Robin Feldman

Copyright and Open Access at the Bedside

Moves to protect the copyright of the Mini–Mental State Examination, the standard of care for cognitive screening, have left clinicians at risk of legal action for infringement and distribution and made a new tool, apparently seen as derivative, unavailable.

A Citizen’s Pathway Gone Astray — Delaying Competition from Generic Drugs

Brand-name drug companies have been filing citizen petitions with the Food and Drug Administration expressing concerns about generic drugs under review, in last-ditch efforts to hold off competition. A promising solution lies in erecting procedural blocks.

Patent Licensing, Technology Transfer, & Innovation

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 without 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.

Perverse Incentives: Why Everyone Prefers High Drug Prices -- Except for Those Who Pay the Bills

Health care spending rarely follows an ordinary, rational model. Yet even in that context, prescription drug prices are rising at a puzzling rate. What is causing the phenomenon? Quite simply, incentives percolating throughout the prescription drug market push players toward higher prices. At the center, lies the highly secretive and concentrated PBM industry — middle players who negotiate between drug companies and health insurers, arranging for rebates and establishing coverage levels for patients. Contracts between drug companies and the middle players are closely guarded secrets. The PBM customers, including Medicare, private insurers, and even their auditors, are not permitted access to the terms. And the middle players are not alone; everyone is feeding at the trough. Markets, like gardens, grow best in the sun; they wither without information. Thus, competitive distortions and suboptimal outcomes are unsurprising. Despite the extreme secrecy, details have begun to seep out — through case documents (including recent contract disputes among parties), government reports, shareholder disclosures, and industry insider reports. Piecing together these sources, this article presents a picture of incentive structures in which higher-priced drugs receive favorable treatment, and patients are channeled towards more expensive medicines. In exchange for financial incentives structured in different ways to appeal to hospitals, insurers, doctors, and even patient advocacy groups, drug companies ensure that lower-priced substitutes cannot gain a foothold. It is a win-win for everyone, except of course for taxpayers and society. This article also analyzes popular proposals that are unlikely to work and suggests approaches for aligning incentives.