Law Commons^™

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

Punishment Without Process: Victim Impact Proceedings For Dead Defendants, Bruce Green, Rebecca Roiphe

Articles & Chapters

After Jeffrey Epstein committed suicide in jail, two judges allowed his accusers to speak in court. This article argues that the proceedings were inappropriate because the criminal case ends when the defendant dies. If the conviction and appeal are not final, there is no finding of guilt, and the defendant is still presumed innocent. Allowing accusers to speak at this time violates the principle of due process and threatens to undermine faith in judges and the criminal justice system in general. While courts are at times legally required to hear from victims of crimes, they were not allowed to do …

Cancer's Ip, Jacob S. Sherkow

Articles & Chapters

The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …

Patent Law's Reproducibility Paradox, Jacob S. Sherkow

Articles & Chapters

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …

God Said To Abraham/Kill Me A Son: Why The Insanity Defense And The Incompetency Status Are Compatible With And Required By The Convention On The Rights Of Persons With Disabilities And Basic Principles Of Therapeutic Jurisprudence, Michael L. Perlin

Articles & Chapters

Interpretations of the General Comments to the Convention on the Rights of Persons with Disabilities (CRPD) — that command the abolition of the insanity defense and the incompetency status — make no theoretical or conceptual sense, disregard the history of how society has treated persons with serious mental disabilities who are charged with crime, and will lead to predictable torture of this population in prison, at the hands of both prison guards and other prisoners. Such interpretation also flies in the face of every precept of therapeutic jurisprudence. Support of this position exhibits a startling lack of understanding of the …

Patent Protection For Microbial Technologies, Jacob S. Sherkow

Articles & Chapters

Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies—both scienti cally and commercially—depend, in part, on the patent regime available for each, and researchers’ willingness to enforce those patents against others.

Merchants And Thieves, Hungry For Power: Prosecutorial Misconduct And Passive Judicial Complicity In Death Penalty Trials Of Defendants With Mental Disabilities, Michael L. Perlin

Articles & Chapters

In spite of the Supreme Court’s decisions in Ford v. Wainwright (1986), Atkins v. Virginia (2002), and Hall v. Florida (2014), persons with severe psychosocial and intellectual disabilities continue to be given death sentences, in some cases leading to actual execution. Although the courts have been aware of this for decades -- dating back at least to the infamous Ricky Rector case in Arkansas -- these base miscarriages of justice continue and show no sign of abating. Scholars have written clearly and pointedly on this issue (certainly, more frequently since the Atkins decision in 2002), but little has changed.

I …

Said I, But You Have No Choice: Why A Lawyer Must Ethically Honor A Client's Decision About Mental Health Treatment Even If It Is Not What S/He Would Have Chosen, Michael L. Perlin, Naomi Weinstein

Articles & Chapters

This paper addresses a remarkably under-considered topic: the ethical standards for lawyers representing persons with mental disabilities. Although there is an extensive body of literature endorsing “zealous advocacy” as the standard for the criminal defense lawyer in “ordinary” cases, there is virtually no literature (or case law) on this question in this context.

Our thesis is simple. We reject the model of “paternalism/best interests” that is regularly substituted for a traditional legal advocacy position, and a substitution that is rarely questioned. We believe this presumption flies in the face of statutory law, constitutional law, and international human rights law, and …

All His Sexless Patients: Persons With Mental Disabilities And The Competence To Have Sex, Michael L. Perlin, Alison Lynch

Articles & Chapters

With the growth in the field of mental disability law over the past 50 years, very few topics involving persons with mental illness remain taboo or off limits to scholars and judges who face these issues daily. However, discussions of the question of whether persons with mental disabilities have a right to voluntary sexual interaction often touches a raw nerve in conversations about mental disability law, even with those who are practicing in the field, and the discomfort people feel in examining this topic is exacerbated when discussing individuals who are institutionalized.

Although this often appears to be a difficult …

A Tale Of Three Hoaxes: When Literature Offends The Law, Molly Guptill Manning

Articles & Chapters

No abstract provided.

John Brown Went Off To War: Considering Veterans’ Courts As Problem-Solving Courts, Michael L. Perlin

Articles & Chapters

In this paper, I seek to contextualize veterans courts in light of the therapeutic jurisprudence (TJ) movement, the turn to problem-solving courts of all sorts (especially focusing on mental health courts), and the societal ambivalence that we have shown to veterans in the four decades since the Vietnam war.

I argue that TJ’s focuses on how law actually impacts people’s lives, on the law’s influence on emotional life and psychological well-being and on the need for law to value psychological health and avoid the imposition of anti-therapeutic consequences whenever possible can serve as a template for a veterans courts model …

Happy 65th Birthday: What Now?, Peter J. Strauss

Articles & Chapters

No abstract provided.

Exceptions: The Criminal Law's Illogical Approach To Hiv-Related Aggravated Assaults, Ari Ezra Waldman

Articles & Chapters

This Article identifies logical and due process errors in HIV-related aggravated assault cases, which usually involve an HIV-positive individual having unprotected sex without disclosing his or her HIV status. While this behavior should not be encouraged, this Article suggests that punishing this conduct through a charge of aggravated assault - which requires a showing that the defendant’s actions were a means likely to cause grievous bodily harm or death - is fraught with fallacies in reasoning and runs afoul of due process. Specifically, some courts use the "rule of thumb" that HIV can possibly be transmitted through bodily fluids as …

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Hepatitis C In Prisons: Evolving Toward Decency Through Adequate Medical Care And Public Health Reform, Andrew Brunsden

Articles & Chapters

Hepatitis C (HCV) in prisons is a public health crisis tied to current drug policy's emphasis on the mass incarceration of drug users. Prison policy acts as a barrier to HCV care by limiting medical care for the infected, especially drug users, and by inhibiting public health measures addressing the epidemic. This Comment argues that courts mistakenly limit prisoners' Eighth Amendment right to basic medical care when they defer to prisons that apply HCV policies as categorical rules of treatment. Where current standards of care mandate individualized patient evaluation for treatment, prison policies that eschew this principle exhibit deliberate indifference …

Dependency By Law: Poverty, Identity, And Welfare Privatization, Frank W. Munger

Articles & Chapters

Privatization of welfare reflects the political pressure to limit public responsibility for protection of social citizenship. Recent welfare reforms incorporate three classic market-like privatization mechanisms--contracting out services forcing allocation of a limited pool of benefits, and deregulation. Deregulation entails strategic diversion and disqualification of large numbers of would-be applicants who are left without alternatives to the labor market. In this article I discuss an empirical study of the effects of deregulation of welfare on the self-perceptions of recipients. Interviews with recipients and with low-wage health care workers, former recipients, show that, criticisms of welfare notwithstanding, they have embraced welfare reforms …

Beyond Welfare Reform: Can We Build A Local Welfare State?, Frank W. Munger

Articles & Chapters

No abstract provided.

Everything's A Little Upside Down, As A Matter Of Fact The Wheels Have Stopped: The Fraudulence Of The Incompetency Evaluation Process, Michael L. Perlin

Articles & Chapters

Health Law in the Criminal Justice System Symposium

Accumulation Of Tissue Factor Into Developing Thrombi In Vivo Is Dependent Upon Microparticle P-Selectin Glycoprotein Ligand 1 And Platelet P-Selectin, Shahrokh Falati, Qingde Liu, Peter Gross, Glenn Merrill-Skoloff, Janet Chou, Erik Vandendries, Alessandro Celi, Kevin Croce, Barbara C. Furie, Bruce Furie

Articles & Chapters

Using a laser-induced endothelial injury model, we examined thrombus formation in the microcirculation of wild-type and genetically altered mice by real-time in vivo microscopy to analyze this complex physiologic process in a system that includes the vessel wall, the presence of flowing blood, and the absence of anticoagulants. We observe P-selectin expression, tissue factor accumulation, and fibrin generation after platelet localization in the developing thrombus in arterioles of wild-type mice. However, mice lacking P-selectin glycoprotein ligand 1 (PSGL-1) or P-selectin, or wild-type mice infused with blocking P-selectin antibodies, developed platelet thrombi containing minimal tissue factor and fibrin. To explore the …

A Constitutional Confluence: American ‘State Action’ Law And The Application Of South Africa’S Socioeconomic Rights Guarantees To Private Actors, Stephen Ellmann

Articles & Chapters

As constitutional protection of human rights expands around the world, the question of whether constitutional rights should protect people not only against state action but also against the conduct of private actors is once again timely. Few nations have so broadly, or so ambiguously, endorsed the application of constitutional guarantees to constrain private conduct (known outside the United States as "horizontality") as South Africa. The constitution approved in 1996 applies fully and without qualification to all "organs of state," and this term is defined in section 239 in potentially very broad terms, notably embracing "any other functionary or institution ... …

Introduction, Arthur S. Leonard

Articles & Chapters

No abstract provided.

Local And Federal Statutory And Regulatory Bases For Preventing Lead Poisoning, Lucy Billings

Articles & Chapters

No abstract provided.

The Meaning Of Daubert And What That Means For Forensic Science, Randolph N. Jonakait

Articles & Chapters

No abstract provided.

Three Visions Of Managed Competition, 1920-1950, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Jails And Prisons – Reservoirs Of Tb Disease: Should Defendants With Hiv Infection (Who Cannot Swim) Be Thrown Into The Reservoir?, Faith Colangelo, Mariana Hogan

Articles & Chapters

No abstract provided.

Decoding Right To Refuse Treatment Law, Michael L. Perlin

Articles & Chapters

No abstract provided.

Tarasoff And The Dilemma Of The Dangerous Patient: New Directions For The 1990’S, Michael L. Perlin

Articles & Chapters

No abstract provided.

Can Mental Health Professionals Predict Judicial Decisionmaking? Constitutional And Tort Liability Aspects Of The Right Of The Institutionalized Mentally Disabled To Refuse Treatment: On The Cutting Edge, Michael L. Perlin

Articles & Chapters

No abstract provided.

Treatment Refusals For The Critically And Terminally Ill: Proposed Rules For The Family, The Physician, And The State, Stephen A. Newman

Articles & Chapters

No abstract provided.