Public Goods & Regulation in Health Economics eJournal, 2016
High drug prices are creating serious health and fiscal problems in the United States today. This... more High drug prices are creating serious health and fiscal problems in the United States today. This reality is vividly illustrated by recently approved medicines to treat Hepatitis C. These new medicines can cure nearly everyone with this potentially fatal infection and may even enable the elimination of this disease. But the drugs’ sticker price — close to $100,000 — has meant that very few patients who could benefit from them can access them. This Article describes an approach, available under existing law, to bring about transformative reductions in the prices of these medicines, at least for federal programs and possibly beyond. Under 28 U.S.C. § 1498, the U.S. government can buy generic versions of these medicines at less than 1% of their list price plus a reasonable royalty. This power has received almost no academic attention, despite the fact that it is regularly used by the government in other sectors, including defense. Indeed, though it has now been forgotten, the federal g...
The article describes the current crisis in access to medicines in the developing world, the exis... more The article describes the current crisis in access to medicines in the developing world, the existing R&D gap, and the role of universities and other public sector research institutions in exacerbating or ameliorating these problems. It proposes that public sector institutions adopt "Equitable Access Licensing" in order to ensure that patients in low and middle income countries have maximum access to medical technologies originating in universities.
Based on an analysis of relevant laws and policies, regulator data portals, and information reque... more Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.
A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically... more A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public’s investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited.
Medicines and vaccines are complex products, and it is often extraordinarily difficult to know wh... more Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must "reboot" its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. In line with the literature that has been critical of simplistic calls for "transparency," we urge a more contextual form of "data publicity." We also show that clinical trial data publicity can be achieved without legislative reform, while respecting privacy, protecting any legitimate trade secrets, and maintaining or improving incentives to innovate. The FDA must adapt to protect and expand structural accountability and to protect the public and its trust. The model we offer here could guide similar action at other regulatory agencies as well, enabling better oversight of information-intensive industries and helping safeguard the agencies themselves.
Litigation involving drug and medical device manufacturers has the potential to reveal important ... more Litigation involving drug and medical device manufacturers has the potential to reveal important information about product efficacy and safety as well as company marketing. Prevailing legal standards recognize the public's interest in having access to certain types of information in lawsuits. However, in practice, courts and litigants commonly use overly broad or unwarranted confidentiality orders, which can prevent the public from accessing important public health information that emerges during litigation. This Special Communication reviews the rules governing confidentiality orders and discusses the tension between these rules and prevailing legal practices relating to court secrecy in medical product litigation, including competing interests among manufacturers, plaintiffs, and courts. Using examples of successful efforts to challenge confidentiality orders, we describe how these prevailing legal practices can undermine access to information by patients, clinicians, and the US Food and Drug Administration and also obscure patterns of injury and disease associated with the drugs and medical devices at issue. We then discuss several ways to advance access to information important to public health that emerges during litigation, focusing particularly on the role of medical experts engaged in cases.
This paper analyzes the spread of intellectual property in trade agreements. We explain how the i... more This paper analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreements. We describe the additional "TRIPS-Plus" rules contained in recent trade agreements, which go beyond the requirements of the World Trade Organization's TRIPS Agreement, and explain the potential challenges that they may create for developing countries. We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again.
102 Cornell L. Rev. 1539 (2017)Today, intellectual property (IP) scholars accept that IP as an ap... more 102 Cornell L. Rev. 1539 (2017)Today, intellectual property (IP) scholars accept that IP as an approach to information production has serious limits. But what lies beyond IP? A new literature on “intellectual production without IP” (or “IP without IP”) has emerged to explore this question, but its examples and explanations have yet to convince skeptics. This Article reorients this new literature via a study of a hard case: a global influenza virus-sharing network that has for decades produced critically important information goods, at significant expense, and in a loose-knit group—all without recourse to IP. I analyze the Network as an example of “open science,” a mode of information production that differs strikingly from conventional IP, and yet that successfully produces important scientific goods in response to social need. The theory and example developed here refute the most powerful criticisms of the emerging “IP without IP” literature, and provide a stronger foundation for t...
When policymakers and academics think about designing optimal innovation incentives, they almost ... more When policymakers and academics think about designing optimal innovation incentives, they almost exclusively limit their considerations to alternative types of reward incentives. But in this article, we show that under specific circumstances innovation stickspotential penalties for failure to innovatecan play a valuable role in our innovation policy, either alone or in conjunction with innovation carrots. What's more, we provide examples of several innovation sticks that already have been used with apparent success, including the Federal Corporate Average Fuel Economy (CAFE) standards. Finally, we apply our approach to a new area to which we think innovation sticks may be well-suited: the problem of car fatalities. Our model suggests that a relatively simple system of yardstick penalties could help reduce national auto fatalities by as much 20%, simply by bringing laggard entities (companies and states) up to the median.
In May 2017, the US Food and Drug Administration (FDA) denied a 6-month extension of market exclu... more In May 2017, the US Food and Drug Administration (FDA) denied a 6-month extension of market exclusivity for Sensipar (cinacalcet), a drug manufactured by Amgen to manage hypercalcemia, common among patients with end-stage renal disease who are undergoing dialysis. The FDA determined that Amgen’s pediatric studies had been conducted inadequately and had provided inconclusive safety data. Amgen brought a lawsuit, Amgen v HHS (US Department of Health and Human Services), to challenge the denial.1 If Amgen prevails, it can delay generic competition for 6 months for a drug that generated $1.24 billion of revenue in 2016.2 More broadly, a decision favoring Amgen could diminish the FDA’s ability to encourage clinically meaningful pediatric studies and thus undermine the purpose of Congress in offering patent extensions to reward pediatric research.
Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with a... more Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with adequate and well-controlled clinical trials, a drug's safety and efficacy for each intended use and has prohibited the "offlabel" promotion of drugs. For companies to market an approved medicine for new indications, they must first conduct trials and submit data to establish safety and efficacy, as was the case for the initial approval. The FDA's approach to off-label promotion is in jeopardy, however. In response to recent US Supreme Court decisions strengthening First Amendment protection for companies, the pharmaceutical industry has framed offlabel marketing as a free speech right. Drug companies have won several important court cases that have weakened the FDA's authority to regulate off-label marketing. Although the legal issue-whether the FDA's restrictions on off-label marketing are unconstitutionalremains unresolved, the agency has initiated a comprehensive review of its approach to off-label marketing. On November 9 and 10, 2016, the FDA will convene a public hearing to address "its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products." 1 The Food, Drug, and Cosmetic Act grants the FDA the authority to approve drugs for specific indications and to prohibit the sale of "misbranded" drugs. When used for a new condition or population, a drug's riskbenefit ratio may change, or new safety considerations may emerge. By requiring studies before permitting marketing of new uses, the FDA gives companies incentives to produce the needed evidence for sound medical decisions. Off-label uses can be clinically appropriate, and physicians are free to prescribe medicines off-label. To help facilitate well-informed decisions, the FDA has created safe harbors that allow companies to communicate about potential new uses with physicians. Under current FDA guidance, drug companies may respond to unsolicited questions from physicians and proactively circulate peer-reviewed journal articles about off-label uses if the articles are based on adequate and wellcontrolled studies. 2,3 Recently, companies have begun to challenge this framework for communicating with clinicians about offlabel uses of drugs. Some have argued that more extensive marketing is not merely good policy, but a constitutionally protected right.
InIP scholarship, patents are commonly understood as more efficient than other approaches to inno... more InIP scholarship, patents are commonly understood as more efficient than other approaches to innovadon policy. Their primary ostensible advantage is allocadve: as a form of property rights, patents act as a conduit between market signals and potential innovators, ostensibly guiding investment toward inventions with the most social value. Exisdng accounts recognize that, in practice, signals of social value that patents facilitate may be attenuated because of, for example, transaction costs and limits on the scope and length of patent rights. We show here, however, a different problem with the conventional allocative account. The appropriability mechanism patents rely on, namely excludability, operates in asymmetrical ways for different kinds of informadon goods. While scholars have noted that patent systems fail to create goods whose value is difficult to appropriate in consumer markets, this fact has not been fiilly appreciated in the literature, nor have its implications for the standard jusdfication for patents. Through detailed examples in the health context we show that some kinds of information goods will be much more difficult to exclude than others. Importandy, there is no reason to expect that the ease of exclusion will be correlated with social value. The analytic point that emerges is generalizible: patents themselves can have distortive effects, stemming from structural features of exclusion rights. Unlike the problem of attenuation, the problem of asymmetric nonexcludability cannot be resolved by increasing patent scope or length. Because excludability is variabk along a continuum, property rights in informadon, even if formally perfected, and even assuming away convendonal transaction costs, will create asymmetrical demand for different kinds of information goods. This argument provides an important new justification for alternadves to patents such as government funding and gives us new insights about how to allocate aich funding. It also reinforces the need for a comparative institutional approach to innovation policy, and for incorporating into our debates currendy unrecognized implications that patents may have for values such as privacy and free speech.
From what are phenomena rescued? Not just or not so much from the ill-repute and contempt into wh... more From what are phenomena rescued? Not just or not so much from the ill-repute and contempt into which they 've fallen, but from the catastrophe when a certain form of transmission often presents them in terms of their "value as heritage "-they are rescued by exhibiting the discontinuity that exists within them. There is a kind of transmission that is a catastrophe.-Walter Benjamin** It is frequently said that there is a necessary relationship between constitutionalism and history. As Stephen Griffin has written, "[c]onstitutional interpretation is always backward-looking .... It draws on the past in order to provide legal authority to the present. Even as it abstracts from historical context, then, constitutional interpretation is dependent on it for its status as law." 1 To say this is to make two
The field of intellectual property (IP) law today is focused, as the name itself advertises, on o... more The field of intellectual property (IP) law today is focused, as the name itself advertises, on one particular institutional approach to scientific and cultural production: IP. When legal scholars explain this focus, they typically do so with reference to the virtues of price. Because price gives us a decentralized way to link social welfare to the production of information, IP is alleged to be more efficient than other approaches. The dominant mode of IP scholarship begins here and then addresses questions internal to IP lawfor example, how broad or narrow should exceptions to IP rights be? But the internalism that characterizes the field of IP cannot, as I show, be justified by the value of efficiency. Economics offers us no a priori reason to assume that IP is more efficient than other possible approaches, most prominently government procurement and commons-based production. If we take the invitation that economists offer us to think external to IP, we also gain new insights about the implications of values other than efficiency for the choice between different institutional approaches to scientific and cultural production. We see, as I argue, that using price to guide scientific and cultural production-which is to say, using IP-may have costs not only for efficiency, but also for distributive justice and informational privacy. The IP approach is in tension with the value of distributive justice because reliance upon price may yield not only unjust distribution of existing information resources but also unjust production of future information resources. The IP approach is in tension with the value of information privacy because relying on price to generate information facilitates the desire, the demand, and perhaps the capacity for price discrimination. That, in turn, generates an impulse for the extensive collection of personal information. Both government procurement and commons-based production plausibly offer more promise than does IP in both distributive justice and privacy terms, and they may be no less efficient than IP. Giving full scope to all three of these values thus requires us to telescope out from the internalism that characterizes the field, and to countenance a broader role for commons-based production and government procurement. In the field of IP, I conclude, we should pay less attention to IP and more to the alternatives.
... South Africa Amy Kapczynski & Jonathan M. Berger Introduction I gave birth to an HIV posi... more ... South Africa Amy Kapczynski & Jonathan M. Berger Introduction I gave birth to an HIV positive baby who should have been saved. That was my experience, the sad one, and I will live with it until my last day.1 Busisiwe Maqungo Mfuleni, Cape Town, South Africa ...
U niversities have long been important in the development of life-saving medicines and technologi... more U niversities have long been important in the development of life-saving medicines and technologies, and they once considered patenting to be antithetical to academic science and public health. Now a fierce debate rages about whether and when patents promote innovation, but in practice, the patenting worm has turned: Seeking revenues and ways to commercialize their inventions, U.S. universities are taking out patents in unprecedented numbers. In 2001, they were granted more than 3000 of them. But patents bring more than revenues. They also bring controversy, when they ensure power over commodities that are the very currency of life itself. Today, universities hold important patents on many life-saving drugs, including the antiretroviral drugs stavudine (Yale University), abacavir (University of Minnesota), lamivudine (Emory University), and enfuvirtide (Duke University). As the AIDS pandemic has demonstrated, patents and exclusive licenses typically drive prices up and thereby impede access to lifesaving medications. Low prices alone cannot solve the global crisis in access to medicines, but they are necessary, particularly for those in lowand middle-income (LMI) countries, where governments have limited resources and people often pay for part or all of their health care. We have seen firsthand the effects of university patenting and licensing decisions. In February 2001, Doctors Without Borders sought Yale's permission to use a generic version of stavudine in South Africa. This prompted global attention and intense discussions between the university and Bristol-Myers Squibb (to whom it had exclusively licensed the drug). The result was the first patent concession on an AIDS drug and a 30-fold reduction in the price of the patented drug in South Africa. This action was taken without negative consequences to the university, financial or otherwise. Recently, a local company began selling generic stavudine in South Africa at up to 40% less than the reduced patented price. A group of experts recently convened at Yale concluded that universities can improve and save lives by working collectively to adopt access-friendly intellectual property (IP) policies (see Access to Essential Medicines and University Research: Building Best Practices at http://cira.med.yale.edu). This will require developing specific licensing and patenting strategies that are applicable to LMI countries. Such strategies must be tailored to the technology and partner, but broadly speaking, they fall into two categories. First, universities could not patent their discoveries in LMI countries. This will promote generic competition as long as all the IP necessary to produce a generic version of a product stays in the public domain and no patent barriers exist in important source countries for generics (such as Brazil, India, and Thailand). Today, universities rarely patent in most developing countries because of the expense, but some will do so if a licensee requests it or if there is a market or potential generic competitor in the country. If universities already hold patents in LMI countries or want them for leverage (for example, over companies who might take out improvement patents), they can still promote competition by granting nonexclusive licenses to these patents. Second-and regardless of where they hold patents-universities should negotiate clauses in their licensing agreements that require the resulting products to be made available in LMI countries quickly, in sufficient quantities, and at an appropriate cost. Such actions should not hurt universities' bottom line, diminish their ability to strike licensing deals, or discourage innovation for one simple reason: There is very little profit at stake. For 2002, Africa was projected to make up a mere 1.3% and Southeast Asia, China, and the Indian subcontinent only 6.7% of the world pharmaceutical market. These markets are too small to significantly influence revenues or, unfortunately, innovation. Universities can, however, seek creative ways to bridge the innovation gap; for example, by licensing compounds that may be useful against neglected diseases to new, nonprofit, drug development initiatives. A few have already done so. Issues of access and IP will be with us for years to come. Some progress has been made in the past few years at the World Trade Organization and by governments, but this provides little comfort when so many people still lack essential medicines. Where lives and health are at stake, universities should not pass the buck. University research is intended to advance the common public good. It is time that it consistently do so globally, as well as locally.
Public Goods & Regulation in Health Economics eJournal, 2016
High drug prices are creating serious health and fiscal problems in the United States today. This... more High drug prices are creating serious health and fiscal problems in the United States today. This reality is vividly illustrated by recently approved medicines to treat Hepatitis C. These new medicines can cure nearly everyone with this potentially fatal infection and may even enable the elimination of this disease. But the drugs’ sticker price — close to $100,000 — has meant that very few patients who could benefit from them can access them. This Article describes an approach, available under existing law, to bring about transformative reductions in the prices of these medicines, at least for federal programs and possibly beyond. Under 28 U.S.C. § 1498, the U.S. government can buy generic versions of these medicines at less than 1% of their list price plus a reasonable royalty. This power has received almost no academic attention, despite the fact that it is regularly used by the government in other sectors, including defense. Indeed, though it has now been forgotten, the federal g...
The article describes the current crisis in access to medicines in the developing world, the exis... more The article describes the current crisis in access to medicines in the developing world, the existing R&D gap, and the role of universities and other public sector research institutions in exacerbating or ameliorating these problems. It proposes that public sector institutions adopt "Equitable Access Licensing" in order to ensure that patients in low and middle income countries have maximum access to medical technologies originating in universities.
Based on an analysis of relevant laws and policies, regulator data portals, and information reque... more Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.
A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically... more A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public’s investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited.
Medicines and vaccines are complex products, and it is often extraordinarily difficult to know wh... more Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must "reboot" its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. In line with the literature that has been critical of simplistic calls for "transparency," we urge a more contextual form of "data publicity." We also show that clinical trial data publicity can be achieved without legislative reform, while respecting privacy, protecting any legitimate trade secrets, and maintaining or improving incentives to innovate. The FDA must adapt to protect and expand structural accountability and to protect the public and its trust. The model we offer here could guide similar action at other regulatory agencies as well, enabling better oversight of information-intensive industries and helping safeguard the agencies themselves.
Litigation involving drug and medical device manufacturers has the potential to reveal important ... more Litigation involving drug and medical device manufacturers has the potential to reveal important information about product efficacy and safety as well as company marketing. Prevailing legal standards recognize the public's interest in having access to certain types of information in lawsuits. However, in practice, courts and litigants commonly use overly broad or unwarranted confidentiality orders, which can prevent the public from accessing important public health information that emerges during litigation. This Special Communication reviews the rules governing confidentiality orders and discusses the tension between these rules and prevailing legal practices relating to court secrecy in medical product litigation, including competing interests among manufacturers, plaintiffs, and courts. Using examples of successful efforts to challenge confidentiality orders, we describe how these prevailing legal practices can undermine access to information by patients, clinicians, and the US Food and Drug Administration and also obscure patterns of injury and disease associated with the drugs and medical devices at issue. We then discuss several ways to advance access to information important to public health that emerges during litigation, focusing particularly on the role of medical experts engaged in cases.
This paper analyzes the spread of intellectual property in trade agreements. We explain how the i... more This paper analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreements. We describe the additional "TRIPS-Plus" rules contained in recent trade agreements, which go beyond the requirements of the World Trade Organization's TRIPS Agreement, and explain the potential challenges that they may create for developing countries. We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again.
102 Cornell L. Rev. 1539 (2017)Today, intellectual property (IP) scholars accept that IP as an ap... more 102 Cornell L. Rev. 1539 (2017)Today, intellectual property (IP) scholars accept that IP as an approach to information production has serious limits. But what lies beyond IP? A new literature on “intellectual production without IP” (or “IP without IP”) has emerged to explore this question, but its examples and explanations have yet to convince skeptics. This Article reorients this new literature via a study of a hard case: a global influenza virus-sharing network that has for decades produced critically important information goods, at significant expense, and in a loose-knit group—all without recourse to IP. I analyze the Network as an example of “open science,” a mode of information production that differs strikingly from conventional IP, and yet that successfully produces important scientific goods in response to social need. The theory and example developed here refute the most powerful criticisms of the emerging “IP without IP” literature, and provide a stronger foundation for t...
When policymakers and academics think about designing optimal innovation incentives, they almost ... more When policymakers and academics think about designing optimal innovation incentives, they almost exclusively limit their considerations to alternative types of reward incentives. But in this article, we show that under specific circumstances innovation stickspotential penalties for failure to innovatecan play a valuable role in our innovation policy, either alone or in conjunction with innovation carrots. What's more, we provide examples of several innovation sticks that already have been used with apparent success, including the Federal Corporate Average Fuel Economy (CAFE) standards. Finally, we apply our approach to a new area to which we think innovation sticks may be well-suited: the problem of car fatalities. Our model suggests that a relatively simple system of yardstick penalties could help reduce national auto fatalities by as much 20%, simply by bringing laggard entities (companies and states) up to the median.
In May 2017, the US Food and Drug Administration (FDA) denied a 6-month extension of market exclu... more In May 2017, the US Food and Drug Administration (FDA) denied a 6-month extension of market exclusivity for Sensipar (cinacalcet), a drug manufactured by Amgen to manage hypercalcemia, common among patients with end-stage renal disease who are undergoing dialysis. The FDA determined that Amgen’s pediatric studies had been conducted inadequately and had provided inconclusive safety data. Amgen brought a lawsuit, Amgen v HHS (US Department of Health and Human Services), to challenge the denial.1 If Amgen prevails, it can delay generic competition for 6 months for a drug that generated $1.24 billion of revenue in 2016.2 More broadly, a decision favoring Amgen could diminish the FDA’s ability to encourage clinically meaningful pediatric studies and thus undermine the purpose of Congress in offering patent extensions to reward pediatric research.
Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with a... more Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with adequate and well-controlled clinical trials, a drug's safety and efficacy for each intended use and has prohibited the "offlabel" promotion of drugs. For companies to market an approved medicine for new indications, they must first conduct trials and submit data to establish safety and efficacy, as was the case for the initial approval. The FDA's approach to off-label promotion is in jeopardy, however. In response to recent US Supreme Court decisions strengthening First Amendment protection for companies, the pharmaceutical industry has framed offlabel marketing as a free speech right. Drug companies have won several important court cases that have weakened the FDA's authority to regulate off-label marketing. Although the legal issue-whether the FDA's restrictions on off-label marketing are unconstitutionalremains unresolved, the agency has initiated a comprehensive review of its approach to off-label marketing. On November 9 and 10, 2016, the FDA will convene a public hearing to address "its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products." 1 The Food, Drug, and Cosmetic Act grants the FDA the authority to approve drugs for specific indications and to prohibit the sale of "misbranded" drugs. When used for a new condition or population, a drug's riskbenefit ratio may change, or new safety considerations may emerge. By requiring studies before permitting marketing of new uses, the FDA gives companies incentives to produce the needed evidence for sound medical decisions. Off-label uses can be clinically appropriate, and physicians are free to prescribe medicines off-label. To help facilitate well-informed decisions, the FDA has created safe harbors that allow companies to communicate about potential new uses with physicians. Under current FDA guidance, drug companies may respond to unsolicited questions from physicians and proactively circulate peer-reviewed journal articles about off-label uses if the articles are based on adequate and wellcontrolled studies. 2,3 Recently, companies have begun to challenge this framework for communicating with clinicians about offlabel uses of drugs. Some have argued that more extensive marketing is not merely good policy, but a constitutionally protected right.
InIP scholarship, patents are commonly understood as more efficient than other approaches to inno... more InIP scholarship, patents are commonly understood as more efficient than other approaches to innovadon policy. Their primary ostensible advantage is allocadve: as a form of property rights, patents act as a conduit between market signals and potential innovators, ostensibly guiding investment toward inventions with the most social value. Exisdng accounts recognize that, in practice, signals of social value that patents facilitate may be attenuated because of, for example, transaction costs and limits on the scope and length of patent rights. We show here, however, a different problem with the conventional allocative account. The appropriability mechanism patents rely on, namely excludability, operates in asymmetrical ways for different kinds of informadon goods. While scholars have noted that patent systems fail to create goods whose value is difficult to appropriate in consumer markets, this fact has not been fiilly appreciated in the literature, nor have its implications for the standard jusdfication for patents. Through detailed examples in the health context we show that some kinds of information goods will be much more difficult to exclude than others. Importandy, there is no reason to expect that the ease of exclusion will be correlated with social value. The analytic point that emerges is generalizible: patents themselves can have distortive effects, stemming from structural features of exclusion rights. Unlike the problem of attenuation, the problem of asymmetric nonexcludability cannot be resolved by increasing patent scope or length. Because excludability is variabk along a continuum, property rights in informadon, even if formally perfected, and even assuming away convendonal transaction costs, will create asymmetrical demand for different kinds of information goods. This argument provides an important new justification for alternadves to patents such as government funding and gives us new insights about how to allocate aich funding. It also reinforces the need for a comparative institutional approach to innovation policy, and for incorporating into our debates currendy unrecognized implications that patents may have for values such as privacy and free speech.
From what are phenomena rescued? Not just or not so much from the ill-repute and contempt into wh... more From what are phenomena rescued? Not just or not so much from the ill-repute and contempt into which they 've fallen, but from the catastrophe when a certain form of transmission often presents them in terms of their "value as heritage "-they are rescued by exhibiting the discontinuity that exists within them. There is a kind of transmission that is a catastrophe.-Walter Benjamin** It is frequently said that there is a necessary relationship between constitutionalism and history. As Stephen Griffin has written, "[c]onstitutional interpretation is always backward-looking .... It draws on the past in order to provide legal authority to the present. Even as it abstracts from historical context, then, constitutional interpretation is dependent on it for its status as law." 1 To say this is to make two
The field of intellectual property (IP) law today is focused, as the name itself advertises, on o... more The field of intellectual property (IP) law today is focused, as the name itself advertises, on one particular institutional approach to scientific and cultural production: IP. When legal scholars explain this focus, they typically do so with reference to the virtues of price. Because price gives us a decentralized way to link social welfare to the production of information, IP is alleged to be more efficient than other approaches. The dominant mode of IP scholarship begins here and then addresses questions internal to IP lawfor example, how broad or narrow should exceptions to IP rights be? But the internalism that characterizes the field of IP cannot, as I show, be justified by the value of efficiency. Economics offers us no a priori reason to assume that IP is more efficient than other possible approaches, most prominently government procurement and commons-based production. If we take the invitation that economists offer us to think external to IP, we also gain new insights about the implications of values other than efficiency for the choice between different institutional approaches to scientific and cultural production. We see, as I argue, that using price to guide scientific and cultural production-which is to say, using IP-may have costs not only for efficiency, but also for distributive justice and informational privacy. The IP approach is in tension with the value of distributive justice because reliance upon price may yield not only unjust distribution of existing information resources but also unjust production of future information resources. The IP approach is in tension with the value of information privacy because relying on price to generate information facilitates the desire, the demand, and perhaps the capacity for price discrimination. That, in turn, generates an impulse for the extensive collection of personal information. Both government procurement and commons-based production plausibly offer more promise than does IP in both distributive justice and privacy terms, and they may be no less efficient than IP. Giving full scope to all three of these values thus requires us to telescope out from the internalism that characterizes the field, and to countenance a broader role for commons-based production and government procurement. In the field of IP, I conclude, we should pay less attention to IP and more to the alternatives.
... South Africa Amy Kapczynski & Jonathan M. Berger Introduction I gave birth to an HIV posi... more ... South Africa Amy Kapczynski & Jonathan M. Berger Introduction I gave birth to an HIV positive baby who should have been saved. That was my experience, the sad one, and I will live with it until my last day.1 Busisiwe Maqungo Mfuleni, Cape Town, South Africa ...
U niversities have long been important in the development of life-saving medicines and technologi... more U niversities have long been important in the development of life-saving medicines and technologies, and they once considered patenting to be antithetical to academic science and public health. Now a fierce debate rages about whether and when patents promote innovation, but in practice, the patenting worm has turned: Seeking revenues and ways to commercialize their inventions, U.S. universities are taking out patents in unprecedented numbers. In 2001, they were granted more than 3000 of them. But patents bring more than revenues. They also bring controversy, when they ensure power over commodities that are the very currency of life itself. Today, universities hold important patents on many life-saving drugs, including the antiretroviral drugs stavudine (Yale University), abacavir (University of Minnesota), lamivudine (Emory University), and enfuvirtide (Duke University). As the AIDS pandemic has demonstrated, patents and exclusive licenses typically drive prices up and thereby impede access to lifesaving medications. Low prices alone cannot solve the global crisis in access to medicines, but they are necessary, particularly for those in lowand middle-income (LMI) countries, where governments have limited resources and people often pay for part or all of their health care. We have seen firsthand the effects of university patenting and licensing decisions. In February 2001, Doctors Without Borders sought Yale's permission to use a generic version of stavudine in South Africa. This prompted global attention and intense discussions between the university and Bristol-Myers Squibb (to whom it had exclusively licensed the drug). The result was the first patent concession on an AIDS drug and a 30-fold reduction in the price of the patented drug in South Africa. This action was taken without negative consequences to the university, financial or otherwise. Recently, a local company began selling generic stavudine in South Africa at up to 40% less than the reduced patented price. A group of experts recently convened at Yale concluded that universities can improve and save lives by working collectively to adopt access-friendly intellectual property (IP) policies (see Access to Essential Medicines and University Research: Building Best Practices at http://cira.med.yale.edu). This will require developing specific licensing and patenting strategies that are applicable to LMI countries. Such strategies must be tailored to the technology and partner, but broadly speaking, they fall into two categories. First, universities could not patent their discoveries in LMI countries. This will promote generic competition as long as all the IP necessary to produce a generic version of a product stays in the public domain and no patent barriers exist in important source countries for generics (such as Brazil, India, and Thailand). Today, universities rarely patent in most developing countries because of the expense, but some will do so if a licensee requests it or if there is a market or potential generic competitor in the country. If universities already hold patents in LMI countries or want them for leverage (for example, over companies who might take out improvement patents), they can still promote competition by granting nonexclusive licenses to these patents. Second-and regardless of where they hold patents-universities should negotiate clauses in their licensing agreements that require the resulting products to be made available in LMI countries quickly, in sufficient quantities, and at an appropriate cost. Such actions should not hurt universities' bottom line, diminish their ability to strike licensing deals, or discourage innovation for one simple reason: There is very little profit at stake. For 2002, Africa was projected to make up a mere 1.3% and Southeast Asia, China, and the Indian subcontinent only 6.7% of the world pharmaceutical market. These markets are too small to significantly influence revenues or, unfortunately, innovation. Universities can, however, seek creative ways to bridge the innovation gap; for example, by licensing compounds that may be useful against neglected diseases to new, nonprofit, drug development initiatives. A few have already done so. Issues of access and IP will be with us for years to come. Some progress has been made in the past few years at the World Trade Organization and by governments, but this provides little comfort when so many people still lack essential medicines. Where lives and health are at stake, universities should not pass the buck. University research is intended to advance the common public good. It is time that it consistently do so globally, as well as locally.
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