Monopoly Rights Research Articles

The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform.

The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers. To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs. We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions. Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. In 2013, per capita spending on prescription drugs was $858 compared with an average of $400 for 19 other industrialized nations. In the United States, prescription medications now comprise an estimated 17% of overall personal health care services. The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents. The availability of generic drugs after this exclusivity period is the main means of reducing prices in the United States, but access to them may be delayed by numerous business and legal strategies. The primary counterweight against excessive pricing during market exclusivity is the negotiating power of the payer, which is currently constrained by several factors, including the requirement that most government drug payment plans cover nearly all products. Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear. High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability; providing greater opportunities for meaningful price negotiation by governmental payers; generating more evidence about comparative cost-effectiveness of therapeutic alternatives; and more effectively educating patients, prescribers, payers, and policy makers about these choices.

“They’re creepy and they’re kooky” and They’re Copyrighted: How Copyright Is Used to Dampen the (Re-)Imagination

“They’re creepy and they’re kooky” and They’re Copyrighted: How Copyright Is Used to Dampen the (Re-)Imagination

Muscling in on unjustified threats: Reform is long overdue but is it enough?

The UK regime of unjustified or groundless threats has long been a controversial subject for IP practitioners and their clients. It is largely unique to the UK and the Republic of Ireland and concerns threats to retailers that are merely selling goods that are alleged to infringe, as opposed to manufacturers. These retailers (‘secondary infringers’) may well want to avoid a legal fight and take the easy option of ceasing to deal in the goods concerned. As a result, the manufacturers (‘primary infringers’) may never have the opportunity to defend the allegations or even know why they have lost that particular customer. Despite its good intentions, the threats legislation and case law usually leads to a difficult discussion with a client and can, in practice, act as a barrier to exercising registered IP rights. So what are unjustified threats all about? To recap, if an IP owner makes a communication to a third party alleging infringement that can be reasonably viewed by it as a threat to take action in the UK courts, that party, or anyone aggrieved by the ‘threat’, can sue the rights owner for making an unjustified threat of proceedings. In such an action injunctive as well as compensatory relief can be sought. The threats legislation can, as might be imagined, easily catch IP owners and their advisers out, especially those based outside the UK who may not even know of its existence or easily understand its complexity. The requirements vary according to which type of intellectual property right (IPR) is being invoked, and the regime does not include all types of IPR. Passing off, copyright, trade secrets and database right are excluded and therefore threats based on these grounds are legitimate, whether made to a secondary or primary infringer. IP rights are, of course, intended to incentivise scientific and technical advancement, development and creativity. Arguably the threats provisions are a disincentive to do this as well as to protect IP by way of registration. Why invest in a new idea and protect it with a patent if to avoid being sued yourself you are forced to sue every infringer? Should it not be possible instead to use your rights to seek in good faith to persuade them to stop the infringement? An IP holder may know only the identity of the retailer/reseller of the infringing products and so has no option but to pursue them in the first instance. The reaction of clients is often one of disbelief when they are told of the risks of the tables being turned on them for, as they see it, perfectly legitimate use of their rights for the purpose for which they were acquired in the first place. Originally conceived to prevent bullying use of IP monopoly rights and as a way to tackle unfair competition, the regime ironically encourages rights holders to go straight to court without any advance notice. This can be a very expensive sledgehammer to crack a nut. Also, far from assisting a negotiated commercial resolution it is more likely to put the parties at loggerheads and delay, or even take away any chance of, achieving a sensible out of court settlement. All of this is at odds with a court system in the UK that puts the onus on the parties to attempt to resolve matters out of court and to view litigation as the last resort. Indeed, failing to attempt to mediate or negotiate before suing, at least in the English courts, can result in costs penalties. The regime has, for the reasons outline above, been the subject of consternation in the IP profession. This is perhaps not surprising taking account of the fact that the lawyer or IP professional sending any relevant communication can themselves be sued if the threat is held to have been unjustified. Often that very angle is used by the lawyers acting for the allegedly threatened party as a nuisance tactic to try and drive a wedge between the lawyer acting for the rights holder and their client, as it raises clear issues of conflict. Frequently IP lawyers will request an indemnity from their clients as a condition of sending the potentially threatening communication, prompting the client to terminate the relationship, especially where they do not have a longstanding relationship with the lawyer concerned. Matters would be far more straightforward if it were always easy to decide what constitutes an actionable

The First Compulsory Licencing Case in India under the TRIPS Agreement: An Analysis of Bayer Versus Natco Pharma Ltd

Intellectual property rights provides protection to inventions and monopoly rights for a limited period of time to encourage innovation in industry. In many cases, it turned out to be an abuse of the monopoly power by different means. A compulsory licence is a mechanism provided under the Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement in order to revoke a patent granted to a patentee in certain circumstances. Across the world, the compulsory licencing (CL) on intellectual property rights (IPRs) is granted on similar grounds like unreasonably exorbitant prices of an essential facility or commodity, or in the country where patent does not work or where substantial public interest is affected by the way an IPR holder exercises his/her right. This article analyses India’s first CL order in favour of Natco Pharma which has garnered a lot of attention all over the world, and CL has been viewed as a remedy to curb the abuse of exclusivity protected by IPR. The case essentially revolves around an anti-cancer drug, Nexavar, which had been patented by Bayer. This article begins by elaborating the concept of CL and its effect on developing countries with a special reference to the TRIPS Agreement. The latter part would deal with the viability of CL order under the Indian framework of IP law and India‘s compliance with TRIPS in the background of the case of Bayer versus Natco Pharma. Finally, the article concludes that CL is a TRIPS-permitted provision that developing countries can use in their favour to protect their health sector, and the present case can be a model for the developing countries.

Corporate Power Unbound: Investor-State Arbitration of IP Monopolies on Medicines - <I>Eli Lilly v. Canada</I> and the Trans-Pacific Partnership Agreement

Despite the deep irony of free trade agreements being subverted to codify and extend anti-competitive monopoly rights and despite the equally deep irony of foreign investors having greater enforcement rights than local investors, the joining of enhanced intellectual property rights (IPRs) and protections and strengthened investor rights is creating a wild-west opportunity for unbounded corporate power. Two current contestations show the dangers of this expanded power in sharp relief. In the Trans-Pacific Partnership Agreement (TPPA), at the behest of its powerful pharmaceutical lobby, the United States is seeking the most extreme forms of pharmaceutical patent, data, and enforcement rights that have ever been proposed at the same time that it is seeking enhanced IP-related investor rights in the most recently leaked Investment Chapter. In the pending investor-state-dispute-settlement case under an older but parallel North America Free Trade Agreement (NAFTA) investment clause, an American pharmaceutical company, in Eli Lilly v. Canada, is for the first time claiming $500 million in investment-related damages because of Canada’s sovereign decision to invalidate previously granted patents on two medicines on the grounds that those patents failed to meet well-established Canadian standards of patentability.This article is not written as an abstract juxtaposition of these two current events. It is written to expose the dangers that countries face, especially low- and middle-income countries, in trade negotiations with the U.S., Europe, and Japan that seek to impose stronger patent, data, and market entry protections and at the same time seek to expand the armamentarium of enforcement powers available to pharmaceutical behemoths. Part II of the paper contains a brief introduction to the international IP regime, namely the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the TRIPS-plus pharmaceutical protections being sought in the mostly recently leaked TPPA Intellectual Property Chapter and Transparency Chapter still being negotiated between twelve Pacific rim countries. Part III gives a brief historical background on investment treaties and investor-state-dispute-settlement (ISDS). Part IV analyses the TPP Investment Chapter in more depth, particularly its provisions that deal with protection for and enforcement of IP-related investments. Part IV discusses the pending Eli Lilly v. Canada ISDS arbitration, including the claims and defenses of the parties. Part V concludes with a recommendation that investment chapters be struck from the TPP and other trade agreements or that such chapters should not apply whatsoever to the protection or enforcement of IPRs given the many other enforcement powers available to patent holders. The article claims that extending boundless corporate power to Big Pharma through adoption of ISDS for IPRs presents a grave danger to the communal right to health and the right of access to affordable medicines for all.

Exploitative Prices in European Competition Law

Undertakings may restrict competition cooperating with their competitors (collusion) or interfering with their ability to compete (exclusion). The main concern about collusive and exclusionary practices is that they enable firms to profitably raise prices over their marginal costs; i.e. they create market power. In European competition law it has been considered that, under certain circumstances, practices which, without reinforcing it, represent a mere exercise of the (substantial) market power already enjoyed by the dominant firm, should be prohibited as well. Among these so-called “exploitative practices”, the most obvious example would be the direct imposition of excessively high prices. This chapter discusses whether purely exploitative prices (i.e., prices aimed at the mere exploitation of the buyers without exclusionary object or effects) should be included in the prohibition of unfair prices as an abuse of dominant position or, on the contrary, an exclusionary effect is also required. The vagueness of the case law of the European Court of Justice has enabled the coexistence of divergent interpretations and, accordingly, very different standards. The assumption of a price control function by a competition authority, and the subsequent prohibition of purely exploitative prices, are not supported by the main legal theories on competition law, and, according to mainstream economics, may impair the efficiency of markets. In addition, neither the definition of unfair prices nor the test employed to determine their existence necessarily include exploitative prices. On the contrary, both of them suggest that an unfair price has to be a supra-monopoly price, whose object and effects would be exclusionary rather than purely exploitative. Purely exploitative prices are just maximizing-profit prices (i.e. monopoly prices), and, as long as they are inherent to the possession of a dominant position should not be regulated, apart from the case when dominance has been achieved through the market being a true natural monopoly or through state-granted monopoly rights; even then, the task of regulating the prices of monopolists – or removing such a legislative privileges – should be done ex ante and left to government or sector-specific regulators.

Isle of Man, Galapagos and sunspot data show net cooling hid double exponential ocean warming danger: +3°C in 2014, +4°C likely by 2016.

Anthropogenic global warming (AGW) heat is trapped by the greenhouse gas (GHG) blanket, and the ocean surface layer. It is 93% in the ocean and drives atmospheric warming. The 111-year mean daily surface temperatures are 10.5±0.5°C at Port Erin (PE) Isle of Man compared with 9.6±4.8°C in Central England (CET) air. The Port Erin 5½-year max-min heat cycle synchronizes to the 11-year solar heat pump sunspot cycle. Tropical heat arrives 2 years after a solar maximum on wind-driven currents in the stratified sea surface. Runoff from bottom-up melted Arctic icesheets arrives 3½ year later at solar minimum. These warm and cold waters are the biodiversity source. PE is unique with seasonal meltwaters of Pacific and Atlantic origin. The North Pacific warms twice as fast as other oceans. All ocean near-surface gyre currents harmonize with sunspot cycles. Net cooling by polar icemelt masks catastrophic exponential ocean warming and icemelt. Eleven counter-rotating surface gyres carry heat and nutrients globally in verified ocean surface circulation system.Exponential growth is unsustainable in a finite system. It trends to infinity. Double-exponential gets there twice as quickly. The GHG blanket, grown double-exponentially for 250 years, is now in control. Ocean heat absorption takes 150-250 years. Arctic icemelt increases double-exponentially. The Arctic long-term annual freeze-melt volume cycle is 16.8±1.3 thousand cubic km per year. Polar land icemelt adds ~500 km3 per year. Freeze-brine of salinity >40‰ and temperature –1°C, sinks to the bottom. Equatorial evaporative-brine of salinity >36.4‰ and >28°C floats subsurface under fresh warm layers thickening westwards in tropical meridional cells to ~75m depth. This is consistent with observed extreme weather.Heat imbalance forced Pacific Ocean temperatures above proposed limits of +2°C in 1993, to +3°C in 2014, and is on track for +4°C for 2016. Century-long daily records confirm processes ongoing for 300 years. Coast locations are where impacts are felt and real-time data collected. Corporate governance degraded physics teaching in only 60 years. Individual discovery and data collection was lost. Big science is unnecessary. Satellites cannot do plankton tows. Computer models are governed by the rule of ‘garbage-in garbage-out’. They must be verified by in situ data that cannot be collected retrospectively. Continuous timeseries surface profile data from fixed ocean station locations on a global variable-boundary network are essential. Scientists, if well-trained in ocean experimental physics, can do the hard work.Time-poor scientists, stripped of their intellectual property rights, under rewarded, poorly educated, and ruthlessly exploited by growth-obsessed commercial interests, missed catastrophic global warming and multiple extreme consequences. Climate scientists abandoned classical physics and Newton-Hooke field verification in favor of unverified beliefs, models, and apps. Climate studies confuse heat with temperature, do not include basal icemelt, density temperature-salinity function, Clausius-Clapeyron evaporation exponential skin temperature function, asymmetric brine-heat sequestration, solar and tidal pumping, infra-red GHG heat trap, vertical tropical cells, freshwater warm pools; or wind-driven surface currents at 3 percent of windspeed. Climate model mistaken assumptions lead to the absurd conclusion that evaporation in the Labrador Sea at midnight in midwinter is greater than at the midday Equator.The Isle of Man provides an ideal location for continued monitoring and mitigation research, teaching and public service in a dedicated non-commercial independent multidisciplinary university-type setting. Quality teaching is the major priority. Commercial monopoly rights need replacement with free, fully open discussions and publications. Quality not quantity should be paramount. Internationally competitive academics should control subservient lower paid support staff.Every day without ocean surface data means vital scientific truth lost of interest and concern to all populations. Predictions are groundless without accurate continuous ocean surface data. Skeptics, politicians, statisticians, those with stakes in the status quo, and established research censors obstructing scientific progress squabble in ignorance while the globe burns.

The Inverse Boomerang Pattern: the Global Kaletra Campaign and Access to Antiretroviral Drugs in Colombia and Ecuador

This paper examines a global campaign in which transnational advocacy networks challenged the monopoly rights of Abbott Laboratories over the antiretroviral drug Kaletra. It focuses on the cases of Colombia and Ecuador and analyzes the different trajectories of the campaign in the two countries and how each trajectory contributed differently to the global outcome. In both of these cases, I show that activism operated in an “inverse boomerang” pattern, by which an international NGO reached out to local allies to expand its global coalition, prioritizing its agenda over other domestic considerations. I argue that in cases where transnational campaigns are initiated globally, there is a potential mismatch between global and domestic goals and that the campaigns’ contribution to global norm-making depends on the type of relationship established between international advocates and domestic actors. Such relationships are in turn influenced by the political and economic context and the institutional arrangements of each country.

Can IPRS System Protect the Interests of Traditional Knowledge: Critical Appraisal

Traditional knowledge (TK) has been transformed into global knowledge with the pace of globalization which is not threat of TK, but western countries’ exploitation of monopoly rights over this TK without acknowledgement is a crucial matter of concern. Therefore, WIPO’s IGC recently is playing a significant role to develop a text based negotiation to protect TK. After analyzing the shortcomings of the existing IP system, this paper scrutinizes the current controversial challenges on TK protection and examines the current IGC’s discussions. This paper mainly analyzes the major recommendations of IGC in order to propose guidance for protecting TK through IP in better ways or through alternative forms such as sui generis system. WIPO’s IGC is the prime area in which both developing nations and indigenous communities have claimed their desired aims concerning the interests of TK holders. It ends with some propositions for achieving a result and suggests that now it’s time to go beyond intellectual property rights to settle this controversial issue.

A Simple Theoretical Model of Bribe Uncertainty

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Judicial protection of intellectual property rights in Republic of Serbia

This paper deals with the judicial protection of intellectual property rights in the case of injury, without which the monopoly right of the legal entity does not make any sense. The subject of protection refers to the intangible assets which, through the economic function, allows the legal entity certain material benefits coming from the economic exploitation. The special importance of protecting intellectual property rights derives from the fact that the intellectual property is created by engaging the most creative human resources together with huge financial investments. In our country, the newly adopted laws are, to the greatest extent, harmonized with the current both regional and international standards in the field of protection of intellectual property rights.

Sovereign trusteeship and multilateral protection of intellectual property rights

TRIPS established a minimum standard of intellectual property rights to be adopted by the member states along with an obligation that mandates mutual recognition of domestic laws which offer the minimum standards of protection. The evolution of this regime has led to concerns over sovereign discretion in matters of domestic importance such as health, food security and education. In the current framework of IP legal pluralism, States must possess an active regulatory discretion, particularly in ensuing that exclusive monopoly rights are not pursued at the cost of its citizens in matters relating to essential needs of their life. In doing so, States must also give due respect to the concerns of global welfare.

Sovereign Trusteeship and Multilateral Protection of Intellectual Property Rights

TRIPS established a minimum standard of intellectual property rights to be adopted by the member states along with an obligation that mandates mutual recognition of domestic laws which offer the minimum standards of protection. The evolution of this regime has led to concerns over sovereign discretion in matters of domestic importance such as health, food security and education. In the current framework of IP legal pluralism, States must possess an active regulatory discretion, particularly in ensuing that exclusive monopoly rights are not pursued at the cost of its citizens in matters relating to essential needs of their life. In doing so, States must also give due respect to the concerns of global welfare.

Bus Competition in Ireland: Delayed by Regulatory Roadblocks

AbstractCompetition in local bus services in Ireland has been prohibited for more than 80 years, with the majority of services operated by state‐owned monopolies. The Public Transport Regulation Act 2009 seemed to herald a radical departure. It established a new transport regulator and provided that, after an initial five‐year period, routes would be opened up to competitive tendering unless an extension of the incumbents' monopoly rights was necessary to guarantee continuity of services. Yet in December 2013 the regulator decided to extend the state bus companies' monopolies on the vast majority of their routes until the end of 2019. This paper argues that there is no economic evidence to support this decision, which is reminiscent of the previous policy approach of protecting the state companies and raises concerns of possible regulatory capture. The paper calls for the phased introduction of competitive tendering of all routes currently operated by the state bus companies as quickly as possible.

Riflessioni sulla politica monetaria internazionale

The present article analyses the current state of international monetary policy and arrangements. The author first examines the nature of monetary arrangements guided by political institutions that are tempted to exploit the monetary system through the monopoly right to issue base money. The development of international institutions for controlling the monopoly right, the system of fixed exchange rates and the gold standard, and the eventual collapse of the Bretton Woods system are then reviewed. The recent development of the European Monetary System, its central issues and its prospects are then assessed. The author concludes that if the bureaucratic approach encouraged by the political process continues to disregard the one and only condition assuring a viable fix-rate system, that is sever constraints national monetary policies, the most likely outcome of the EMS will be a new series of speculative waves and an erratic monetary growth in the stronger currency areas with intermittent pressures on the stronger currency areas to accommodate the comparatively weaker area. JEL: E52, E42, F33

Market Power and Welfare in Electricity Markets Employing Tradable Green Certificate Systems

Within the last 25 years, liberalization (deregulation) of electricity markets around the world has been undertaken with the goal of replacing long-standing monopoly rights with fully competitive markets. In addition, many nations have begun employing “tradable green certificate” systems to promote electricity generation from renewable (“green”) energy sources (wind, solar, biomass, hydroelectric, etc.), with the primary objective of mitigation of greenhouse gas emissions from fossil fuel (“black”) producers. In this paper, we examine some welfare implications of the use of green certificate systems in electricity markets under alternative market structures. We demonstrate that under a wide variety of scenarios, an oligopolistic market structure may perform better in terms of welfare than a competitive market structure. We also demonstrate that there will typically be an optimal level of market power summarized by a conjectural variations parameter that depends on the cost structure of both green and black firms. Our model provides insights into the policy challenge of electricity market design and suggests an approach that could be applied in a more general model.

Patent=Monopoly: A Legal Fiction

A patent right is an exclusionary right. With it, the patent holder can exclude third parties from making, using, selling, etc. products or processes protected by his patent. In the past, this right has also been referred to as a 'monopoly right' and this has lead to considerable confusion about the scope of patent rights and the role of the patent system in a modern economy. This paper seeks to provide some clarity on this issue and highlight the distinction between the exclusionary right granted by patent law and the notion of monopoly in economic regulation.

Copyright, Free Speech, and The Public's Right to Know

This study explores the problems that US journalists face in employing the copyright doctrine of fair use under copyright in their work, and heralds a solution. US copyright policy's expansion of monopoly rights since 1976, harshly shrinking the public domain, has forced journalists to understand their fair use rights better. Fair use permits use of copyrighted material without permission or payment, under some circumstances. Without vigorous application of fair use, freedom of the press and its public sphere functions are impaired. Interviews with 81 journalists in a range of media show that journalists receive inadequate and conflicting fair use advice in their education and work environments, and often share misinformation. As a consequence they delay, limit coverage and even choose not to release information. The problem is most acute in emergent digital platforms and in small organizations. Journalists made aware of this problem have taken action to shape a set of principles interpreting their fair use rights. This set of principles offers an opportunity to share journalistic standards for US fair use, following the model of other communities of practice that have been able to do their work more easily and effectively as a result. The US situation is particular to US law, but has international implications.

How Intellectual Property Rights, Licensing and Foreign Direct Investments Shape the Technology Transfer Landscape in Small Developing Countries? Case Study of the Republic of Macedonia

In the last twenty years, many developing countries have undertaken serious reforms of their intellectual property rights (IPR) systems in terms of strengthening of their protection and regulating for more efficient enforcement. This process has been stimulated by numerous multilateral, regional and bilateral agreements, such as the TRIPS (Agreement on trade related aspects of intellectual property), the NAFTA (North American Free Trade Agreement), and a series of Partnership Agreements negotiated and concluded between the European Union and certain developing countries from Europe and the Middle East. In today’s globalized society, knowledge and information are at the core of the growth agenda, and are increasingly essential for gaining and maintaining competitive edge. It seems that the economic and political globalization have deepened the gap between the rich nations and the poor even more, contributing to the imbalanced distribution of material wealth and knowledge, where most of the intangible resources, protected by intellectual property rights (IPRs), are created and kept in developed nations. IPRs can be defined as monopoly rights given by the society for a limited period of time as a reward for creativity and innovativeness. Even though they are intended to promote scientific and social progress, in the case of small, landlocked developing countries they might act as inhibitor to knowledge and technology absorption and diffusion. It is beyond the scope of this paper to consider each of these issues in detail and their multifaceted interrelationships. Rather, this paper aims to contribute to the academic discussion on the impact of the degree of IPR protection on the intensity of technology transfer transactions through licensing and foreign direct investments (FDI) in small developing countries, by taking the example of the Republic of Macedonia.

Solving the Problem of New Uses

One of the most dramatic public-policy failures in biomedical research is the lack of incentives for industry to develop new therapeutic uses (“indications”) for existing drugs once generics are available. Policymakers and commentators are well aware of this “problem of new uses,” but fail to appreciate its magnitude. Over the past decade, this gap in the incentives for pharmaceutical R&D has become one of the greatest barriers to medical progress. Recent technological advances have allowed researchers to identify hundreds of potential new indications for older drugs that could address critical unmet medical needs. And researchers are poised to discover hundreds more. Developing new indications for existing drugs is much faster, cheaper, and less risky than developing new drugs, and therefore offers the single most promising avenue for delivering new medical treatments to the public. However, pharmaceutical companies invariably lose interest in developing new uses for existing drugs when patients have access to low-cost generics. This article explores the nature and source of this gap in the incentives for developing new medical treatments, showing that it ultimately stems from a simple information problem. At present, the government encourages drug development by granting firms temporary monopoly rights that block generic manufacturers from making or selling imitations of their drugs. The government also makes available an alternative type of monopoly protection for new indications that applies to the act of taking or administering a drug for a new therapeutic use. The latter monopoly rights could provide the appropriate incentives for developing new uses of existing drugs. However, pharmaceutical companies cannot enforce these rights without knowing when physicians prescribe the drug for the patented indication as opposed to some other use. If the government established an infrastructure for pharmaceutical companies to monitor the prescribed indications when pharmacists fill a prescription, those firms would possess the information necessary to enforce patents on new indications, thereby solving the problem of new uses. This article argues that the government could easily create such an infrastructure through the expanding use of e-prescribing software and electronic medical records.