US District Court Research Articles

Pharmacist Conscience Clauses: Continuing Debate

After the 1973 Supreme Court decision in Roe v. Wade, which affirmed a constitutional right to privacy and thereby overturned several state laws curtailing abortion, many states enacted or proposed legislation that allowed health care providers or hospitals to refuse to participate in abortion procedures based upon moral or ethical objections. This type of legislation came to be known as a conscience clause, which has been defined as ‘‘the medical providers’ right to exercise conscientious refusal to provide services to which they have religious or moral objections.’’ Although initial conscience clause legislation was developed as a reaction to Roe v. Wade, the conscience clause debate has expanded over the ensuing decades due to the development of new medical practices such as in vitro fertilization, embryonic stem cell research, and assisted suicide. This debate more significantly embroiled pharmacists during the 1980s when physicians began to prescribe the contraceptive, Ovral, in doses that would ensure postcoital contraception. At that time, some pharmacists conscientiously refused to dispense legitimate prescription orders for this medication and other contraceptives, which they viewed as abortioninducing treatments. These rare instances of conscientious refusal continued into the 1990s with the arrival of mifepristone (RU-486) and the newer ‘‘morning after pills,’’ Plan B and Preven. Many of these pharmacists were fired for refusing to dispense a legitimate prescription despite their personal moral or ethical objections. In 1998, the American Pharmacists Association (APhA) adopted an official policy regarding pharmacist conscience clauses. This policy ‘‘recognizes the individual pharmacist’s right to exercise conscientious refusal and supports the establishment of systems to ensure the patient’s access to legally prescribed therapy without compromising the pharmacist’s right of conscientious refusal.’’ Basically, APhA supports allowing an individual pharmacist to step away from dispensing a medication to which he or she has an ethical or moral objection, but does not support allowing a pharmacist to interfere with such dispensing (ie, an appropriate alternative to ensure medication access must be provided to the patient). In 2005, the House of Delegates of the American Medical Association (AMA) adopted a similar resolution, which reaffirmed the importance of patient access to medical care and the immediate provision of alternative means to dispense a legal prescription if a pharmacist exercises conscientious refusal. One of the earliest cases involving the issue of a pharmacist’s conscientious refusal to dispense a legally prescribed medication is Brauer v. K-Mart. In 1999, Karen Brauer filed suit against K-Mart after she was terminated for refusing to sign an agreement, which stated that she ‘‘would dispense all lawfully prescribed medications regardless of her feelings or beliefs.’’ Ms Brauer conscientiously refused to dispense oral contraceptives as she personally believed that these medications prevented implantation of a fertilized ovum resulting in abortion. K-Mart attempted to have the case dismissed from the US District Court in Cincinnati; however, District Court Judge Weber disagreed with the narrow reading of the state conscience statue applied by K-Mart. Judge Weber declared that the conscience statute is obviously intended to allow individuals to refuse to participate in abortion procedures and because oral contraceptives can prevent implantation of a fertilized ovum, which Ms Brauer believed to result in abortion, the clause protected her conscientious refusal to dispense. Other notable legal cases involving pharmacist conscience clauses include Stormans v. Washington State Board of Pharmacy and the cases of Paula Koch and Neil Noesen. These cases aided in further delineating the nuances of such clauses when invoked by a pharmacist. First, courts and administrative bodies appear to prefer that pharmacists make timely, written, and substantive disclosures detailing pharmacy activities in which the objecting pharmacist chooses

Something more is necessary: are genes and genetic diagnostic tests statutory subject matter for US patents?

In a recent decision (AMP v. USPTO) from the US District Court, patent claims directed at DNA sequences corresponding to human genes and to diagnostic tests based on such genes have been found to be invalid, primarily on the basis that the DNA molecules claimed, which included cDNA, primers and probes, are ‘products of nature’ and are thus unpatentable. If upheld, this decision will have considerable impact on the ability of biotechnical companies and universities to patent the results of their research. In this article, we will explain the basis for this decision and discuss the appropriateness of patenting discoveries and their (obvious) uses in the light of this fascinating case. While our focus will primarily be on the product claims, diagnostic method claims were also revoked in AMP v. USPTO on the basis that they were for mental acts or did not involve any ‘transformation of matter’. This will be discussed in the light of the recent US Supreme Court decision in Bilski v. Kappos, which focused on the patent-eligibility of process claims.

Introducing new evidence in patent appeals from USPTO

Introducing new evidence in patent appeals from USPTO

Personal jurisdiction and the improper service of process

As emerging markets play a bigger role in the global economy, and corporate entities located in them continue to avail themselves of US markets, when and how such entities become subject to personal jurisdiction in US Courts for alleged patent infringement is a matter of increasing concern. In Nuance Communications, Inc. v Abbyy Software House, et al., the US Court of Appeals for the Federal Circuit laid out in great detail how two of the defendants (Abbyy Software, a Republic of Cyprus corporation, and Russian Federation Abbyy Production) were improperly dismissed for lack of personal jurisdiction and improper service of process outside the Hague Convention by the US District Court for the Northern District of California.

Deconstructing the promise of embryonic stem-cell research

Deconstructing the promise of embryonic stem-cell research

US employment discrimination cases: does race/gender matter?

PurposeThis study aims to examine whether the diversity of the US federal judiciary has an influence on case outcomes in employment discrimination cases. Specifically, this paper investigates if the gender and race of both judges and plaintiffs result in significantly different employment case outcomes in the US district court system.Design/methodology/approachA random sample of 657 federal employment discrimination cases from the last decade were analyzed utilizing chi square analysis testing combinatory and interaction effects of race and gender.FindingsThe results intimate that the demographic characteristics of judges and plaintiffs do have an effect on case outcomes. Specifically that different combinatory types and interactions of judges and plaintiffs are associated with different case outcomes.Practical implicationsThese results could be useful to potential litigants in employment discrimination cases to assist employees and employers alike in the determination of their chances for success in the courtroom. Judges may also benefit from more information on possible biases and take steps to guard against being influenced by them.Social implicationsSuch research focuses more attention on the fundamental principle of the American judicial system of fair and equal treatment for all. Furthermore, some findings have implications for the demographic composition of the US Supreme Court and other judiciary bodies where decisions are arrived at by a group.Originality/valueLittle to no research has examined the possible differences in case outcomes associated with different combinatory types of both judges and plaintiffs in employment discrimination cases.

The Tragedy of the Microarray Anticommons

The public awareness of gene patenting has grown because of the most recent court ruling on the BRCA patents held by Myriad Genetics ( Association for Molecular Pathology v. United States Patent and Trademark Office , US District Court, Southern District of NY, March 29, 2010). Many scientists and professional societies have advocated a change in the practice of patenting and licensing individual human genes, but most of the discussion has focused on the mutational analysis of single genes. In the past decade, numerous multimarker microarray and proteomic assays with potential clinical use have been developed. Each of these assays contains dozens of markers that are all required for clinical utility; however, the creators of these assays do not typically address the potential problems that may occur when one or more of the biomarkers of interest have already been patented and licensed by another party. The barrier to utilizing a technology that contains multiple pieces of intellectual property assigned to multiple owners is reminiscent of the predicted “tragedy of the anticommons” (1). The concept of the tragedy of the anticommons in biomedical research was described a decade ago as the underutilization of a scarce resource with too many overlapping owners (1). It is an adaptation of the “tragedy of the commons” explanation for the opposite type of problems, which occur when shared public resources are overused because no individual has the ownership authority to prevent use by another. The result of this unrestricted use was hypothesized to be the cause of overpopulation, pollution, deforestation, and depleted fisheries (2). As an example of the tragedy of the commons, imagine 2 sheepherders overgrazing the same public field (a common) until the land was overused and could no longer support any …

Gene Patents are Under Attack in the US

A US District Court has called into question the validity of patents directed to DNA sequences and diagnostic methods based on such sequences. If upheld on appeal, the District Court ruling will severely impair the ability of universities and the biotech industry to patent their inventions, raise capital and maintain share prices. Since the reasoning could equally be applied to novel drugs based on naturally occurring compounds, the decision should also be of concern to the pharmaceutical industry in general.

XML feature in Microsoft Word permanently enjoined in US patent case

The US District Court properly found irreparable harm to a patentee, based on prior injury caused by infringing conduct.

Failure to plead originality of copyright design is fatal to complaint

Copyright, as the name implies, provides the owner of a copyright the ability to control who has the ‘right’ to ‘copy’ the copyright material. Unlike patent law, in order to be qualified for copyright protection in the USA, the material need not be novel (i.e. new compared to that which existed before), it merely needs to be original. Under US law, the threshold level of originality to obtain copyright protection is ‘extremely low’. In LA Printex Industries, Inc. v Forever 21 Inc., the US District Court for the Central District of California explored the parameters of the minimal level of originality that is necessary to be entitled to copyright protection, and the elements necessary to plead such a cause of action.

The Case of Binyam Mohamed: National Security or National Embarrassment?

This paper reviews the case of Binyam Mohamed, a British resident and former Guantanamo detainee. Mohamed’s case generated litigation in four different places: 1) proceedings in the military commissions court in Guantanamo Bay to try him under terrorist charges; 2) federal proceedings under an application for habeas corpus in the US District Court in Washington D.C.; 3) an application in the High Court in London where Mohamed’s lawyers sought disclosure of exculpatory material that the US had refused to provide to his US attorneys; and 4) a civilian litigation action under the Alien Tort Statute action in California in which the US Government invoked the state secrets privilege to block the lawsuit. In each forum the government refused to hand over materials or evidence to Mohamed’s lawyers, or attempted to block the lawsuit. The refusal to provide the evidence and exculpatory documents or the attempt to block the litigation in each case was claimed to be for reasons of national security or state secrets. The legal issues and role of the US and UK governments in the refusal to disclose evidence for alleged national security reasons, and an unusual method used to seek exculpatory evidence from a foreign court, through litigation in the UK High Court are discussed. The paper will consider whether the US and the UK acted for reasons genuinely related to national security, or for other reasons, such as to avoid national embarrassment. Few would dispute that politics should trump the law when real national security issues are at stake and where sources and intelligence have to be protected, but all too often the knee-jerk claim of national security, or state secrets is a cover-up for what a government has done on the fringes of the law.

Google Books Settlement: A Post-Conference Interview With the California Digital Library (CDL) Director of Mass Digitization

It is important for academics, commercial information services, librarians, policy makers, and the public to understand both the opportunities and the risks that may flow from the October 2009 US District Court fairness hearing in the case Authors Guild v. Google Inc., No. 05 CV 8136 (S.D.N.Y. filed Oct. 28, 2008). This interview offers my thoughts, and the opinions of an information professional working on the project for the University of California.In this paper, I examine aspects of private-public partnerships and the opinion that the US should (at least in the area of scholarly publications) transform a 19th century legal framework of copyright registration to one that recognizes the open source movement and the need to remove litigation risks from madd digitization efforts. Unless these restrictions are managed more effectively, the US will continue to trail the efforts of the EU national libraries to adequately build a national digital library of American / English works.The School of Information at Berkeley hosted a one-day conference on August 28th to address major issues arising from the proposed settlement. This was a follow-on interview with the current Director of the Mass Digitization Project.

Betamax Redux

By broadly equating RS-DVR with VCR technology, the US Court of Appeals for the Second Circuit reversed an earlier US District Court judgment and has paved the way for the US Supreme Court to consider accepting a Petition of Certiorari.

Secondary considerations of non-obviousness must still be considered

A US District Court erred in granting summary judgment of obviousness and in failing to consider secondary considerations of non-obviousness.

Permanent injunction affirmed in US patent case

A US District Court was entitled to find irreparable harm even though the patentee had previously granted licences to other competitors.

The American Red Cross dispute

The US District Court, Southern District of New York, held that the American National Red Cross's licensing of the Red Cross name and emblem violated neither the Geneva Convention nor US federal law governing the use of the Red Cross name and emblem. The court based its decision on a finding that licensing the Red Cross name and emblem to commercial entities in order to raise funds for Red Cross activities was itself an activity within the scope of the authority granted to the American National Red Cross.

Modeling patent legal value by Extension Neural Network

This study aimed at the basis of patent law and proposed a revolutionary valuation model for the monetary legal value of patents. The damage award of a patent infringement lawsuit was deemed to be the legal value of a patent. Sixty-five effective samples were extracted from 4289 patent related lawsuits retrieved in US district courts of Delaware, California and Texas. Seventeen quantitative patent indicators for describing dimensions of patents were summarized. The Extension Neural Network incorporated with the factor analysis was applied to construct the valuation model of patent indicators and damage awards. The proposed valuation model was validated to have the predictive power by error analysis and was accommodated to valuate the possible damage award or to negotiate the settlement fee in disputing patent infringement suits. It also contributed to patent transaction deal, patent licensing, hypothecation of intangible assets, and shareholding by patent-based technologies, etc.

Integrated evaluator extracted from infringement lawsuits using extension neural network accommodated to patent assessment

This study aims at the basis of the patent law and proposes an integrated evaluator for patent assessment. The damage award of a patent-infringement lawsuit is deemed to be the legal value of the patent. Sixty five effective samples are extracted from 4289 patent-related lawsuits retrieved from the US district courts of Delaware, California and Texas. Seventeen indicators are summarised to describe quantitatively the dimensions of the patents. Nine extracted factors are generated from the 17 patent indicators by Factor Analysis. Extension neural network is applied to build the patent valuation model, wherein the extracted factors are the input variables and the damage award is the output variable. The patent valuation model is validated to be made feasible by error analysis. The integrated evaluator for patent is then established by transforming the output of the patent valuation model via the Z-score. The proposed integrated evaluator accommodated to the patent assessment to improve any existing financial approaches. It also contributed to the patent transaction, patent licensing, hypothecation of intangible assets, shareholding by patent-based technologies and venture capital, etc.

The Gender Influence on US District Court Decisions: Updating the Traditional Judge Attribute Model

ABSTRACT. The present study contributes to the literature on federal lower court decision‐making as well as the broader body of research on gender effects on elite behavior by showing how gender, as a determinant of behavior, is filtered through other sociological determinants of decisional behavior. Starting with the assumption that personal attributes influence decision‐making patterns, our argument is that gender effects are not direct; rather, they subtly and indirectly influence elite behavior by providing another “lens” or “layer” by which a judge will view his or her world. These effects cannot be directly observed using traditional attribute behavioral models. We test our hypotheses with data on 35,038 published decisions by federal district court judges from the 1977 to 2005 terms. The results of this analysis indicate that gender has a subtle and indirect influence on judicial behavior that is not captured by traditional judge attribute models.

Ruling creates uncertainty under Section 13(d)

PurposeThe purpose of this paper is to explain the implications of a June 11, 2008 decision by the US District Court for the Southern District of New York in CSX Corp. v. The Children's Investment Fund Management (UK) LLP concerning beneficial ownership and reporting obligations under Section 13(d) of the Securities Exchange Act of 1934 for long parties to cash‐settled total return equity swaps.Design/methodology/approachThe paper summarizes the decision, discusses the court's analysis as written by Judge Lewis A. Kaplan, notes the court's limitation of its ruling to the facts of the case, explains why two funds that “compare notes” may be considered a group, discusses the permanent injunction against the defendants enjoining them from future violations of Section 13(d), and analyzes the implications of the judge's decision.FindingsA new decision by the federal district court in New York creates uncertainty regarding whether the long party to a cash‐settled total return equity swap will be deemed to beneficially own the publicly traded reference security for purposes of Section 13(d) of the Securities Exchange Act of 1934. Holders of cash‐settled total return swaps have historically relied on the absence of the legal right to vote or dispose of the reference security as a basis not to file a 13D with respect to the shares referenced in those swap contracts. The new decision casts doubt on that reasoning, and finds that an investor that consciously structured its swap contracts to try to end‐run its otherwise applicable reporting obligations was deemed to beneficially own the shares subject to the swaps, and accordingly had violated Section 13(d) by failing to file a Schedule 13D in the required time.Practical implicationsThe ruling is important for financial institutions and investors who deal in derivatives such as equity swaps and who must determine whether and when reporting under Section 13(d) is required.Originality/valueThe paper is an analysis and provides guidance by experienced securities lawyers.