The recent enactment of the Leahy-Smith America Invents Act (AIA) on September 16, 2011, marked a significant shift in the patent laws of the United States. This Bill, proposed on March 30, 2011, was finally passed in both the House of Representatives and the Senate by September 8, 2011, and was introduced to President Obama on September 12, 2011. Before this enactment, there had been no major changes to the substantive U.S. Patent laws since 1952, though case law has continued to shape some minor substantive and procedural policies. While some changes to the new Patent Laws took effect on the date of enactment, many of them will be ‘phased-in,’ going into effect after the first 12 or 18 months.
100,000,000,000. One hundred billion is the number of neurons contained in the human brain. To put that number in perspective, it is also the same number of stars contained in the Milky Way galaxy. Although only three pounds, “[a] single human brain has more switches than all the computers and routers and Internet connections on Earth.” It is able to complete an astonishing one hundred trillion computations every second. However, these are very rough estimates, because as much as the human brain can accomplish, it has failed to fully comprehend the internal workings of the brain. New York’s legal system has suffered this same fate.
Science abounds with unanswerable questions—those for which necessary data or even the necessary scientific methods are simply unavailable. Yet, for a variety of legal and political reasons, many such questions still require an answer. One way the Nuclear Regulatory Commission has cut this Gordian Knot has been through expert elicitation—a formal, highly structured, and well-documented process for obtaining the judgments of multiple experts. Yet, at least within the litigious context of nuclear energy regulation, this useful and creative process has been almost completely ignored by scholars, judges, and even the NRC’s own Commissioners. This article examines the Nuclear Regulatory Commission’s use of the expert elicitation process and provides an overview of both the process and the history of expert elicitation at the Commission from 1996 forward, and concludes with recommendations for its use of this process in the future. Although these questions, recommendations, topics, and sources are directed specifically to the Nuclear Regulatory Commission, they should also be useful to other agencies that likewise employ expert elicitation as a means of addressing otherwise-unanswerable questions.
The Human Genome Project was initiated in October 1990 with the goal of identifying all the roughly 25,000 genes in the human genome and sequencing the three billion nucleotide base pairs that comprise human deoxyribonucleic acid (DNA). Hundreds of genes have been linked with specific clinical phenotypes since the Project was completed two years ahead of schedule in April 2003. The vast majority of such phenotypes have been connected to mutations in DNA that code for a protein product. Other diseases have been linked with noncoding DNA, which was once commonly described as “junk DNA.” The study of noncoding DNA is now at the forefront of genetics studies because research has revealed that various noncoding regulatory elements, such as enhancers, repressors, and insulators, may alter gene expression in a tissue-specific manner.
Today, many patents that fail the constitutional mandate “[t]o promote the Progress of Science and useful Arts” are issued. Patents are granted irrespective of whether they are actually needed to incentivize innovation. Consequently, many patent grants fail to reflect an appropriate balance between the ex post costs of short-term monopoly and the benefits of higher ex ante incentives to innovate. Other patents are issued without having any prospected commercial use, so no one actually makes an economically beneficial use of them. The worst of these are those that are sought solely for the purpose of initiating infringement lawsuits and extorting licensing fees from competitors
Jody had been put on this earth to be a mother. She was married at age twenty-four, had a career as a microbiologist, and was ready to have children at age twenty-six. But her dream started to shatter after having her first miscarriage. She did not give up hope, and by age twenty-eight, she was ready again. However, she had another miscarriage. Still holding on to her dream, she tried again at age thirty, and had a third miscarriage. Jody was losing sight of her dream. She, like many women, was infertile.
Trust is one of the underlying themes in many discussions, media coverage, laws, and policies about contraception. Although women are generally held responsible for contraception, the myriad laws, as well as forms of surveillance and normalization, surrounding it give the impression that women are not trustworthy with it. Men are typically not thought to be the ones responsible for contraception and a significant part of the reason why, at least according to popular press articles on developing a “male pill,” is that they are not considered trustworthy with contraception. My goal in this paper is to discuss some of the gendered social norms that contribute to the perception that neither women nor men are trustworthy with contraception.
Women who are poor or have low incomes tend to underutilize preventive health care services even though those services can save lives and help avoid costly medical procedures. Studies show that “even moderate co-pays for preventive services such as mammograms or Pap smears result in fewer women obtaining this care.” For example, in one study, eliminating deductibles and co-pays resulted in a nine percent increase in the number of women who received mammograms.
I will be talking about is the issue of the compelling state interest regarding requiring insurers to provide coverage for birth control, and issue that New York State’s courts have tried to the highest levels, California has moved to the highest levels, and that there are 33 lawsuits that have been filed already. None so far have been successful, several have been dismissed for lack of brightness but certainly we’re not done on this issue. Though let me tell you, the Court of Appeals, the Appellate Division, and the trial level here in New York, all of that very sound rationale is being upheld. The compelling state interest has even been upheld recently in a Missouri court by a judge George Bush appointee to the Court.
My perspective on the symposium topic stems from client representation and litigation in this area involving religious freedom, one of our most treasured liberties, the freedom to practice one’s religion without government interference. Religious liberty is under constant scrutiny and ongoing challenges, in New York and on the Federal level. Within the context of health care, specifically reproductive health services and plans, religiously affiliated institutions including church entities are presented with a Hobson’s Choice.
The topic for the initial panel is the Affordable Care Act,1 primarily, and women’s primary preventive health care regulation. This regulation covers a variety of women’s preventive health care services, including domestic violence screenings, breast cancer screenings, sexually transmitted infection counseling, and a variety of other services. The aspect of this regulation that has received the most attention is, of course, the contraception requirement. There has unfortunately been a lot of misinformation about this requirement. One of the most prevalent myths has been that this is a taxpayer funded regulation or that it would require any government money to subsidize coverage of contraception or to provide contraception.
Hearing Sandra talk brought me back to a memory that I was not planning to share but I feel like I should because I’m a Georgetown Law alum myself. I started law school in the fall of 1990, coming from an undergraduate atmosphere where you went to the infirmary, you could get an exam, and you literally left with a paper bag full of a supply of birth control pills. So, I arrived quite naively on Georgetown’s campus and visited the nurse, who couldn’t give me pills or a prescription. I remember having to travel to some place that felt like the middle of nowhere in Maryland, in the dark, by myself one night, trying to find her off-campus clinic so that I could get an exam and get prescription that I could then take back into the city to get filled. I had never had such a complicated experience for something that seemed like just a basic part of a twenty-something’s health care.
What I’m going to speak to you about today is some of the legislation that’s standing before the New York State legislature now. I am also going to talk about some more legislation that’s being passed around the country and producing some challenges in the courts. When we talk about where we are, where we’ve been, and where we’re going, where we’ve been is women have died from abortions. Where we are is that fewer women are dying. And where are we going? I hope to a society that recognizes that women should make their own personal private health care decisions. Women might ask lots of people to be part of that decision making process. We might ask a person of faith, we might ask our family, we may ask our medical provider. However I’m sure the one person we’re not going to call up and invite to the kitchen table to have a conversation with is our local elected official, the President of the United States or a Supreme Court justice.
Reproductive health care is itself an expansive health topic. In my remarks today I’m going to really center on what that term is often euphemistically used to mean – abortion. Then I’m going to put contraception in quotes to refer to drugs, chemicals, and procedures that are aimed at halting the reproductive process. When you listen to speeches at the Democratic National Convention this year, or if you’ve received e-mail from any policy group or any politician, you have heard a lot of heightened rhetoric about where we are and where we’re going on the topic of reproductive health care legislation. Though phrased in admittedly catchy slogans and always delivered with much passion, it’s often divorced from the actual reality of the landscape of legislation.
I’m going to be talking about an area of law and medicine that I’ve had a real privilege to speak about and teach about for decades. In the decades that I’ve been teaching about reproductive technologies and bio-ethics in general, I’ve developed a bit of a mantra - the more we learn, the less we understand. Certainly that is true in the area of reproductive technologies and the law. Over the last twenty to thirty years, we’ve learned a great deal about human embryonic development. We can manipulate eggs and sperm in a way that would have been unheard of many years ago. We can watch the human as it develops from those commutic portions to where we stand today. But I would suggest to you that we still don’t understand human nature. We have deciphered the human genome, but we still don’t understand women.