternative synthetic routes" by reverse engineering. n220 As a result, while patented pharmaceuticals are extremely costly and time-consuming to create, they are relatively easy and inexpensive to copy. n221 In addition to billions of dollars in lost sales, however, global piracy has also reduced pharmaceutical R&D investment by hundreds of millions of dollars each year. n222 At least in theory, it could be argued that if all pirating producers were made to share in the burdens of R&D (by means of royalty payments), not only could the level of R&D be enhanced, but global prices could be reduced. As of 2002, more than one thousand new medicines were under [*794] development, either in human clinical trials or awaiting FDA approval, including thirty-eight AIDS antivirals, fifteen drugs aimed at AIDS-related cancers, and fourteen AIDS vaccines. n223 The potential benefits of these drugs for suffering individuals around the world cannot be overstated. Nevertheless, companies simply cannot make these types of investments when their successes can be copied and sold at reduced prices by competitors who need not recover R&D expenses. n224 PhRMA maintains that without intellectual property protection, there would be no research-based pharmaceutical industry (at least as we know it), no generic pharmaceutical industry (since there would be no new drugs to copy), and a greatly diminished flow of life-saving medicines. n225 Additionally, any reduction in protection would first be felt by those with diseases that afflict smaller numbers of individuals or those with diseases that primarily afflict the poor. n226

B. Link/Impact – licensing AIDs drugs will create more resistant strains and bankrupt pharmaceutical companies with the capacity to develop new drugs, turning case Jennifer Bjornberg, J.D. Candidate Northwestern University School of Law, Fall 2006, “Brazil's Recent Threat on Abbott's Patent: Resolution or Retaliation?” Lexis, [IK]

Another problem with compulsory licensing involves the nature of the diseases these drugs are meant to treat. It is possible that more resistant strains of the AIDS virus will develop, rendering existing drugs useless. n120 Currently, there are no drugs that cure AIDS or HIV, and the argument goes that providing widespread access to these drugs without strict supervision will only lead to more virulent and drug-resistant strains of the virus that will kill more victims. n121 According to this argument, the loss of profits [*215] from compulsory licensing and uncontrolled distribution triggers a domino effect crippling, and in a worst case scenario bankrupting, the pharmaceutical companies forced to license their patents and develop drugs for an exploding number of strains of the virus. The argument for recouping costs for AIDS drugs through the use of patent protection and high prices thus becomes more relevant and applicable in the case of a mutating disease.

C. Impact – Innovation is critical to stop the next global epidemic Doug Bandow, senior fellow at the Cato Institute, 3/27/05, “A strong pharmaceutical industry is the best defense against pandemics,” The San Diego Union-Tribune, http://www.signonsandiego.com/uniontrib/20050327/news_lz1e27bandow.html, [IK]

For a time SARS, severe acute respiratory syndrome, seemed to threaten a deadly new global epidemic. But, thankfully, SARS faded away after killing fewer than 800 people. Bird, or avian, flu now worries many medical professionals. Outbreaks have been reported in Indonesia and North Korea, and the disease has killed two score people in Thailand and Vietnam. Should the disease mutate and infect humans, we could see a phenomenon like the flu pandemic that swept the world in 1918 and 1919, killing 40 million or 50 million people. Indeed, former Health and Human Services Secretary Tommy Thompson called the avian flu "a really huge bomb" that could kill upward of 70 million people. Diseases like SARS and avian flu, which have proved resistant to drugs commonly used to fight influenza viruses, demonstrate how we all benefit from profitable drugmakers and abundant pharmaceutical research. Although governments have an important role to play in fighting any disease pandemic, necessary for developing any effective treatment and putting into mass production any vaccine or other medicine is private industry. Indeed, the initial fight against SARS focused on finding an existing medicine that worked. Laboratories screened some 2,000 federally approved and experimental drugs to see if they were useful in fighting SARS. Gurinder Shahi, a doctor in Singapore, explained: "Given how little we know about SARS and the reality that it is killing people, it is justified for us to be daring and innovative in coming up with solutions." Daring innovation is most likely in a competitive, profit-driven market.