Introduction
A TRIBUTE TO PROFESSOR STEVEN G. GEY
INNOVATORS AND IMITATORS: AN ANALYSIS OF PROPOSED LEGISLATION IMPLEMENTING AN ABBREVIATED APPROVAL PATHWAY FOR FOLLOW-ON BIOLOGICS IN THE UNITED STATES
Donna M. Gitter
Biopharmaceuticals, also called biologics, account for nearly one out of eight prescriptions written worldwide. One source estimates that more than $10 billion worth of biologics will come off patent by 2016. Few generic competitors are likely to enter this market, however, in light of the fact that no abbreviated approval pathway presently exists for generic biologics, also called follow-on protein products. Without such a system in place, generic manufacturers must perform a full complement of lengthy and costly clinical trials in order to receive approval from the U.S. Food and Drug Administration to market their follow-on biologics. Congress is presently considering legislation, titled the Access to Life-Saving Medicine Act, which would permit expedited approval of certain off-patent biologics. This legislation is modeled upon the Hatch-Waxman Act of 1984, which facilitates abbreviated approval of generic versions of traditional pharmaceuticals.
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SHIFTING CONSTITUTIONAL SANDS: CAN AND SHOULD PATENTHOLDERS RELY ON THE DUE PROCESS CLAUSE TO THWART GOVERNMENT ACTION?
Davida H. Issacs
Today there are more patentholders than ever who may seek relief when government action detrimentally affects the value of their patents. The expected explosion in patentholders’ due process claims creates a danger of enjoining government policy changes or crucial government use. Historically, courts have characterized patents as “property” and thus accorded them protection under the Takings and Due Process Clauses. But patents are not a form of traditional property; rather, they are federally granted benefits. In light of the Federal Circuit’s recent repudiation of patentholders’ rights to Takings Clause protection, and the Supreme Court’s denial of certiorari, it is fair to say that courts are no longer reflexively granting patentholders property protection. If the courts choose to reconsider that protection, it would make sense for them to analyze patentholders’ rights to such protection using the same test that is used to determine the due process rights of recipients of other government benefits.
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DOMESTIC VIOLENCE AND THE WORKPLACE: THE EXPLOSION OF STATE LEGISLATION AND THE NEED FOR A COMPREHENSIVE STRATEGY
Deborah A. Widiss
In recent years, domestic violence legislation has migrated out of its traditional locus in family law and criminal law to include a rapidly growing body of employment law. The new laws respond to a relatively simple problem: Economic security is one of the most important factors in whether a victim of domestic violence will be able to separate from an abusive partner, but domestic violence often interferes with victims’ ability to maintain jobs, thus causing job loss that further traps victims in abusive relationships. By providing support to victims and empowering employers to take direct legal action against perpetrators of actual or threatened workplace violence, the new legislation helps employers and employees work together to address a shared interest in reducing the effects of domestic violence on the workplace. Thus, addressing domestic violence as an “employment” issue bolsters other strategies for combating domestic violence. Equally important, because the vast majority of victims of domestic violence are women, the new legislation complements traditional employment laws, such as Title VII and the Family and Medical Leave Act, that seek to promote sex equality by addressing a significant, though little recognized, barrier to women’s full participation in the workplace.
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CONFRONTING THE “ONGOING EMERGENCY”: A PRAGMATIC APPROACH TO HEARSAY EVIDENCE IN THE CONTEXT OF THE SIXTH AMENDMENT
Ellen Liang Yee
The Supreme Court’s pathbreaking decision in Crawford v. Washington held that admission of an extrajudicial testimonial statement by an unavailable declarant-witness violates the Confrontation Clause unless the defendant has an opportunity to cross-examine the declarant. Unfortunately, the determination of admissibility for the trial court judge has not been simplified after Crawford. The role of the trial court judge has now shifted from determining the reliability of the hearsay evidence (as was required before Crawford) to a determination of the testimonial nature of the declarant’s statement. However, with some small exceptions, the Court in Crawford explicitly decided that it would “leave for another day” a more specific definition of the term “testimonial,” which would have helped to clarify how to address admissibility issues in many cases.
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