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PubMed2001

Sustainable growth, the DuPont way.

Like many manufacturers, DuPont traditionally has grown by making more and more "stuff." And its business growth has been proportional to the amount of raw materials and energy used--as well as the resulting waste and emissions from operations. Over the years, though, DuPont became aware that cheap supplies of nonrenewable resources wouldn't be endlessly available and that the earth's ecosystems couldn't indefinitely absorb the waste and emissions of production and consumption. Chad Holliday, chairman and CEO of DuPont, believes strongly in the challenge of sustainable growth and makes the business case for it: By using creativity and scientific knowledge effectively, he says, companies can provide strong returns for shareholders and grow their businesses--while also meeting the human needs of societies around the world and reducing the environmental footprint of their operations and products. In fact, a focus on sustainability can help identify new products, markets, partnerships, and intellectual property and lead to substantial business growth. Holliday describes how DuPont developed a three-pronged strategy to translate the concept of sustainability into nuts-and-bolts business practices. Focusing on integrated science, knowledge intensity, and productivity improvement, the strategy was accompanied by a new way to measure progress quantitatively. Sustainable growth should be viewed not as a program for stepped-up environmental performance but as a comprehensive way of doing business, one that delivers tremendous economic value and opens up new opportunities. Ultimately, companies will find that they can generate substantial business value through sustainability while both enhancing the quality of life around the world and protecting the environment.

Conservation of Natural Resources↗
PubMed2001

Biotechnology--updates and new developments.

Areas of priority for intensive discovery would be the agbiotechnology and biomedical sectors using gene technology as a platform. The use of genetic manipulation in farming and the use of plants as 'pharma' factories to manufacture therapeutics would be on the rise. The human genome will continue to have a powerful impact on research and development of human diseases and healthcare. Discovery of genetics and pharmacogenomics will have great impact on drug development and will allow the prediction of the patient' s response to various drugs as well as the onset of individualised or 'designer drugs'. Human stem cells could have their cellular clocks reset by the cloning process, enhancing opportunities to grow young cells, tissues and organs for an aging population. The cellular clock could also be reset by therapeutic cloning. Bioinformatics would be a technology which would be synonymous with biotechnology. The analyses of biotechnology research would be conducted in silico and would involve the exchange of information among sophisticated computer databases. Applications of biotechnology would be even more evident in environmental technology, food development and food processing. In electronics, the use of the specificity of proteins in biochips is underway. In tandem with the explosions in research, regulatory issues, legislation and intellectual property rights will evolve to enhance the climate of discovery and innovation. Public education will have to be continually enhanced as awareness could negate any fear resulting from novel and innovative improvements from biotechnology.

Agriculture↗
PubMed1995

[Historical sketch of modern pharmaceutical science and technology (Part 4). Post World War II 50 years].

A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceutical companies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans.

Biotechnology↗
PubMed2001

Etanercept Immunex.

Immunex has developed and launched etanercept, a soluble TNF receptor (TNFR) fusion protein, for the treatment of early and moderate to severely active rheumatoid arthritis (RA). Etanercept was launched as a first-line agent in the US for the treatment of moderate-to-severe active RA in June 2000 [375481]. It can also be used in conjunction with methotrexate (MTX) in patients who do not respond adequately to MTX alone [303266], [310436]. It was launched in the EU in November 2000 [388846]. Enbrel was also launched for the treatment of polyarticular-course juvenile RA (JRA) patients who have an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs) in May 1999. Additionally, it is in phase III trials for psoriatic arthritis and a BLA filing for this indication is expected for the first half of 2001 [364948]. Etanercept was launched in the US in November 1998, for the treatment of moderate-to-severe RA in patients with inadequate responses to one or more DMARDs, or in combination with MTX in patients who do not respond adequately to MTX alone [306175]. The drug was subsequently approved by the US FDA for use as a first-line therapy to treat patients with moderately to severely active RA [375481]. In February 2000, Wyeth Europe received clearancefor etanercept in 15 EU countries by the EMEA for the treatment of active arthritis in adults when the response to DMARDs has been inadequate [354844]. It has since been launched in the UK (June 2000) [388840], and by October 2000 had been launched in all EU member states [388846]. In November 1998, the company filed a supplemental BLAfor the treatment of children and teenagers with moderately to severely active polyarticular course JRA. In May 1999, etanercept was approvedfor this indication by the US FDA and approvedfor this indication in Europe in February 2000 [307061], [310436], [326379]. The increasing understanding of the role of TNF in a number of other diseases has led to its clinical assessment in these areas. Following positive clinical results in phase II studies [317562], [315793], (320666], (359789], (373980] in patients with chronic heart failure, etanercept entered phase III trials for this indication in June 1999 [330068], and a BLA filing for this indication is expected in 2003 [396110]. Additionally, Immunex initiated a phase III trial of etanercept in psoriatic arthritis in March 2000, and as of May 2000, the company was planning a BLA filing for this indication in the first half of 2001 [364948]. An open-label trialfor the treatment of Crohn's disease is in progress in Belgium [367,039], and results from this trial were presented at Digestive Disease Week in May 2000 [379907]. While WO-09103553 claims the recombinant human receptor, the fusion protein consisting of the etanercept domain and the immunoglobulin region was disclosed in WO-09406476. In February 1997, US-05605690 was issued to Immunex for methods of using etanercept to treat diseases mediated by TNF. The patent also claims methods of using recombinant etanercept to decrease the levels of TNF in RA patients [235456]. In June 1999, Immunex strengthened its patent estate covering the product with a patent licensing agreement for Genentech's immunoadhesin patents covering the product [327250]. A royalty agreement with Serono SA and Immunex on sales of etanercept was agreed in 1999. The agreement reflected the strength of Ares-Serono's intellectual property status [352813]. In June 1999, Lehman Brothers predicted Immunex's sales at US $300 million in 1999, rising to peak annual sales of US $1.5 billion [328701]. Salesfor the drug's first full quarter on the market in 1999 were US $59.7 million [330068]. By November 1999 the drug had made sales of US $500 million; Immunex expects the drug will generate over US $2 billion in annual sales by 2004 [353185]. In September 2000, Merrill Lynch reported that if sales of the drug continue at the present rate then it is likely that demand will temporarily outstrip supply in 2001. Resolution of the supply issue is expected by 2002. Also in September 2000, Merrill Lynch lowered their estimate of ENBREL sales in 2001 from US $1 billion to $927 million. In the long-term, Merrill Lynch believe that the drug has the potential to exceed US $5 billion in sales in the US [382577].

Animals↗
PubMed2000

Canada loses appeal of WTO panel ruling on minimum patent terms.

In the last issue, we reported on a ruling of a Panel of the World Trade Organization (WTO) that Canada was in breach of the international Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). The Panel found that Canada's Patent Act does not provide the minimum patent terms required by the trade agreement. Canada appealed that decision, but on 18 September 2000 the WTO Appellate Body upheld the Panel ruling.

Anti-HIV Agents↗
PubMed2000

US files WTO complaints against Brazil over requirement for "local working" of patents.

At the end of May 2000, the US (later joined by the European Communities) filed a complaint against Brazil at the World Trade Organization (WTO), alleging Brazil was in violation of its obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) and the 1994 General Agreement on Tariffs and Trade. Brazilian legislation that came into force in 1997 establishes that, in order to enjoy exclusive patent rights in Brazil, the holder of a patent on an invention must satisfy a "local working" requirement. In other words, the patent holder must "work" the patent in Brazil to enjoy full patent protection. If it fails to do this, the law says it shall be subject to the possibility of the government issuing a compulsory license, allowing someone else to use the invention and pay a royalty fee to the patent holder.

Anti-HIV Agents↗
PubMedDate not supplied

Federal court of appeal strikes claim for extending patent term.

In a short October 1999 decision, Pfizer Inc v Canada, the Federal Court of Appeal affirmed a lower court decision that Canadian law currently provides only 17 years protection for drug patents filed before October 1989, and that the 20-year minimum period stated in intellectual property treaties negotiated under the auspices of the World Trade Organization have not (yet) taken effect in Canada with respect to these drugs.

Anti-HIV Agents↗
PubMedDate not supplied

Panel rules against Canada on patent terms for pre-TRIPS patents.

On 5 May 2000, the WTO Panel issued another ruling regarding patents of relevance to pharmaceutical products. Upholding a complaint by the US, the Panel ruled that Canada's Patent Act was in breach of the minimum patent terms for inventions required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement).

Canada↗
PubMed2001

Three Rs potential in the development and quality control of pharmaceuticals.

The intention of a pharmaceutical company is to develop new, efficient products quick and with a minimum of costs. Compared to in vitro methods, animal experiments in general consume much more time and resources (costs as well as time to the market) than in vitro methods. Therefore, the use of whole animal models depends primarily on the judgement of their efficacy in the screening process, but the willingness to incorporate in vitro methods in general is high and is furthered by new developments such as high-throughput screening. Nevertheless, in vitro tests might be politically promoted by increasing their costs (quality controls, requested housing conditions) and duration (time to start of an experiment, sequential performance). Which models are favoured by industry to include them in a screening process: They have to be based on our most recent understanding of the respective disease, well characterised to allow interpretation of results and require only limited development time. All these aspects argue in favour of collaboration between industry and academia, where our understanding of pathophysiology is generated and mechanism based models are developed and characterised. However, technology transfer towards industry represents a bottle-neck for industrial use of these new in vitro models. New platforms to promote this transfer should be developed in order to bring together developer and user of novel in vitro systems and promote demonstration projects. Financing of such collaborations is not the key problem (the development of a single drug makes up to 500 million $) but the dilemma of publication of results: The development advantage compared to competitors depends on the exclusive use of novel models. The protection of intellectual property rights and the public interest in spreading alternatives to animal experiments must be balanced, e.g. by delayed but indispensable publication or advantages for companies employing alternatives in the regulatory approval process for a new drug. Quality control of therapeutic drugs (except hormones and blood products) represents a minor field of animal consumption with the exception of pyrogenicity testing. Despite considerable progress due to the introduction of the Limulus assay which represents the most successful in vitro alternative in use so far. However, some limitations of this in vitro test might be overcome in the near future by the currently validated human whole blood assay. During the last few years considerable progress has been made in the replacement (and deletion) of animal tests required for the potency and safety testing of hormones. This has been made possible by biotechnical production methods, by better-defined products, and because physico-chemical methods can be used for the potency testing of these products. In general, the better defined a drug is, the easier chemical, physical or in vitro techniques can be used for batch control. Control authorities should therefore urge the use of highly standardised components.

Animal Testing Alternatives↗
PubMed2001

INGN-201. Introgen Therapeutics.

In April 2001, Aventis and Introgen signed a letter of intent to restructure their collaboration arrangement, giving Introgen responsibility for the worldwide development of all p53 programs under the existing collaboration and obtain exclusive worldwide commercial rights to p53-based gene therapy products, including INGN-201. In February 2001, Introgen was awarded US-06194191 for the commercial production of adenovirus vectors. In November 2000, the company and the University of Texas System were issued with US-06143290, entitled 'Recombinant p53 adenovirus methods and compositions', further solidifying the company's current p53 patent portfolio. In June 2000, the University of Texas System was awarded US-06069134, entitled, 'Methods and compositions comprising DNA damaging agents and p53.' This is the second US patent to be issued that is equivalent to WO-09528948. In May 1998, US-05747469, entitled 'Methods and compositions comprising DNA damaging agents and p53', was awarded to the Board of Regents of the University of Texas. This patent covers the use of the p53 gene in combination with chemotherapeutic agents, radiation therapies or other agents, which damage the DNA of cancer cells. It is one of several intellectual properties licensed to Introgen through an agreement with the MD Anderson Cancer Center.

Animals↗
PubMedDate not supplied

[Patenting human genetic material: ethical and legal implications].

If we introduce the subject of patents on human genetic material in a Bioethics Conference we must answer two questions. Firstly, whether the debate can be universalized, bearing in mind the national nature of norms governing intellectual property, and, secondly, whether there are links between patent law and ethics. Using the example of the patenting of biological material, we will see how this impacts on society, which, beyond the technical or legal knowledge required, is voicing its concern on the ethical level.

Bioethical Issues↗
PubMed2002

[Bioactive compounds from marine sponges and cell culture of marine sponges].

Presented a survey of bioactive compounds discovered from marine sponges in the recent five years, including the classes, distribution and their potential pharmaceutical uses. In particular, the compounds with antitumor, antivirus and antibacteria activity were discussed with their originating marine sponge species. Whereas the "Supply Problems" were identified to hinder the clinical tests and commercial applications of most of the sponge bioactive compounds. In vitro cell culture of marine sponges is one of the most promising approaches to solve this problem. The state-of-the art of marine sponge cell culture and the challenging areas were discussed. A brief summary of the R&D status was also given on the bioactive compounds from marine sponges in Chinese oceans. It is crucial to invest more efforts on studying marine sponges and their bioactive compounds in our country in order to develop new marine drugs of independent intellectual property.

Animals↗
PubMed2002

The growth crisis--and how to escape it.

At a time when companies are poised to seize the growth opportunities of a rebounding economy, many of them, whether they know it or not, face a growth crisis. Even during the boom years of the past decade, only a small fraction of companies enjoyed consistent double-digit revenue growth. And those that did often achieved it through short-term measures--such as mergers and inflated price increases--that don't provide the foundation for growth over the long term. But there is a way out of this predicament. The authors claim that companies can achieve sustained growth by leveraging their "hidden assets," a wide array of underused, intangible capabilities and advantages that most established companies already hold. To date, much of the research on intangible assets has centered on intellectual property and brand recognition. But in this article, the authors uncover a host of other assets that can help spark growth. They identify four major categories of hidden assets: customer relationships, strategic real estate, networks, and information. And they illustrate each with an example of a company that has creatively used its hidden assets to produce new sources of revenue. Executives have spent years learning to create growth using products, facilities, and working capital. But they should really focus on mobilizing their hidden assets to serve their customers' higher-order needs--in other words, create offerings that make customers' lives easier, better, or less expensive. Making that shift in mind-set isn't easy, admit the authors, but companies that do it may not only create meaningful new value for their customers but also produce double-digit revenue and earnings growth for investors.

Commerce↗
PubMed2002

Non-curated distributed databases for experimental data and models in neuroscience.

Neuroscience is generating vast amounts of highly diverse data which is of potential interest to researchers beyond the laboratories in which it is collected. In particular, quantitative neuroanatomical data is relevant to a wide variety of areas, including studies of development, aging, pathology and in biophysically oriented computational modelling. Moreover, the relatively discrete and well-defined nature of the data make it an ideal application for developing systems designed to facilitate data archiving, sharing and reuse. At present, the only widely used forms of dissemination are figures and tables in published papers which suffer from inaccessibility and the loss of machine readability. They may also present only an averaged or otherwise selected subset of the available data. Numerous database projects are in progress to address these shortcomings. They employ a variety of architectures and philosophies, each with its own merits and disadvantages. One axis on which they may be distinguished is the degree of top-down control, or curation, involved in data entry. Here we consider one extreme of this scale in which there is no curation, minimal standardization and a wide degree of freedom in the form of records used to document data. Such a scheme has advantages in the ease of database creation and in the equitable assignment of perceived intellectual property by keeping the control of data in the hands of the experts who collected it. It does, however, require a more sophisticated infrastructure than conventional databases since the software must be capable of organizing diverse and differently documented data sets in an effective way. Several components of a software system to provide this infrastructure are now in place. Examples are presented, showing how these tools can be used to archive and publish neuronal morphology data, and how they can give an integrated view of data stored at many different sites.

Animals↗
PubMed2002

Biotechnology's foreign policy.

From its inception, biotechnology has been a uniquely international enterprise. An American and an Englishman working together elucidated the structure of DNA almost 50 years ago; more recently, the Human Genome Project linked researchers around the world, from the Baylor College of Medicine in Houston to the Beijing Human Genome Center. Today our industry's researchers hail from African villages and Manhattan high rises; from Munich and Melbourne; from London, Ontario, and London, England; from Scotland and Nova Scotia--New Scotland; from Calcutta and Calgary. But in the beginning, the infrastructure that supported these efforts--intellectual property, venture capital, streamlined technology transfer--was less widely dispersed and the world's brightest biotech researchers clustered in only half a dozen scientific Meccas. Previous technological revolutions have spread around the world. Following in their footsteps, biotechnology's global diaspora seems inevitable, especially since governments are promoting it. But as our science and business emigrate from early strongholds in the United States, Canada and Europe across oceans and borders and into new cultures, international tensions over biotechnology continue to grow. In just the last few years, controversies have rolled over R&D spending priorities, genetic patents, bioprospecting, transgenic agriculture and drug pricing. My premise today is that our industry needs to formulate its first foreign policy, one which is cognizant of the miserable judgments and mistakes of other industries--and avoids them.

Biotechnology↗
PubMed2002

The research and development of CAD-CAM system in restorative dentistry.

OBJECTIVE: To develop a dental CAD/CAM system with the autonomic intellectual property. METHOD: 28 standard teeth crowns were scanned using a newly 3-D laser scanner. As a development platform the Matlab 5.3 were used to process the acquired data, also be used to define the characterized areas on the surfaces of the crowns and to change the crowns form. The software of Surfacer 10.5 to develop a new CAD software for fixed prosthetics, and the 3.5 axis numerical controlled machine to manufacture the prosthetics were used. RESULT: It is the first time, the 3D graphic data bank of Chinese teeth crowns with a standard form was established. A software of the occlusal adjustment and the form modification were developed. It is also the first time, the authors realized the whole process to use the CAD-CAM for the manufacture of a crown. CONCLUSION: The successful result shows, that we have already mastered well the base theory, the mathematics method, the technology of a CAD-CAM system. It provides the basics for the future development.

Computer-Aided Design↗
PubMed2002

Patenting DNA.

The protection of inventions based on human DNA sequences has been achieved mainly through application of the patent system. Over the past decade, there has been continuing debate about whether this use of intellectual property rights is acceptable. Companies and universities have been active during this period in filing thousands of patent applications. Although many have argued that to claim a DNA sequence in a patent is to claim a discovery, patent law allows discoveries that are useful to be claimed as part of an invention. As the technology to isolate DNA sequences has advanced, the criterion for inventiveness, necessary for any invention to be eligible for filing, has become more difficult to justify in the case of claims to DNA sequences. Moreover, the discovery that a gene is associated with a particular disease is, it is argued, to discover a fact about the world and undeserving of the status of an invention. Careful examination of the grounds for allowing the patenting of DNA sequences as research tools suggests such rewards will rarely be justified. The patenting of DNA sequences as chemical intermediates necessary for the manufacture of therapeutic proteins is, however, reasonable given that the information within the sequence is applied to produce a tangible substance which has application as a medicine. Despite the legal, technical and political complexities of applying the flexibilities with the current law, it is argued that much could be achieved in the area of patenting DNA by raising the thresholds for patentability.

Animals↗
PubMed2000

Biomedical patents and ethics: a Canadian solution.

World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.

Animals↗