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Life forms protectable as subjects of U.S. patents -- microbes to animals (perhaps).

Scientists, businessmen, universities and industries with fundamental or peripheral interests in technology as applied to life processes will be keenly interested in recent U.S. Patent Office decisions. These decisions indicate that new higher life forms, animal or plant, are proper subjects of patents if they are not naturally occurring (and are not human in the case of animals). In contrast to plants and other organisms, genetically modified animals have had no mode of protection as intellectual property except possibly as a trade secret or utility patent. The Ex parte Allen decision, reached by the Patent Office Board of Appeals and Interferences, directly addressed the issue of animal patentability in view of the broad reading of 35 U.S.C. section 101 by the U.S. Supreme Court in the Chakrabarty decision. The subject invention concerned polyploid oysters. Claims directed toward polyploid oysters produced by a particular process were rejected under 35 U.S.C. section 103 and section 101. The Board, reversing the 35 U.S.C. section 101 - based rejection in view of the Chakrabarty decision, indicated that the claimed polyploid oysters were non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 U.S.C. section 101. A similar decision affecting the patentable status of plants or segments thereof had previously been reached by the Patent and Trademark Office in the case of Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985). The Hibberd utility patent application concerned "genetically engineered" maize which had high levels of the tryptophan.

Animals↗

Efforts to regulate the collection and use of genetic information.

Public fascination with and support for genetic medicine is complicated by a deeply held fear that genetic information will be used by third parties (eg, insurers, employers, school systems) in ways that will harm the individuals from whom it was derived. Since the mid-1990s there has been much state and some federal legislative activity to address 2 closely related issues: the maintenance of genetic privacy and the prevention of genetic discrimination. These laws have had to confront several challenging questions such as what constitutes a genetic test, is genetic information qualitatively different from other medical information, and is there a means to distinguish between the two. In general the state laws are not well crafted. I will argue that a far more preferable policy is to draft a global, comprehensive medical records privacy law and to develop a model statute that defines the role of predictive genetic information in insurance underwriting. Concerns over misuse of genetic information also pose major issues for the conduct of genomic research. Among those I discuss are ownership of the DNA sample, significant changes in the scope of consent that must precede the decision to volunteer as a subject in genomic research, the reuse of long-archived samples, the challenges to intellectual property rights that flow from research, and the rise of the doctrine of community consent.

Confidentiality↗

"Congo" red: out of Africa?

CONTEXT: Congo red is the essential histologic stain for demonstrating the presence of amyloidosis in fixed tissues. To the best of my knowledge, nothing has been written about why the stain is named "Congo." OBJECTIVE: To understand the etymology and history of the Congo red histologic stain. DESIGN: Primary sources were consulted extensively, including 19th-century corporate documents, newspapers, legal briefs, patents, memoirs, and scientific papers. SETTING: Sources were obtained from multiple university libraries and German corporate archives. RESULTS: To Europeans in 1885, the word Congo evoked exotic images of far-off central Africa known as The Dark Continent. The African Congo was also a political flashpoint during the Age of Colonialism. "Congo" red was introduced in Berlin in 1885 as the first of the economically lucrative direct textile dyes. A patent on Congo red was filed by the AGFA Corporation of Berlin 3 weeks after the conclusion of the well-publicized Berlin West Africa Conference. During these important diplomatic talks, German Chancellor Otto von Bismarck presided over a discussion of free trade issues in the Congo River basin. A challenge to AGFA's Congo red patent led to a precedent-setting decision in intellectual property law. CONCLUSIONS: The Congo red stain was named "Congo" for marketing purposes by a German textile dyestuff company in 1885, reflecting geopolitical current events of that time.

Africa↗

Essential drugs in the new international economic environment.

Recent global developments in the regulation of trade and intellectual property rights threaten to hinder the access of populations in developing countries to essential drugs. The authors argue for state intervention in the health and pharmaceutical markets in order to guarantee equitable access to these products.

Biotechnology↗

CONTU revisited: the case against copyright protection for computer programs in machine-readable form.

Professor Samuelson casts a critical eye on the Final Report of the National Commission on New Technological Uses of Copyrighted Works (CONTU) which recommended that copyright protection be extended to machine-readable versions of computer programs. CONTU appears to have misunderstood computer technology and misinterpreted copyright tradition in two significant respects. The Commission failed to take into account the historical importance of disclosure of the contents of protected works as a fundamental goal of both the copyright and patent laws. It also erroneously opined that the utilitarian character of a work was no bar to its copyrightability when both the statute and the case law make clear that utilitarian works are not copyrightable. Since computer programs in machine-readable forms do not disclose their contents and are inherently utilitarian, copyright protection for them is inappropriate. Congress acted on CONTU's recommendation without understanding the significance of these conceptual flaws. Professor Samuelson recommends the creation of a new form of intellectual property law specifically designed for machine-readable programs.

Computers↗

Educational implications for copyright in a digital world.

Statutory law and court cases currently leave fair use of copyrighted material poorly defined and fail to provide effective guidance for the use of others' work. Copyright legislation is undergoing significant change, accelerated by the evolution of computing and communication technologies. This paper reviews copyright issues, fair use guidelines, and applicable laws and statutes to help administrators and educators understand and comply with copyright regulations. The paper describes principles of copyright and ownership, the rights of copyright holders, and the conditions under which copyrighted material can be used by others. Recently introduced legislation, such as the 1998 Digital Millennium Copyright Act, may significantly affect how educators can use copyrighted material in the future. The integration of computer and communication technology into education raises a number of intellectual property issues for dental schools. This paper provides some general guidelines regarding copyright issues in academic environments.

Communication↗

Patenting biotechnologies: the European Union Directive 98/44/EC of the European parliament and of the council of 6th July 1998 on the legal protection of biotechnological inventions.

Before the Directive 98/44/EC of the European Parliament and the Council of 6th July 1998, notwithstanding some decisions of the European Patent Office (still presently under opposition) and some patents already granted by the Italian Patent Office, the existing legal framework did not allow the patentability of living organisms in the European Community countries. The Directive has dramatically changed the perspectives. It ensures free circulation of patented biotechnological products harmonising the national legal system of each Member State, guaranteeing compliance with the European Patent Convention signed in Munich on 5th October 1973, the Trade-Related Aspects of Intellectual Property Rights agreement of 15th April 1994 and the Rio de Janeiro Convention on Biological Diversity of 5th June 1992. The legal basis of the Directive and the fundamental principles of protection are that discoveries as such are not considered patentable. Plant and animal varieties as such, as well as essentially biological procedures for the production of plants and animals are excluded from protection by patent. On the contrary, the new field of patentability covers plants and parts of animals with new introduced genetic characters. Methods of surgical and therapeutic treatment and diagnostic methods applied to animal bodies are not considered inventions suitable for industrial applications and excluded from protection by patents. Biological materials and material isolated from its natural environment and isolated elements of the human body with technical processes may be patented. Excluded from patentability are inventions that are contrary to law and order or public morality as well as processes for human cloning for reproductive purposes and for modifying the germ-line genetic identity of human beings, as well as the use of human embryos. The processes for modifying the genetic identity of animals without any substantial medical benefit for man (with the exception of studying new medicinal products useful for treating serious diseases such as cancer, hepatitis or AIDS, by means of Oanimal modelsO) are also excluded. The rights of farmers are also guaranteed, by allowing them to re-sow seeds and freely use breeding stock covered by patents on their farms, without paying costly royalties to the holders of patents.

Animals↗

Ethical limitations in patenting biotechnological inventions.

In order to connect ethical considerations with practical limits to patentability, the moral judgement should possibly move from the exploitation of the invention to the nature and/or objectives of Research and Development (R&D) projects which have produced it: in other words, it appears quite reasonable and logical that Society is not rewarding unethical R&D activities by granting intellectual property rights. As far as biotechnology R&D is concerned, ethical guidance can be derived from the 1996 Council of EuropeOs OConvention for the protection of human rights and dignity of the human being with regard to the application of biology and medicineO, whose Chapter V - Scientific research - provides guidelines on: i. protection of persons undergoing research (e.g. informed consent); ii. protection of persons not able to consent to research; iii. research on embryos in vitro. As far as the specific point of patenting biotechnology inventions is concerned, the four exclusions prescribed by Directive 98/44/EC (i.e. human cloning, human germ-line gene therapy, use of human embryos for commercial purposes, unjustified animal suffering for medical purposes) are all we have in Europe in terms of ethical guidance to patentability. In Italy, in particular, we certainly need far more comprehensive legislation, expressing SocietyOs demand to provide ethical control of modern biotechnology. However it is quite difficult to claim that ethical concerns are being raised by currently awarded biotechnology patents related to living organisms and material thereof; they largely deal with the results of genomic R&D, purposely and usefully oriented toward improving health-care and agri-food processes, products and services. ONo patents on lifeOO can be an appealing slogan of militants against modern biotechnology, but it is far too much of an over-simplified abstraction to become the Eleventh Commandment our Society.

Biotechnology↗

Patentability and perspectives of biotechnology large-scale applications.

This meeting has suggested many conclusions and opens many problems for the application of the biotechnologies. Patents are a useful legal instrument developed to protect intellectual property rights, thus allowing Society to promote and support the innovation and development of useful inventions.

Agriculture↗

Auto-disable syringes for immunization: issues in technology transfer.

WHO and its partners recommend the use of auto-disable syringes, "bundled" with the supply of vaccines when donor dollars are used, in all mass immunization campaigns, and also strongly advocate their use in routine immunization programmes. Because of the relatively high price of auto-disable syringes, WHO's Technical Network for Logistics in Health recommends that activities be initiated to encourage the transfer of production technology for these syringes as a means of promoting their use and enhancing access to the technology. The present article examines factors influencing technology transfer, including feasibility, corporate interest, cost, quality assurance, intellectual property considerations, and probable time frames for implementation. Technology transfer activities are likely to be complex and difficult, and may not result in lower prices for syringes. Guidelines are offered on technology transfer initiatives for auto-disable syringes to ensure the quality of the product, the reliability of the supply, and the feasibility of the technology transfer activity itself.

Disposable Equipment↗

Pharmaceutical policies in Canada: another example of federal-provincial discord.

Pharmaceutical policy in Canada is set at both the federal and provincial levels of government. The federal government is responsible for intellectual property rights of manufacturers (patents) and the initial approval and labelling of prescription drugs and for ensuring overall market competitiveness. The provincial government has responsibility and jurisdiction over the funding of all health care services, including pharmaceuticals. Various interactions between the pharmaceutical industry, the federal and provincial governments and consumers have shaped the current landscape for prescription drugs in Canada. One key failing of the system is that the federal government is almost completely insulated from the impact of its policies because, although it regulates drug prices, it does not buy any drugs. In contrast, provincial governments have no jurisdiction over market competitiveness or pricing, yet end up paying for most of the drug expenditures incurred.

Canada↗

Patenting inventions in combinatorial chemistry.

I have intended to provide an overview of some patent strategies for protecting intellectual property in the combinatorial chemistry arts, along with examples taken from recently issued patents. The opinions in this paper are those of the author, and are not intended to be relied upon as legal advice. Specific questions about any particular patent or invention should be discussed with competent counsel before action is taken. If you would like to look at the patents discussed in this article, they are available on-line at http:¿www.patents.ibm.com/boolquery and at other locations.

Combinatorial Chemistry Techniques↗

The ENN project. ENN exploitation plan.

The objective of the ENN-European Neurologic Network project is to improve knowledge and treatment of sleep disorders, headache and epilepsy. The means to obtain this objective shall be certain software to be distributed to the appropriate users in the medical field and the collection of relevant cases, in order to set up a neurological database. It is intended that the distribution of the above mentioned software and access to the database, will be able to finance research projects in the neurological field. The outcome of the EU funded project have been six prototypes, which need further work in order to establish a system of compatible and linked products. A particular emphasis of this work should be put on making the products as process oriented as possible. At the time being there are already products available in the market, which would be competing with particular ENN prototypes, but there is no set of compatible and linked products, which would be comparable with the intended set of ENN neurological tools. Such set of tools therefore could be a unique selling proposition. Intellectual property rights and legal implications have to be taken into consideration for the marketing of the ENN products. It has to be made sure, that no third party can assert violation of its IPRs and that, a protection of the products can be attained by appropriate application for IPRs. In the legal field in particular the prescriptions of data protection legislation have to be observed e.g. by obtaining the written consent of patients, whose cases are reported. The marketing concept should be set up as a short-term, middle-term, long-term strategy. The short-term strategy should concentrate on carrying out a market validation study at European level and simultaneously the development from prototype to products. The middle-term strategy should be directed towards the market introduction of the ENN products in Europe. The long-term strategy should comprise marketing of the products in all potential markets worldwide. It is very important to create an ENN brand, which means a common label, a common layout and a common user interface.

Computer Communication Networks↗

Technology transfer: a review for biomedical researchers.

Why is technology transfer important for cancer and other biomedical researchers? What do biomedical researchers need to know about technology transfer? This report will address these questions in the context of the United States technology transfer system, which is now approximately 20 years old. To accomplish this goal, this report first summarizes the importance of technology transfer and the role of intellectual property rights. Then it describes the sequential steps in technology transfer from universities to industry. Next, it describes technology transfer from the NIH intramural laboratories and other federal laboratories to industry. Finally, it describes unique aspects of technology transfer involving clinical trials. URL citations to the latest federal guidelines and regulations governing technology transfer are provided. Where appropriate, comparisons will be made with technology transfer systems in other countries. I hope that this step-by-step description of the technology transfer process will enable cancer researchers to play a more proactive role in this process and thus increase the likelihood that their discoveries will be successfully commercialized. I also hope that this report will assist such researchers to understand the policy and institutional considerations that underlie current debates concerning technology transfer.

Clinical Trials as Topic↗

Therapeutic antibody production technologies: molecules, applications, expression and purification.

Antibody-based therapeutics are currently being tested in an increasingly diverse range of therapeutic modalities. Many different engineered formats for the antibody molecule and multiple methods for raising and tailoring binding specificities are currently available. Comparison of the relative function and efficacy of these molecules and the many competing methods for their production is crucial for making an informed selection of a new therapeutic entity. In addition, these choices may be influenced by the attached intellectual property burden.

Animals↗

Reprivatizing pharmaceutical supplies in Africa.

Perhaps no part of the health system is as imperiled by neoliberal economic reforms as the public drug sector. The national bill for pharmaceuticals can claim one-third of a developing country's annual health budget. This article describes the essential drugs program created by WHO in the 1980s to protect financially reduced ministries of health from the high prices charged by multinational pharmaceutical companies. It describes the backlash from the World Bank and UNICEF, which launched the Bamako Initiative and other community financing schemes and revolving drug plans in which individuals, families or community groups buy drugs above the wholesale purchase price; clinics use the proceeds to maintain drug supplies and subsidize other health services. When this plan failed, the Bank proposed outright privatization of drug purchase and supply, returning power to the multinational suppliers. The article ends with a consideration of patents and the new intellectual property rights as they pertain to pharmaceutical production in Africa.

Africa↗

Alemtuzumab (Millennium/ILEX).

Alemtuzumab, a lymphocyte-depleting humanized monoclonal antibody, is being developed by Millennium Pharmaceuticals Inc and ILEX Oncology for the potential treatment of chronic lymphocytic leukemia (CLL) [274580]. The utility of the compound for treating bone marrow (BM) stem cell transplantation-associated graft-versus-host disease (GVHD) [372946] and for ex vivo purging of BM to remove malignant T-cells [244056] is also being investigated. Additional potential therapeutic areas for which clinical trials are planned or ongoing include vasculitis, multiple sclerosis [288762] and organ transplantation [338304]. A Biologics License Application (BLA) was filed with the FDA in December 1999 by ILEX and Millennium [351523], [351524], [373873]. The FDA accepted the application for filing in February 2000 [355775] and returned a complete response letter in June 2000 [372172]. Millennium and ILEX submitted a response to the FDA in August 2000 [379766]. Alemtuzumab has received Fast Track designation [304771] and orphan drug status from the FDA [288762], and the drug was reviewed by the FDA's Oncologic Drugs Advisory Committee on 14 December, 2000 [387228]. The committee voted 14 to 1 to recommend accelerated approval of alemtuzumab for patients with CLL who have been treated with alkylating agents and who have failed fludarabine therapy [393778], [393894]. In March 2000, Millennium and ILEX also submitted a Marketing Authorization Application (MAA) for alemtuzumab to the European Agency for the Evaluation of Medicinal Products (EMEA) [363595]. In October 2000, EMEA accepted the MAA for alemtuzumab under the agency's centralized approval procedure [387228]. Alemtuzumab was originally synthesized by Herman Waldmann and colleagues at Cambridge University and licensed to Burroughs Wellcome (BW) via the British Technology Group (BTG) [162622]. BW conducted phase I and II trials for a broad range of indications, but then discontinued development because of disappointing results in phase II rheumatoid arthritis trials [326848]. In April 1997, LeukoSite licensed rights to the antibody from BTG for the treatment of CLL and prolymphocytic leukemia, plus an option to develop it for other indications. BW agreed to supply LeukoSite with intellectual property [244056], [326848]. In May 1997, LeukoSite entered into a joint venture with ILEX Oncology for the further development of alemtuzumab [245986]. By the end of 1999, Millennium acquired LeukoSite with commitment to pursue development of the compound through the joint venture Millennium & ILEX Partners LP [351523], [370237]. In August 1999, Schering AG and its US affiliate Berlex Laboratories obtained exclusive worldwide marketing rights for alemtuzumab, excluding Japan and East Asia. In the US, Berlex, Millennium and ILEX will divide profits from alemtuzumab sales equally [337702], [338837].

Alemtuzumab↗

Building local research and development capacity for the prevention and cure of neglected diseases: the case of India.

This paper examines the proposal to build research and development (R&D) capabilities for dealing with neglected infectious and tropical diseases in countries where they are endemic, as a potentially cost- and time-effective way to fill the gap between the supply of and need for new medicines. With reference to the situation in India, we consider the competencies and incentives needed by companies so that their strategy can be shifted from reverse engineering of existing products to investment in R&D for new products. This requires complex reforms, of which the intellectual property rights agreement is only one. We also consider whether Indian companies capable of conducting research and development are likely to target neglected diseases. Patterns of patenting and of R&D, together with evidence from interviews we have conducted, suggest that Indian companies, like multinational corporations, are likely to target global diseases because of the prospect of much greater returns. Further studies are required on how Indian companies would respond to push and pull incentives originally designed to persuade multinational corporations to do more R&D on neglected diseases.

Communicable Diseases↗