Band 3, Heft 1

Introduction A database is defined as “any organized collection of information” and can include any number of different categories, from clients list, to phonebooks to nucleotide sequence data for E. Coli. As the speed and storage capacity of next generation computers continue to Moore's law, doubling every 12–18 months, databases are becoming vital tools to extract information that to date has gone unnoticed. Nowhere is this more applicable or more evident than in the burgeoning field of bioinformatics, the science of applying computers to biological problems. Bioinformaticians are a loose consort of biologists, physicists, chemists, mathematicians who also understand principles of computer science. These Bioinformaticians invest substantial resources in the form of money, time, and personnel in gathering information, verifying the accuracy of that information, and bringing it together in one location. Until very recently, scientists who fit this definition have largely been academic researchers, but with the mapping of the Human Genome completed, these scientists have now begun to become more and more prevalent in commercial settings. To date, these academic scientists have participated in open source data sharing to speed scientific progress, but as the cost of development increases and commercial entities continue to exploit bioinformatics tools for the production of new drug candidates this compiled information has become the topic of hot debate. The difficulty associated with a discussion of such a highly technical subject both intellectual property and genomics, coupled with a paradigm shift in the science makes for a very difficult and perhaps insurmountable barrier. In spite of these difficulties, one should not be discouraged, as the innovation at this level is the beginning of the end of death and disease in human beings.

Introduction Since ancient times gestation has been part of a woman's role starting from her very existence. To give birth is no doubt an universal experience and although this experience may be the cause of death of the mother, the child or both, all the Treaties of Medicine (Ancient, Middle Age, Renaissance, Islam and Modern days) have devoted special attention to such an important event in a woman's life. Starting with the ancient culture, the assistance to the birth of a child (banned to men in the Christian or Arab world) has been endorsed to the hands of women nominated as “mid-wives” or “matrons”; it is only by the end of the XVIII century that physicians begin to act, and, starting from then, the obstetrics practice is promoted in various Universities. Practices connected with the birth or abortions were only of public knowledge long after they were used, through various manuscripts and documents. Even the finding of pregnant women with newborns buried next to them does not prove that difficult deliveries were not in the basis of these findings. Regarding the scientific philosophers little is known viewing the field of obstetrics. The IX and VIII centuries (BC) were followed by the pre-Hippocratic philosophers of the VI century. These philosophers created medical schools, masters in medicine and practicing students, but they were not really concerned about sexual problems – gestation, deliveries, abortion, etc.

Introduction The exemption from patent infringement under 35 U.S.C. § 271(e)(1) was significantly extended by the Supreme Court in Merck KGaA v. Integra Lifesciences I , Ltd. (“ Merck KGaA ”) to encompass biotechnology “research tools.” The Merck KGaA opinion permits otherwise infringing use of patented research tools pursuant to the safe harbor provision of Section 271(e)(1) if such activity can be objective supported as being “reasonably related” to the gathering of information intended to be submitted to the Food and Drug Administration (“FDA”) for a new drug approval (“NDA”). In this paper, a brief overview is provided of the Merck KGaA matter and several strategic tools are presented to lessen the negative consequences to research tool manufacturers from the effect of the broadened exemption from infringement after Merck KGaA .

Collections of human bodily substances as a promising instrument of medical and pharmaceutical research Human bodily substances are an important resource for establishing the causes and mechanisms of a large number of disorders, in particular those widely disseminated among the population. The more thoroughly the human genome is understood, the more it is becoming possible to identify the role not only of external factors such as environmental agencies or lifestyle but also of hereditary predispositions (genes) in their causation. Scientific interest here as a rule centres not on individuals but mostly on very large population groups. For this reason, collections of human bodily substances and the associated medical data have taken on enormous significance in modern medicine. Lately these collections have even acquired a specific name: “biobanks”.

The ascendancy of psychological therapy over the last few decades has been phenomenal. During this period, the health care scene has witnessed the continuous proliferation of distinct therapeutic modalities and a marked increase in the demand for psychotherapeutic services. In response, there is now a growing concern as to whether clients who enter therapy do so on an adequately informed basis both as to the range of treatment on offer and what they entail. One movement in this direction has been to call for the adoption of the doctrine of informed consent in this realm. This paper questions the viability of this move. By retracing the doctrine's development to its conception at the dawn of the twentieth century, it will be shown that although the law has undergone three major changes since then, the ‘patient's right to self-determination’ remains the one consistent feature that runs through the doctrine's history and that now, as then, this principle relates primarily to the patient's interest in his bodily integrity. This paper argues that not only are the factors which gave rise to the notion of informed consent peculiar to the medical model, but since psychotherapy does not characteristically involve physical contact, the current law's consequent emphasis on risks-disclosure and freedom from unauthorized bodily intrusions are also generally incompatible with the ethos and reality of psychotherapeutic practice.