Promoting Academic Entrepreneurship in Europe and the United States: Creating an Intellectual Property Regime to Facilitate the Efficient Transfer of Knowledge from the Lab to the Patient

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the European Union (“EU”) needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (“PPPPs”), but focuses on the regulatory infrastructure necessary to support the efficient commercialization of publicly funded university medical research in both the European Union and the United States (“U.S.”). Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate certain of the open innovation aspects of the European Innovative Medicines Initiative and the tighter patenting standards imposed by the European Patent Office. Thus, a secondary purpose of this article is suggesting amendments to the U.S. laws governing the patenting and licensing of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools

Snake Oil Salesman or Purveyors of Knowledge: Off-Label Promotions and the Commercial Speech Doctrine

The Second Circuit’s December 2012 decision in United States v. Caronia striking down the prohibition on off-label marketing of pharmaceutical drugs has profound implications for economic regulation in general, calling into question the constitutionality of restrictions on the offer and sale of securities under the Securities Act of 1933, the solicitation of shareholder proxies and periodic reporting under the Securities Exchange Act of 1934, mandatory labels on food, tobacco, and pesticides, and a wide range of privacy protections. In this Article we suggest that Caronia misconstrues the Supreme Court’s holding in Sorrell v. IMS Health, which was motivated by concerns of favoring one industry participant over another rather than a desire to return to the anti-regulator fervor of the Lochner era. Reexamining the theoretical justification for limiting truthful commercial speech shows that a more nuanced approach to regulating off-label marketing with the purpose of promoting public health and safety would pass constitutional muster. We argue that as long as the government both has a rational basis for subjecting a particular industry to limits on commercial speech intended to further a legitimate public interest, rather than unfounded paternalism, and does not discriminate against disfavored industry participants, those limits should be subject to intermediate scrutiny under the Central Hudson standard. We believe that our articulation of the commercial speech doctrine post-Sorrell will help resolve the current split in the Circuits on the appropriate standard of review in cases involving both restrictions on commercial speech and mandated speech. Finally, we critique the FDA’s 2011 Guidance for Responding to Unsolicited Requests for Off-Label Information (draft) and present a proposal for new rules for regulating the off-label marketing of pharmaceutical drugs based on transparency, the sophistication of the listener and the type of information offered, and the requirement that the pharmaceutical company comply with ongoing duties of training, monitoring, reporting, and auditing

Leader of the Pack: A Proposal for Disclosure of Board Leadership Structure

To reform corporate governance, this article proposes that the New York Stock Exchange and the National Association of Securities Dealers amend their listing policies to require a listed company to disclose in its proxy statement (1) whether or not there is a separate independent chair of its board of directors, and if there is not, (2) whether or not its board of directors has designated a senior independent director who functions as a leader of its independent directors. The proposals are designed to encourage directors to select an independent chair or a lead director, thereby increasing the likelihood that a company\u27s independent directors will not be beholden to a CEO. The authors survey management under-performance in publicly traded U.S. companies and the practical effects of implementing their proposal to show the benefits to shareholders from independent directors

Preparing for the Apocalypse: a Multi-Prong Proposal to Develop Countermeasures for Biological, Chemical, Radiological, and Nuclear Threats

The false alarm of an Hawaiian nuclear attack in January 2018 is an example of the lack of U.S. preparedness for attacks using nuclear and other weapons of mass destruction. To address such threats, this Article proposes the establishment of a nation-wide integrated defense of health countermeasures initiative (“DHCI”), which is a multi-prong program to create a defensive triad comprising government, private industry, and academia to develop countermeasures for health threats posed by biological, chemical, radiological, and nuclear (“BCRN”) attacks. Key elements of our multi-faceted proposal include the use of the government’s Other Transaction Authority to simplify procurement arrangements, the establishment of public-private partnerships with an information commons for the sharing and the use of certain information and trusted intermediaries to protect proprietary information pursuant to cooperative research and development agreements (“CRADAs”), and the creation of a network of incubators sited in ecosystems of excellence. Although our proposal focuses on health countermeasures, it may be applied to other urgent national needs, such as rebuilding U.S. infrastructure

Preparing for the Apocalypse: A Multi-Prong Proposal to Develop Countermeasures for Chemical, Biological, Radiological, and Nuclear Threats

The false alarm of an Hawaiian nuclear attack in January 2018 is an example of the lack of U.S. preparedness for attacks using nuclear and other weapons of mass destruction. To address such threats, this Article proposes the establishment of a nation-wide integrated defense of health countermeasures initiative ( DHCI ), is a multi-prong program to create a defensive triad comprising government, private industry, and academia to develop countermeasures for health threats posed by chemical, biological, radiological, and nuclear ( CBRN ) attacks. Key elements of our multi-faceted proposal include the use of the government’s Other Transaction Authority to simplify procurement arrangements, the establishment of public-private partnerships with an information commons for the sharing and the use of certain information and trusted intermediaries to protect proprietary information pursuant to cooperative research and development agreements ( CRADAs ), and the creation of a network of incubators sited in ecosystems of excellence. Although our proposal focuses on health countermeasures, it may be applied to other urgent national needs, such as rebuilding U.S. infrastructure

The Devil Made Me Do It: Replacing Corporate Directors\u27 Veil of Secrecy with the Mantle of Stewardship

This Article argues that the nature of the corporate form coupled with an exclusive focus on shareholder value leads to economically and socially inefficient results. The profit maximization view of directors\u27 duties ignores the historical reasons why corporations were given special privileges, such as limited liability, by the state. This narrow view should be replaced with a doctrine of stewardship that imposes a more comprehensive view of the corporation\u27s and directors\u27 responsibility to manage the vast resources held in corporate form. This broader view is consistent not only with the values of a free market economy, but also with modem corporate jurisprudence. It also reflects modem organizational theory that emphasizes the importance of systems thinking, or thinking about the whole rather than just the parts. In the spirit of stewardship, transparency, and self-regulation, this Article recommends an additional securities disclosure requirement that public corporations disclose the impact of major corporate decisions on affected constituencies, including shareholders, employees, customers, suppliers, creditors, communities, governmental entities, and the corporation\u27s management. In this manner, this Article proposes to replace the veil of secrecy with the mantle of stewardship

Genome-wide analysis identifies 12 loci influencing human reproductive behavior.

The genetic architecture of human reproductive behavior-age at first birth (AFB) and number of children ever born (NEB)-has a strong relationship with fitness, human development, infertility and risk of neuropsychiatric disorders. However, very few genetic loci have been identified, and the underlying mechanisms of AFB and NEB are poorly understood. We report a large genome-wide association study of both sexes including 251,151 individuals for AFB and 343,072 individuals for NEB. We identified 12 independent loci that are significantly associated with AFB and/or NEB in a SNP-based genome-wide association study and 4 additional loci associated in a gene-based effort. These loci harbor genes that are likely to have a role, either directly or by affecting non-local gene expression, in human reproduction and infertility, thereby increasing understanding of these complex traits