In the warped world of prescription drug pricing, generic drugs can cost more than branded ones, old drugs can be relaunched at astronomical prices, and low-cost options are shut out of the market. In Drugs, Money and Secret Handshakes, Robin Feldman shines a light into the dark corners of the pharmaceutical industry to expose a web of shadowy deals in which higher-priced drugs receive favorable treatment and patients are channeled toward the most expensive medicines. At the center of this web are the highly secretive middle players who establish coverage levels for patients and negotiate with drug companies. By offering lucrative payments to these middle players (as well as to doctors and hospitals), drug companies ensure that inexpensive drugs never gain traction. This system of perverse incentives has delivered the kind of exorbitant drug prices - and profits - that everyone loves except for those who pay the bills.
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For almost thirty years, a new form of intellectual property has grown up quietly beneath the surface of societal observation. It is a set of government-granted rights that have the quintessential characteristic of intellectual property and other forms of property—that is, the right to exclude others from the territory. If Regulatory Property should be understood as a unified system, one must have some theoretical grounding for its existence. Without a coherent construct, there is no way to intelligently shape its development and test its success. Thus, Section III of the paper sets out a general theoretical framework for the type of regulatory property that has emerged. This Section also explores a series of benchmarks to use in establishing Regulatory Property, describing the logic for these benchmarks, and tests the current forms of Regulatory Property against these measures. The benchmarks include: (1) minimizing overlap with other forms of intellectual property; (2) ensuring that the system is capable of stimulating results, and that those results are desirable; and (3) ensuring that there is a metric for measuring outcomes in relationship to goals. With these and other perspectives, society has an opportunity to think critically and cohesively about the new form of intellectual property that has developed incrementally over the last several decades. The Regulatory Property that has emerged so far falls within the life science industry. That is understandable. The FDA's all encompassing approval scheme and regulatory system has provided a perfect vehicle for the creation and dissemination of Regulatory Property. The lessons, however, are widely applicable to other innovative industries. As newcomers in industries such as transportation (think Uber and Lyft), hospitality (think Airbnb and Villas), 11 and domestic and construction services (think TaskRabbit) press the boundaries of creativity up against regulatory networks, government actors may be tempted to create forms of Regulatory Property related to these innovations, in the hopes of incentivizing innovative entrants as well as placating existing industry players. For example, local, state, or federal authorities might try to attract an industry, such as solar energy innovation, devising benefits for new entrants balanced against protections for existing energy industries. Such is the story of the creation of Regulatory Property for the life science industry, and it is one that easily could be replicated. It is also a story with echoes in the international arena. Various aspects of these rights have tentacles that now reach into the European Union, the North American Free Trade Agreement, and most recently, the Trans-Pacific Partnership.12 Thus, after thirty years, it is more than time to think comprehensively about this new form of intellectual property rights, a regime that lies entwined throughout our system
Abstract:It is an honor to be invited to speak at this symposium, both for the kind invitation to address this society, and for the opportunity to honor an esteemed scholar from my alma mater, Stanford.I come to this symposium, not as an expert in cultural property, but as an inhabitant of the field of biotechnology and intellectual property law. Although the view from a distance can provide different perspectives, it lacks the layers of understanding and meaning that are accumulated by those who are steeped in the field. I cannot possibly hope to offer solutions to issues with which many brilliant minds have spent a lifetime grappling. Thus, I temper my comments with the caution appropriate for the exercise. What I can do is offer comparisons from the treatment of human cells, as well as observations I have suggested in that context.
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Traditional justifications for patents are based on direct or indirect contribution to product creation. Non-practicing entities (NPEs) might provide such innovation, either directly, through working the patent or transfer of technology to others who do, or indirectly, when others copy. Available evidence suggests, however, that ex post licensing demands from NPEs do not normally involve these activities. Some have argued that patents are valuable without01/technology transfer because the ability to exclude may drive commercialization that would not otherwise occur. We demonstrate that even if commercialization theories sometimes justify patent protection, they cannot justify most NPE lawsuits or licensing demands.