This file includes links to papers published by Eubios Ethics Institute, and some other organizations, in the first section. Next it includes topical extracts from EJAIB and EEIN between January 1994 - 2006 (older news items are in separate files). Last date of updating is referenced in the main News page. Latest news and papers is at the bottom of each of the two sections.
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Related Papers from Eubios Ethics Institute Publications
Macer, Darryl (1991) "Whose Genome Project?", Bioethics 5, 183-211.
Macer, Darryl (1993) "Alte Angste Neue Welt; Gentechnologie, Im visier Nippons", Edition Zeitthema (Austria) No. 2: 46-47(To English original).
Srinives, P.Biotechnology in Thailand EJAIB 5 (1995), 91.
Fujiki, N. & Macer, D.R.J., eds., Human Genome Research and Society (Christchurch, N.Z.: Eubios Ethics Institute 1992).
Fujiki, N. & Macer, D.R.J., eds., Intractable Neurological Disorders, Human Genome Research and Society (Christchurch, N.Z.: Eubios Ethics Institute 1994).
Japan / US Comparisons of Biotechnology Patents - M. Okada-Takagi , EJAIB 6 (1996), 166-8.
HUGO Ethics Committee - Statement on Benefit Sharing EJAIB 10 (2000), 70-71.
Understanding Morality as a Ground for Exclusion From Patentability Under European Law - Sivaramjani Thambisetty EJAIB 12 (March 2002), 48-53.
Patent Law: Commentary on Thambisetty - Tade Matthias Spranger EJAIB 12 (May 2002), 109.
Macer, DRJ. (2002) Patent or perish? An ethical approach to patenting human genes and proteins, The Pharmacogenomics Journal 2: 361-6.
Kato, M. and Macer, DRJ. (2003) How companies respond to bioethical issues. Journal of Commercial Biotechnology 9: 153-62.
Bhardwaj, M. and Macer, DRJ. (2003) Policy and ethical issues in applying medical biotechnology in developing countries, Medical Science Monitor 9: RA49-54.
Macer, DRJ. and Bhardwaj, M. (2003) How well does Japan meet its challenges and responsibilities in biotechnology and development for Asia?, Asian Biotechnology and Development Review 5 (2): 23-36.
Access & benefit sharing in population based research:
Indirect benefit sharing as a model of regulation - Juergen Simon & Cristina Blohm-Seewald , EJAIB 14 (2004), 199-203.
IPR and the Controversy between Developed and Developing
Countries: Is It Ethical to Take Care for Animals' Suffering but to Forget the Needs of Humans for Survival? - Carlos Mar’a Romeo-Casabona , EJAIB 14 (2004), 203-208.
Tade Matthias Spranger, Biotech Patents in Australia: Recommendations of the Australian Law Reform CommissionEJAIB 15 (March 2005), 46-7.
Dipankar Saha and Darryl Macer, Bioethics in Property Rights and Biosafety of Biotech-
governance: Role of Behaviourome Mapping EJAIB 15 (May 2005), 76-83.
Chamundeeswari Kuppuswamy, It is Time we addressed Intellectual Property Rights
Issues in Genomics Research
EJAIB 16 (March 2006), 30-33.
Darryl Macer, Editorial: Social responsibility and bioethics EJAIB 15 (Sept. 2005), 137.
Alireza Bagheri & Darryl Macer, Ethics Review of Externally-Sponsored Research in Japan EJAIB 15 (Sept. 2005), 138-41. / p. 140-141
Kato, M. & Macer, DRJ. (2006) “Bioethical concerns in Japanese biotechnology companies”, Journal of Commercial Biotechnology, 12: 205-212.
A debate over the concept of gene patents and the absence of a need for having a specifically cloned DNA sequence for patent claims in the USA is discussed in Biotechnology 11 (1993), 1306-7. This policy means that if you think how to do something you can patent it, without needing the money to actually do it. (Of course this does apply to the whole genome I suppose!) A commentary on the US court decision that recognised the validity of the Burroughs Wellcome patent claim on AZT, and its impact on inventiveness, is in Biotechnology 11 (1993), 1513; see also p. 1582-3.
The price controls suggested by the proposed US Health Security Plan have made some companies voice much concern; GEN (1 Oct 1993), 1, 28-9. This is not surprising at it will cut into their profits, and perhaps some small ones will fall, or at least spend less on R&D. Ethically it is welcome to see price controls and something is needed to reduce the growth in profits by pharmaceutical companies and the growth in health care costs. Medical practice and money is the subject of a book review in Science 262 (1993), 442-3.
A review of Northern California biotechnology industry is GEN (1 Oct 1993), 31-41. There have been 350 new bioscience companies funded there during the 1980s and they generate US$5.6 billion annually. On agricultural research and biotechnology business see Biotechnology 11 (1993), 1221, 1510-1; Science 262 (1993), 121-2.
Technology transfer from the US federal government is reviewed in Science 262 (1993), 496-8; Biotechnology 11 (1993), 1226; Nature 366 (1993), 524. A general comment on the financing of biotech business is in GEN (15 Nov1993), 14-5; and on alliances, Biotechnology 11 (1993), 1529-32. A list of alliances is in Biotechnology 11 (1993), 1230, 520. The collapse of the Texas supercollider is discussed in Nature 366 (1993), 607-10.
A special issue of Science (15 Oct) 262: 245-383, looks at science in Asia. A review of the commercial development of production of Ginseng and traditional medicine is in GEN (1 Nov 1993), 18, 20, 34. A review of plant biotechnology in China is Science 262 (1993), 377-8. The discussions in Japan for a superministry of science are in Nature 366 (1993), 196, however, it would seem to face immense hurdles in combining all the science ministries into one big one. The second science city of Japan is gaining shape; Nature 366 (1993), 292, but still has only 6000 researchers, much less than in Tsukuba. Science in India is the subject of several special papers in Nature 365 (1993), 611-627
A review of the German biotechnology industry and its approaches to attempt to loosen some regulations on genetic engineering paperwork is in GEN (1 Oct 1993), 6-7, 16. Other comments on biotech funding in Europe are in GEN (1 Oct 1993), 1, 8. A review of biotech industry in the Baltic Republics is GEN (1 Oct 1993), 10-1, 22. There is very little government funding of research in those countries now.
The NIH has decided not to appeal the rejection by the US Patent Office that the cDNA patent claim be rejected; Nature 367 (1994), 583. It appears to be a last minute decision, and the day after the deadline expired, the MRC in the UK also said it would suspend its patent applications on cDNA fragments. There are several studies of patenting of life and genes currently underway. The OTA is preparing a report on the subject, which could have broad implications for US patent policy. Another study is underway in Canada jointly between the Westminster Institute of Ethics and Human Values and the McGill Centre for Medicine, Ethics and Law. If anyone has particular material on their own country you may want to send them to Prof. M. Somerville, McGill Centre for Medicine, Ethics and Law, 3690 Peel Street, Montreal, Quebec, Canada H3A 1W9.
A discussion of patent protection for biotechnology inventions in Eastern Europe is in Biotechnology 12 (1994), 191-2. In recent years many have adopted laws to strengthen protection. China has recently said it will introduce full patent protection as an attempt to rejoin GATT; Nature 367 (1994), 308. General comments for scientists who may be involved in future patent developments are in Biotechnology 12 (1994), 79. They include keep a proper notebook and no prior disclosure. Plant variety rights and patents are discussed as complementary in Biotechnology 12 (1994), 112.
A summary of the 1993 fortunes of the biotech industry on Wall Street is in GEN (15 Jan1994), 16-7; Biotechnology 12 (1994), 119-20; and predictions for 1994 are in Biotechnology 12 (1994), 20-1. The fall and later rise of Agracetus is discussed in Biotechnology 12 (1994), 122. A discussion of US policy on biotechnology by Vice President Gore is in GEN (1 Jan 1994), 4, 12; and a review of Clinton's policy is Biotechnology 12 (1994), 130-1. A new paradigm for pharmaceutical pricing and control in the US is suggested by L. Rothenburg in GEN (1 Jan 1994), 30.
In the San Francisco area the Pacific Gas & Electric Company has decided to convert some empty space into 15-20 new biotech companies; Science 263 (1994), 311. The conversion of a defense-related factory into a biotechnology facility as part of the demilitarisation of US research is reported in GEN (Dec 1993), 1, 14; see also GEN (15 Jan1994), 1, 26. Collaboration between US and Japan is discussed in Science 263 (1994), 168-9. Updates on recent alliances are found in Biotechnology 12 (1994), 28, 136.
A summary of the incentives used in the European Community (should we say European Union) for encouragement of biotechnology business is in GEN (15 Jan1994), 3, 30-31; see a general comment in Biotechnology 12 (1994), 208; Nature 367 (1994), 587. A prediction for dramatic growth in the UK biotech industry is predicted in Nature 367 (1994), 674. A discussion of biotech development in Asia is in GEN (Dec 1993), 16-7, 24.
The NIH and MRC have thrown away their cDNA patent applications; New Scientist (19 Feb 1994), 4-5; Biotechnology 12 (1994), 348. There are still some company patent applications, but they are not expected to succeed. The UK President of the Board of Trade is quoted for his opinions on patenting of human cDNA sequences in BME (Feb), 8. Although a formal position has not been made, the European Council is expected to issue such a position soon, against filing any applications. The UK House of Lords has agreed with the European Parliament moves to add ethical criteria to patenting life; Nature 368 (1994), 278. An editorial on the fears of eugenics and patents on animals is Nature 368 (1994), 572. On gene patents, TIBTECH 11 (1993), 407-11; Biotechnology 12 (1994), 406-7. A controversy in France arose when a proposal was made to give a US company exclusive rights to a DNA bank collected from 800 French families, Nature 368 (1994), 175.
A book on the patenting debate between the USA and Brazil is Marilia Bernades Marques, Patenting Life: Foundations of the Brazil United States Controversy, (Oswaldo Cruz Foundation, Rio de Janeiro, Dec. 1993, 104pp). It looks at the economic, ethical and social background to US biotechnology patent policy, and at whether there should be different policies for developing countries and industrialised competitors of the USA. The US has decided not to sign the world patent treaty to standardise the patent system, which 140 nations were expected to sign this year, New Scientist (12 Feb 1994), 6. The US is the only country which says a patent should go to the first to invent, not the first to file an application. This policy can help small inventors, lacking money to file applications, but the appeal system used in the USA is claimed to discriminate against foreign claims to inventions.
A Japanese court has rejected a claim by Roche that a Japanese company has infringed its patent on interferon, but the case will be appealed, Nature 368 (1994), 486. In Japan the annual market for interferon is about US$1.5 billion. A patent awarded to Ciba-Geigy in 1992 in Europe, for transferring genes directly into plant cells, has been revoked after a joint challenge by Sandoz and another company; Nature 368 (1994), 5. A conference report discussing patenting is in Human Genome News (March), 6-7, 12; see also Biotechnology 12 (1994), 297-8. The papers will be in the spring issue of Risk: Health, Safety, & Environment.
A new book that reviews biotechnology, economics, and the situation globally is Albert Sasson, Biotechnologies in developing countries: present and future, Vol. 1: Regional and national survey (764pp., ISBN 92-3-102875-8, 1993). A commentary on the misappropriation of indigenous knowledge, including a Maori perspective from New Zealand (Aotearoa) is in Otago Bioethics Report 3:4-7. It includes discussion of the Mataatua Declaration, mentioned last year, which opposed the human genome diversity project, as well as general exploitation of biodiversity. An example of the type of patent that is opposed by many is the recent patent claim on a cell line derived from a woman who is a Guaymi Indian, which was recently withdrawn, geneWATCH 9 (1994), 6-7. Comments on laws restoring cultural rights to American Indians are in Science 264 (1994), 20-2.
The isolation of thermophilic bacteria from Yellowstone National Park by companies is reported in GEN (15 March 1994), 34-5. It is suggested that companies should start contributing some royalties to help preserve the national park and biodiversity, and some said that they would if asked.
Harvard University buildings will include both academic and companies in the same building, further progressing the transfer of technology; GEN (15 March 1994), 1, 16. On technology transfer, Biotechnology 12 (1994), 349. A review of commercial biotechnology in Shenzhen, China, is in GEN (1 March 1994), 10, 31. A discussion of the background behind the exclusion of a part of the GATT agreement that would have allowed government funded research to be debated under trade action is in GEN (1 Feb 1994), 3, 26.
On biotechnology in the USA, JAMA 271 (1994), 648; Biotechnology 12 (1994), 222, 333-5, 340. In 1993 only 14 US biotechnology companies made profits. BASF has opened a large biotech lab in Massachusetts, rather than in Germany; Nature 368 (1994), 679. Book reviews on drug industry are in Nature 368 (1994), 370-3; Science 263 (1994), 1299. A report on recent alliances is in Biotechnology 12 (1994), 229-30, 242-3, 357-8; more alliances are expected in Europe, Nature 368 (1994), 178; Biotechnology 12 (1994), 345; also the EU is promoting biotechnology, Biotechnology 12 (1994), 233. A discussion of European biotechnology lobbying groups is in Biotechnology 12 (1994), 371-4. On Canada, CMAJ 149 (1993), 1395-7. A conference discussion on information retrieval systems for biotechnology business is TIBTECH 12 (1994), 1-2.
UK pharmaceutical companies that bribed doctors to buy drugs included golfing holidays in Spain, BMJ 308 (1994), 810. On other financial scandals in the UK NHS, BMJ 308 (1994), 215-6. A US study found that doctors requests to add drugs to the hospital pharmacy were strongly associated with their interactions with drug companies, M.M. Chren & S. Landefield, "Physician's behaviour and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary", JAMA 271 (1994), 684-9. A Canadian study is J. Lexchin, "Interactions between physicians and the pharmaceutical industry: What does the literature say?", CMAJ 149 (1993), 1401-7; and CMA policy on physicians and drug companies was debated in CMAJ 149 (1993), 335-7, 1391-2. In Japan, as said before, the pharmaceutical companies encourage hospitals to buy drugs by selling them to the doctors at prices less than the official government price, so that the hospital doctors can keep the difference. The UK High court is considering a libel case brought by Upjohn against several specialists, and the BBC, who claimed that Upjohn deliberately suppressed knowledge about the sleeping pill Halcion, BMJ 308 (1994), 221, 292. Fraud in US breast cancer studies are claimed in BMJ 308 (1994), 809-10; Nature 368 (1994), 679.
Despite the approval by the European Parliament of a directive on regulation of patents from biotechnology, there is still likely to be debate when it comes to the Council of Ministers later in this year; New Scientist (14 May 1994), 6-7; Lancet 343 (1994), 1028, 1220. It is still seen as too broad approval for some groups such as farmers, and the variety of opposition groups that has been debating the idea of patenting life. A report on Patenting Human Genes has been released from the Danish Council of Ethics, 43pp. It recommends a rejection of some types of patenting, and the establishment of a body to look at the legal implications of biotechnology. The report has a converse report of 43pp. outlining the activities of a very active ethics group. Their address for copies of the report is Det Etiske Rad, Ravnsborggade 2-4, DK-2200, Copenhagen N, DENMARK. The impact of GATT on biotech patents is discussed in Biotechnology 12 (1994), 458.
The fears from a patent application that is designed for germ cell selection of genetically engineered animals but which has raised eugenic fears are discussed in New Scientist (9 April 1994), 3-5; Nature 369 (1994), 589.
Agracetus has acquired the rights to all transgenic soyabean plants from a European patent it has been awarded, which when combined with its US patent on transgenic cotton, makes it very powerful, New Scientist (30 April 1994), 3, 7. There are concerns that the patent is too broad from the USDA, Science 264 (1994), 495. A discussion of how much a private conversation may constitute a patent claim as a public disclosure is in Biotechnology 12 (1994), 523-5.
A patent dispute between Cell Genesys and GenPharm International over ownership to a mouse with a genetically engineered human immune system, making human antibodies, is discussed in New Scientist (26 March 1994), 4-5; GEN (15 May 1994), 1, 9. They reported independently the production of fully monoclonal human antibodies; L.L. Green et al., "Antigen-specific human monoclonal antibodies from mice engineered with human Ig heavy and light chain YACs", Nature Genetics 7 (1994), 13-21. A patent dispute over cord blood treatment may be slowing therapy, Scientific American (May 1995), 106-7.
The ownership of gene sequences from donated DNA samples in France is being debated due to commercial agreements being made with the CEPH gene bank, New Scientist (26 March 1994), 9; BMJ 308 (1994), 873-4 (EEIN 4: 36). Hoffman-La Roche and Millenium have signed a US$70 million deal on development of genomics technology; GEN (15 April 1994), 1, 16. Yellowstone Park is discussing how to gain some profit from the microbe hunters from the biotech industry, Science 264 (1994), 655.
The US Congress is considering changes to the Orphan Drug Legislation, so that they would lose their market exclusivity if the patient population reaches over 200,000; GEN (15 April 1994), 1, 28. Price controls seem to boost innovation in Japan, but are opposed in the USA, Nature 368 (1994), 785. General discussion of science benefits are Science 264 (1994), 221-2; Nature 369 (1994), 197. There have been less patent applications in 1993 than in 1992 in Europe, suggesting some effect of the long recession, Nature 369 (1994), 694.
Discussion of Russian biotechnology research institutes is in New Scientist (28 May 1994), 9; Science 264 (1994), 1264-7. European biotechnology is reviewed from a conference in GEN (15 April 1994), 1, 12-14; Nature 369 (1994), 11-2; also Biotechnology 12 (1994), 456-7; Nature 369 (1994), 432. In the UK, the Biotechnology Industry Association has announced that it will form alliances with several major businesses to promote UK science growth. Scottish Enterprise has said it will give £10 million in a five year strategy to promote biotech; GEN (1 April 1994), 6, 26-7. Israeli biotech appears to be rapidly growing, and there are now 50 companies, GEN (15 May 1994), 1, 12, 29; Biotechnology 12 (1994), 480-6. Canada has recently approved a number of biotech drugs, and the government has committed another C$80 million over the next 4 years to biotech, GEN (15 May 1994), 30-1. A review of the plans of the major Japanese pharmaceutical companies, and biotechnology alliances is GEN (1 June 1994), 8-9, 22, 35. The Scripps-Sandoz partnership will involve less money then first reported, Science 264 (1994), 1077. In the USA contract research organisations are often used to perform clinical trials, Biotechnology 12 (1994), 526-8.
On alliances, Science 264 (1994), 1523; Biotechnology 12 (1994), 465-6; Nature 369 (1994), 88. Taiwanese biotechnology is discussed in GEN (1 June 1994), 11, 14.
The prescription of brand name drugs is discussed in BMJ 308 (1994), 1140-2. Money and career choice in medicine is discussed in NEJM 330 (1994), 1311-2; and on careers in genetics, Nature 369 (1994), 341-2. See also the letter from Bela Blasszauer in the front of this newsletter on corruption.
An ethical discussion of the promises that company executives some times make to increase stocks is L. Rothenburg, "Is corporate and analyst hype unethical?", Biotechnology 12 (1994), 763-5. Not only is it unethical, it doesn't serve the longterm interests of anyone. See also Biotechnology 12 (1994), 555, 651. A discussion of the Brazilian views on patenting is M.B. Marques, "Brazil-US controversy on the impact of patenting in biotechnology: some relevant questions for pharmaceuticals", Science & Public Policy 21: 165-72. It criticises the pressure put on Brazil by the USA.
The USDA has filed the US Patent Office for a reexamination of the patent awarded to AgraCetus for genetically engineered cotton, GEN (July 1994), 1, 13; Biotechnology 12 (1994), 659. It follows another filing for reexamination of the patent by an unknown interest. There has been much debate because this patent, No. 5,159,135 combined with an earlier patent, No. 5,004,863, which covers product by process, would mean AgraCetus has a patent on any genetically engineered cotton - undesirable as discussed in earlier issues.
There are court cases in many countries over the rights to hepatitis C testkits, Nature 370 (1994), 493. A letter on the debate whether US biotechnology companies can own genes that are derived from donated French cell lines is Science 265 (1994), 589. General discussion of biotech patents are in Biotechnology 12 (1994), 552, 639-40, 713-5. A commentary on how to establish utility for inventions is Biotechnology 12 (1994), 766, 768. Trademarks are discussed in Biotechnology 12 (1994), 824-5.
A discussion on soybean seed protection in New York is W. Lesser, "Valuation of plant variety protection certificates", Rev. Agricultural Economics 16: 231-8. A discussion of the industrial impact of the UN Convention on Biodiversity is in GEN (15 June 1994), 4, 9.
The US company Cambridge Biotech has filed for bankruptcy protection, and is said to have tried to spread itself too thinly, GEN (August 1994), 1, 22. Genzyme has acquired BioSurface Technology Inc. and will establish a tissue repair division, GEN (August 1994), 3, 43. A new deal has been approved by the NIH for an agreement between Scripps and Sandoz; GEN (15 June 1994), 3. It will involve US$20 million over 5 years, in return for Sandoz to have a right to a 90 day evaluation, and patent option on about half of the general research at Scripps. Reports on the US biotech stocks are in Biotechnology 12 (1994), 652-5, 753-4. There is increased research spending between 1992 and 1993, with a survey of 152 companies showing an 89% increase, after several years of no growth. Agbiotech companies have increased 44% in a survey of 15 companies involved, Biotechnology 12 (1994), 755-6.
The relations between industry and science are discussed in Science 265 (1994), 299, 596-7. Two book reviews of R. Teitelman, The Profits of Science. The American Marriage of Business and Technology, New York: Basic Books, 1994, 258pp., US$23, are Science 265 (1994), 687-8; JAMA 271 (1994), 1964-5. On biobusiness, Biotechnology 12 (1994), 565-6, 579-80, 674-7. Different locations provide different benefits or costs for companies, a discussion in general is Biotechnology 12 (1994), 770-77.
Education of biotechnology in science classes is being promoted, Biotechnology 12 (1994), 647, 667-73. The information superhighway is discussed in BMJ 308 (1994), 1651-2.
Orphan drug regulation was discussed at a recent conference, Lancet 343 (1994), 1560-1. Reasonable pricing on products of collaborative NIH research may be dropped from some future NIH deals, Nature 370 (1994), 238. President Clinton has been accused of neglecting biotechnology, Biotechnology 12 (1994), 571-3. This is despite many efforts at lobbying by BIO (Biotechnology Industry Organization), Biotechnology 12 (1994), 567.
A discussion of pharmaceutical use in Asia, and relations between US and Asian business partners is in GEN (August 1994), 20-1. On Chinese science and investment, Science 265 (1994), 866-7. US-Israeli biobusiness exchanges are discussed in GEN (August 1994), 32-3. The UK proposals for promotion of biotechnology are discussed in GEN (15 June 1994), 1, 29. Canadian biotech is discussed in GEN (July 1994), 28; Biotechnology 12 (1994), 756-7. On European biotechnology, TIBTECH 12 (1994), 253-4; and conversion of UK military research, Nature 370 (1994), 237.
In New Zealand a private company, Genesis Research and Development Coorporation Ltd, has begun operation in Auckland Hospital. It has 30 staff and is focusing on tuberculosis and other communicable diseases, and immune disorders. Citation analysis shows a declining influence of Australian science, Nature 371 (1994), 86.
There has been debate on patenting of genes following the discussion over patent claims that may interfere with free access to the breast cancer risk gene recently discovered (see genetic disease markers below); Nature 371 (1994), 270-2. There has also been discussion of the availability of cDNA databases (also see Genome project section). Merck has made arrangements with the University of Washington to develop an open cDNA database, and the topic was in US newspapers, Wall Street Journal (23 Sept), B4; (28 Sept), B1; (29 Sept), B8, 11. The Smith-Kline Beecham approach with TIGR is to include an option agreement. Smith-Kline Beecham (of the UK) has bought the US company Sterling Health, and the new merger makes it the largest pharmaceutical company in the world; BMJ 309 (1994), 629. It is perhaps symbolic that it now has options on most of the human cDNA, but the debate is more fundamental.
The US government failed to ratify the Biodiversity Convention in time to officially attend the first meeting of the parties to the Convention in November; Science 265 (1994), 859-60; Biotechnology 12 (1994), 968-9. The US delegates would have opposed a Biosafety Protocol, being supported by less-industrially developed countries. The Protocol would impose a requirement for impact assessments prior to any transfer of genetic engineering technologies or products, especially to countries with inadequate scientific expertise of their own. The Australian Gen-Ethics Network fears Australia is likely to oppose it, and if you want more information, contact Bob Phelps, Co-ordinator, Australian Gen-Ethics Network c/- ACF 340 Gore Street, Fitzroy 3065. Tel (03) 416.2222 Fax (03) 416.0767. They have sent a sample letter on Internet to be sent to Senator John Faulkner, Minister for the Environment. On the power of trade associations, Biotechnology 12 (1994), 972-3.
Amgen's patent on erythropoietin is being challenged by Genetics Institute, on the grounds that it lacks an inventive step, Nature 371 (1994), 645. The GATT decision to extend the length of patents to 20 years, instead of 17 years will help most industry, but the time will move from the time of issue to the time of filing. Biotechnology industry representatives in the USA are opposing this, as they say it will give shorter patent protection; GEN (1 Sept 1994), 1, 12; Science 265 (1994), 1999. In the US officials have agreed to stop the clock if the patent is challenged or held up, as about 4500 patents a year are, especially in biotechnology. The US debate on drug price limits is discussed in Biotechnology 12 (1994), 970-1. Commercialising biotech products is discussed in Biotechnology 12 (1994), 877-8. A debate about costs of the European patent office is continuing, Nature 371 (1994), 371. In general see, FASEB J. 8: 901.
GEN (1 Sept 1994), 26-27, 35; Biotechnology 12 (1994), 957-8, argues that the biotech stock index has reached a bottom. The continuing buying up of small biotech companies by Eli Lilly is discussed in Biotechnology 12 (1994), 956-7. On the chance of directly marketing products, Biotechnology 12 (1994), 951. On the biotechnology business situation in different countries: Germany, Nature 371 (1994), 189; Pasteur Institute, France, Nature 371 (1994), 277; Rhone-Poulenc Rorer, Nature 371 (1994), 546; European research funds, University of Birmingham Biotechnology News 32 (1994), 1-4; New York, Biotechnology 12 (1994), 944. General comments: Science 265 (1994), 1641-2; BMJ 309 (1994), 422-3; Biotechnology 12 (1994), 858-61, 865-9; on science careers, Science 265 (1994), 1905-1940; Nature 371 (1994), 460, 555. A letter on the role of industry in education is Biotechnology 12 (1994), 848.
Discussion against the patenting of breast cancer gene tests is in New Scientist (24 Sept 1994), 4;GenEthics News 3 (1994), 1-2. The NIH has filed a counter patent application against the University of Utah and Myriad Genetics claim, Nature 372 (1995), 118. The ICSU statement on gene patents is in IJB 5: 124. A letter on the status of gene segments from endangered species is in Science 266 (1994), 713. The European biotechnology patent directive and differing standards in European countries for recognising biotech inventions are causing concern to companies, Biotech 13 (1995), 21-2; Nature 372: 310, 384, 393. US companies are not so happy with the US Patent Office either, Science 266 (1994), 537.
In the UK the High Court has blocked an attempt to use the "public interest" clause by challengers to Chiron's monopoly of hepatitis C test kits, Nature 372 (1995), 485, 487-8814. The US Trade and Patent Office has begun measures to revoke the broad genetically engineered cotton patent given to Agracetus; New Scientist (17 Dec 1994), 4. There are also claims against the soybean patent given to Monsanto, Nature 372 (1995), 488. In Japan a single amino acid difference in tissue plasminogen activator has allowed Sumitomo Corporation to defeat a claim from Genentech that it was infringing its patent; Nature 372 (1995), 123.
The European Patent Office has granted a broad patent to Hoffmann-Roche for Taq polymerase, whether used in PCR or not, - to cover all thermostable polymerases within the molecular weight range 86,000 and 90,000; Nature 372 (1995), 212, 312. It has been challenged in the US Patent Office, Nature 372 (1995), 714. The points to consider in patent applications are discussed in Biotech 13 (1995), 9, 42-3. A commentary on property rights for plants is Plant Cell (Nov) 1524-28.
The International Plant Genetic Resources Institute has proposed that their should be no private company claims to limit access to germplasm that it has, EBN 189 (1994), 2. In November the UN group took charge of the network of 12 international seed banks, New Scientist (4 Nov 1994), 7; Nature 372 (1995), 9. See also New Scientist (17 Sept 1994), 41.
A court ruling against the copying of articles from journals in the USA is in Science 266 (1994), 1315. A Texaco employee who made one copy of eight papers from a journal and put these in his files was found guilty by a federal appeals court ruling in October. It may have been different if he had used the copies immediately - so I must use all the copies I make for this Newsletter! Many bioethics centres keep files of papers for reference, and so does Eubios Ethics Institute. Perhaps the more comprehensive we try to keep the collection, the more guilty we become!
A discussion of liability fears and medical implants from a conference is Science 266 (1994), 726. A review of companies developing medicines for the neurosciences is GEN (1 Nov 1994), 6-7. On pharmaceutical company interactions with doctors, CMAJ 151 (1994), 731-2. Also on medical biotechnology, JAMA 272 (1994), 1395; JRSM 87 (1994) 709-11; Biotech 13 (1995), 13; GEN (Dec 1994), 8-9. Agbiotech is discussed in Biotechnology 12 (1994), 1062-4; GEN (Dec 1994), 11, 35. Business reports include: Biotechnology 12 (1994), 1047, 13 (1995), 10-12. A list of biotechnology suppliers is in Biotechnology 12 (1994), 1149-62+ (special issue); or in a GEN guidebook or disc. A discussion of whether a university can be a business is Nature 372 (1995), 579-80. Science education is discussed in Science 266 (1994), 711, 741-3, 837, 844- 744, 1637; Nature 372 (1995), 122, 206.
In South Florida, GEN (1 Nov 1994), 1, 24; Maryland, GEN (1 Oct 1994), 28; Canada, GEN (15 Oct 1994),21; South Korea, GEN (15 Oct 1994), 10, (1 Nov), 12; Italy and EMBL, Nature 372 (1995), 305; A new chief, Dr John Sime, for the UK BioIndustry Association; Latin America, Science 266: 1317-8. The way regulations on markets may restrict access to technology and international competition is discussed in Nature 372: 303-4; Science 266 (1994), 1623; Lancet 344 (1994), 967-8. There are several major mergers in the US biotech industry, with Ciba-Geigy acquiring a 49% stake in Chiron, and Amgen has bought out Synergen, GEN (Dec 1994), 1, 29.
Science in Japan is featured in a special issue of Science 266 (1994), 1139, 1170-1190; see also p. 1473-4 on the University of Tsukuba; and on policy, p. 307; Nature 372 (1995), 125-6, 721-3. In France the CNRS was told to spend only 60% of their budget in a large research funding cut, that is bringing protests, New Scientist (5 Nov 1994), 10. Letters on basic research are in Science 266 (1994), 1305-6; Nature 373 (1995), 1-2. Also on science, Nature 372 (1995), 51-2.
The UK -based company, Derwent Information, has produced a 1995 document on Global Patent Sources, called Patent Manual Number 1. Contact: Derwent Information Limited, Derwent House, 14 Great Queen Street, London WC2B 5DF, UK. The US Patent Office has released new patent review guidelines, GEN (1 Jan 1995), 1, 41.
A recent English Court of Appeal decision was tough on revoking a patent on a DNA sequence patent, Gene Therapy Newsletter 6: 23. The claim against the Biogen patent by Medeva, was upheld saying that it was obvious and not really an invention. Also on gene patents, Nature 373 (1995), 185, 376, 550.
The BRCA1 gene patent application has been edited to include two scientists whose names were missing from the original application, Nature 373 (1995), 649. The European Patent Directive on biotechnology patents is still being debated and in fact, the November meeting between the European Parliament and the Council of Ministers broke down. The major problems are the patenting of human genes and the rights of farmer's to bred their own seed or animals, even if the products are patented. There was another vote in early March, which could be the last; see also GenEthics News 4 (1995), 4.
Changes in Indian patent law to allow patents on novel compounds have been made, Nature 373 (1995), 96. US rules on biotech inventions have changed so that human efficacy data are no longer needed, Science 267 (1995), 23-4. They also have new utility guidelines in general, Biotechnology 13 (1995), 116-7. On medical patents, Biotechnology 12 (1994), 1322. 1379-80; and the USA is accused of a cover-up in defense of Gallo claims for discovery of HIV, Nature 373 (1995), 372.
China is tripling Internet connections, Science 267 (1995), 168; and on information, Biotechnology 12 (1994), 1381-3. PCR and CITES is discussed in Science 266 (1994), 1930. The trademark on Taxol is criticised in Nature 373 (1995), 370.
The European company GenePharming Europe has acquired from Biogen, a US patent (#4873316) covering transgenic techniques; EBN (3 Feb1995), 3. Chiron's hepatitis C patent has been challenged (see also AIDS section), Science 267 (1995), 23; Lancet 344 (1994), 1632. There is still debate in the Taq polymerase dispute, Nature 373 (1995), 377.
The UK company Glaxo has tried to buy Welcome plc for £8.9 billion, and if it succeeds it would be the world's biggest pharmaceutical company, ahead of Merck; EBN (3 Feb1995), 1; (17 Feb), 3; Nature 373 (1995), 271. Wellcome is aiming for more profits,Biotechnology 13 (1995), 124-6. On mergers, Biotechnology 13 (1995), 106-7, 140-1. The prospects for a biotech stock market in the UK are discussed in GEN (15 Jan 1995), 4-5, 28; EBN (20 Jan 1995), 1. On European biotech, Biotechnology 12 (1994), 1322. On the US stock market, Nature 373 (1995), 178; Biotechnology 12 (1994), 1322-3; 13: 109-10.
A tale of foiled espionage of the development of the gene for erythropoietin, before it was patented, is discussed in GEN (15 Jan 1995), 3, 11; Science 266 (194), 1941. It raises the issue of industrial spying in biotech. The MicroGeneSys funding of the AIDS vaccine trial is being changed yet again in the US, to spend the US Army funds of peer-reviewed grants, Science 267 (1995), 335. A discussion of 15 prime areas for commercialisation of biotechnology isGEN (1 Jan 1995), 8-9. On general science policy, in the USA, Science 267 (1995), 20-2; in Japan, Nature 373 (1995), 177; Biotechnology 12 (1994), 1325-6.
A review of biotechnology in Thailand is Bhumiratana, S. & Sriwatanapongse, S. "The second decade of intensive biotechnology development in Thailand", Plant Biotechnology Newsletter (Jul-Sept. 1994), 2-5. A review of biotechnology in Asia in 1994 is GEN (15 Jan 1995), 10-1; in the Middle East, Biotechnology 12 (1994), 1344-6. Hopes for Africa are in Biotechnology 12 (1994), 1400.
The European Parliament voted against the proposals for regulation of biotechnology patents, and this ends the long passage of the directives over the last few years. A new draft may be made in the future. Industrialists are concerned that companies will take research to the USA or Japan. The vote was 240-188, and many were opposed to gene patents. For the opinion of the Group of Advisors on Ethical Aspects of Biotechnology of the European Commission see IJB 5 (1994), 351-6; New Scientist (11 March, 1995), 7; Biotechnology 13 (1995), 305; Nature 374 (1995), 101, 103. There has been a report in the UK produced from a working party of the National Academies Policy Advisory Group, Intellectual Property and the Academic Community, Nature 374 (1995), 391. The European Patent Office still does issue some biotechnology patents, and for example, in January they rejected challenges against a patent on human DNA, New Scientist (28 Jan, 1995), 8.
World parliamentarians called for a ban on the patenting of human genes and a clarification of rules governing biomedical research. Politicians from 114 national parliaments, meeting in Madrid, approved a resolution on bioethics on 1st April, the final day of the biannual Inter-Parliamentary Union (IPU) conference, Reuters World Service, (1 April). The resolution stressed ''the urgent need to ban the patenting of human genes...(and) prohibit all financial gain from the human body or parts thereof, subject to exceptions provided for by law.'' The IPU, wary of a threat to fundamental human rights from advances in medical science, called on national parliaments to define a common legal framework within which rules on genetic research could be established.
The NIH has won a patent in the US on the general techniques of gene therapy, Nature 374 (1995), 393. The first inventor is named as W. French Anderson, and it covers all ex vivo manipulations in which malfunctioning human cells are genetically altered to produce therapeutic levels of protein outside the body and then replaced. There is much controversy over the broad nature of it. The US has made it easier for patents, while Europe has made it more restrictive, Nature Medicine 1 (1995), 104; Science 267 (1995), 1083; New Scientist (11 Feb, 1995), 12-3. Company debate over patenting of gene sequences is in GEN (1 Feb 1995), 3,4, 7, 9. A paper on the issue is Byk, C. "Patenting human genes", IJB 5 (1994), 301-10.
The European Patent Office has restricted the breadth of a biotechnology patent. The appeals of of the European Patent Office has judged that a patent granted to Plant Genetic Systems for herbicide-tolerant plants cannot cover the plants and seed resulting from the genetically engineered plants because of the general exclusion of the European Patent Convention; EBN 197 (1995), 5; New Scientist (4 March, 1995), 5; Nature 374 (1995), 8. In general on patent claims in biotechnology, Biotechnology 13 (1995), 318-9.
Wellcome's board of directors advised shareholders to accept a 9.4 billion pounds takeover offer from Glaxo. The new company Glaxo-Wellcome will have annual sales of 8 billion pounds; EBN 197 (1995), 1; Science 267 (1995), 1261. On biotechnology business in Canada, GEN (15 Feb 1995), 19; and there are now 475 biotech companies in Europe, a 25% increase over the last 12 months,Biotechnology 13 (1995), 311-2; Nature 374 (1995), 488.
Genentech and Eli Lilly have settled there patent infringement dispute over human growth hormone and other products, GEN (15 Feb 1995), 1, 23. The patent challenges to the Hoffman-la Roche Taq polymerase claim are still being investigated in Europe, Nature 374 (1995), 108.
Biotechnology grants in the EU are discussed in Nature 374 (1995), 298. A comparison between US and Europe and Japan in different fields of science and technology is Nature 374 (1995), 397; on science in China, New Scientist (7 Jan, 1995), 3; in Russia, Nature 374 (1995), 395; in Japan, New Scientist (4 March, 1995), 32-7; Latin America, Science 267 (1995), 771, 826-8, +; and in universities in the UK, Nature 374 (1995), 112. On technology transfer, Biotechnology 13 (1995), 410. In general on biotech business, Biotechnology 13 (1995), 316-7, 322; TIBTECH 13 (1995), 39-41.
A call for renewed energy and better ideas in science policy is de la Mothe, J. & Dufour, P. "Is science policy in the doldrums?", Nature 374 (1995), 209-10.
Animal patents in Europe are discussed in GEN (15 April 1995), 1, 23. A report from the Italian National Bioethics Committee on animal patents is IJB 6 (1995), 73-5. More on the European Parliament rejection of the biotechnology directive is in BMJ 310 (1995), 619-20; Science 268 (1995), 1417-8. A UK Nuffield Council Report on tissue ownership and tissue use is discussed in the organ transplant section; Science 268 (1995), 492. The high costs of patents may be discouraging people from applying in Europe, Nature 375 (1995), 270-1.
A coalition of more than 80 religious leaders called for an immediate halt to patenting human or animal genes, saying commercial patents devalue the sanctity of life; BMJ 310 (1995), 1351; Nature 375 (1995), 168, 268. The religious leaders forming the Joint Appeal Against Human and Animal Patenting said they do not oppose genetic research or biotechnology, or the patenting of drugs, lab procedures, diagnostic tests or research results. HUGO has released a statement on gene patents, Science 268 (1995), 487; Nature 375 (1995), 351, 750, 751. HUGO has a different view over utility to Human Genome Sciences Inc. In a US appeals court, a judge has ruled that discovery of the gene sequence of a known protein is "not obvious", Nature 375 (1995), 94. This is a ruling to help the biotechnology industry, but one wonders on what is obvious given modern technology. Columbia University has announced it will donate its work on human gene fragments to a public database; Science 268 (1995), 487.
A general comment on the US Patent Office policy of giving broad patents in biotechnology is Science 268 (1995), 657-8; and on usefulness criteria, Science 268 (1995), 188-9. More on the gene therapy patent (see also gene therapy section), Lancet 345 (1995), 852. The BRCA1 cancer gene patent dispute has ended with the NIH including names of persons from 3 companies on the patent application as inventors, JAMA 273 (1995), 833. The PCR patent is still being disputed, and 150 researchers have been drawn into the dispute by Hoffman-Roche for using Promega company enzyme! Nature 375 (1995), 344, 348.
A discussion of international rules is Enayati, E. "Intellectual property under GATT", Biotechnology 13 (1995), 460-2. The question of ownership of medical technology is raised in Lancet 345 (1995), 1125-6; MJA 162 (1995), 341, 376-8. The potential problems of losing patent rights in cyberspace (computers) is discussed in GEN (15 May 1995), 4-5. More critique of the trademark on the drug Taxol (it should not be spelt taxol) is in Lancet 345 (1995), 753; Nature 375 (1995), 432. A review on the action of taxol is NEJM 332 (1995), 1004-14.
Comments on the dropping of the reasonable pricing clause from NIH cooperative research and development agreements (CRADAs) is welcomed by the biotech industry, GEN (1 May 1995), 1, 23. The estimated yield for worldwide sales of cytokines and growth factors in the year 2000 is US$13.4 billion, according to a Business Communications Company study, EBN 201 (1995), 3. Drug promotion is discussed in NEJM 332 (1995), 1031-3; and pricing in Biotechnology 13 (1995), 435-6.
On European biotech industry, GEN (1 May 1995), 1, 31-3. The US$1.3 billion losses of US biotechnology companies in 1994 are discussed in Biotechnology 13 (1995), 422-3, 433. Taiwanese biotech and genetically engineered products is discussed in GEN (1 April 1995), 1, 24. Science in Russia is said to be in a coma in Science 268 (1995), 693-4. Funding in the US is discussed in Science 268 (1995), 24, 192-4. Industrial funding in research is discussed in Lancet 345 (1995), 1189-90; BMJ 310 (1995), 762; Science 268 (1995), 631.
More on the patenting of genes in GEN (1 June 1995), 1, 12; Biotechnology 13 (1995), 656-7;Monash Bioethics Review 14 (May 1995), 26-38; Biotechnology and Development Monitor No. 23 (June, 1995), Biotechnology and Development Monitor No. 23 (June, 1995), 24. Comments against the patenting of genes and review of the success of the opposition campaigns is in The Ram's Horn 127 (June 1995), 1-3. Religious opposition to gene patents is discussed in Center for Biotechnology Policy and Ethics Newsletter 5 (Jul 1995),1-4; Biotechnology 13 (1995), 643-4; Science 268 (1995), 1126. The OTA study on gene patents is to be published only in part, despite the pressure and debate on the subject, Nature 376 (1995), 541. The fall of the EU patent directive is discussed in Biotechnology 13 (1995), 734-5.
US Biochemical Corp., a subsidiary of Amersham, has been granted a license to use a thermostable DNA polymerase (Thermo Sequenase) for use of PCR in DNA sequencing, EBN 204 (1995), 1; PNAS (3 July 1993). A review of the product is in Nature 376 (1995), 796-7.A controversy over the Mycogen patent on BT resistant plants with Monsanto is continuing in counter legal suits, Science 269 (1995), 1119. There is also debate over antisense patents, Nature Medicine 1 (1995), 389. The NIH filed about 150 patents the week before the patent law changed on 8 June, about the same as one year's patents, Science 269 (1995), 1573. The length of a patent will change to 20 years from filing instead of 17 years from issuance, which could be less time for major patents.
The AMA opposes patenting of medical and surgical procedures, BMJ 311 (1995), 12; and on molecular biology and money in medicine, JAMA 273 (1995), 331-4; Nature 376 (1995), 622. On ownership of ancient artefacts and bones, and indigenous peoples, Science 268 (1995), 1424-6.
Visions of the future of biotechnology by Newt Gingrich, speaker of the US House of Representatives, are in GEN (August 1995), 4-5. The Institute for Biotechnology Information predicts in its report, Biotechnology in the US pharmaceutical Industry-1995, that the sales of biopharmaceuticals in the year 2003 will top US$13 billion, with erythropoietin and granulocyte-colony stimulating factor as the top sellers. It also included 680 million for artificial blood and organs, Biotechnology Bulletin 14 (No. 4, 1995), 4-5.
Pharmaceutical industry in the Pacific Rim is the subject of a review in GEN (August 1995), 26, 50. African biotechnology research is reviewed in Biotechnology and Development Monitor No. 23 (June, 1995), 12-5. On European biotechnology, Biotechnology 13 (1995), 752-64. Issues in Brazil include patenting, Biotechnology 13 (1995), 818; and on the effect of recent laws in India, Science 269 (1995), 297-8.
US biopharmaceutical companies have increased spending on research by 35% this year, Biotechnology 13 (1995), 632-5; but there is only a 3% increase in agbiotechnology companies, Biotechnology 13 (1995), 732-3. The future profits of agricultural biotechnology are discussed in the context of a list of current products, including biopesticides and GMOs, GEN (August 1995), 1, 20-1. It includes reviews of latest research from major US biotech companies.
Also on biotech business, Biotechnology 13 (1995), 638-642, 652-5, 765-6; Nature 376 (1995), 9, 521-2. Research and economics is reviewed in FASEB J. 9 (1995), 833-40; Science 268 (1995), 1827.
The European Patent Office has decided to restrict the hearing on the latest round of human gene patenting to groups professionally concerned with patents, EBN 208 (1995), 3; drawing some criticism, Nature 377 (1995), 188. New US guidelines on utility are discussed in Biotechnology 13 (1995), 962-4, which make it easier for companies to patent unproven products
A list of reasons against extending patents to plants and animals is made by Busch, L. "Eight reasons why patents should not be extended to plants and animals", Biotechnology and Development Monitor 24 (1995), 24. They include: lack of evidence that patents do stimulate invention, distinction between discovery and invention, need to allow access to the organisms, extended protection, the ideas of biotechnology were developed in the public, no special reason to privatise public goods, need for uniform utility patents, inequality among the different countries in access. The North American-based Council for Responsible Genetics is circulating a petition and special supplement, No patents on life.
Religion and patenting is discussed in CBPE Newsletter 5 (2, 1995), 2-3; Science 270 (1995), 52. A commentary arguing for the opposing view is in GEN (15 Sept 1995), 4-5. Challenges to the patent awarded to a process to extend the life of neem tree extract, a product used in history for hundreds of years as an insecticide, are being made by a European group, Nature 377 (1995), 90, 95; Science 269 (1995), 1506; Time (4 Sept 1995), 51. Agbiotech and polymer coated seeds are discussed in Biotechnology 13 (1995), 937-9.
A patent on a genetic identity method applied to tuna fish is also under dispute, Nature 377 (1995), 9. Data put on the Internet may affect patent claims, however, DNA sequence data is needed as it is too large to include in printed journals, Science 270 (1995), 13-4.
Pharmacia and UpJohn Inc. have announced a merger to produce one of the ten largest pharmaceutical companies in the world, EBN 207 (1995), 1-2; 510 (1995), 5; GEN (1 Sept 1995),1, 26; Lancet 346 (1995), 585. A review of Hong Kong biotechnology is in GEN (1 Sept 1995),18-9. Industry support for clinical trials is being sought by the NIH, Nature 378 (1995), 116.
A plan by the FDA to disclose financial interests for clinical investigators has failed, Biotechnology 13 (1995), 939-40. The biotech industry is considered favourably in the US Congress, Lancet 346 (1995), 1027; Nature 377 (1995), 113. Industry is slow to invest in Germany, Nature 378 (1995), 6; but has been seeking gene therapy alliances in the USA, Nature 378 (1995), 7; including Sandoz's purchase of the NIH gene therapy patent US005399346A, Biotechnology 13 (1995), 945-7; SA (Sept 1995), 45.
On biomedical research in the USA, NEJM 333 (1995), 811-5; and in Japan, Nature 377 (1995), 694; 378 (1995), 8; Biotechnology 13 (1995), 932. French research centres have been asked to make their patents pay, Nature 377 (1995), 566. A discussion of Genentech former chief executive GK. Raab and business ethics is Biotechnology 13 (1995), 936-7. Also on biotech industry, Biotechnology 13 (1995), 934-6, 949-53; Time (4 Sept 1995), 44-5; Lancet 346 (1995), 953. On Russian science and intellectual property protection, Science 269 (1995), 752.
The newly created National Ethics Advisory Committee in the USA includes the mandate to look at human gene patenting, TIBTECH 13 (1995), 1431; and the Patent and Trademark Office is also considering the issue, Science 270 (1995), 1287. A law in the USA making it easier to patent biotech products, by adding words to say that a familiar biotechnological process - using an organism or cell line to express a foreign gene, for example - can be considered novel if it uses or produces a novel material, Science 270 (1995), 728. The further discussion of patenting biotechnology in Europe is based on resolution of the three main issues, farmer privilege, exclusion of germ-line gene technologies and a clear distinction between invention and discovery, EBN 212 (1995), 3; Nature 378 (1995), 328, 756; NS (21 Oct 1995), 13. See also, BME 113 (1995), 5; Gene Therapy Newsletter 17 (1995), 21-2; TIBTECH 13 (1995), 160-4, 319-23; Hospital Ethics (July/Aug 1995), 9-10; BMJ 311 (1995), 1593. There is also further debate on Oncomouse, Science 270 (1995), 1427; Nature 378 (1995), 427; GenEthics News 9 (Nov/Dec 1995), 4. A group opposed to gene patenting has put a 900,000 base pair sequence on the Internet (made public) that contains the second breast cancer gene, Nature 378 (1995), 424. An argument for patenting is Poste, G. "The case for genomic patenting", Nature 378 (1995), 534-6. The Danish Council of Ethics 7th Annual Report 1994, comes with a report on Extreme Prematurity Ethical Aspects, 67pp. Copies are available from them. A review is in IJB 6 (1995), 254.
The US Patent Office has awarded a patent for a cell line resistant to cancer isolated from a New Guinea tribesman, BMJ 311 (1995), 1452; Science 270 (1995), 1112; GenEthics News 9 (Nov/Dec 1995), 1-2. The patent number 5397696 is owned by the US Dept. of Health and Human Services, and has led to much protest regarding the commercialization of DNA (see also Genome Project section). The neem tree case is discussed in Nature 378 (1995),532 . On drug prospecting, Newsweek (27 Nov 1995), 52-3; TIBTECH 13 (1995), 415-7; Nature Medicine 1 (1995), 742-4; NS (4 Nov 1995), 4; (25 Nov 1995), 5; Biotechnology and Development Monitor 25 (Dec 1995), 16-21.
US drug companies have won a court case to extend patent protection to the 20 year GATT ruling, extending the US patent protection, but the case is being contested and a law may be made to prevent it, Lancet 346 (1995), 1218. Several companies were preparing to market generic products and are now delayed another year or two, Nature Medicine 1 (1995), 726. In the UK a doctor has been able to claim patent rights on a device he invented and not the hospital where the work was done, BMJ 311 (1995), 1248. The ownership of data also affects access to it in joint research, Science 270 (1995), 927-8.
A prediction of double digit economic growth for biotechnology in the coming ten years is in GEN (Dec 1995),6. The total US sales in 1996 are estimated to be 10.1 billion 1996 US dollars, and by 2001, 18.1 billion, and 32.4 billion in 2006. See also Bullock, W.O. & Dibner, M.D. "The state of the US biotechnology industry", TIBTECH 13 (1995), 463-7. German biotechnology is discussed in GEN (1 Nov 1995),4-5; and in the UK, GEN (1 Nov 1995),18-9; and in France, GEN (15 Oct 1995), 22-3. A review of a conference held in the Philippines on biotechnology in developing countries is GEN (15 Oct 1995),1, 20-1.
In general on biotech business, NEJM 333 (1995), 1292-3; NS (21 Oct 1995), 7; TIBTECH 13 (1995), 313-9, 474-81; and on science funding, Science 270 (1995), 1448-50. The federal government closures in the USA also closed down many labs, NS (25 Nov 1995), 7. New Zealand science funding is discussed in light of survey results in NZ Science Review 52 (1995), 1-45; NS (2 Dec 1995), 54. Pharmaceutical sales are discussed in JAMA 274 (1995), 1267-8. A special issue on science in China is Science 270 (17 Nov 1995), 1099, 1131-1156; as in Nature 378 (7 Dec 1995), 537-52.
India's genetic exports are causing more concern about genetics and patents, BMJ 312 (1996), 464; Nature Genetics 12 (1996), 111-2. The US Dept. of Energy has announced that it will make up to US$1.3 million available next year for studies on intellectual property protection of the human genome, Nature 379 (1996), 670. The reasons why the mandate of the US National Advisory Committee on Bioethics was modified to include gene patenting are discussed in Biotechnology 13 (1995), 1431. Letters on the subject are in Nature 379 (1996), 294, 484, 672. The codiscovery of the second breast cancer gene, BRCA2 has led to debate on the patent rights, Nature Medicine 2 (1996), 133; Nature 379 (1996), 574. The journal Nature has joined those journals which require all published papers on genes and structures of molecules to be deposited in a publicly accessible database, Nature 379 (1996), 191.
Patenting animals are discussed in AgBioethics Forum 7 (Nov 1995), 1-7; in what is the last hard copy issue of that journal. From now they can be found on www,
The commercial interests in genes and obesity are discussed in Rothenberg, L. "Fat media-hype greets obesity genes: is industry among the potential losers?", TIBTECH 14 (1996), 35-7. It remains to be seen how such potential products and genetic modification will be used.
The journal Biotechnology will change its name to Nature Biotechnology in March 1996, joining the array of Nature magazines. There have been proposed changes to increase biotechnology business in the USA, Nature Medicine 2 (1996), 17; see also JAMA 275 (1996), 73-4; AJHG 58 (1996), 247-8; Nature 379 (1996), 194. On bioindustry in Canada, GEN (15 Jan 1996), 1, 12; and India, Science 271 (1996), 442-3. The funding reductions for biomedical research in New Zealand suggest a 12% reduction in workforce this year, Lancet 347 (1996), 124.
Business ethics and industry-academia relations are discussed in Science and Engineering Ethics 2 (1996), 15-20; Blumenthal D. et al. "Relationships between academic institutions and industry in the Life Sciences - an industry survey", NEJM 334 (1996), 368-73; and secrecy in NEJM 334 (1996), 392-9. The results show that companies often require researchers to keep results quite, delaying publication beyond the period required for patents. 90% of US companies had relationships with academic institutions in 1994 but federal funding is still the major research source, and industry may not be expected to replace the federal reductions. On the reductions, Lancet 347 (1996), 51.
A review of the 1175 patents so far awarded for human gene sequences is in Thomas, SM. et al. "Ownership of the human genome", Nature 380 (1996), 387-8. A discussion of the issues involved in world patenting is Nature Biotechnology 14 (1996), 288--91; and of human genes, GEN (1 March 1996), 4, 39; BMJ 312 (1996), 926. In November 1995 the new US Biotechnology Process Patent Act was signed into law, Biotechnology 14 (1996), 158-9; see also p. 121. On US regulations, Biotechnology 13 (1995), 1042-5. On the renewed European patent directives, Biotechnology 14 (1996), 139. Discussion of the patent on Neem and a call for a US role in Biodiversity Convention implementation is Biotechnology 14 (1996), 1029, 1164.
A review of why the US Patent Office made differing opinions on who can patent IL-1 is discussed in Nature Biotechnology 14 (1996), 275-9. There is dispute over patent claims on anticoagulants, Science 271 (1996), 1800-1. A review of Markman v. Westview Instruments Inc., patent infringement case is Biotechnology 13 (1995), 1178-9; also p. 1065. There is continued patent debate on Genentech's claim on human growth hormone, Biotechnology 13 (1995), 1038-9. A discussion of Canadian patenting law is GEN (15 March 1996), 20-1.
A review o a 30 year discussion on patents and control of schistosomiasis is SA (April 1996), 22-26. A study suggesting commercial biotechnology does not hinder research publication is in Science 271 (1996), 1367. A book review on the pharmaceutical industry is NEJM 334 (1996), 609-10; also on price control, J. Health Economics 14 (1995), 551-65.
The companies Ciba and Sandoz have announced a merger, valued at US$27 billion plus, and they will form a new company Novartis, EBN 218 (1996), 1-2; Science 271 (1996), 1490. The new company will have a combined value of US$60 billion, in similar league to Roche, Merck, and Johnson and Johnson. On mergers, Biotechnology 14 (1996), 135-6.
A series of papers on biotechnology in Europe are in Biotechnology & Development Monitor 26 (1996), 1-24. Included are discussion of public debate, industrial promotion strategies, biodiversity conservation, and comparisons between India and France. A report suggesting nationalism is holding up the development of commercial biotechnology in Europe, NS (23 March 1996), 12. There is also competition within a country, for example Germany, Nature 379 (1996), 759. A report from Business Communications Company says the sales of enabling technology for genetic technology totaled US$1.1 billion in 1995, and are expected to be 1.7 billion in 2000, an average growth rate of 9%, EBN 217 (1996), 4. Research on the role of individuals is NS (2 March 1996), 6. On Indian biotechnology, GEN (15 Feb 1996), 4, 31; and in Asia, GEN (1 Feb 1996), 10, 19.
The role of biotechnology in negotiations of Latin America's debt in debt for nature schemes is reviewed in GEN (1 April 1996), 4, 35; and on exploiting biodiversity, TIBTECH 14 (1996),181-2; SA (May 1996), 23-5. On gene patents, Insights on Global Ethics 6 (1996), 1, 8-10; Nature 381 (1996), 1, 11-5, 265, 360, 664; Lancet 347 (1996), 1323. Plant patents in Europe are discussed in Nature 381 (1996), 175, 178, 642; TIBTECH 14 (1996), 67-9. The backload of DNA patent applications is estimated to be 90 years for a single examiner, and many more examiners in the US PTO are being called for, Science 272 (1996), 643. The recent completion of the sequence of yeast is expected to result in more patent applications, Nature Biotechnology 14 (1996), 547-8. A call for Nature and other journals to require that not only non-human gene sequence, but all gene sequence related to papers in it is publicly available is Nature 381 (1996), 17.
An indigenous Indian tribe has been awarded intellectual property rights to the drug jeevani, from the plant Trichopus zeynicus, called Indian ginseng, Nature 381 (1996), 182. A debate on the pricing of drugs is Brody, B. "Public goods and fair prices: Balancing technological innovation with social well-being", HCR 26 (March/April 1996), 5-11. A case of suppression of publication of research due to commercial reasons and drug efficiency is in Nature 381 (1996), 4. Boots Inc. forced a researcher to withdraw a paper from JAMA that showed other products were biologically equivalent to theirs, just before it sold related stock to another company. Another case is in Lancet 347 (1996), 1628-9; and related, Pepin, JF. "Pharmaceutical sales representatives and physicians: ethical considerations of a relationship", J.Med.Phil. 21: 83-99; Kreiner, A. "The ethics of the pharmaceutical industry and the need for a dual market system", J. Medical Humanities 16 (1995), 55-70.
A review of the International Centre for Genetic Engineering and Biotechnology is GEN (15 April 1996), 39-41. A review of biotechnology and cosmetics (called cosmeceutics) is GEN (1 April 1996), 1, 26-7. On the benefits of environmental industry, NS (15 June 1996), 3.
The US financing of biotechnology exceeded US$2 billion in the first quarter of 1996, GEN (1 May 1996), 3; and in general, Lancet 347 (1996), 1497; Transgenic Research 5 (1996), 145-6; Davis, EB. et al. "The biotechnology "wheel of fortune": Who gives, who gets, who profits?", J. Medical Humanities 16 (1995), 23-38. Companies earn about US$10 billion of the industry US$30 billion a year, Nature Biotechnology 14 (1996), 560-1. A review of German biotechnology partnerships in the USA is GEN (15 April 1996), 1, 8-9, 31. On Taiwan biotechnology industry, GEN (a April), 12-3, (15 April 1996), 29, 42; on France, Nature Medicine 2 (1996), 618; China, Nature Biotechnology 14 (1996), 419; Turkey, Critical Reviews in Biotechnology 16 (1996), 53-94; Cuba, Time (13 May 1996), 50-1; and on Chile, GEN (1 April 1996), 1, 30. On the pros and cons of academic-industry ties, Nature Biotechnology 14 (1996), 441-2; and the economic case for basic research, Nature 381 (1996), 187-8.
India is challenging the US patent on the use of turmeric to heal wounds, Nature 382 (1996), 106. Scientific research in India in 1953 was done, although US researchers claimed a patent recently! It was known much longer as a traditional medicine, raising general issues. Relating to the Biodiversity Convention, Hardon, J. "National sovereignty and access to genetic resources", Biotechnology and Development Monitor 27 (June 1996), 24. In a controversial decision, the New Zealand government sold off NZ$1.8 billion of trees and forest to a company to allow it to square the balance of payments figure, Christchurch Press (14 August 1996), 1.
The NIH recommended on 9 April, 1996, that raw sequences of DNA should not be patented. On genome research, the HUGO Intellectual Property Committee is considering how HUGO may be involved in these issues, HUGO Genome Digest 3 (No. 3, July 1996), 1-3. See also the genome project section below for a new business deal by HGS Inc. On gene patents, Nature Medicine 2 (1996), 728-9; NS (27 July 1996), 60; Scrip Magazine (Feb. 1996), 38-47, (June 1996), 22-4. The US patent office backload is discussed in SA (August 1996), 33.
The Dutch company Pharming has been awarded a European patent for the generation of transgenic cattle from immature ovocytes, EBN 227 (1996), 2. There are protests against the patent application of Biocyte corporation on the use of stored haematopoietic cells from umbilical cells (which has been granted in Europe), Nature 382 (1996), 17, 108. Hoffman-Roche has failed to get a European patent on Taq polymerase, based on non-novelty, Nature 382 (1996), 100. This enzyme is used in PCR reactions, and the price is well above production costs. The company has been charged with misleading the office, in a judgment of gross misconduct, Nature 382 (1996), 660. On intellectual property, Nature 381 (1996), 750.
A 650 page report by Frost and Sullivan of 50 European biotechnology companies, reports that the 1995 sales from biotechnology in Europe were US$29.2 billion, a 17% annual increase. It predicts 20% annual growth until the year 2000, and that by 2020 the market in Europe will be US$106.5 billion; EBN 227 (1996), 1-2. General comments on the need to promote long term research, and Japanese research investment in Oceania, NS (27 July), 61; (31 August 1996), 44. China is looking for partners for research, in an editorial written by Li Peng, the premier... Science 273 (1996), 13.
AgrEvo, the agrichemical part of Hoechst/Schering has bought the company Plant Genetic Systems for US$673 million; EBN 228 (1996), 2-3; Nature 382 (1996), 661. Last year its profit was US$147 million, and it is a major crop protection company, including corn, oilseed rape (approved in Canada and the EU) and some vegetables. On biotech industry, Science 273 (1996), 300-1.
Economic corruption of research is reviewed in Nature 382 (1996), 123-4. Questions of the funding of research by tobacco companies are discussed in Lancet 347 (1996), 1782; and on use of tobacco taxes, Science 273 (1996), 178.
The debate on patenting life in the European Parliament is set to reopen this autumn, BMJ 313 (1996), 964. The latest draft legislation attempts to separate biotechnological progress from ethical issues. The current text maintains that interpretation of unpatentability on ethical grounds should continue to be determined at national level. This is a view shared by the German socialist MEP Willi Rothley, who is leading the parliamentary examination of the draft rules. The opposing view is held by Danish Europe of Nations MEP Ulla Sandbaek, who argues for a global approach. She wants ethical questions to be raised before the adoption of new technical legislation. The Danish Cystic Fibrosis Association, and The European Alliance of Genetics Support Groups are supporting the law, claiming medicine will advance. On the other side stand various consumer, environmental, and farming groups who fear that the real impact of any legislation will be in agriculture as patents are taken out on genetically manipulated plants and animals. This is in the shadow of the parliamentary assembly of the Council of European organization independent of the European Union-voted by a large majority to adopt a draft Convention on Human Rights and Biomedicine and recommended that it should be open for ratification by the 39 member countries by the end of the year.
The Group of Advisors on the Ethical Implications of Biotechnology to the European Commission (GAEIB) adopted its 8th position on 25 September, 1996, on the "Ethical aspects of patenting inventions involving elements of human origin". They stressed the ethical principle of non-commercialization of the human body; that informed and free consent of this person should be respected; and that the granting of an invention derived from the knowledge of a human gene (or a sequence of it) is acceptable only if, in one hand, the identification of the function associated with the gene allows for new possibilities (for instance the production of new drugs), and, on the other hand, if the intended use of the patent is sufficiently specific and identified. The group is seeking to obtain consensus on the issue. Any queries should be directed to Dr Isabelle Arnal, Secretary, Group of Advisors on Ethical Implications of Biotechnology, European Commission, Rue de la Loi 200, B-1049 Brussels, BELGIUM.
On the debate on plant patents, Nature Biotechnology 14 (1996), 680; and for patenting, AJLM XXII (1996), 85-108; Nature 382 (1996), 17-8, 99. Rifkin has added feminists to the movement against gene patents, if there were not already against it, Nature Biotechnology 14 (1996), 814. See also, Capson, TL et al. "A new paradigm for drug discovery in tropical rainforests", Nature Biotechnology 14 (1996), 925, 1200-9. A series of papers on different perspectives of the Fourth International Technical Conference for Plant Genetic Resources, and the Leipzig Declaration of June 1996, is in Biotechnology and Development Monitor 28 (1996), 1-24. The Declaration looks at technology transfer. Some botanic gardens are selling samples from their collections to companies, NS (29 June 1996), 7. Researchers are resisting copyright laws that may endanger free data access, Nature 383 (1996), 653.
Indigenous Scottish Crofters have started a land claim in the UK after land was ceased from them between 1746-1886, following the success of New Zealand Maori claims, Christchurch Press (14 Oct 1996), 20. In West Australia, thieves have sawn off rocks of rare dinosaur footprints, angering both aborigines and scientists, Nature 383 (1996), 655. On the pressures of recipients of aid to follow the donor countries wishes on what to do, NS (12 Oct. 1996), 12-3.
Prior art considerations when patenting DNA sequences are revised in Nature Biotechnology 14 (1996), 1309-14. A comment on the benefits of patents to the progress of pharmaceuticals is GEN (1 Oct 1996), 4, 35, 43. Methods to search the patent pipeline are reported in Nature Biotechnology 14 (1996), 1165-7. Also on patents, Nature Biotechnology 14 (1996), 1028-30; The new section 103(b) of the US patent law: concerning obviousness is discussed in Nature Biotechnology 14 (1996), 773.
The industrialization of plant genetic engineering is discussed in Nature Biotechnology 14 (1996), 715-6. A review of employment in genetics is Nature 383 (1996), 739-44. A special issue of Science 274 (4 Oct 1996), 1, 43-57, is on Science in Japan: Competition on Campus. In New Zealand biotechnology industry may be built on genetically engineered sheep, NS (6 July 1996), 46.
A report on Bavarian (Germany) investment
into biotechnology is in GEN (1 Oct 1996), 1, 24-5, 28;
On French biotechnology, Nature Biotechnology 14
(1996), 1078; in South America, pp. 951-4; in Quebec, pp. 955-7;
Japan, p. 958; Southeast Asia, pp. 960-1; Scotland, pp. 962-4;
Wisconsin, pp. 965-7. An international listing of regional development
organizations is Nature Biotechnology 14 (1996), 968-74.
A book review on the history of technology in the UK is Nature
383 (1996), 681.
A criticism of biotech patents is NS (16 Nov 1996), 6; GeneWatch 10 (Oct 1996), 1-7, 10-8. p53 based therapies are being linked to business and stock markets, and patent claims may affect the use of the gene, Nature Medicine 2 (1996), 1170. The US Congress has made a step towards restricting patents on medical procedures by including a clause in the Sept 30, 1996 spending bill that says holders of medical-procedure patents will no longer have recourse against medical professionals who use these procedures for patient care, Lancet 348 (1996), 1025. From July 1996 there is also a one year ban on such patents. However an exemption for biotechnology patents is included!, GEN (15 Oct. 1996), 1, 10.
US trade negotiators are calling for clear exemptions for scientific research in proposed new international rules of the World Intellectual Property Organization protecting private databases from piracy, Science 274 (1996), 494, 1074; Nature 383 (1996), 653; 384 (1996), 293, 299. There are concerns that copyright laws could exclude open access to databases. Secrecy is already a problem with patent applications, SA (Nov 1996), 15; and with research results conducted in the USA (and supposedly other countries) that are kept secret under national security reasons, but which would not compromise security, SA (Nov 1996), 41, 44. The Camadian law C-91 of 1993 which gave 20 year protection to pharmaceuticals is debated in GEN (15 Nov 1996), 10, 20, 34. A review of the problems of foreign scientists claiming patent protection on traditional Indian medicines is NS (26 Oct 1996), 14-5. The USA has asked the World Trade Organization to set up a panel in its dispute with India over patent protection for pharmaceuticals, Nature 384 (1996), 392.
A decision by the European Patent Office (EPO) in Munich, in favor of Hoffmann-La Roche in its patent dispute in the US with the biotech company Promega over a patent for a Taq polymerase used in the polymerase chain reaction (PCR), was made in November, 1996, Science 274 (15 Nov 1996); Nature 384 (1996), 100. In the UK, the House of Lords rejected Biogen's patent claim on hepatitis B vaccines, Lancet 348 (1996), 1375.
Amgen is in a dispute with Transkaryotic Therapies on their erythropoietin patent in their gene therapy research using gene-activated EPO, Nature Biotechnology 14 (1996), 1641. European patent legislation is again under consideration, Nature Biotechnology 14 (1996), 1648. On other patents, Nature Biotechnology 14 (1996), 1602-5. Biotechnologists in Israel are calling for more investment in research to expand on the 1995 sales of US$249 million, Nature 384 (1996), 396. A review of biotechnology in Europe is GEN (1 Nov 1996), 1, 38; and in Singapore, GEN (15 Oct 1996), 12-3, 28.
In general on biotech business, Nature Biotechnology
14 (1996), 1515, 1645-6, 1657-67; Nature 384 (1996), 389.
A letter criticizing the Japanese grant system is Nature
384 (1996), 402-3.
A submission from a working group of the European Ecumenical Commission for Church and Society (EECCS) is against the draft European Commission Directive on patenting, SRT Bulletin 12 (1997), 1. Also against patenting is The newsletter Splice of Life (The Genetics Forum, 5-11 Worship Street, London EC2A 2BH, UK); Nature 385 (1997), 672. Statements from the UK Clinical Genetics Society on gene patenting are in BME 124 (1997), 8-9; and numerous other papers in BME 124 (1997), 11-36. A House of Lords decision in the Biogen versus Medeva case allows broad patents in biotechnology to be challenged, GEN (1 Jan 1997), 22. US experience finds that plant patents increase biotechnology litigation ,NatBio 15 (1997), 216. The TIGR cDNA database is going to be publicly available from April 1997. The US patent office has decided to grant patents to expressed sequence tags, Nature 385 (1997), 755; NS (22 Feb, 1997), 11; BMJ 314 (1997), 43-5.
The US NIH has renounced all rights to US patent 5,397,696 which covers white blood cell lines from a Hagahai tribesman in Papua New Guinea (Official gazette of US Patent and Trademark Office, 10 Dec 1996); Nature 384 (1996), 500. A call to protect Chinese genetic resources from foreign companies is repeated in HUGO Digest (Jan 1997), 11. On biodiversity as a resource, Ram's Horn 144 (Jan 1997), 1-4. On the interpretation of US patent law, NatBio 15 (1997), 86-7, 183-5. On biotechnology patents worldwide, Nature 384 (1996), 608; NatBio 15 (1997), 121; Eisenberg, RS. "Structure and function in gene patenting", NatGen 15 (1997), 125-31.
The World Intellectual property Organization has delayed the proposed database protection treaty being implemented, Nature 385 (1997), 5. On international collaboration in genetics research NatGen 15 (1997), 124-5. A proposal for Internet being a duty free zone is NS (11 Jan, 1997), 7.
Monsanto has offered to purchase the remaining 46% of Calgene that it does not own, NatBio 15 (1997), 213. A report on biotechnology in Asia from the Fifth Pacific Rim Biotechnology Conference in Seoul, Korea, is GEN (15 Jan 1997), 1, 10, 27. There are now 250 biotechnology companies in Canada, double the number two years ago, GEN (Dec 1996), 20, 44. On biotechnology business, which is now the combined valued at $205 billion, NatBio 15 (1997), 193; Nature 385 (1997), 189. On general on science business, PNAS 93 (1996), 12655-760; Nature 385 (1997), 281, 312, 373, 497; NS (21/28 Dec, 1996), 70-1. Research in Russia is in serious trouble, Science 275 (1997), 468-71. On the dangers to ethics of commercial backing, Nature 384 (1996), 501.
The patenting of neem tree extract azadirachtin by W.R. Grace ltd. is debated in Biotechnology & Development Monitor 30 (March 1997), 8-10. The NIH is likely to challenge the decision to allow patents on ESTs, Nature 386 (1997), 312. On the ethics, Resnik, DB. "The morality of human gene patents",KIEJ 7 (1997), 43-62. The withdrawal of the NIH patent claim on a cell line from a Hagahai cell line is in GeneWatch 10 (4-5) (Feb 1997), 6. Also on gene patents see TIBTECH 14 (1996), 67-9, 298-317, 333-4.
The US Court of Appeals for the Federal Circuit (Washington, DC) started a case in January 1997 considering recombinant insulin. The regents of the University of California (UC, Berkeley, CA), are against the pharmaceutical company Eli Lilly, Nature Biotechnology 15 (1997), 307. On the doctrine of equivalents in the patent law, Nature Biotechnology 15 (1997), 383-4; and on harmonizing patent practices in Europe, Nature 386 (1997), 641. Copyright law changes may affect the sharing of information on databases, Nature 386 (1997), 635.
Following the announcement of the cloning of Dolly on Sunday, February 23, the price of the stock of PPL Therapeutics (Roslin, UK),the company involved in the work increased from £3.35 ($5.36) to a high of £5.62 ($7.22) on the day before the paper was actually published in Nature (Wilmut et al., Nature 385: 810-813, 1997), a 67% increase, Nature Biotechnology 15 (1997), 306.
A call for research in Africa is Gbewonyo, K. "The case for commercial biotechnology in sub-Saharan Africa", Nature Biotechnology 15 (1997), 325-7. Marseilles, France is seeking to attract foreign biotech firms to set up facilities there, GEN (15 March 1997), 1, 26, 33; Nature Biotechnology 15 (1997), 313. On genomics and gene therapy company mergers, GEN (1 March 1997), 6, 30; (15 March 1997), 4, 31. On German-US genome mergers, GEN (15 Feb 1997), 1, 13. The revenues of UK biotechnology companies in 1995-1996 were 702 million pounds, and are expected to double in1997-8; Nature 386 (1997), 211. A review is May, RM. "The scientific wealth of nations", Science 275 (1997), 793-6. The wealth of US biotechnology millionaires is listed in GEN (1 April 1997), 10.
The patenting of neem tree extract azadirachtin by W.R. Grace ltd. is debated in Biotechnology & Development Monitor 30 (March 1997), 8-10. The NIH is likely to challenge the decision to allow patents on ESTs, Nature 386 (1997), 312. On the ethics, Resnik, DB. "The morality of human gene patents",KIEJ 7 (1997), 43-62. The withdrawal of the NIH patent claim on a cell line from a Hagahai cell line is in GeneWatch 10 (4-5) (Feb 1997), 6. Also on gene patents see TIBTECH 14 (1996), 67-9, 298-317, 333-4.
The US Court of Appeals for the Federal Circuit (Washington, DC) started a case in January 1997 considering recombinant insulin. The regents of the University of California (UC, Berkeley, CA), are against the pharmaceutical company Eli Lilly, Nature Biotechnology 15 (1997), 307. On the doctrine of equivalents in the patent law, Nature Biotechnology 15 (1997), 383-4; and on harmonizing patent practices in Europe, Nature 386 (1997), 641. Copyright law changes may affect the sharing of information on databases, Nature 386 (1997), 635.
Following the announcement of the cloning of Dolly on Sunday, February 23, the price of the stock of PPL Therapeutics (Roslin, UK),the company involved in the work increased from £3.35 ($5.36) to a high of £5.62 ($7.22) on the day before the paper was actually published in Nature (Wilmut et al., Nature 385: 810-813, 1997), a 67% increase, Nature Biotechnology 15 (1997), 306.
A call for research in Africa is Gbewonyo, K. "The case for commercial biotechnology in sub-Saharan Africa", Nature Biotechnology 15 (1997), 325-7. Marseilles, France is seeking to attract foreign biotech firms to set up facilities there, GEN (15 March 1997), 1, 26, 33; Nature Biotechnology 15 (1997), 313. On genomics and gene therapy company mergers, GEN (1 March 1997), 6, 30; (15 March 1997), 4, 31. On German-US genome mergers, GEN (15 Feb 1997), 1, 13. The revenues of UK biotechnology companies in 1995-1996 were 702 million pounds, and are expected to double in1997-8; Nature 386 (1997), 211. A review is May, RM. "The scientific wealth of nations", Science 275 (1997), 793-6. The wealth of US biotechnology millionaires is listed in GEN (1 April 1997), 10.
The US Patent Office said it may award patents on expressed sequence tags (ESTs) leading to criticism by the NIH and others, Science 276 (1997), 187; Nature 386 (1997), 747; though it was the NIH who first attempted to file patents on ESTs in the early 1990s. A debate on patent infringements and exclusive license in biotechnology is Science 276 (1997), 1488-91; also Nature 387 (1997), 13-4. In Europe there are varied policies, BMJ 314 (1997), 1296. The use of copyright for protection is suggested in Liedes, J. "Copyright: Evolution, not revolution", Science 276 (1997), 223-5. The issue of secrecy in research is debated in Blumenthal, D. et al. "Withholding research results in academic life science. Evidence from a national survey of faculty", JAMA 277 (1997), 1224-8; Science 276 (1997), 523-6. In the JAMA study 20% of researchers in the life science said once in the past 3 years they had delayed publication by up to 6 months because of patent applications.
In June the European Parliament legal affairs office approved a revised directive on biotechnological inventions that allows patenting of human genes and transgenic animals and plants, Nature 387 (1997), 835. The EU Group of Advisors on the Ethical Implications of Biotechnology statement on ethics of patenting is Politics & Life Sciences 16 (1997), 139-42. The USA threatened not to renew its science agreement with India over Indian patent laws, Nature 387 (1997), 540. The US Court of Appeals for the Federal Circuit has invalidated Genentech's patent for human growth hormone (No. 5,424,199), GEN (15 April 1997), 1, 8, 32.
A review is Fears, R. et al. "Life-sciences R&D, national prosperity, and industrial competitiveness", Science 276 (1997), 759-60; and on the future of science, Science 276 (1997), 761-2; and in German on biotechnology prospects, Naturwissenschaften 84 (1997), 178-80. The US has expressed concern over German sales of technology to Iran, SA (June 1997), 36, 8. In general on academic and industry research relationships in genetics, NatGen 16 (1997), 104-8; also, Lancet 349 (1997), 1338-9. Disclosing data that allows someone to sell shares can lead to criminal charges, as seen in a US case, Science 276 (1997), 671-2. On the relationship between university and private companies from an ethical view see papers in Ag Bioethics Forum 9 (No.1, June 1997), 1-10.
A study of generic products showing they are bioequivalent is levothyroxine products for treating hypothyroidism, JAMA 277 (1997), 1205-13, 1200-1. On the ethics and business of Cargill and Monsanto, Ram's Horn 149 (June 1997), 5-7.
A review of the top 50 biotech companies in the USA by market capitalization is GEN (1 June 1997), 23; and a survey of 10 selected ones is EBN 246 (1997),8-9. In 1996 there were equal number of citations for the EU as the USA, reducing the gap, Nature 387 (1997), 537. Openness of information on public funds has been a threat to a merger of the medical schools of UC Berkeley and Stanford, Nature 387 (1997), 329. A review of careers for plant scientists is Nature 387 (1997), 431-6.
Good manners for the pharmaceutical industry
is the subject of an editorial, Lancet 349 (1997), 1635.
The health care market in China is reviewed in BMJ
314 (1997), 1543-5; and there are foreign companies developing
collaborations in Chinese biotechnology industry, NS (3
May 1997), 5. US-Korean cooperatives are reviewed in GEN
(1 June 1997), 10, 38. Science policy in Europe following
a report of the European Science and Technology Assembly is being
reviewed, Science 276 (1997), 1186. A breakdown of European
companies in biotech is EBN 245 (1997), 9, 14; 246 (1997),
4-5. Biotechnology in Scotland is growing, now having
8% of European biotechnology companies, GEN (15 April 1997),
11, 25, 29. Book Reviews of on 21st Century Miracle Medicines
are Nature 387 (1997), 669-70; NS (31 May 1997),
42-3. A global map of Internet access is in SA
(July 1997), 26. On hope for the future of Internet connection
speed, Nature 387 (1997), 8-9.
The European Parliament approved by a vote of 378 to 113 the revised patent directive, Nature 388 (1997), 309, 314-5; Science 277 (1997), 472; Lancet 350 (1997), 272; BMJ 315 (1997), 207; GenEthics News 18 (June/July 1997), 1, 2, 6; NS (12 July 1997), 3; (19 July 1997), 51. It includes setting up an ethics commission to examine whether transgenic animals will suffer without any substantial benefit to humans or animals. Farmers could resell patented seeds or animals for farming use, but not commercial breeding. A discussion on the controversy surrounding patenting of transgenic animals, Science 277 (1997), 24-5; and in general, Crespi, RS. "Biotechnology patents and morality", TIBTECH 15 (1997), 123-9.
The HUGO Statement on patenting issues related to early release of raw sequence data is in Genome Digest (July 1997), 3. Contact: Prof. Joseph Strauss, Email jss@intellecprop.mpg.de. On the debate whether ESTs are patentable, NatBio 15 (1997), 586-7, 911+; NatGen 15:125. A call for faster patents and longer lives is in NatMed 3 (1997), 706-7.
. A report from the Goa conference in May in India on the fears of patent and ethics abuses is NatBio 15 (1997), 613. On the issue of profiting from gene collections, NS (21 June 1997), 50.
A series of papers on how to set priorities in biotechnology research are in Biotechnology & Development Monitor 31 (June 1997), 1-24. There is increasing biotech business outside of the USA, Lancet 349 (1997), 1893. On biotech in Minnesota, NatBio 15 (1997), 737-40; India, NatBio 15 (1997), 727-32; Nature 388 (1997), 530-2; Mexico, NatBio 15 (1997), 742-50; and the Islamic world, NatBio 15 (1997), 733; Australia, NatBio 15 (1997), 733-6; Latin America GEN 17(August 1997), 1, 8, 47; Hong Kong in GEN 17(July 1997), 10, 36; Ireland, GEN 17(July 1997), 15, 27, 43; Germany, FASEB J. 11 (1997), 505-8. The Canadian government is investing C$60 into a vaccine program against cancer, Lancet 350 (1997), 42; Nature 388 (1997), 214.
$5.2 billion was spent by biotechnology companies in 1996 on research,
from $12.4 billion earned, supporting those who argue the creation
of companies makes more investment, NatBio 15 (1997), 393,
412. On agricultural biotech in Europe, NatBio 15 (1997),
695. In general on biotech business, GEN 17(August 1997),
3; Lancet 350 (1997), 270. The free market paradigm for
science is in a book review in Science 277 (1997), 188-9;
also BMJ 315 (1997), 200-1. There are fears that clinical
research will be more difficult in the USA, JAMA 278 (1997),
241-6. Calls for change in Japanese universities are made in Nature
388 (1997), 223.
India has applauded the US Patent Office for its reversal of the patent on tumeric, Science 277 (1997), 1429; Lancet 350 (1997), 724. A discussion of patenting and neem, and other natural products from India is Honey Bee 8 (3, 1997), 1, 14-5. The NIH has sided with John Hopkins University in a patent battle over a cell sorter, Science 277 (1997), 759. On a dispute over insulin gene patent, Science 277 (1997), 1028-30.
OncorMed of USA has been granted a US patent on the BRCA1 gene, Nature 389 (1997), 821. There is a counter-claim over BRCA1 Nature Biotechnology 15 (1997), 936. A study of 1995 published patent applications on human genes found 40% from public sector institutions, 26% from multinationals, 24% from US biotech companies, 3% from European companies, Nature 389 (1997), 709. Yellowstone Park is open to biotech prospecting, Science 277 (1997), 1027.
Breast cancer is getting increased funding in the
USA, Lancet 350 (1997), 377. The genome research budget
for 1998 of the Japanese STA increased 171%, Nature 389
(1997), 4. On research funding in Australia, Nature
388 (1997), 711; and New Zealand, NS (16 Aug. 1997), 45;
though the ANZAAS will probably end in Dec. 1997 due to lack
of funds, Nature 389 (1997), 532. On biomedical research
and insider trading, NEJM 337 (1997), 631-4. A prediction
is that there will be 300 German biotechnology companies by 1998,
Nature Biotechnology 15 (1997), 943. On Israeli biotechnology
funds Nature Biotechnology 15 (1997), 938.
A review is Morin, E. "Of mice and men: The ethics of patenting animals", Health Law Journal 5 (1997), 147-197; and a report with several contributions is A Special Supplement to HCR 27 (Nov. 1997), Hanson, MJ et al. "Religious Voices in Biotechnology. The Case of Gene Patenting", 22pp. On the recent US court of appeals decision on insulin gene patents, GEN 17 (15 Nov 1997), 28, 41; Science 278 (1997), 560-1. Genentech and Novo continue to battle over hGH patents, NatBio 15 (1997), 1338. The number of patent applications considered by the biotechnology patent examining group of the US Patent and Trademark Office has fallen 55% in the past two years, NatBio 15 (1997), 1236. Myriad Genetics has been awarded a US patent on 47 mutations in BRCA1 gene, Nature 390 (1997), 546; but it is being challenged, Science 278 (1997), 1874. Australia has annulled the native Taq patent, Nature 390 (1997), 327.
India and China have controls on gene export to lessen exploitation of genetic resources by commercial interests, Science 278 (1997), 376-7; Nature 390 (1997), 108; GenEthics News (Oct 1997), 5; also see McNally R & Wheale, P. "Biopatenting and biodiversity. Comparative advantages in the new global order", Ecologist 26 (1996), 222-8. There are fears of sharing genetic material even within USA, Science 278 (1997), 564-6. On 5 Dec 1997 a group of persons from 45 countries agreed to the Thammasat Resolution against patenting, in Bangkok, Thailand. On EuropaBio's core ethical values, Biotechnology & Development Monitor 32 (Sept 1997), 6-7. The European Union Council of Ministers backed the draft patent directive, Science 278 (1997), 1699; Nature 390 (1997), 429; BMJ 315 (1997), 1487.
At the American Intellectual Property Law Association (AIPLA) meeting in October, 1997, John Doll, director of the biotechnology group at the US Patent and Trademark Office (PTO; Washington, DC), stated that express sequence tags (ESTs) were not only patentable, but would be likely to receive broad patent protection. This reopened the general debate on whether technology that is primarily useful for further basic research, such as ESTs, cell lines, and transgenic animals, should be patented. Debate on patentability of research tools is in, NatBio 15 (1997), 1336. On genome patenting, Science 277 (1997), 1752-3; 278 (1997), 785. A comment on the free exchange of research materials, Science 278 (1997), 212-3.
The USA is pressurizing Ecuador to sign a bilateral intellectual property rights (IPR) agreement beyond GATT commitments, which is being criticized regarding limits on the implementation of the Convention on Biological Diversity, Biotechnology & Development Monitor 33 (Dec 1997), 20-2. Native claims to a site in Australia are discussed in Science 278 (1997), 1556-7. An alleged biotechnology thief was acquitted of charges of foreign export of cells, Science 277 (1997), 1929. Advertising of levothyroxine preparations is discussed in JAMA 278 (1997), 895-900; and the AMA faced much controversy for endorsing some Sunbeam products, which it reversed, Science 278 (1997), 26; NatMed 3 (1997), 1183.
A strong 1998 year is predicted for biotech business in the USA, GEN 17 (Dec 1997), 12, 36. The forecast for sales is 9.1 billion in human therapeutics, 2.1 billion in diagnostics, with 420 million in agriculture; with 11% annual growth predicted. On US industry, Nature 391 (1998), 242-3. On government funding of research, Science 278 (1997), 878-80. On biotech partnerships in Japan, GEN 17 (15 Oct 1997), 4, 38; Japan may merge the Science ministry with Education, Nature 390 (1997), 327; and industry/university ties are being encouraged, Nature 390 (1997), 105; Korea is still promoting biotechnology despite the economic crash, Nature 390 (1997), 213; 391 (1998), 111; and German biotech companies, NatBio 15 (1997), 1334. Millennium is one of the latest to sign to Monsanto, NatBio 15 (1997), 1334. This five-year, $218 million venture gives Monsanto exclusive access to Millennium's genomics expertise and technologies for all crop plants in all countries. A review of the Wellcome Trust is NatMed 3 (1997), 1185-7. Indian national laboratories are encouraging contract research with foreign companies, NatMed 3 (1997), 1182. On pharmaceutical economics, NEJM 337 (1997), 1854. An report on biotech is Visalakshi, S. & Sandhya, GD. "An analysis of biotechnology and non-biotechnology R&D capabilities in the Indian pharmaceutical industry", R&D Management 27 (1997), 165-75; Visalakshi, S. "R&D and commercialization status of hybridoma technology in India: an international comparison", Science and Public Policy 22 (1997), 231-8.
A Delaware US Federal Court has ruled that by selling products genetically engineered with a synthetic form of insecticidal Bacillus thuringiensis (Bt) crystal-protein gene, Monsanto (St. Louis, MO) and its partners are not infringing on two patents held by Mycogen (San Diego, CA) that describe a method for making synthetic forms of the gene. Monsanto, DeKalb Genetics (DeKalb, IL), and Delta & Pine Land (Scott, MO) can sell Bollgard Bt cotton, YieldGard corn, and New Leaf potato seed, engineered with a synthetic Bt crystal-protein gene, without paying Mycogen royalties, NatBio 16 (1998), 230. There is also a patent battle on biochip technology, Science 279 (1998), 311.
India is challenging the US patent on Basmati rice, Nature 391 (1998), 728. The FAO is considering a moratorium on patents from seed held in CGIAR seedbanks. A discussion from a report on Biopiracy released from the Research Foundation for Science, Technology and Ecology of India is GenEthics News 21 (Jan 1998), 6-7. Chiron is seeking a patent on pertussis patent NatBio 16 (1998), 228. On patenting transgenics in the European Union, NatBio 16 (1998), 299+. Managing genomics-based intellectual property is discussed in NatBio 16 (1998), 203-5. A discussion of human tissue is Andrews, L. & Nelkin, D., "Whose body is it anyway? Disputes over body tissue in a biotechnology age", Lancet 351 (1998), 53-7.
A group of 11 companies has formed France Biotech, an association with shared goals, GEN 18 (1 Feb 1998), 1, 12. Roche has an agreement called deCODEs to look at genes in the Icelandic population for a $200 million deal, NatBio 16 (1998), 225; Science 279 (1998), 991. On German biotech, NatBio 16 (1998), 226-7; Science 279 (1998), 171; and in Korea, NatBio 16 (1998), 151; and in general, NS (31 Jan. 1998), 42-3. The future of the profit-lead science in New Zealand is discussed in Nature 391 (1998), 419, 426-7. Tokyo University is trying to increase the number of patents it produces, Nature 391 (1998), 622. The share prices of biotech companies are subject to rapid rises depending on publication, Science 279 (1998), 472. On regulating the pharmaceutical industry, BMJ 316 (1998), 226-8. Conflicts of interests in calcium-channel antagonists are NEJM 338 (1998), 101-6.
A book review of Marks, HM. The Progress of Experiment: Science
and Therapeutic Reform in the United States, 1900-1990 (Cambridge
Univ. Press 1997, ISBN 0-521-58142-7) is NEJM 338 (1998),
68. A report on the publication patterns of 48 countries is Nature
391 (1998), 628. A report on scientists who fund their own research
is Science 279 (1998), 178-81. A study of education and
employment of US Ph.D.'s shows more are moving to private jobs,
FASEB J 12 (1998), 139-48.
Several activists have joined Stephen Newman to write patent applications for human-animal chimeras as efforts to stop people making them, Newsweek (13 April, 1998); Nature 392 (1998), 423-4. A series of papers on bioprospecting are in Nature 392 (1998), 117, 525, 535-40. Calculating the value of plant genomes is difficult, PNAS 95 (1998), 2011-6. Two Australian agencies applied for patents on chickpeas that were obtained from an International genebank, NS (14 Feb. 1998), 14-5. The Australian Senate rejected a controversial law that would have limited Aboriginal land rights on 9 April, 1998. Brazil is trying to protect income from biological resources, Science 279 (1998), 1445; as is the Organization of African Unity, Nature 392 (1998), 423. On scientists views on the HGP, Nature 392 (1998), 325.
On the complexities of why some medical technologies are patented and others are not, Lancet 351 (1998), 518-9. A series of papers on the TRIPS agreement and plant protection are in Biotechnology & Development Monitor 34 (1998), 1-11. A review of arbitration to resolve patent disputes is TIBTECH 15 (1997), 484-6. Smith-Kline Beecham has been accused of launching a smear campaign against a hepatitis B vaccine made in India, NatMed 4 (1998), 257.
About a half of life scientists at US institutions said they had accepted a gift in the past three years from companies, although they are generally against university rules, Nature 392 (1998), 427; JAMA 279 (2 April 1998). The Asian financial crisis may affect biotech business, thought Japan and Malaysia have continued strong support for biotechnology, GEN 18 (1 April, 1998), 1, 18, 36. A list of molecular millionaires is in GEN 18 (1 April, 1998), 10. There has been concern in Israel over the proposed US$100 million increase for biotech, Nature 392 (1998), 117. There has also been concern in Israel over a revised patent law that will allow companies to develop generic versions of patented drugs before there patents expire, BMJ 316 (1998), 725. On encouragement of research, FASEB J 12 (1998), 391-4. In general on biotech and science, BMJ 316 (1998), 494; Nature 392 (1998), 123-4, 746; and in Southeast Asia, Science 279 (1998), 1465-83. Japan plans continued economic growth through biotechnology, NatBio 16 (1998), 329.
In March 1998 GlaxoWellcome signed a deal potentially worth $300
million for the development of PowderJect's hepatitis B and other
DNA vaccines. Data from animal studies indicate that its DNA vaccine
formulations reduce the amount of DNA needed for the vaccine 2000-fold,
NatBio 16 (1998), 309. New Zealand universities may be
privatized, Nature 392 (1998), 120-2, 320.
On May 12 the European Parliament approved the EU biotechnology patent directive, after much debate. There continue to be divided opinions on it, Science 280 (1998), 1188; GenEthics News 23 (April/May 1998), 1, 9; Ram's Horn 159 (May 1998), 2-3; BME 137 (April 1998), 1; Lancet 351 (1998), 1500; BMJ 316 (1998), 1558; Nature 393 (1998), 200. A paper on patenting of DNA is in Science 280 (1998), 689-90.
On the European database directive and protection, TIBTECH 16 (1998), 284-6. A review on North American patent law trends is GenEng News 18 (1 June 1998), 11, 33. The Canadian Federal Court has rejected the claims that Oncomouse can receive a patent in Canada, supporting earlier court decisions, Nature 393 (1998), 506. A meeting report on whether partial gene sequences are patentable is TIBTECH 16 (1998), 197-8. Researchers who made a fast gene sequencer are giving away the blueprints so others can freely copy it, NS (23 May 1997), 12. The NIH has been urged to share research tools also, Nature 393 (1998), 505. A discussion of whether patents deter innovation is Science 280 (1998), 698-701; NS (16 May 1998), 20-1. On biopiracy in Brazil, Science 280 (1998), 657. Japan is trying to increase the number of academic patents, Science 280 (1998), 1340-1. Efforts to limit prices on drugs made using public discoveries are being made, Nature 393 (1998), 297; Science 280 (1998), 1687; but is it good that companies who make drugs pay the scientists who test them?, NS (9 May 1998), 18-9.
A new book is William Lesser, Sustainable Use of Genetic Resources Under the Convention on Biological Diversity (Oxford: CAB International, 1997, 240pp., ISBN 0-85199-197-1, 35pounds). It focuses on transfer of genetic resources and associated technologies especially looking at articles 8, 9, 15, 16, 18 and 19 of the Convention. A paper on philosophical foundations of business ethics is in Ethics & Society Newsletter (Hong Kong Baptist University) 6 (May 1998), 2-8; and on bioethics and business from interviews with 11 stakeholders in Holland, C&B Bulletin 1 (May 1998), 5-8; also further comments on business and bioethics in that issue (Contact: Consumer & Biotechnology Foundation, P.O. Box 100, NL 2500 BA The Hague, the Netherlands).
Cargill and Monsanto have formed a 50-50 joint venture for biotechnology, combining two major companies; and Monsanto has been bought out by American Home Products, GenEng News 18 (15 June 1998), 1, 8, 37; NatBio 16 (1998), 612; Ram's Horn 160 (June 1998), 1-2. On the valuing biotechnology assets of companies, NatBio 16 (1998), 525. Novartis Pharma of Switzerland is starting a US$250 million genomics institute, Science 280 (1998), 193; and new gene ventures have been announced in Germany, Science 280 (1998), 999-1000 (see also HGP section). European bioindustry is discussed in NatBio 16 (1998), 494; and ethics at British Biotech in NatBio 16 (1998), 503, 608; Nature 393 (1998), 291, 509, 852; Lancet 351 (1998), 1338. A California company Agouron Pharmaceuticals has been judged guilty of stealing research results on a paper on rat polymerase B, Nature 393 (1998), 504. On S&T research in New Zealand, Science 280 (1998), 655; and on Taiwan, Science 280 (1998), 1190. An Asian molecular biology network for Asia is discussed in Science 280 (1998), 1708.
The ethics of corporate gifts to biotech researchers are
discussed in NatBio 16 (1998), 495. A book review of Jeremy
Rifkin's new book on The Biotech Century is Nature
393 (1998), 31-2. On biotech business, NS (4 July 1998),
3, 20-1.
Letters on patenting of genes are in Science 281 (1998), 517; Perspectives in Biology & Medicine 41 (1998), 391-408. On the commercialization of human genetics, Molecular Medicine Today (April 1998), 148-50. The US Patent office is still considering patents on ESTs, NatBio 16 (1998), 711.
India has decided to join the WIPO patent treaty and allow patents for products, Nature 394 (1998), 709. A call for case-by-case decisions is Wear, SE. et al. "Patenting medical and surgical techniques: An ethical-legal analysis", J. Med. & Phil. 23 (1998), 75-97. Debate on whether drug prices are influenced by patents is Lancet 352 (1998), 582. The question of profits from museum holdings is discussed in a Russian case in Science 281 (1998), 773-4. A discussion of the patent claim on human-animal chimeras that was intended to stop scientists develop such techniques is GeneWatch 11 (1998), 1-3. A new book called Biotechnology Patents is available from Financial Times, http://www.fthealthcare.com>
A series of papers on business ethics in Europe is Business Ethics 7 (1998), 127-85. Trust and business ethics are discussed in Business Ethics Quarterly 8 (1998), 193-336. A paper on oil companies and human rights is Business Ethics 7 (1998), 69-72. A call for professional codes of conduct in biotech. is Chemistry & Industry (17 Nov. 1997), 922; and for people with more conscience, Lancet 351 (1998), 1942. Papers on the issue of industrial sponsorship of medical research (especially tobacco funds) are in BMJ 317 (1998), 217, 333-9. A discussion of Monsanto policy in the Cargill merger is Ram's Horn 161 (July 1998), 3-6.
A summary of the scientific investments of 12 countries and the
link with economic wealth is May, RE. "The scientific investments
of nations", Science 281 (1998), 49-51. Science does
create wealth, but it may not be within national boundaries. On
science in Korea, Science 281 (1998), 781. On biotechnology
in Scotland, GEN (1 Sept. 1998), 1, 10, 14, 67. The stock
market crash may affect also biotech companies, Nature
395 (1998), 104. On genetics business in Asia and employment,
Nature 394 (1998), 601-4.
The Consultative Group on International Agricultural Research has banned the use of terminator genes (that prevent plants making fertile seeds) in Africa, following India's decision to ban import of any seeds containing the genes, Nature 396 (1998), 11. A discussion with several papers on gene patents and ethical issues is CQHE 7 (1998), 417-35; also Issues in Science and Technology 14 (1998), 37-41. A comment against patents is in GeneWatch 11 (Oct. 1998), 1, 5-7. Patenting DNA sequences is discussed in NatBio16 (1998), 877; The Modern Law Review 61 (Sept. 1998), 740-65.
Gene piracy is one of the terms used to describe the exploitation of genetic resources, Time (9 Nov. 1998), 36-41. Bioprospecting in an African context is discussed in Science 282 (1998), 41-2. China has issued new rules on export of genetic material, Science 281 (1998), 1779.The Netherlands are challenging the European patent directive, Nature 395 (1998), 736. UK researchers at the Roslin Institute (Roslin, UK) have been falsely accused of biopiracy, because protesters incorrectly interpreted the address given on a patent, NatBio16 (1998), 904. Human Genome Sciences has said that it is still finding new genetic data in the database of sequences, Nature 391 (1998), 834.
On the general idea of making money from the body, Nelkin, D. & Andrews, L. "Homo economicus: The commercialization of body tissue in the age of biotechnology", HCR 28 (Sept. 1998), 30-9. One of the main issues for intellectual property protection is how much the patient pays, Lancet 352 (1998), 726-9, 1072. The patent income from ApoE4 testing is discussed in Science 281 (1998), 1805. An Australian judge has confused the system for marketing of drugs by saying that a drug already patented for one use cannot be patented for another use, NS (29 August 1998), 16. Rising costs may be delaying drug discovery, Nature 395 (1998), 835. Amgen has been discussing EPO in Congress, NatBio16 (1998), 999-1000.
India has signed the Paris Convention for the protection of intellectual property, Nature 395 (1998), 737. A new look in North-South biopartnerships is in NatBio16 (1998), 986. The ownership of scientific papers is discussed in Science 281 (1998), 1459-60; and copyright in Science 281 (1998), 1451; Nature 395 (1998), 730. The ownership of Dolly (including the image) and the right to profit from cloning techniques is being defended by Roslin Institute, NS (19 Sept. 1998), 4; Nature 395 (1998), 205. The NIH and DuPont have agreed to conditions for an end to a two year struggle on sharing of mice modified with the cre-lox engineering system for editing DNA at specific sites in the genome, Science 281 (1998), 1261; NatGen 20 (1998), 1-3. One of the dangers of open information access to patents is that information on production of weapons, like nerve agent VX, are easily available and it appears some countries, like Iraq or Sudan have used these sources for their chemical weapons programs, SA (Nov. 1998), 42.
The United Nations Development Programme (UNDP) is funding efforts
to improve the marketing of products from Cuba's biotechnology
industry, NatBio16 (1998), 813. On October 13, Monsanto
(St. Louis, MO) and American Home Products (AHP; Madison, NJ)
canceled their $33.6 billion merger, which was originally announced
in June, NatBio16 (1998), 991; Ram's Horn 163 (1998),
3-5. The US stock market crash has threatened some new biotech
companies, Nature 395 (1998), 104. In general on Monsanto,
Splice 5 (Oct. 1998), 4-7. Efforts to make a Dept. of Science
in the UK government are discussed in NS (12 Sept. 1998),
3. The New Zealand Dept. Science has been downgraded in rank,
Nature 395 (1998), 109. A book review discussing Akademgorodok,
the Siberian Science City is Nature 392 (1998), 33-4. A
book review on Indian science is Nature 395 (1998), 233-4.
Japan STA has called for a 5% increase in funds next financial
year, Nature 395 (1998), 3. On German biotech, NatBio16
(1998), 997. A book review of Biotech Century is JAMA 280
(1998), 575.
Incyte Pharmaceuticals has received the first US patent on an EST, Nature 396 (1998), 499. Letters on patenting genomic technologies are in Science 282 (1998), 1420-1. A series of papers on options for sui generis rights systems is in Biotechnology & Development Monitor 36 (Sept/Dec 1998), 1-19. India has amended its Patent Act to meet international standards, but it may still take several years before some foreign drugs are introduced as the Patent Office examines whether to grant exclusive marketing rights, Indian Express (6 Jan. 1999), 1; NatBio 17 (1999), 8.
An editorial arguing to share research tools is Nature 396 (1998), 97. Personal computers are challenging copyright, Nature 396 (1998), 293. Access to medical and health information in the developing world is discussed in CMAJ 160 (1999), 63-4. The demise of public data on the web is discussed in NatBio 16 (1998), 1323-4. Actually that journal has also made its abstracts subject to payment of subscription fee on the www, reversing a trend for on-line information.
A review and cover story is McGirk, T. "Dealing in DNA", Time (30 Nov. 1998), 46-52. A book review of Maxwell, J. et al. Access to the Genome: The Challenge to Equality (Georgetown University Press, 1998) is JAMA 280 (1998), 1455. An editorial on knowledge-based economy is in Nature 397 (1999), 1; following a UK government decision, Nature 396 (1998), 714-5. The US Supreme Court is considering the grounds for appeals on patents, Science 282 (1998), 1622. On ethical issues, J. Med. & Phil. 23 (1998), 318-21.
Hoechst and Rhone-Poulenc have announced a merger of their life science divisions into a new 50:50-owned company Aventis, GEN (Jan 1999), 1, 4, 27, 31, 35. They will have a research budget of US$2.5 billion a year. France and the UK are making more efforts to encourage new biotechnology companies, GEN (Dec. 1998), 1, 14, 41, 54. A review of biotech in Canada is GEN (15 Nov. 1998), 20-5, 41, 43, 45, 54; and on tough times for new US biotech companies, Nature 397 (1999), 191. Israeli industry has asked for more R&D funds, Nature 396 (1998), 611. A comparison of the biotechnology industry to the computer industry is BIOforum International 2 (No.2 1998), 163-5. On support for science, Science 282 (1998), 621-2; and the shifts of chemistry industry to invest in biotechnology, Science 282 (1998), 608-9. In general on biotechnology, Science 282 (1998), 1239, 2160. There have been some scientists accused of insider trading in the US stock markets, Nature 397 (1999), 185. Taiwan promotes biotechnology, NatBio 16 (1998), 1308-9. Cuba is also developing much biotechnology, Science 282 (1998), 1626-8.
Italy has supported the Third World Academy
of Sciences by a long-term commitment, Nature 396 (1998),
610. The World Bank is supporting a scheme of Third World
Centres of excellence, Nature 396 (1998), 711; 397 (1999),
6-7. The US State Dept. is attempting to rejoin UNESCO but budget
concerns have not allowed it, Nature 396 (1998), 606. At
the Indian National Science Congress, India has been urged
to develop gene-based industry more, The Hindu (6 Jan.
1999), 14. A paper on Japan in the Systemic Evolution of
World Society has been written by Helmar Krupp (Burgunderweg 7,
Weingarten, D-76356, Germany). New Zealand universities are losing
money to polytechnics and Crown Research Institutes, Nature
396 (1998), 502. A comparison of the impact of different countries
research in different aspects of life is made in Nature
396 (1998), 615-8. On the impact of globalization, Progress
in Human Geography 22 (1998), 475-7.
A discussion of patents in India is Currents in Science, Technology, Policy & Ethics 2 (No. 2, Winter 1999), 1, 6-8, 12; Lancet 353 (1999), 305. Biotechnology in India is reviewed in GEN (1 March 1999), 6, 30, 48. The Kani community is selling their traditional medical knowledge as a commercial venture, Lancet 353 (1999), 1164; Science 283 (1999), 1614-5. Problems in the interpretation of the European Patent Convention article 53 and exclusions on animals are discussed in GEN (1 Feb. 1999), 1, 6, 29. The Italian government has complained to the European Court of Justice that the EU directive on patenting needs revision because it gives inadequate consideration to the right of life and health and for the preservation of nature, NatMed 5 (1999), 363. The top GMO patent application holders are discussed in NatBio 17 (1999), 410. On intellectual property protection for plants, NatBio 17 (1999), 197-8. African countries are split over a bar on patents to plants, Nature 398 (1999), 99; and on biotech there, Nature 398 (1999), 744. A book review of Shiva, V. Biopiracy (Green Books 1999) is NS (30 Jan. 1999), 44.
An EST patent has been granted for human kinase homologues, NatBio 17 (1999), 125. The question whether it is worth is debated in NatGen 21 (1999), 145-6. An interpretation of utility requirement for US patents is California Law Review 87 (1999), 423-56. A letter on US/European systems is Nature 398 (1999), 555. A series of papers on intellectual property and contract law for the information age are in California Law Review 87 (1999), 1-300+. There are concerns over secrecy clauses in contracts, Nature 398 (1999), 359. Europe has tougher copyright rules, Nature 397 (1999), 379.
Yellowstone National Park will have to conduct a full environmental review before allowing it to share profits with the company Diversa which it has a deal with for bioprospecting, NS (10 April 1999), 15; Nature 398 (1999), 358. DuPont has attempted to acquire Pioneer Hi-Bred International to expand into biotechnology, GEN (1 April 1999), 1, 9, 37; NatBio 17 (1999), 315. BASF has joined Svalof Weibull to become another major plant seed company, Nature 397 (1999), 283; Wellcome is trying to house companies next to the genome center in Hinxton, Cambridgeshire, Nature 398 (1999), 353, 355. A list of biotechnology millionaires is in GEN (1 April 1999), 13. A study on university industry cooperation is Cassier, M. "Research contracts between university and industry: co-operation and hybridization between academic research and industrial research", Int. J. Biotechnology 1 (1999), 82-104. There are hidden costs of research, Nature 398 (1999), 457-9.
On biotech business in general, Sharp. M. "The science of
nations: European multinationals and American biotechnology",
Int. J. Biotechnology 1 (1999), 132-62; NatBio 17
(1999), 429 - 436; Nature 398 (1999), 360; and in East
Europe, NatBio 17 (1999), 437 - 439; Japan, NatBio
17 (1999), 126-7, 320-1; Nature 397 (1999), 554; Taiwan,
NatBio 17 (1999), 440 - 441; UK, NatBio 17 (1999),
442 - 443; Canada, NatBio 17 (1999), 444 - 446; France,
NatBio 17 (1999), 447 - 448; Germany, GEN (1 April
1999), 7, 33; Washington State, NatBio 17 (1999), 449 -
450. NatBio 17 (1999), Supplement pp. 1 - 41 is on bioentrepreneurship.
A book review of Riddle, Eve's Herbs: A History of Contraception
and Abortion in the West (Harvard Univ. Press 1997) is JAMA
279 (1998), 86-7. The question of whether doctors should reconstruct
the vaginal introitus of adolescent girls to mimic the virginal
state is discussed in BMJ 316 (1998), 459-62.
A review of unmarried mothers is Lewis, J. & Welshman, J., "The issue of never-married motherhood in Britain, 1920-70", Social History of Medicine 10 (1997), 401-18. Teen pregnancies are rising in the UK, BMJ 316 (1998), 882. There is still secrecy associated with contraception in Ireland. China has agreed to change its one child per family in some parts of the country, La