Patent first, ask questions later: morality and biotechnology in patent law

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patents later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.     

Welfare and Work: Job-Retention Outcomes of Federal Welfare-to-Work Employees

On March 8, 1997, President Clinton announced the federal government's Welfare-to-Work Initiative, a major effort to provide job opportunities for welfare recipients in federal agencies. Using data from the U.S. Office of Personnel Management's Central Personnel Data File, the authors compare differences in job-retention outcomes for Welfare-to-Work employees and similar non–Welfare-to-Work employees in federal agencies. This approach provides an innovative way to measure job-retention by comparing job-retention outcomes of Welfare-to-Work employees against non–Welfare-to-Work employees. The findings suggest that Welfare-to-Work employees have greater odds of retaining their jobs than non–Welfare-to-Work employees. The results provide useful insights into the dynamics of job retention among welfare recipients who are hired into federal-sector employment.     

Misreading the Post-tsunami Political Landscape in Sri Lanka: The Myth of Humanitarian Space

The 2004 tsunami is one of several recent high profile natural disasters that raise important questions about ‘disaster geopolitics’ or the relationship between humanitarian assistance for victims of natural disasters and the stabilisation of political spaces. In Sri Lanka, it was thought that a ‘silver lining’ would result from the collaborative effort on behalf of victims of the tsunami by the government of Sri Lanka and the Liberation Tigers of Tamil Eelam, belligerents in a decades-old war. Ultimately, however, the contest over tsunami aid deepened the rift between the two sides. This paper considers this misreading of the post-tsunami political landscape in Sri Lanka by examining two key spatial assumptions contained in popular humanitarian discourses: that humanitarian space can be identified, represented and maintained separately from political space, and that humanitarian relations are confined to the places where a disaster has occurred and chiefly serve its victims. Several key events are highlighted in the paper including the curtailed visit of the UN Secretary General in January 2005 and the failure of the Post-tsunami Operational Management Structure, a mechanism designed to allow both parties to the conflict to distribute aid. The paper concludes with a discussion on the difficulties of setting politics aside even during times of humanitarian crisis.     

Patient Profiles of Criminal Behavior in the Context of Traumatic Brain Injury

Traumatic brain injury (TBI) can lead to significant post‐traumatic disturbances in mood and behavior, with the frontal lobes playing a key role in emotional and behavioral regulation. Injury to the frontal lobe can result in disinhibition and aggression which can result in police intervention and/or incarceration. We highlight four adult cases with a history of severe TBI with frontal lobe injuries and the presence of post‐TBI criminal behaviors. There is evidence to support an anatomical basis for aggressive behaviors, yet there are other risk factors to be considered. Behaviors must be investigated thoroughly by obtaining adequate pre‐ and post‐TBI psychiatric and psychosocial histories. By having a comprehensive understanding of aggression while appreciating the complex relationship between TBI, aggression, and premorbid risk factors, clinicians can more adequately treat patients with TBI, with the aim of potentially preventing criminal behaviors and recidivism.