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Comment on the provisions of the French laws of 6 August 2004 and 8 December 2004 relative to the protection of genetic inventions.

The question of gene patentability has raised some opposition in France. Too broad a definition of the rights conferred by patent would hamper the development of research. The French legislature strictly defined genetic inventions in the Laws of 6 August 2004 and 8 December 2004. Exclusivity of use applies only to the function or functions precisely described in the patent application. Potential abusive use of rights by the holder of the patent has also been addressed through reinforcement of the provisions of the Code of Intellectual Property to combat such abuse. The Laws we discuss smooth the way to the granting of dependency licenses and broaden the field of application of ex officio licenses. The French legislature has achieved satisfactory balance between the legal protection of genetic inventions necessary to finance research, and the free circulation of scientific knowledge indispensable for medical progress.

France↗

When your contract manufacturer becomes your competitor.

PC maker Lenovo started out as a distributor of equipment made by IBM and other companies; now it has formed a joint venture with IBM and will eventually affix its own logo to its computers. Shanghai Automotive Industry Corporation (SAIC) started out manufacturing vehicles for Volkswagen and GM; now it's preparing to sell its own cars in China, Europe, and North America. Lenovo and SAIC represent a host of formerly anonymous makers of brand-name products that are breaking out of their defined roles and pushing the brands themselves aside. In this article, the authors explore the double-edged relationships original equipment manufacturers (OEMs) forge with their contract manufacturers (CMs). On the one hand, an OEM can reduce its labor costs, free up capital, and improve worker productivity by outsourcing all the manufacturing of a product. The company can then concentrate on value-adding activities--research and development, product design, and marketing, for instance. On the other hand, an OEM that retains a contract manufacturer may find itself immersed in a melodrama replete with promiscuity (the ambitious CM pursues liaisons with other OEMs), infidelity (the OEM's retailers and distributors shift their business to the upstart CM), and betrayal (the brazen CM transmits the OEM's intellectual property to the OEM's rivals or keeps it for itself when the contract is up). OEMs cannot simply terminate their outsourcing arrangements--they need contract manufacturers in order to keep specializing, adding value, and staying competitive. But OEMs can manage these relationships so that they don't become weak or the CMs too strong. Doing so requires modesty about revealing trade secrets; caution about whom one consorts with; and a judicious degree of intimacy, loyalty, and generosity toward partners and customers.

Commerce↗

Basic concepts and issues: a primer on distribution and sales representative agreements in the medical device and durable medical equipment industries.

Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.

Commerce↗

Can science be a business? Lessons from biotech.

In 1976, Genentech, the first biotechnology company, was founded by a young venture capitalist and a university professor to exploit recombinant DNA technology. Thirty years and more than 300 billion dollars in investments later, only a handful of biotech firms have matched Genentech's success or even shown a profit. No avalanche of new drugs has hit the market, and the long-awaited breakthrough in R&D productivity has yet to materialize. This disappointing performance raises a question: Can organizations motivated by the need to make profits and please shareholders successfully conduct basic scientific research as a core activity? The question has largely been ignored, despite intense debate over whether business's invasion of basic science-long the domain of universities and nonprofit research institutions- is limiting access to discoveries, thereby slowing advances in science. Biotech has not lived up to its promise, says the author, because its anatomy, which has worked well in other high-tech sectors, can't handle the fundamental challenges facing drug R&D: profound, persistent uncertainty and high risks rooted in the limited knowledge of human biology; the need for the diverse disciplines involved in drug discovery to work together in an integrated fashion; and barriers to learning, including tacit knowledge and murky intellectual property rights, which can slow the pace of scientific advance. A more suitable anatomy would include increased vertical integration; a smaller number of closer, longer collaborations; an emphasis by universities on sharing rather than patenting scientific discoveries; more cross-disciplinary academic research; and more federal and private funding for translational research, which bridges basic and applied science. With such modifications, science can be a business.

Biotechnology↗

The science of medical librarianship: investing in the future.

Information science is changing from an applied service-oriented activity to a basic research discipline. The library profession must earn a central place in this endeavor, and must address a number of important issues. These include ownership and intellectual property rights, a stronger research component for the profession, development of quality assurance systems for health information services, and a conceptual framework for training and career development of health sciences library technicians. The future of medical librarianship as a profession depends on a lasting commitment to research, a clear vision of the profession's fundamental mission and of the library's place in society.

Forecasting↗

Funding resuscitation research.

The present trend in managed care has meant downsizing expectations concerning the availability of support for resuscitation research. This trend applies to funding possibilities from industry, governmental agencies, and nongovernmental agencies (Table 1). There will be increasing barriers to making innovations. Truth, science, and good patient care alone will not make potential donors give grants. Investigators must also understand the potential donors' expectations and be persuasive. "Delight your donor". Industries' concerns include intellectual property rights and publications. The National Institutes of Health, recently favoring molecular biology over lifesaving therapies or integrated physiologic research, is an anomaly. The current peer review system propagates itself without having advocates for resuscitation research. This system has become a self-fulfilling prophecy. The American Heart Association is only recently, after 30 yrs of educational activities concerning cardiopulmonary resuscitation, considering putting some basic research money into resuscitation research. In university hospitals, where clinical departments have made significant contributions to innovative, clinically relevant life-support research, funded with incomes from patient care, the sky is beginning to fall. Resuscitation researchers need persuasive advocates with clout and hard data to convince funding agencies to give support to multilevel research and development in areas of pathophysiology and reversibility of terminal states and clinical death--to give these topics a higher priority than is currently available.

American Heart Association↗

The Internet and medicine: past, present, and future.

The enormous growth of the Internet and the World Wide Web has made these two technologies an important potential adjunct to cost-effective health care research and delivery. This article surveys some recent developments in telecommunications, networking and artificial intelligence that are likely to have a significant impact on improving the efficiency and quality of future health care. Issues discussed include: clinical record keeping on the Internet, Internet-assisted medical diagnosis, privacy and security matters, financial transactions, digital money, bandwidth concerns, multimedia (music, audio and video) information delivery via the Internet, intellectual property, and the concept of Information Philanthropy.

Clinical Medicine↗

[Public laboratories for vaccine production: a new paradigm].

In Latin America and the Caribbean, public laboratories that produce vaccines have contributed in varying degrees to the control and eradication of vaccine-preventable diseases, and several of them are manufacturing vaccines that are routinely applied in national immunization programs, such as the vaccine against tuberculosis (made with the bacillus of Calmette-Guérin, BCG), the triple vaccine against diphtheriatetanus-pertussis (DTP), tetanus toxoid (TT), the vaccine against measles and the oral vaccine against polio. Thanks to recent scientific strides, one can foresee an important increase in the number of safe and effective vaccines that will be available in the near future for use in routine vaccination programs. However, there are high costs involved in developing such vaccines and in protecting the intellectual property rights involved, and few laboratories in Latin America have the technical capacity to research and develop these vaccines. Such factors will affect the speed with which they are assimilated into vaccination programs in countries of the Region. Currently, public laboratories that manufacture vaccines in the Region are not equipped to compete in this new scenario and run the risk of being completely outmarketed. Thus, they must radically change their style of management and their scientific and technical capabilities, backed by a commitment from governments to improve and strengthen those political and financial aspects that can assure that national laboratories participate in the sustainable supply of vaccines to immunization programs, as well as in researching, developing, and producing new vaccines.

Caribbean Region↗

Seeing and believing: children's understanding of the distinction between appearance and reality.

When young children are asked questions about objects with misleading appearances, they make two kinds of errors: (1) phenomenism--they report appearance when asked to report reality; and (2) intellectual realism--they report reality when asked to report appearance. Two studies with 3-year-old children tested the hypothesis that phenomenism errors predominate when children are asked about objects' real and apparent properties, whereas intellectual realism errors predominate when children are asked about objects' real and apparent identities. The results of these studies provided some support for the property-identity hypothesis; children's appearance-reality judgments about properties tended to differ from those about identities. More phenomenism errors were elicited when the stimuli were described to the children in terms of their properties than when the very same stimulus objects were described in terms of their identities. Identity tasks were not found to elicit predominantly intellectual realism errors, although the data showed trends in this direction. The implications of these results for theories about young children's tendency to accept things in terms of their perceptual characteristics were briefly discussed.

Child Development↗

Glasgow Anxiety Scale for people with an Intellectual Disability (GAS-ID): development and psychometric properties of a new measure for use with people with mild intellectual disability.

BACKGROUND: Self-rating scales are widely used in general adult practice; however, there is no reliable and valid method for assessing state anxiety in people with intellectual disability (ID). The present study describes the development and psychometric evaluation of a new scale, the Glasgow Anxiety Scale for People with an Intellectual Disability (GAS-ID). METHODS: First, an item pool was generated from focus groups, a review of the literature and clinician feedback. Secondly, a draft scale was administered to 19 anxious and 16 non-anxious people with ID for further validation and appraisal of reliability. Thirdly, the scale was completed by 19 anxious, non-ID people for cross-validation with the Beck Anxiety Inventory (BAI). Finally, physiological concomitants were validated by pulse-oximetry. RESULTS: The 27-item GAS-ID discriminated anxious from non-anxious participants, had good test-retest reliability (r = 0.95) and internal consistency (alpha = 0.96), and was reasonably correlated with the BAI (rho = 0.75). The correlation between the physiological subscale of the GAS-ID and changes in pulse rate was moderately significant (rho = 0.52). CONCLUSIONS: This preliminary study suggests that the GAS-ID offers a psychometrically robust and practical (5-10 min) approach to the appraisal of anxiety in this population.

Adult↗

Cancer chemotherapy, biodiversity, public and private property: the case of the anti-cancer drug taxol.

The drug taxol has been hailed by many in the cancer community as a major breakthrough in the treatment of cancer. It has already been approved in use against ovarian and advanced breast cancer in many countries worldwide. Taxol has also promoted profound debates in the policy arena not, as one might expect, because of the characteristics or purposes of the drug itself, but because of other far-reaching effects. Taxol is a complex compound found in the bark of the Pacific yew tree, primarily in Oregon and Washington in the USA. The bark was first collected in 1962 and cytotoxicity demonstrated in 1964. Yet it was not until 1989 that the first results of clinical trials were reported. In the US taxol was then rushed through the Food and Drug Administration's regulatory procedures, approval being granted for use in refractory ovarian cancer in 1992. The controversies surrounding taxol surfaced in 1989 and grew substantially over the next few years. In this paper we examine two principal controversies concerning taxol, the first of which focused on apparent conflicts between the needs of environmental protection and those of cancer chemotherapy. Although the media portrayed this as a clash of interests between the environment and people with cancer, we argue that it was an attempt to increase lay participation in biomedical decision making and policy formulation. The second controversy was between health policy and the transfer of public scientific property to the corporate sector. The pharmaceutical company Bristol-Myers Squibb was given exclusive rights to provide taxol from Pacific yew trees under a Co-operative Research and Development Agreement signed in 1991. While this was seen to be in the US Government's (as well as the company's) interest, it provoked a public reaction questioning the terms and consequences of the transfer of publicly generated scientific knowledge to the private sector.

Antineoplastic Agents, Phytogenic↗

Tocqueville revisited. The meaning of American prosperity.

Why is business so admired in the United States and so often denigrated in Europe? How has America created 30 million new jobs in the last 20 years while the European Union, with a bigger population, only managed 5 million? What is feeding America's apparently inexhaustible appetite for growth and its recent dramatic improvements in productivity? In 1831, French philosopher Alexis de Tocqueville came to America to examine its prison system and returned with a vision of democracy so profound it has become part of our cultural heritage. More than a century and a half later, renowned British business philosopher Charles Handy retraces Tocqueville's intellectual journey, this time focusing not on democracy but on capitalism. The result is an eye-opening look at some of the fundamental assumptions underpinning business in America today. It is America's optimism that Handy finds most striking, the unquestioned belief that tomorrow can--and should--be made better than today. He contrasts this with the Spaniards when they came to the New World: No haya novedades, those Spaniards would say, "Let nothing new arise." The energy engendered by American optimism, coupled with the Puritan belief in work and in the nobility of earned wealth (as opposed to Europe's furtive attitude toward its nobility's inherited wealth) lies, in Handy's view, at the heart of America's success. Will American capitalism, born as it was from a property-owning democracy, now adapt to a dematerialized world, where property is intellectual rather than physical? Handy draws no absolute conclusions, but rather lays out the challenges that must be overcome for tomorrow to indeed continue to be better than today in this still-young country.

Commerce↗

Owning genetic information and gene enhancement techniques: why privacy and property rights may undermine social control of the human genome.

In this article I argue that the proper subjects of intangible property claims include medical records, genetic profiles, and gene enhancement techniques. Coupled with a right to privacy these intangible property rights allow individuals a zone of control that will, in most cases, justifiably exclude governmental or societal invasions into private domains. I argue that the threshold for overriding privacy rights and intangible property rights is higher, in relation to genetic enhancement techniques and sensitive personal information, than is commonly suggested. Once the bar is raised, so-to-speak, the burden of overriding it is formidable. Thus many policy decisions that have been recently proposed or enacted--citywide audio and video surveillance, law enforcement DNA sweeps, genetic profiling, national bans on genetic testing and enhancement of humans, to name a few--will have to be backed by very strong arguments.

Commerce↗

Perusing property rights in DNA.

Many practical questions have arisen since the use of patents relating to DNA has become progressively more common after the landmark case of Diamond v. Chakrabarty in 1980: What ownership rights do patents confer? What is owned? Who owns it? What does ownership mean to nonoweners? The central theme of the chapter is that much of the debate about patent rights relating to DNA is needlessly burdened by concerns that are inapposite, given an informed understanding of how things actually work in this area; and that as a result, insufficient attention is paid to exploring propositions that might elucidate or even alleviate pertinent problems in need of solutions. The approach of the chapter is more analytical than prescriptive. It endeavors to unpack how property rights in this area actually operate and concludes by making a few modest prescriptions about areas for future study, including efforts to explore the mechanisms that might be at play when actual transactions in basic biological materials and protocols break down. The intuition behind the chapter is that although many of the problems identified by patent critics do exist and, in theory, might be pernicious in creating some inefficiency in the form of dead-weight loss, in practice these problems turn out to be less pernicious than those likely to be caused by alternative regimes and are mitigated through various behaviors of market participants.

Commerce↗