Patenting and Business OLD News

Extracts from EEIN 1991-1994. Latest news is at the bottom. Provided by Eubios Ethics Institute , at http://eubios.info/index.html

An appeals board at the European patent office has told patent examiners to reconsider the application for a patent for Oncomouse. The application was initially refused because of section 53(b) of the European Patent Convention, and the issue of ethics from section 53(a). The patent office is advised to consider the ethics of animal patenting: Dickman, S. (1990) "Mouse patent a step closer", Nature 347: 606. Du Pont considers that the silent majority support animal patents, but they should read the results of New Zealand public attitudes data, which indicates a significant percent of the population reject such patenting (SG 183). An amendment to the Australian patent law leaves the decision up to the patent office, which can decide whether or not to allow patenting living organisms (Nature 347 (1990), 320). It excludes human beings and their biological processes for generation from patenting.
A three-tiered structure for assigning legal property rights to human biological material is outlined in Swain, M.S. & Marusyk, R.W. "An alternative to property rights in human tissue", HCR (Sept/Oct 1990), 12-15. This paper considers whether tissue donors should receive part of the profits from the development of commercial cell lines or products, and uses examples from US law.
The question of patenting every new procedure that academic's develop that may have the slight prospect of commercial development is discussed by Greene, H.E. & Duft, B.J. (1990) "Disputes over monoclonal antibodies", Nature 347: 117-118. They argue for more input from scientists in these decisions, which are usually made by distant lawyers. The backlog of protection patents in the USA continue to grow, despite of more staff in the Patent Office.
A thoughtful paper on the longterm benefits of basic research in general is Crouch, M.L. (1990) "Debating the responsibilities of plant scientists in the decade of the environment", The Plant Cell 2: 275-277. No scientific activity is neutral, even if the knowledge may be. The type of research performed in biotechnology today will have many economic implications for developing countries, who rely on agricultural exports of products which in the future may be produced by alternative means.

To avoid patent infringement, drug companies alter drugs in a minor way, to obtain new patents. However, with patents on proteins, the US Courts have said that protein microheterogeneity (minor differences) is not sufficent reason to allow alternative patents. There is still discussion about this matter, and it is important because many companies are developing improved versions of naturally occuring enzymes, proteins or antibodies: Biotechnology 9 (1991), 25. The debate is important to the future of the biotechnology business, and continues.
A background to the recent court battle over the Cetus patent claims to the PCR, brought by Du Pont is in Science 251 (1991), 739-40.
A broad-reaching patent has been granted in the USA to T. Cech and the University of Colorado for the use and synthesis of enzymatic RNA (ribozymes): Science 251 (1991), 521. There will be challenges to the broadness of the patent, and the question is not yet resolved in other countries. Such ribozymes can be used to cut out specific RNA sequences, which has many potential applications.
A study of the funding of biotechnology in the USA, is summarised by C.E. Hess (1991) "Resource allocation to state agbiotech research: 1982-1988" Biotechnology 9: 29-31. The number of research scientists in the field has remained similar, but there has been more emphasis on biotechnology research, which may have a longterm negative effect in that the proportion and amount of general biological research in animal and plant breeding, that is required before developing biotechnology, has been reduced.
The question of obtaining profit from donated human cells is very topical, and will continue to be so with the quest for profits from the DNA sequencing project. The US legal situation particularly the case of John Moore, is discussed by G.J.Annas, "Outrageous fortune: selling other people's cells", Hastings Center Report 20 (Nov/Dec 1990), 36-9. A general paper on the topic of patenting living organisms and the relation to agriculture is S.Watts, "A matter of life and patents", NS (12 Jan 1991), 38-43.
Of general interest is that the US government and two Canadian companies are challenging the patent for AZT, the drug used for treating AIDS that has been sold at a very expensive price: Nature 349 (1991), 93. It is of general interest because much government research and public funds went into the development of this drug, which will be a constant issue faced in the future of biotechnology.
The lack of cooperation among different countries in recognition of patents is the subject in B.Fox, "An international charter for inventions?" NS (19 Jan 1991), 33-5. There are poor prospects for such a scheme however.

A new book has been published by the Eubios Ethics Institute, by William Lesser it is entitled Equitable Patent Protection in the Developing World: Issues and Approaches, 150pp, Paperback, ISBN 0-908897-01-4. An excerpt from the back cover explains the theme of this book:
For more than a century developing countries have been reassessing the merits of participation in the Paris Convention and indeed the overall value of intellectual property for countries in the earlier stages of industralization. Then biotechnology with its promise of enhancing agricultural productivity appeared, along with a push by the major developed countries to use GATT as a means of enhancing intellectual property protection in developing nations. This book examines the economic record on patents and the related Plant Breeder's Rights and comes to a judgement about the benefits and recommended forms of protection in developing countries. It is intended for policy makers, business people and researchers alike for they are all affected by the form (or absence) of this legislation.
Details on ordering this book are on the back page of this issue. It includes revisions to a model patent law which could be adopted by developing countries. The keywords are: Patents, Plant Breeders' Rights, Intellectual Property, economics of patents, patents and development.
A general paper on biotechnology patenting is J.H.Barton (1991) "Patenting life", Scientific American 264 (March 1991), 18-24.
Cetus corporation has had its US patent on the PCR upheld by a US Court, by a challenge by Du Pont; Nature 350 (1991), 6; Science 251 (1991), 1174. Cetus is now waiting for the outcome of a case in which they claim Du Pont has been infringing on their PCR patent. In another patent dispute, Amgen has obtained sole patent cover of erythropoietin in the USA; Nature 350 (1991), 99; Biotechnology 9: 327. This decision was a surprise to some, and a blow for Genetics Institute of Cambridge, MA. The dispute between Scripps Clinic and Genentech regarding Factor VIII continues. A review of the book Gene Dreams: Wall Street, Academia, and the Rise of Biotechnology, R.Teitelman (NY: Basic Books 1989, pp.237, US$20) is in JAMA 265 (1991), 1319-20. Two other books describing pharmaceutical development are reviewed in Nature 350 (1991), 201-2.
In Australia the major fermentation-based biotechnology company Sirius Biotechnology, has been paid A$7.3 million to keep it in business by the government; The Australian, March 12, 1991. Its major product is a citric acid substrate, and the Australian government is attempting to encourage biotechnology research commercialisation. Another biotechnology development is called "gene-shears" and was developed by CSIRO but is being commercially developed with sevral foreign companies, Johnson and Johnson of the USA and Groupe Limagrain of France; NS (30 March 1991), 10. There will be a challenge to the patented use of "gene-shears" by the holders of the RNase patent awarded to Cech (EEIN 1:21).
A U.K. company Agricultural Genetics has waved its patent on the introduction of cowpea trypsin inhibitor gene into sweat potatotoes and has been commissioned by the U.K. Overseas's Development Administration to insert this digestive inhibitor gene into the sweet potato, which is an important staple crop in developing countries; NS (16 Feb 1991), 20; Biotechnology 9 (1991), 216. The work will be conducted in several countries, including the International Potato Centre in Peru, in addition to Britain. Interestingly enough, the patented gene was first hinted at by African farmers' observations so it is fitting that it should be opened up. We can hope that other companies also allow humanitarian access to their patents.
A new book Shattering: Food, Politics and the loss of Genetic Diversity, C.Fowler & R.Moeney (University of Arizona Press, 295pp., US$25) is reviewed in NS (30 March 1991), 40. It discusses the International Agricultural Research Centres and genebanks, among its contents.
A comment on the patent challenge to Burroughs-Welcome Inc. regarding the AIDS treatment AZT is in NS (30 March 1991), 6. A significant proportion of the research that led to the development of AZT was publicly funded which has resulted in major criticism of the high price charged for AZT and the exclusive patent cover.

In the first half of 1991 the biotechnology business has been growing at a very fast rate, if the investment of money in stocks, is an indicator; Nature 351: 86. Up to May, in this year alone, 20 companies have gathered US$915 million in investments in the US stock market. Part of the confidence may be the recent patent court cases that have indicated how the courts will respect patent rights.
The subject of industrial liasons with Universities is the subject of a recent report, Government-university-Industrial Research Roundtable, Industrial Perspectives on Innovation and Interactions with Universities (Washington D.C.: National Academy Press Feb.1991), which is briefly reviewed in an editorial in Science 252: 9. Comments on the US Technology strategy are in Science 252: 20-4. It comments on the encouragement of civilian research over military research, and how the US government is trying to do this. A case of University-Company aggreement is being criticised in the US; Nature 350: 645. The question of the ethical bias in the research paid for by pharmaceutical companies is addressed in NEJM 324: 1362-5; JAMA 265: 2309, see also Science 252: 370.
A new OTA report, Federally Funded Research: Decision for a Decade, on the subject of research funding is summarised in Science 251: 1555. It suggests that scientists may not be the best people to decide which research should be funded at the cross-discipline level, and says that US scientists are better off than a decade ago. Comments appear in Science 252: 629.
Two articles on biotechnology are J.S.J.Manuso, "From startup to star: How Biotech CEOs get the job done", Biotechnology 9: 430-3; and B.J. Spalding, "Payer pressure: the emerging force in drug development", Biotechnology 9: 427-9. The cost effectiveness of orphan drugs is discussed in the AJPH 81: 414-5. On the pricing of drugs see P.R.Vagelos, "Are prescription drug prices high?" Science 252: 1080-4. The state of biotechnology research as a national review is R.D.Scnid & H.J.Rehm, "Aspects of biotechnology in a united Germany", Appl. Microbiol. Biotechnology 35: 135-43. On the very high salaries of executives in US biotechnology companies see Science 252: 775. On careers in biotech see Science 252: 1120.
A new book is L.Busch et al. Plants, Power and Profit (275pp., US$40, Blackwell 1991). It is reviewed in Nature 350: 568, it discusses the development of biotechnology and how it will impact on agriculture.
A dispute in Europe is over the recent UK governments' decision not to extend the lifetime of patents, to 16 years from their commercial lauch similar to what is done in the US (14 years) and Japan (15 years), and the same as in France and Italy. Because a drug must be patented before clinical trials begin, at the time that it is patented the remaining 20 year patent may only have 8 years left. The UK government has said it will extend the lifetime to 13 years after commercial use; Nature 350: 645. A comment on scientific secrecy is in Nature 350: 551-2.

A paper on the situation regarding patenting of animals in Europe is in Biotechnology 9: 619-22. It is written by R.E. Bizley, one of the lawyers involved in submitting the case for accepting the "Oncomouse" patent in Europe, and discusses the EPO appeal decision and the question of morality. The terms of European patents should be extended following decisions by the European Commission; BMJ 303: 151. A comment on the UK rules for patenting of recombinant DNA is in NS (27 July 1991), 8. Meanwhile in the USA there are several bills being considered to tighten up the US patent law for protecting biotechnology inventions; Nature 352: 4. The US Patent Office will be charging bigger fees in future: Science 253: 20-4.
There is still much money being spend on research and development in biotechnology; Biotechnology 9: 690-2. The research expenditures are still being increased among US biopharmaceutical companies. See also a paper on search consultants in Biotechnology 9: 623-5. In the USA, Cetus company will be merging with Chiron, to make a large biotech company; Nature 352: 364. Cetus is selling its patent rights to the PCR to Hoffman Roche for US$300 million, plus royalties.
The progress of China's biotechnology programs is discussed in two papers in Biotechnology 9: 705-9, 711-12. There is much work on the production of genetically modified plants, including the insertion of Bacillus thuringiensis toxin genes underway, virus resistant plants have also been developed, and there is research using anther culture, and vegetative propagation, and vaccine research. Plant and animal varieties are not patentable in China. A comment on biotech in Hong Kong is in Nature 352: 273.
A letter on the commercial development of human cell lines is in NEJM 324: 1745-6, in response to a paper in the NEJM 324: 998-1000, and the Moore case. A comment on the selling of cells in autolymphocyte therapy for kidney cancer is in SA (June 1991), 87.
The challenges to the AZT patent are commented on in Science 252: 1369; Nature 351: 508 (EEIN 1: 35, 48). The NIH has granted a non-exclusive patent licence to Barr Laboratories for a generic form of AZT; Nature 352: 268, though it may only be sold from mid 1992 (estimated to cut the current price by 50%). The patent on erythropoietin is still being fought in the USA; Biotechnology 9: 684.

The European Patent Office has approved a patent application on the Harvard "Oncomouse", after six years of debate; Nature 353: 589; NS (19 Oct 1991), 11. This will be challenged by opponents in the courts. A European Parliament Committee directive on animal patents is also expected soon, to encourage biotechnology investment; Nature 353: 8; Science 254: 19.
On the question of patents on genes, see comment on a recent application for patents on 337 human genes simultaneously, in Nature 353: 485-6.
Comment on biotechnology and international research centres is in Biotechnology 9 : 900. On the issue of sharing research fruits; Lancet 338: 811-2. On the question of technology transfer and taxol, a new anti-cancer drug; Biotechnology 9 : 1012. China has introduced a copyright protection law, though patents are covered by a different piece of legislation. It may result in more companies marketing goods in China; Nature 352: 750.
The approval of products can have big effects on the success of companies, and patent trials may do much harm. A monoclonal antibody for therapeutic use against Gram-negative infections and septic shock has been approved in the US. The antibody is produced by Centrocor, whereas a similar product produced by another company, Xoma, is still waiting for possible approval; Nature 353: 101; Biotechnology 9 : 910, 912. A new journal, Biotechnology Therapeutics , is reviewed in Nature 353: 467-8.
The large company American Home Products has bought a 60% share of the biotechnology company, Genetics Institute, for US$666 million; Nature 353: 291. Meanwhile, Hoffman-la Roche, which recently bought PCR patents, is working out how to market PCR-based diagnostics. Also on biotechnology strategies see Science 253: 503-4.
In Japan, an Osaka local court has told the company Toyobo that it cannot market TPA, because it conflicts with the Japanese patent given to Genentech in January 1991. Genentech licensed two other companies to sell TPA in Japan. TPA has been sold in Japan since May 1991. Toyobo is challenging this court case, saying that Genentech's patent is not valid.
A list of the stock holdings of biotechnology companies in the USA is in Biotechnology 9 : 914. On French pharmaceutical industry interests in biotechnology, see Nature 353: 487; and on the joint ventures in Japan see Biotechnology 9 : 916. On the increasing use of private research money for biomedical research see Science 253: 1200-2. An historical essay on the beginnings of the biotechnology industry is in Nature 353: 492-4.
On the issue of commerce in medicine see A.S. Relman, "Shattuck Lecture - The health care industry: Where is it taking us?", NEJM 325: 854-9. Society can not avoid all the health care that industry can give, rather only what is medically appropriate. On pharmaceutical product promotion see JRSM 84: 564-6; NEJM 325: 201-3.
Three Indian pharmaceutical companies are challenging the AZT patent; Nature 353; 589.

The European Parliament legal affairs committee has given their opinion a current draft directive in Europe regarding patenting of animals; NS (23 Nov 1991), 12. The considerations to be made in granting a patent include environmental considerations (including GMO release) and animal suffering, in addition to public concern. The Patent Office will also have to consider applications filed for plant patents, such as that filed by ICI for a tomato that stays firm, though in 1989 it awarded a patent for modifying seed storage genes. On patenting in biotechnology see two papers by R.S. Crespi, TIBTECH 9: 117-22, 151-7.
A report on business is M. Crawford, "Wall Street takes stock of biotechnology", NS (23 Nov 1991), 36-7. By October 1991, an extra US1.5 billion had been raised in 1991, and the balance sheet for the whole industry may have turned to the black for the first time. There are 750 US biotech companies. The industry sales in 1990 were US 1 billion, in 191 they were US$4 billion, and they may be US$50 billion by the year 2000. Genentech is one company with profitable products, in 1988 the sales of human growth hormone reached US$100 million a year, and in 1989 and 1990 the sales of TPA were US$200 million annually. Amgen is expecting about US$400 million from the 1991 sales of erythropoietin. It is unsure whether their will be more biotech companies or not, there are different predictions.
Other discussions on the stock success and biotechnology companies are in Biotechnology 9: 799-801, 818-20, 1032, 1334-7. Also on biotech stock selling see GEN (Nov/Dec 1991), 46-7. However, the bottleneck of approval must be passed; Science 254: 369-70. On the public versus private funding of scientific research see TIBTECH 9: 76-7, 338-9. On European biotech spending see Biotechnology 9: 794, 795. On Canadian biotech business see Nature 354: 423. On global competitiveness, and biotechnology see Science 254: 796, 1565;Nature 353: 785. A new OTA report has been published in the USA, Biotechnology in a Global Economy (USGPO: October 1991, OTA-BA-494). On the new US biotech caucas see Biotechnology 9: 796.
Hoffman-Roche is constructing a new US$100 million research facility in the USA; GEN (Nov/Dec 1991), 3. American Home products has bought 60% of Genetics Institute; Biotechnology 9: 1030. The funds will allow research to continue. There has been a case of BioTechnology General buying back its US sales rights to human growth hormone from Du Pont Merck; Biotechnology 9: 793. There are efforts to improve the biotech industry in New York state see GEN (Nov/Dec 1991), 5, 53. It is said to have a favourable regulatory environment. On biotechnology business in Asia, namely the Pacific Rim countries of Asia, see GEN (Nov/Dec 1991), 11, 53. On technology transfer see TIBTECH 9: 367-8.
On the Japanese court case involving Genentech and Japanese rights to sell TPA (EEIN 1: 77), see Nature 354: 4. It also discusses the case involving the rights to EPO in Japan, which was solved out of court. A court in the US declined to hear a case by Genetics Institute against Amgen, which could set an example, saving companies from costly law suits defending patents against such claims; Science 254: 368. Meanwhile there is a court case being brought by Kodak against Cetus's patent on PCR, which may postpone the transfer to Hoffman-Roche; Biotechnology 9: 1028-30. On biotechnology patents in the USA see Biotechnology 9: 817, where the patents by biotech companies have had more success in this area than those by the giant pharmaceutical companies.
On pharmaceutical research see Nature 353: 873-4; BMJ 303: 1005-6 and on price control see Biotechnology 9: 1338-40. The question of free speech and drug promotion under the new FDA rules is raised in Nature 354: 421; JAMA 266: 2947-8. On scientists ethics rules barring government scientists using time for scientific societies see Science 254: 365.

Greens in the European Parliament have added another case to the protests against patenting of life and living organisms. They are appealing several patent decisions by the European Patent Office, including the decision to award a patent to "Oncomouse" (EEIN 1: 76); Nature 355: 382. The draft directive of 1988 that allows patenting of animals in Europe was finally approved by the legal affair's committee of the European Parliament, but it may be only approved by the Parliament later in 1993. A recent appeal is against the decision to patent the human hormone, relaxin, that was granted in 1991; NS (1 Feb 1991), 18. On the debate in Europe on "the ownership of life" see NS (4 Jan 1991), 9-10. The question of determining whether isolated genes are useful in the patent sense is discussed in Biotechnology 10: 52,55 (see section on the Human Genome Project). In another move on patents, the European Community has agreed to extend the patent life of medicinal products to 15 years from approval; BMJ 304: 74.
The boom in biotechnology business is discussed in NS (11 Jan 1991), 11; SA (Jan 1991), 114-5; and many further products are in the pipeline; Biotechnology 10: 127 A table showing the pharmaceutical companies with the biggest sales is in Science : 407. Among a list of several recent patents is one granted for recombinant hemoglobin to deliver more oxygen to tissues; Biotechnology 10: 114. We can wonder whether future athletes will abuse this.
Sandoz has bought a 60% share of the US company SyStemix in another deal involving a large company buying a majority stake in a biotechnology company; Biotechnology 10: 112, 118. Britain is selling the British Technology Group (BTG); Nature 355: 485. The difficulties of commercial biotechnology in Poland are mentioned in Nature 355: 390. Discussion of the general issues in East-Western European collaborative biotechnology deals is in Biotechnology 10: 21. A recent industry-research collaboration in India is a positive sign for the development of research there; Nature 355: 192. University-Industry relations is discussed in a book review in Nature 355: 121-2; a book review of The Business of Medicine is in JAMA 267: 298; and book reviews on heath care and the market economy are in NEJM 326: 72-4.. For letters on the health care industry; NEJM 326: 205-6, and on drug promotion; NEJM 326: 133-4..
Roche has lowered its controversial PCR fees and has lifted restrictions on the use of PCR; Nature 355: 379. It may have been wise to do so, because it is possible that if there was enough opposition the government could have said that it was such an important patent that it was a "national resource".
There is a favourable review of Equitable Patent Protection by William Lesser (see back page) in the NS (25 Jan 1991), 56.
The question of patenting discoveries in medicine is discussed in an editorial; F.J. Leavitt, "Should we move toward a free-market economy in medicine? Some ethical aspects of desocialization", Public Health Reviews 18: 151-7. It discusses the different paradigms of free market versus socialised medicine. As the author noted in a recent letter; the decision about patenting can be seen in a slightly more favourable light if the patent fees are used to fund charitable work or research, as in the case of the Darwin Trust at the University of Edinburgh.

In 1991 a controversy arose when a a single patent application for 337 human genes was made in the USA which raised questions about patenting policy. In February 1992 an application for patents on another 2375 genes was made by the same people; EEIN 2: 25; Science 255: 663, 912-3; BMJ 304: 725-6, 861-2; Nature 355: 665; NS (22 Feb 1992), 4, (14 March 1991), 7, 9. The patents were applied for on behalf of the US National Institutes of Health, though many inside the NIH are against it. This government body may sublicence particular US companies to pursue research on these genes in an attempt to "protect" the US biotechnology industry from international competition. Governments are debating what policy should be made. The French government; Nature 356: 368, and Japanese genome researchers; Nature 356: 181, have announced that they will not apply for similar patents because of ethical reasons. England's Medical Research Council (MRC) has applied for a similar patent on more than 1000 genes, though England is joining France in calling for an international agreement to waive any of these patents if they should be granted; Nature 356: 98. The human genome is common property of all human beings, and no one should be able to patent it. Public opinion (see results in my new book) could force a policy change regarding the patenting of genetic material, even if it is judged to be legally valid. OECD minister's tried to defuse the debate; NS (14 March 1991), 9, and speedy decisions on the validity of such patents should be made.
Third World countries should control their own genetic resources; NS (15 Feb 1992), 7. On the responsibilities of chemical companies in the Third World see Science 255: 1489. European biotechnology patent policy is still being debated (EEIN 2: 21) see Lancet 339: 355. Australia is likely to permit patenting of living organisms; Nature 356: 372.
Comments on drug development and patent law are in NY State J Medicine 92: 86-7. The guidelines on the use of PCR have been eased by Roche, and royalties will drop to 9%; EEIN 2: 21, Science 255: 927; Biotechnology 10: 236.
The profits of biotech firms in the USA in 1991 are presented in Biotechnology 10: 354, 7. Total sales were about US$2 billion, but still the total industry may not have made a profit. On investment in biotechnology and industry fears of FDA regulations in the USA see Biotechnology 10: 364-5; Science 255: 381; Chemistry & Engineering News (10 Feb 1992), 20-21. The public offering of stocks by British Biotechnology Group is expected soon; Biotechnology 10: 363, and of a company in Boston, Nature 356: 183. A group aimed at encouraging biotechnology commercialisation from Chinese research has been formed in Hong Kong; Science 255: 1635. Reviews of three books on biotechnology are in Nature 356: 203-4.
Government biotechnology research funding for fiscal year 1993 in the USA is discussed in Biotechnology 10: 230, 234, 238, 240, 242-3, 370, 372, with the NIH receiving 73% of the total. Canadian drug research has been boosted by decisions on patent policy; Nature 355: 666. Orphan drugs remain contentious because of the large profits from some of them and the 7 year monopoly granted to them; Biotechnology 10: 464; Science 255: 681; BMJ 304: 465. A general shift in the USA to more government funding of industrial research is discussed in Science 255: 1062, 1500-2. A review of scientific research in Europe is in BMJ 304: 899-903.

The debate over patents on gene sequences continues (see EEIN 2: 25, 35). The US Pharmaceutical Manufacturers Association has written a letter to the Health Secretary Louis Sullivan calling for the sequences to be placed in the public domain; SCRIP (10 June 1992), 19. Scientists also continue to voice their opposition; Science 256: 1273-4. The resignation of Jim Watson from the head of the US Genome project is related to two issues involving finance, at least, and many suggest it is mainly because he disagreed with the patenting of cDNA sequences which the NIH is attempting; Lancet 339: 980-1; Biotechnology 10: 469; NS (18 April 1992), 6. A voice in favour of such patents is in Biotechnology 10: 600, and addiitonal comments in Science 256: 11, 603; Nature 356: 738; 357: 270. The US patent position become more isolated in the Rio conference, as it refused to sign the biodiversity treaty, primarily because of the waiver and sharing of patent rights; Washington Post (6 June 1992), A20.
On the question of legal rights to cell lines, and arguing against the property law approach used in the case Moore v. Regents of the University of California, see AJLM XVIII: 127-45. The gene entrepreneur, Frederick Bourke, who has been involved with several attempts to commercialise genome research, is now attempting to find some European scientists to form a cooporation; Science 256: 955.
More on the European patent debate in Lancet 339: 981; NS (23 May 1992), 7. New developments in international patent law of interest to biotechnology are discussed in TIBTECH 10: 108-10; and the major industrialised countries may be harmonising their patent systems; Nature 356: 645-6. In the sensitive regulatory climate of Germany and Switzerland, Ciba-Geigy has recently started building a plant for production of recombinant DNA products in neighbouring France, where the regulations are less; Science 256: 608-9.
A break down of the percentage of the world market that some major pharmaceutical comapnies have, and the world share of pharmaceuticals in Sept 1991 is in Chemistry & Industry (20 April 1992), 298-300. A review of research sources and research productivity internationally in molecular biology is in Science 256: 460-4. Amgen is going to be marketting recombinant DNA products (erythropoietin) in China by the end of 1992, in competition with other comapnies from the US and Japan ; SCRIP (3 June 1992), 13. The agricultural biotechnology companies are beginning to show profit, and a report on 1991 earnings is in Biotechnology 10: 497. Realted to biotechnology business see Nature 356: 630.
The plans of British Biotechnology for public stock are discussed in Chemistry & Industry (4 May 1992), 326-7; SCRIP (10 June 1992), 10-11; Nature 356: 736. The stock successes of biotech companies are reported in Biotechnology 10: 481, 484. The links between Japan and the USA in biotechnology are being questioned by a US National Research Council's report; Chemical & Engineering News (25 May 1992), 11-2; Chemistry & Industry (1 June 1992), 307; Science 256: 1133. Government spending on the biotechnology initiative in the USA compared to other research is discussed in Science 256: 439; Amer. Soc. Micro. News 58: 252-3; and in the state of Massachusetts Science 256: 768-9. A discussion of the formation of international alliances is in Biotechnology 10: 528-33. Meanwhile, Japan is spending less on biotechnology due to the economic downturn; Biotechnology 10: 495. In Italy, a vaccine research institute has been purchased by a US company, which will save closing the research institute; Nature 357: 6.
On what is called the second generation biotechnology, see a series of articles in Science 256 (8 May 1992).
Korea is encouraging research imports from the industrialised countries; Nature 357: 100. The description of one US-based technology transfer scheme for agricultural biotechology is in Nature 356: 735, which has several restrictions, such as transferring technology for crops that may not compete with US products, and only transferring technology to politically and economically friendly countries. We can hope that more transfer occurs, but that it is not selected by political forces.

Arguments against the patenting of life forms are in geneWATCH 8(2), 8-9. Arguments for the patenting application by business concerns are in GEN 12(1), 4, 32.
Regarding the NIH cDNA gene patent applications, see a letter including some public opinion data that I sent in Nature 358: 272. Extended articles on the topics include: R.S. Eisenberg, "Genes, patents, and product development", Science 257: 903-8; R.G. Adler, "Genome research. Fulfilling the publics expectations for knowledge and commercialisation", Science 257: 908-14; T.D. Kiley, "Patents on random complementary DNA fragments", Science 257: 915-8. Kiley calls the patent applications a mistake, while Adler focuses on technology transfer to industry. Other comments are in Biotechnology 10: 740-1, 811-2; Nature 357: 525, 358: 176; SA (July 1992), 82-3. Venter has recently signed a joint letter calling for an end to "patents of naturally occurring gene sequences" in favour of gene patents only on the uses of those patents, which was also approved by participants in a recent South-North human genome conference held in Brazil. The UK MRC applied for patents in the UK on 1,100 cDNA gene fragments; NS (4 July 1992), 9.
A new report is U.S.-Japan Technology Linkages in Biotechnology. Challenges for the 1990s (National Research Council, 98pp. It lists many of the US-Japan linkages, and business cooperation. A review is in Biotechnology 10: 744-5; SA (Aug 1992), 96. A recent court decision in Japan involving several cross-licensing agreements on TPA has gone against Toyobo in favour of Integrated Genetics, which crosslicensed its TPA to Mitsubishi Kasei and Kyowa Hako; Yomiuri Shimbun (25 Aug 1992), 15. Sumitomo is also preparing to launch TPA, under license from Welcome UK so it may also be under court challenge. The Japanese market for TPA is about US$80 million, and is expected to reach the order of US$800 million in the future - so it is a serious loss. Moves to encourage more industrial development in biotechnology in Britain are discussed in Biotechnology 10: 736-7; and on the low investment in European biotechnology see NS (11 July 1992), 4.
A review including data on recent European Patent Office (EPO) biotechnology patent applications is U. Schmoch et al., "Patent law and patent analysis in biotechnology", BFE 9: 379-84. They report that the legal restrictions regarding European patent law are not as strict as commonly believed in biotechnology, and the number of patent applications is a measure of R&D activity. Meanwhile, the EPO has upheld the first plant patent it issued after appeals were made to revoke the patent; Nature 357: 525. The EPO has said that patents may be granted on plants, but not on plant varieties - just what exactly this means and the final policy after political pressure, is not so clear.
A review of biotechnology in the Western Pacific Rim countries, in particular in Hong Kong is in GEN 12(9), 12-3; and in China , GEN 12(3), 12-3; 12(7), 12-3. On biotech companies in Canada see GEN 12(7), 14, 22. Other comments on biotechnology business are in Biotechnology 10: 647-53, 654-8, 728-9, 738-9, 842-4, 846-7, 850, 873-5, 867-9, 928; Nature 357: 626-35 (in Texas); 705-6.
An editorial in Nature 358: 2, calls for a court case to settle the AIDS patent case, between the French and the NIH. A court case would bring the facts into the open, and is preferable to negotiations behind closed doors (or the current lack of negotiations). British researchers accuse the Pasteur Institute of ignoring their help in developing the HIV test; Nature 358: 358.
The issue of pharmaceutical promotions is in NEJM 327: 351-3.

The US Patent Office has made a preliminary decision against the NIH cDNA patent applications (EEIN 2: 63); Science 257: 1620, 1855; Nature 359: 263. They said that they could find some partial sequences in existing databases so the application lacked non-obviousness; and they also said it lacked novelty since they used a publicly available cDNA library. It is expected that this decision will be appealed, as it raises some problems for patent applications on DNA sequences. The issue will therefore probably continue; also see comments in Nature 358: 617; Science 257: 1462. Most applications for patents are rewritten after the first ruling. A secretary of the British MRC has suggested that copyright law might provide researchers with a better way to protect commercial applications while avoiding any obstruction in data flow; NS (10 Oct 1992), 9. But the MRC was not planning to pursue it. The ethical arguments against copyright would be similar to those against patenting, basically the information is naturally occurring, and common property. Technology transfer in general from the NIH to industry is reviewed in Nature 359: 187. Meanwhile the NIH has attempted to apply for patents on a further 4,000 genes; NS (3 Oct 1992), 7. A US lawyer in the Department of Health and Human Sciences has blocked the application; Nature 359: 467.
The future of patents for monoclonal antibodies is discussed in Biotechnology 10: 1082-3. The difficulties of introducing monoclonal antibodies to the healthcare market are discussed in NS (26 Sept 1992), 31-5. Reforms in the US patent system are likely, see Science 257: 1195. The intellectual property system in Britain is discussed in Nature 359: 264. The dispute over the HIV testing patent between France and the USA continues, though the US has not reopened the case; Science 257: 1855.
The question of how much we own our body is discussed in C.S. Campbell, "Body, self, and the property paradigm", HCR (Sept.-October), 22: 34-42. It touches on issues of patents and commercial organ markets, and considers the idea of stewardship over the body.
The average cost of developing a pharmaceutical in the USA during the 1980's has been estimated to be US$114 million. This high cost raises questions about where comparatively small biotechnology companies can get enough finance to sell even a single product, and this is discussed in GEN (15 Sept 1992), 1, 6-7. One can wonder whether it is possible at all without the cooperation of a large pharmaceutical company.
One way many small US companies are obtaining finance is by alliances with Japanese pharmaceutical companies; GEN (15 Sept 1992), 8, 10-12. A new biotech company called Fuji Biotech is being started as a US company in Boston; Science 257: 1627. On science research in Japan see Nature 359: 573-82. Business news boasting the worth of the company Myogen is in Biotechnology 10: 1090-1. The market values of biotech companies are reported in Biotechnology 10: 951, 954-5. The views of company representatives on selling stock is in Biotechnology 10: 946-8, 1074-6, 1084-5; and wages are in p. 963-6; with the employment situation discussed in Science 257: 1718-21, 1765. European biopharmaceutical companies and their research are discussed in Biotechnology 10: 1108-10. The company ICI in the UK has said it will split, forming a large biotech company; Biotechnology 10: 952. A special case of a Lithuanian biotech company and their success in selling and developing restriction enzymes is reported in Science 257: 1473-4.
Agricultural research in the USA is a mixture of federal, state, university and industry, and more funding is called for; Science 257: 1187. The US Congress has announced that it will transfer US$210 million from military budgets into breast cancer research; Science 359: 471. In Japan, the Ministry of International Trade and Industry has increased biotechnology investment; Bio 10: 1084-5.

More comments on the cDNA patent applications from the robotic human gene sequencing at the NIH (EEIN 2: 63, 77) are in Science 258: 209-10; Biotechnology 10: 1410. It includes a summary of the reasons why the US Patent Office rejected the first cDNA patent applications - interesting because the NIH has not made public the US Patent Office report. The application was rejected on all three grounds needed for patents: novelty, non-obviousness, and utility. However, lawyers suggest it may be possible to overcome the Patent Office objections. A comment from Dr Bernadine Healy on the role of the NIH in the future bioeconomy of the USA, including comment on the cDNA patent applications is in GEN (15 Nov 1992), 4-5.
The European Parliament may be getting closer to approving more biotech patents on plants or animals; Lancet 340: 1152-3. The amended European Parliament rule may allow "farmer's privilege", so that farmers pay royalties on a patented gene in a seed or livestock only once, not every time the gene is passed to a descendant. It will also forbid the patenting of cloned "human parts"; NS (28 Nov 1992), 8. Final decisions are not expected until later in 1993. There continue to be protests; Nature 360: 286 The change to first-to-file system will make life easier for biotech companies; Biotechnology 10: 1383; but is it fair? If two people think of the same idea and one files for a patent and the other doesn't, does the act of filing make one entitled to benefit commercially from it, and to exclude others from doing so - including the other inventor?
Although not a case of patents, it may be interesting to think about who owns fossils, and the cases where academics and collectors dispute over dinosaur bones; Science 258: 391-2.
In the last few months both Science (23 October) and Nature (15 October) had special issues on science in Japan . The Nature papers are specifically designed to aid the reform of Japanese science, while the Science issue includes more papers and may be more descriptive, in addition to featuring some research articles written by Japanese scientists. A letter pointing out the capitalism in Japan' hospitals is in Lancet 340: 1293.
Hungarian biotechnology is reviewed in Biotechnology 10: 1429-32. Book reviews on US research are in Science 258: 674-5; and Genentech has begun a new giant biotech research center; Science 258: 895. The merger of the two large US biotechnology industry associations IBA and ABC is expected soon; Science 258: 879. The biotechnology stocks in the USA rose and fell in 1992, a report review is in Nature 360: 200. It is expected that about 80 new companies may have started in 1992 in the USA. A review of biotechnology research centres in the USA is in an 8pp. supplement to GEN (15 Nov 1992).
The importance of GATT negotiations are discussed in Nature 360: 195-6. The strategies to accelerate commercialisation in biotech are discussed in Biotechnology 10: 1400-1. A book review on the world pharmaceutical industry is in Lancet 340: 1274. On the balance between basic science and commercial science see Biotechnology 10: 1387. The Clinton agenda for technology is discussed in Science 258: 1076-8. A report on the reorganisation of science organisations in Australia and New Zealand to attempt to obtain more industry funding is discussed in NS (31 Oct 1992), 12-3.

A Japanese company, Sagami Central Chemical Research Institute, has applied for patents on 60 human gene sequences; Yomuiri Shinbun (13 Feb 1993),15. Although it is thought that these genes produce useful proteins, details are unknown. Further comment on the NIH cDNA patent application is in BioScience 42 (1992), 336-9; Nature 361: 199. A report from the Biotechnology and Law Conference '92 suggesting that the cDNA patent applications by the NIH will damage NIH-industry relations is in GEN (Dec 92), 1, 29. The US Congress is introducing a law to make it easier for biotech companies to win patents on manufacturing processes; Science 259: 898. On the otherhand, the US has admitted that tropical countries have rights to plants, in the case of a vine from Cameroon which may produce a useful anti-AIDS compound; NS (16 Jan 1993), 12-3.
Patent fees are being requested on the cystic fibrosis gene, even though the patent is not yet awarded; NS (23 Jan 1993), 4; Lancet 341: 300. For some researchers, such patent fees may discourage studies. European researchers are challenging these royalties; Biotechnology 11: 23. Roche is asking other companies who make the enzyme Taq Polymerase which can be used for PCR to stop producing it, and is trying to enforce its patent; Science 258 (1992), 1571-2. Other companies are selling large quantities of the enzyme at up to 60% less than Roche. Although officially for other purposes, researchers are using it for PCR reactions, because it is cheaper.
The US Patent and Trademark Office awarded three further animal patents on the 29 December; Nature 361: 103. These are the first patents issued on animals since the 1988 patent for the Harvard Oncomouse. The three patents were mouse models for disease study, for prostrate enlargement (from Harvard); for production of beta-interferon to protect against viral infections; and a mouse that fails to develop T-cells that may serve as a model for AIDS, transplant rejection or rheumatoid arthritis. There are a further 185 applications being processed. The issuing of these patents signals the policy that animals can be patented, though these claims are all much narrower than the 1988 Harvard patent, only applying to the one species, mice. The Oncomouse patent applied to all non-human transgenic animals containing an activated carcinogen, which is very broad.
In Europe , a coalition of 26 animal welfare groups are formally opposing the European Patent Office Decision to grant a patent to the Oncomouse; Nature 361: 103, 192; NS (16 Jan 1993), 7. The debate is over the morality clause, and the patent office will have to reconsider what is moral. Also the European Parliament is considering definitions of morality for the purposes of patent exclusion; Biotechnology 10 (1992), 1525; Nature 361: 285. On the question of what is immoral in patent law see TIBTECH 10 (1992), 375-8. Europe may increase the length of patent duration in general; NS (2 Jan 1993), 20-21.
Predictions on the future market size of biopharmaceuticals are in GEN (Jan 1993), 4-5. The total U.S. sales for the year 1992 were US$2,430 million, and this is predicted to increase to US$9.3 billion in the year 2,000. Predictions on the 1993 biotechnology stock market by various analysts are in GEN (15 Jan 1993), 16-7; Biotechnology 11: 168-72. At the end of 1992, the biotech stock market was weak; Biotechnology 10 (1992), 1518-9. The company Centocor lost much ground, and will have to make reductions in staff following bad clinical trial results with its monoclonal antibody product Centoxin in treatment against sepsis, namely, unexpected patient deaths, Nature 361: 290; Lancet 341: 298.
Research in biotechnology in Finland is reviewed in Nature 360 (1992), 528; and in Carlsberg breweries in Denmark, in Nature 360 (1992), 519. On the situation in the EC market see Biotechnology 10 (1992), 1545-8. Positive reports on Spanish molecular biologists are in Science 258 (1992), 1876-7. A report on the Third Conference on Biotechnology in the Pacific Rim held in Taiwan in November 1992 is in GEN (Jan 1993), 10.
On January 11 the Association of Biotechnology Companies and the Industrial Biotechnology Association announced that they will form a single US organisation, the Biotechnology Industry Organisation. This will include 490 firms, about 90% of the total. This is subject to ratification by the annual meetings in February and April of the two "former" groups. The US pharmaceutical industry is under challenge from the new US administration; Lancet 341: 231; and a report on Clinton/Gore possible policy on biotechnology is in Biotechnology 10 (1992), 1514-6; 11: 24-5. A report on the Texas company Agristar is in a Texas supplement in SA (Jan 1993), TX10. Japanese company investment in research, including biotechnology, is discussed in Science 258 (1992), 1431-3, 259: 596-8; Biotechnology 10 (1992), 1535-8. Sandoz Pharmaceuticals will provide Scripps Research Institute with research funding of US$300 million over ten years from 1997, in exchange for rights to patents; Biotechnology 11: 13. University-industry ties and agreements are discussed in Science 258 (1992), 1570, 1874-5; JAMA 268 (1992), 3344-9; Nature 360 (1992), 701. Possible conflicts of interest are the subject of letters in Science 258 (1992), 1717; NEJM 327 (1992), 1686-8.

Birth Control In the US state of Washington a proposal has been made to support the involuntary insertion of Norplant contraceptive in a woman following the birth of a child with fetal alcohol syndrome or addicted to drugs; Reproductive Freedom News (5 Feb 1993), 7. A report from Tibet of enforced family planning by the Chinese government is in BMJ 305 (1992), 1505. This includes forced sterilisation.
Positive comments on the US acceptance of Norplant contraceptive are in Nature 360 (1992), 699; JAMA 268 (1992), 3418. The use of oral contraceptives by adolescents in Finland is discussed in BMJ 306: 63; and in Sweden in J. Epidemiology & Community Health 47: 32-5.
A book review of the autobibliography of Carl Djerassi is in Nature 361: 28. A conference report stressing the safety and efficacy of IUDs is in MJA 157 (1992), 582-4. Bad publicity has meant that they are not widely used in many countries. The use of hysterectomy (female sterilisation) in Australia has declined in the past decade, but may be changing again; MJA 157 (1992), 651-3. A book review of Germaine Greer, The Change: Women, Aging and the Menopause (Penguin), is in Nature 361: 217-8. A call to stop male circumcision is made in BMJ 306: 1-2, 28.
A review of the world population explosion is G.C. Daily & P.R. Ehrlich, "Population, sustainability, and Earth's carrying capacity", BioScience 42 (1992), 761-71. The Indian loving attitude to children is blamed as one reason for the failure to curb the birth rate; BMJ 305 (1992), 1582-3. Family planning problems in Iran are reviewed in Lancet 340 (1992), 1401.

A US movement against animal patents has regrouped; NS (13 Feb 1993), 8, following the recent granting of patents to transgenic animals (EEIN 3: 20; Biotechnology 11: 270). A US company, GenPharm, has reduced the price of knockout mice to lower concerns about its patents, Science 260: 234. Europeans continue their protests against the original animal patent, Nature 361: 574; 362: 490; Biotechnology 11: 245-7. As reported in the last issue (EEIN 3: 20), the Sagami Chemical Research Centre in Japan has applied for patents on 60 human genes, the cDNAs of which have been partially characterised; Nature 361: 576. The OTA has opened its inquiry into gene patents; Nature 362: 386.
A discussion of process or product patenting for biotechnology is in Biotechnology 11: 474-6. The US rules on process patents may be made easier if new bills in the Congress and Senate are passed; Science 259: 898. The Congress is examining whether drug companies should profit from research funded by the US government, as discoveries are sold; NS (20 Feb 1993), 7; Science 259: 889. Also on patents see NS (20 Feb 1993), 44; TIBTECH 11: 39; Nature 362: 489.
The rising costs of pharmaceutical drugs are discussed in Time (8 March 1992), 43-5. A Canadian study found that generic drug competition can lower prescription drug prices, CMAJ 148: 35-8, 23-5.
Amgen has set up a US$80 million facility in Toronto, Canada, to research immunology, GEN (1 Mar), 1, 25; Nature 361: 194. On the role of science in wealth creation and the likely British strategy on science funding see Nature 362: 584. The relationship between basic and applied research is often misunderstood according to a paper in R&D Innovator 2(4), 1-3, 10. The main product of universities is said to be trained people, not results. A book review of Technology and the Wealth of Nations is in NS (13 Feb 1993), 45.
The 1993 biotechnology budget of the Science and Technology Agency (STA) in Japan has increased 17% from the 1992 total, to 26.5 billion yen. The genome project will receive 1.64 billion yen from the STA. The Ministry of Agriculture, Forestry and Fisheries (MAFF) is spending 10.11 billion yen on biotechnology; the Ministry of Education plans to spend about 20 billion yen on bioscience. However, Japanese companies are keeping their general research rates constant; Nature 362: 193. The sales of interferon are rapidly rising in Japan, since it was approved for use against chronic hepatitis C; Nature 362: 6. Last year sales were 150 billion, and they should be about 200 billion in 1993. this is about one third of the Japanese biotech sales. The sales now total 1% of the drug bills of the national health insurance, and restraint is called for. The lack of clear Japanese guidelines to encourage biotechnology research is criticised in Science 259: 1678.
British companies are asking for more investment in biotech; Nature 361: 572. A review of Genentech is in Nature 362: 397. A series of articles on the history and future of biotechnology are in a 42 page supplement to the March issue of Biotechnology . It includes a breakdown of sales of biotech recombinant DNA protein products in the USA and in the world. The 1992 stock market fates of biotech companies in the USA is reviewed in Biotechnology 11: 426-8. On agbiotech see Biotechnology 11: 268, 274-5.
A list of companies that belong to the Industrial Biotechnology Association and Association of Biotechnology Companies is in GEN (1 April 1993), 18-9.

The Australian patent office has issued its first animal patent , for a fast-growing lean pig; Washington Post (15 April 1993). The company Bresatec is owned 44% by the University of Adelaide and 20% by American Cyanamid Co. Pig growth hormone genes are transferred and only 5 of 150 pigs so treated have changed. On the issues of patenting animals see D. Nelkin, "Living inventions: Animal patenting in the United States and Europe", Stanford Law & Policy Review (Winter 1992-3), 203-10. The need for public involvement in the development of policy is stressed. Letters on opposition to Oncomouse patents are in Nature 363: 577; C&I (1 Feb 1993), 68.
The advantages and problems of a harmonised patent law are debated in GEN (15 Feb 1993), 3, 20. In Japan the Ministry of International Trade and Industy is spending more money on improving gene banks and microbial dispositories; Yomiuri Shinbun (22 July 1993), 6.
The long dispute between Genetics Institute and Amgen over erythropoietin (EPO) has been settled by a mutual agreement; GEN (1 Jun), 1, 30-1; Nature 363: 196. Their original dispute began 6 years ago, with several variations. The settlement applies to all US court cases involving the issue. Genetics Institute is paying US$14 million to Amgen. The 1992 US sales of EPO to Amgen were US$506 million, for dialysis patients.
A discussion of patenting of cDNA patents and other human gene patents is in Biotechnology 11: 736-7. The Coulmbian immunologist M. Patarroyo has donated patent rights on the malaria vaccine to the United Nations; Science 260: 1238. A protest campaign by Greenpeace against patenting a herbicide-resistant plant in Belgium is discussed in C&I (4 Jan 1993), 4.
The PCR patent is being challenged by a US company Promega Corp; Science 260: 486. On patent law see Biotechnology 11: 742. The patents owned by Stanford University are listed in Nature 363 (17 June 1993). The recombinant DNA technology patent has earned them about US$14 million.
A review of an agricultural biotechnology Agribusiness conference is in GEN (1 May 1993), 1, 24. It is suggested that the companies are undervalued, and are becoming more profitable. A list of US scientist millionnaires with stocks in biotech industry is in GEN (15 April 1993),15. A report on where the US biotech companies get their money is in Science 260: 908-10. A list of venture capital companies with interests in biotech is in GEN (15 April 1993),16-8. The yearly changes in US biotech companies to the 8 March are reported in GEN (15 March 1993), 19; and to 3 May, in GEN (1 Jun), 22. Also on financial reports see Biotechnology 11: 545, 548, 554, 654-5. On recent alliances between companies see Biotechnology 11: 672. In Canada venture capital is begining to be used much more than in the past in the biotech industry; GEN (15 March 1993), 3, 23. A list of some recently founded Canadian biotech companies is also given.
On the emerging US biotech policy see Biotechnology 11: 536, 544-5, 558-9. A review of biotech in Southern California is in GEN (15 April 1993),19-23. The regulatory environment also favours the continued development there, and many institutes are centred there. New York City has been suggested as another area that should encourage biotech industry; GEN (1 Jun), 1, 12, 32.
Technology transfer incentives from John Hopkin's University School of Medicine and the University of California are part of a trend in universities to encourage commercial funding of academic research; GEN (15 April 1993),5, 7. On Caltech see Science 260: 1825-7. In the USA the companies Calgene and Quadrant have formed a joint company to commericalise applications of trehalose , a naturally occuring sugar that stablises biological matter when drying; GEN (15 Feb 1993), 1, 14, 25. Research into DNA sequencers and synthesisers is a major area of commercial research, and is reviewed in GEN (15 March 1993), 8-9, 24. Research into cell adhesion is reviewed in Science 260: 906-8; and marine biotechnology is receiving more funding in Nature 363: 200.
A general description of European bioindustry is in GEN (1 Jun), 4, 19, 20; and on the law in Europe see p. 8, 30; French biotech, p. 10-11, 37; The Netherlands, p. 12-3; the U.K., p. 14-5. European biotechnology trade associations are consolidating, following the joining of the US associations; Biotechnology 11: 551. Switzerland has loosened regulations for foreign workers; Nature 363: 483. A Latvian biotech company has been involved in illegal production of the drug speed; Biotechnology 11: 549. A review of science in Europe including biotechnology is in Science 260: 1734-58. A review of a book on the history of biotechnology is in Biotechnology 11: 620. On biotechnology in Chile see Nature 363: 489.
A review of Italian biotechnology is N. Jordan & K. Simpson, A Strategic Overview of the State of Italian Biotechnology, March 1992. Contact them at Benezech-Simpson & Co., Hameau de Bobon, 07610 Vion, France (FAX Int+33-75-06-86-33). There is a small section on regulatory and social aspects, public opinion in Italy is favourable as shown by the Eurobarometer poll in 1991. It includes a list of Italian biotech firms, and biotech research projects. They criticise the lack of a strategic policy for biotechnology in Italy, a lack of technology transfer. Italy is one of the world top five economies they say, and it should spend money and invest in biotechnology.

The company Pfizer has decided to give out free 11 of its drugs that are not reproduced by other companies, to poor people in the USA, Nature 364: 746. This is a public relations exercise, that is also good for medicine. A review of the contributions of charities and foundations in scientific research in US, Europe and Japan is Nature 364: 741-4.
Oncomouse was the first animal to be patented, but 5 years later there has been little profitable use of it by companies, so Du Pont is lowering prices and trying to encourage sales; NS (26 June 1993), 4. It is ironic after all the attention given to the patent case that in the end industry does not want it, researchers can use it without royalty.
Problems in US regulations for biotech industry are in Science 260: 1867. Comments on patent reform, for the process patent bill in the USA are in Nature 364: 274; Biotechnology 11: 778-9. The AZT patent case is being appealed, following a decision saying that the NIH did not have enough of a claim to invention in the law to overturn the Burroughs-Wellcome patent; Science 261: 545. Big users of the PCR will get discount from Roche, but there is still concern that the price of the enzyme Taq polymerase is too high compared to the costs of making it, Science 261: 678.
A review of biotechnology industry in Maryland, USA is in GEN (July 1993), supplement 12pp. Sales of monoclonal antibodies are expected to rise to US$3.8 billion, from there 1993 level of US$740 million; GEN (Aug 1993), 3. The spending in the USA on agbiotech in 1992 was 40% higher than in 1991; Biotechnology 11: 875; but overall biotech spending increased 71%, Biotechnology 11: 768-80. On the Scripps-Sandoz deal, Science 260: 1872, 261: 27; Nature 364: 477. The Stanford patent on Cohen/Boyer recombinant technology will expire in 1997, after earning an estimated US$87 million; Nature 363 (27 June 1993). NAFTA may increase agricultural markets in Mexico, Biotechnology 11: 781-2; and on competition, Nature 364: 271. A conference report of the meeting of the former two US biotech industry groups which have now formed the Biotechnology Industry Organisation (BIO), based in Washington, is TIBTECH 11: 220-2.
Papers on science in Europe are in a special issue of Science 260: 1734-78, 1703. On regulations see pp. 1734-5. On proposals to reform the UK biotech industry, Nature 364: 666-8.

A Russian scientist has made a claim against the patent on the Taq polymerase enzyme used in PCR ; Nature 364: 2. The enzyme he described is identical to one that received a US patent. Therefore the European Patent Office has turned down the patent application on novelty grounds. A report on European patents is in Nature 364: 3, saying that the average cost of filing a patent in Europe is US$38,000, compared to about one half in the USA and one quarter in Japan. Different types of patent protection in Europe are compared in Biotechnology 11: 1174-5. Biotechnology patent protection in Japan is described in Biotechnology 11: 1056-8.
Conflicts of interest in drug regulation is debated in Lancet 342: 732. The reasons for conflict of interest in the USA may include the compensation scientists can receive, see a report on 1993 figures in Biotechnology 11: 994-6. The grey areas of defining basic research are discussed in Science 261: 972-3. The deregulation of Pakistan drug prices is causing many complaints about rising costs of main drugs, Lancet 342: 809.
The discussion of royalties to countries whose germplasm are used for commercial plant breeding or perhaps for other medical or agricultural benefits is being discussed, Science 261: 107. See also the above section on biodiversity for recent papers on valuing germplasm. The merits of plant variety rights protection and patents are debated in Biotechnology 11: 1102-3. The exemptions for research may be misused by competing companies. A commentary on the US corn genetics business is in Biotechnology 11: 980. Nutriceutical development is slow in the USA, possibly due to ill-defined regulations, Biotechnology 11: 969-70.
A new biotech group called the California Healthcare Institute has been formed, Nature 365: 100. A list of recent alliances in biotechnology business world is Biotechnology 11: 992, see also p. 1112, 1120-23. International biotechnology business deals are discussed in Biotechnology 11: 1106-7, 1109, 1110.

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