Making Knowledge and Making Drugs? Experimenting with University Innovation Capacity

The innovation process for novel medical therapies needs repair. The United States spends more than ever before on drug discovery without a corresponding increase in new medical therapies

Pre-Competition

As the costs of pharmaceutical research and development rise and concerns grow about the pace of innovation, both federal agencies and industry participants have turned to new forms of collaboration to increase the efficiency and effectiveness of biomedical research. Industry participants, many of them competitors, come together to define joint research and development objectives and to share project results in what are widely known as “pre-competitive” collaborations. There is a prevailing understanding among both industry and governmental actors that these pre-competitive endeavors are not only permissible, but encouraged. While the term “pre-competitive” is prevalent in the pharmaceutical industry, it is missing from the antitrust lexicon. Neither the courts nor the federal agencies charged with enforcing U.S. antitrust laws have ever recognized precompetitive activity as immune from antitrust challenge. Rather, antitrust regulators have repeatedly emphasized that when competitors collaborate, anticompetitive behavior may arise regardless of the stage at which collaborating occurs. This Article critically examines the phenomenon of precompetitive collaboration through an antitrust lens. It analyzes the apparent disconnect between the industry reliance on precompetition as a way of demarcating procompetitive arrangements among competitors, on the one hand, and the absence of any such distinction in antitrust law or practice, on the other. It then explores the ways that this disconnect may manifest itself in the choice and structure of collaborative arrangements and suggests a framework for refocusing attention on collaborations that are procompetitive, irrespective of the stage of development

Public-Private Litigation for Health

Public health litigation can be a powerful mechanism for addressing public health harms where alternative interventions have failed. It can draw public attention to corporate misconduct and create a public record of the actions taken and the harms done. In an ideal world, it could achieve compensation for past harms and incentivize deterrence of future misconduct. But the full public health potential of these lawsuits is rarely achieved, even when the suits are brought on behalf of federal, state, and local governments with the ostensible goal of protecting the health of the citizens. The increasing involvement of private attorneys in public litigation only adds to the challenges of using litigation to achieve public health goals. While there are continuing debates over the desirability of litigation partnerships between state attorneys general (AGs) and private counsel, as a practical matter, the involvement of private law firms in public litigation is unlikely to disappear any time soon. This Article fills a critical gap in the literature on the privatization of public litigation by showing why, despite their shortcomings, arrangements between state and private lawyers have the potential to satisfy public health goals that might otherwise remain out of reach. It provides a theory of legal research and development to show why these arrangements are not only likely to persist but are also most likely to occur in high-impact public health litigation. This Article then examines how the incentives of both state AGs and private law firms influence choices along the litigation pathway in ways that may undermine the potential to achieve public health value. It concludes by proposing a novel impact-based approach to public-private litigation, providing a decision-making framework that AGs can adopt to increase the role of public health objectives in the litigation process

Making Knowledge and Making Drugs? Experimenting with University Innovation Capacity

The innovation process for novel medical therapies needs repair. The United States spends more than ever before on drug discovery without a corresponding increase in new medical therapies

Genetic Paparazzi: Beyond Genetic Privacy

The domain of accessible information about celebrities, political leaders, and other public figures is expanding as technology evolves, placing new stresses on already uneasy legal boundaries around their privacy. The availability of cheap, fast, and informative genetic sequencing technologies, combined with growing public interest in genetic information, make it likely that we will soon witness paparazzi carrying swabs and sterile tubes in search for genetic materials connected in some way to the public figures they pursue. In a world in which genetic paparazzi are not only a possibility, but a probability, courts will inevitably be asked to determine the legal status of genetic materials and information obtained from public figures without consent. The genetics of public figures serves as a useful test case of the legal framework governing genetics and privacy because public figures are at the same time beneficiaries of more rights than most of us — in the form of rights of publicity — and fewer rights — in the form of diminished expectations of privacy.When disputes involving genetic paparazzi ultimately reach the courtroom, judges will have to confront scenarios that touch on fundamental questions regarding the nature of genetics and its relationship to concepts of personhood and identity, property, health and disease, intellectual property, and reproductive rights. While the question of what courts will decide is intriguing, this Article moves beyond such predictions to focus on how resulting court decisions in seemingly narrow cases may have broad and potentially harmful impact. Despite the complexity of the legal issues that such suits will implicate, the constraints of existing law make it likely that courts will address such disputes largely through the lens of traditional privacy and publicity rights. In this Article we argue that pursuing genetic paparazzi cases through the narrow lens of existing privacy and publicity law would ignore the multidimensional nature of genetic materials and information, leading to unintended and problematic consequences for how the law approaches genetics. We go on to highlight additional aspects of genetic materials and information that policymakers, courts, and lawyers ought to consider when responding to media excursions into the genetics of public figures so as not to impede other genetic interests that might be implicated