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

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

The Need for the Tort Law Necessity Defense in Intellectual Property Law

The COVID-19 pandemic has laid bare inherent tensions between the protection of intellectual property (IP) and the health of individuals touched by life-threatening medical conditions. A few examples have even made front page news. Hospitals are searching desperately for ventilator parts while 3-D printing instructions for such parts remain unshared for fear of liability. And potentially lifesaving medicines remain out of reach because their manufacture and distribution on sufficient scale is limited by the threat of patent infringement. The threat of liability for IP infringement also dampens the ability to innovate under emergency conditions, intensifying the tension between the protection of IP and the protection of human lives. A number of policy responses have been proposed to address this tension, including the exercise of government rights under the Defense Production Act to IP contexts; government use of patented technologies; compulsory licensing; legislation that would allow for emergency overrides to IP protections; and efforts to encourage companies to make their IP freely available on a voluntary basis, most notably through the Open COVID Pledge. But fears of disrupting IP protections have curtailed the use of these measures, leaving the tensions between IP protection and lifesaving access largely untouched. Instead of looking for solutions that would entail legislative action, a stretch of emergency powers, or vague private commitments, we suggest that the law already provides a mechanism for addressing this tension in the form of the age-old common tort law doctrine of necessity (aka lesser-harm or lesser-evil defense). Our proposed use of the necessity defense is specifically designed to address the lack of adequate mechanisms within IP law to balance the social value of preventing harm through unauthorized use of IP against the social value of providing strong property rights in lifesaving technologies. Even where the public interest is explicitly taken into account--such as in the case of judicial decisions to grant an injunction against a patent infringer or under the copyright fair use doctrine--the nature of this public interest remains amorphous, the weight it carries limited, and it is usually untethered from concerns about access to lifesaving technologies. We suggest that the defense of necessity can help inject responsiveness to urgent public health needs into the IP ecosystem in a way that avoids significant changes or impediments to its functioning. While drawing from examples that are specific to a highly disruptive public health crisis, our proposal also responds to broader, systemic shortcomings in the way IP law impacts access to lifesaving technologie