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Australian medical patents granted in the United States in 1984-1999.

OBJECTIVE: To describe all medical patents granted in the United States to Australian-resident inventors between 1984 and 1999. DATA SOURCES: All patent data originated from the US Patent and Trademark Office. Data for 1984-1994 were compiled by CHI Research Inc, and data for 1995-1999 were obtained from the Community of Science website. MAIN OUTCOME MEASURES: Number of medical patents granted in the US to Australian-resident inventors; assignees (owners) of these medical patents; proportion of these medical patents related to biotechnology. RESULTS: From 1984 to 1999, 7835 utility patents were granted in the US to Australian-resident inventors. Of these, 1308 patents (17%) were identified as medical patents; 489 (37%) of these were biotechnology patents. Medical patents account for an increasing proportion of all US patents granted to Australian inventors, increasing from 10% in 1984 to 25% in 1999. Biotechnology accounted for an increasing proportion of medical patents, rising from 10% to 55% between 1984 and 1999. More than half the medical patents are owned by commercial interests, and 33% by only 14 organisations, six of which are universities and their affiliated institutions. CONCLUSION: Only a few organisations account for most of the patenting of medical technology. The inventors and their organisations listed on medical patents could be canvassed when developing government policy and targeted for support in commercialising their medical technology.

Australia↗

Exploiting abstract possibilities: a critique of the concept and practice of product patenting.

Developments in biotechnology and genomics have moved the issue of patenting scientific and technological inventions toward the center of interest. In particular, the patentability of genes of plants, animals, or humans and of genetically modified (parts of) living organisms has been discussed, and questioned, from various normative perspectives. This paper aims to contribute to this debate. For this purpose, it first explains a number of relevant aspects of the theory and practice of patenting. The focus is on a special and increasingly significant type of patents, namely product patents. The paper provides three general arguments against the concept and practice of product patenting. The first argument briefly considers the claim that patents are legitimate because they promote socially useful innovation. Against this claim, it is argued that product patents may hamper rather than promote such innovation. The second and main argument concludes that product patents are not adequately based on actual technological inventions, as they should be according to the usual criteria of patentability. The principal moral issue is that product patents tend to reward patentees for inventions they have not really made available. The final argument proposes a method for patenting the heat of the sun. Assuming that granting this patent will be generally considered absurd, the argument exposes a further, fundamental problem of the concept and practice of product patenting.

Animals↗

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↗

Linkage between research sponsorship and patented eye-care technology.

PURPOSE: To examine the linkage between the funding of ophthalmologic and related biomedical research and the development of patented eye-care technology using data on patents granted and the scientific literature cited by those patents. METHODS: The United States patents granted during the 20-year period from 1975 through 1994 were screened using patent office classifications and key words to identify all eye-care-related patents. Each patent's nonpatent references (references to literature other than previously granted patents) were examined, and those references to scientific papers then were reviewed to determine the authors' institutions and acknowledged funding sources. RESULTS: Major findings include the following: (1) Eye technology innovation has grown steadily, with a threefold increase in number of patents granted from 224 in 1975 to 662 in 1994. (2) The cited scientific base that supports this technology has grown even more rapidly, with a sixfold increase in the average number of nonpatent references, from fewer than 0.5 per patent in 1975 to more than 3.0 in 1994; as a result, the total number of nonpatent references has increased by a factor of 20, from 100 in 1975 to 2000 in 1994. (3) The National Eye Institute is the leading single institution in providing support for this research: 31% of all eye-care patents with science references cite papers that contain at least one acknowledgment to National Eye Institute (NEI) support; and when NEI is combined with the rest of the National Institutes of Health (NIH), 41% of the patents with science references are linked to NIH-funded research. (4) Patent science dependence, as measured by science references, is greatest for technologies related to medical treatment, surgical instruments, and intraocular lenses; moderate for diagnostic instruments and contact lens; and least for eyeglasses. CONCLUSIONS: The NIH and other sponsored vision research is of direct and increasing relevance to the growing number of US patented eye-care technologies.

Animals↗

Patent literature as a source of information for research and development: an investigation on calcium phosphate-containing biomaterials, Part I.

The usefulness of patent literature for research and development is mostly unknown. Therefore a specific patent retrieval has been carried out concerning calcium phosphate-containing biomaterials. This research field includes chemical, medical, and engineering problems and is of importance to the development of bioactive materials for bone replacement. The preliminary work includes information on the characteristics and the availability of patent literature as well as about patent classification systems according to which the documents are filed in patent collections. By reading the non-patent literature searching questions can be formulated. The proper patent retrieval starts with the study of secondary literature especially that in Chemical Abstracts, which report on patents since 1907. The structure of Chemical Abstracts, their indexes and sections help to find relevant patents of chemical or chemical engineering contents fast and inspire to read patents of bordering areas. This retrieval from Chemical Abstracts led to 171 patents disclosed 1975-1985 and to 95 patents disclosed in 1986; the latter are listed in a table. The contents of the abstracts inform on the research activity and help to reduce time and effort for a continuation of the retrieval in a patent collections or database.

Bibliographies as Topic↗

Patenting nanotechnology.

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. This rush to the patent office is so significant that many law firms have established nanotechnology practice groups and the U.S. Patent and Trademark Office has now created a new technology class designed to track nanotechnology products. Three big differences between the emerging science of nanotechnology and other inventions make the role of patents more significant in this arena than elsewhere. First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. In many of the most important fields of invention over the past century--computer hardware, software, the Internet, even biotechnology--the basic building blocks of the field were either unpatented or the patents were made available to all users by government regulation. In others, patents were delayed by interferences for so long that the industry developed free from their influence. In nanotechnology, by contrast, companies and universities alike are patenting early and often. A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well. This overlap may significantly affect their incentives to license the patents. Finally, a large number of the basic nanotechnology patents have been issued to universities, which have become far more active in patenting in the last twenty-five years. While universities have no direct incentive to restrict competition, their interests may or may not align with the optimal implementation of building-block nanotechnology inventions. The result is a nascent market in which a patent thicket is in theory a serious risk. Whether it will prove a problem in practice depends in large part on how efficient the licensing market turns out to be.

Biotechnology↗

Biotechnology patents and ethical aspects.

Should we set any limits on patenting? More specifically, must we set any limits on patenting in the field of biotechnology? There should be general agreement on the exclusion of humans from patentability. The European Parliament voted unanimously on an amendment to the Community Directive regarding patenting stating that the human body and its parts are not patentable as such. Patenting of humans indeed would be against fundamental human rights; against the shared principles of freedom, autonomy, and dignity of each single human being. The same reasons apply to requests to reject the "commercialization of the human body." However, much more difficult is reaching a consensus on what are the parts of humans that should not be marketed--organs, tissues, cells, genes, smaller DNA fragments? Probably there is no consensus on where to draw the line when we deal with parts of the human body. Nevertheless, an ethical component is very strong in raising opposition to patenting human DNA. Whatever our personal view on the issue, we cannot deny that ethical aspects must be considered in granting patents on human DNA. With reference to animals, the fears raised are that the patenting of transgenic animals could amplify the instrumental use (reification) and the neglect of their sentient nonobjectual nature: patenting could motivate, instead, the tendency to consider animals as the standard of things invented and as new consumer products. Moreover, animal patenting increases production and thus brings about the great suffering of animals. In regard to plants, the ethical implications of patenting have more to do with their socioeconomic effects, in particular on Third World countries, than for the organisms involved.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Do patents for antiretroviral drugs constrain access to AIDS treatment in Africa?

Public attention and debate recently have focused on access to treatment of acquired immunodeficiency syndrome (AIDS) in poor, severely affected countries, such as those in Africa. Whether patents on antiretroviral drugs in Africa are impeding access to lifesaving treatment for the 25 million Africans with human immunodeficiency virus infection is unknown. We studied the patent statuses of 15 antiretroviral drugs in 53 African countries. Using a survey method, we found that these antiretroviral drugs are patented in few African countries (median, 3; mode, 0) and that in countries where antiretroviral drug patents exist, generally only a small subset of antiretroviral drugs are patented (median and mode, 4). The observed scarcity of patents cannot be simply explained by a lack of patent laws because most African countries have offered patent protection for pharmaceuticals for many years. Furthermore, in this particular case, geographic patent coverage does not appear to correlate with antiretroviral treatment access in Africa, suggesting that patents and patent law are not a major barrier to treatment access in and of themselves. We conclude that a variety of de facto barriers are more responsible for impeding access to antiretroviral treatment, including but not limited to the poverty of African countries, the high cost of antiretroviral treatment, national regulatory requirements for medicines, tariffs and sales taxes, and, above all, a lack of sufficient international financial aid to fund antiretroviral treatment. We consider these findings in light of policies for enhancing antiretroviral treatment access in poor countries.

Acquired Immunodeficiency Syndrome↗

Percutaneous closure of the small patent ductus arteriosus using occluding spring coils.

OBJECTIVES: This report summarizes our experience with the use of occluding spring coils to close the small patent ductus arteriosus. BACKGROUND: Several patent ductus arteriosus occluders (most notably the Rashkind device) have been developed and studied. Occluding spring coils have been used to close abnormal vessels and vascular connections. We previously reported the use of occluding spring coils to close the small patent ductus arteriosus in a small group of patients. This report describes our series of patients having patent ductus arteriosus closure with occluding spring coils. METHODS: Between June 1990 and June 1993, 30 patients underwent cardiac catheterization to have patent ductus arteriosus closure by occluding spring coils. Selection criteria were age > 6 months and narrowest patent ductus arteriosus internal dimension < or = 3.0 mm by color flow imaging. Definitive selection was based on review of aortograms performed at catheterization. A 5.2F coronary catheter was used to deliver one or two standard occluding spring coils. A loop was delivered in the main pulmonary artery, and the remainder of the coil was delivered across the patent ductus arteriosus and into the aortic diverticulum. Patent ductus arteriosus closure was confirmed by aortography or color flow imaging, or both. Follow-up after coil placement occurred at 6 weeks and 6 months and included two-view chest radiography, echocardiography and color flow imaging. RESULTS: Of the 30 patients, 29 had successful implantation by one (27 patients) or two (2 patients) occluding spring coils. Of these 29 patients, 19 had a clinically apparent and 10 had a silent patent ductus arteriosus. Average ductus minimal internal dimension was 1.7 mm (range 1.0 to 3.0). Complete closure of the ductus was confirmed in 27 patients by aortography or color flow imaging or both (in 24 within 4 h, in 2 after 6 weeks and in 1 after 6 months). Six weeks after implantation, two patients had a tiny residual patent ductus arteriosus noted on color flow imaging. One patient did not have successful implantation. This patient had a 3.2-mm ductus, and two coils migrated to the distal left pulmonary artery and could not be retrieved. There were no deaths or any significant complications noted during early or late follow-up in these patients. CONCLUSIONS: Occluding spring coils may have additional application in closing the small patent ductus arteriosus.

Aortography↗

The university-promoted patent at the crossroads of the research results and immediate industrial use.

The departments, indeed the laboratories of the public research institutions, no longer are satisfied with displaying a certain number of annual scientific publications meant to highlight their expertise and know-how. In effect, for some years now, a new trend has been in vogue: stimulated by all the national and international public bodies, they are calling increasingly on the "patent pending" solution to make optimum use of the results of specific researches on the one hand and, on the other hand, to assert their excellence vis-à-vis the Ministry of Research of their country which is supposed to finance them. However, caught up in the euphoria of the research results, and lost in their formulae and practices, these researchers lose sight of the basis for a patent and its real reason for being (patent charter). A patent necessarily must be of service to the community, that is to say that essentially it must contribute to the improvement of the quality of life of the population. To achieve this goal, going through certain stages is a must, namely that to start with a patent must be absolutely profitable to industry in order that, subsequently, it be consistent with its being of service to the community. In this context, its validity is set at 10 years renewable for another 10 years based on specific parameters as stipulated by the national and international patent institutions, indeed by the EPO (European Patent Office) the headquarters of which is in Munich. Its use by industry ensures proceeds for 10, even 20 years and must represent the material fruit of the applicant's effort. Beyond this period, the patent becomes public and therefore available to everyone. But the crucial problem is this: when can a patent really be used and how to do so as best as possible to guarantee profits for both parties involved and thus justify its reason for being? The purpose of this work thus is to incite university researchers to think about the real usefulness of a patent on the one hand and, on the other hand, to ponder over the best way of using, in close cooperation with industry, the fruit of the research and the registering of the patent, both financed by public funds. For the latter, owing to their nature, demand that there be no wastage and cautious management thereof.

Industry↗