From elastic!lethe!geac!onramp.ca!news2.insinc.net!news.iosphere.net!news.supernet.net!news.magicnet.net!feed1.news.erols.com!howland.erols.net!news.mathworks.com!uunet!in2.uu.net!world!srctran Wed Nov 20 20:40:07 1996 Xref: elastic misc.int-property:821 Newsgroups: misc.int-property,alt.inventors,sci.bio Path: elastic!lethe!geac!onramp.ca!news2.insinc.net!news.iosphere.net!news.supernet.net!news.magicnet.net!feed1.news.erols.com!howland.erols.net!news.mathworks.com!uunet!in2.uu.net!world!srctran From: srctran@world.std.com (Gregory Aharonian) Subject: PATNEWS: Tons of biotech patent news from Minneapolis Message-ID: Organization: The World Public Access Internet, Brookline, MA Date: Fri, 15 Nov 1996 03:45:55 GMT Lines: 361 A few weeks ago I attended a biotechnology patents conference out in Minneapolis. I had a fine time, met a few people who get my patent news, and got to visit the Mall of America (three floors of every trendy store in the country surrounding a Snoopy theme park - though I did have some good ribs). The conference was sponsored by the Minnesota Intellectual Property Law Association, the law firm of Merchant & Gould, and one other firm that escapes me at the moment. Some of you might wonder why biotech conferences are being held in the MidWest (which for those of you fans of Mark Twain is part of the drainage plain of the Mississippi River system which is that part of the country that separates the puritans on the East Coast from the wackos on the West Coast, though as a woman friend of mine wise beyond her beauty in Missouri has pointed out, if the Mississippi was based on the Missouri it would be the longest river in the world, but I digress). Anyways, the fortunes of the agricultural industry in the future will rise and fall on biotechnology. Germ lines of many food seeds are getting as bad off as the germ lines of the Romanovs, so the seed companies either have to combine new genes from wild plants (incuring the wrath of the third world) or genetically transform their existing seed lines (incuring the wrath of groups in the United States), or both (and both). Throw in biotechnology for altering plants to make fuel oils, transform plants to require less chemical processing (i.e. strains of cotton that are colored, eliminating dyeing), etc., and it is not surprising that biotechnology is of increasing interest in the MidWest, and that law firms like Merchant & Gould (3100 Norwest Center, Minneapolis, MN, 55402) are expanding into this area. Minneapolis is also home of 3M, which while not known as being big in biotech, is a player (for example, their patent 5444065 "Fused cycloalkylimid asopyridines as inducer of interferon .alpha. biosynthesis"). The conference speakers were very informative, and the conference flowed quite smoothly. My only suggestion for future such conferences is to prohibit speakers from directly reciting the contents of their handouts. Instead, give everyone ten minutes to read through the handout, and then allow questions and short discussions. Other than that, the speakers provided a lot of useful information, even the bureaucrats. What follows is interesting comments and tidbits about biotech patenting that I wrote down, with some biotech patenting news from other sources that you can give credit to the conference organizers for inspiring me to include. I might have misinterpreted some parts of the talks, so don't take the following as gospel. ==================== The first speaker was Doctor Leo Furcht, from the University of Minnesota medical school, talking about the convergence of the biotechnology information manipulation (using DNA) and silicon-based information manipulation (global networks). At one point, he reflects on comments made by Lester Thurow that "The research and development funds that produced biotechnology 'would never have been advanced by capitalism', Thurow writes. They came from 30 years of massive government investment, mainly in basic research funded by the NIH." Dr. Furcht noted that a good way to measure these money flows is to look at all of the labs that the NIH funded and the resulting spinoff companies nearby. Dr. Furcht recommends for those interested in biotech and law a book that was published last year, "The Golden Helix: Inside Biotech Ventures" by Arthur Kornberg. Another interesting comment was that at his labs in the University Hospital, it sometimes costs more to draw the blood than to do genetic tests on the blood, a weird way technology has changed the economics of medicine. ==== The next speaker was Mark Ellinger of the law firm of Fish and Richardson, who gave a talk titled "Is DNA a chemical - implications of applying chemical case law concepts to biotechnology compounds". He spoke a fair amount about two cases, "Amgen v. Chugai Pharmaceutical", 927 F.2d 1200, 18 USPQ2d 1016, and "Fiers v. Revel", 984 F.2d 1164, 25 USPQ2d 1601. The problem is that nucleic acids have two kinds of roles - performing information transfer inside the cell for which applying chemical patent laws don't seem appropriate - except for the fact that secondary and tertiary structural features of nucleic acids are functional and subject to chemical patent laws (giving nucleic acids kind of a management and employee role in the cell). What interested me in listening to Mark was a parallel line of argument "Is DNA a computer", given recent developments in a few universities. I asked him his thoughts, in particular, how one would handle a DNA computing patent. He basically deferred to John Doll (another speaker), who is Director of Group 1800 at the PTO, the biotechnology group, who said that this is actually a real problem the PTO is facing, given that there are DNA computing patents pending at the PTO. The PTO's current solution is to have such patents handled jointly by an examiner from Group 1800 and Group 2300, one of the computing groups. ==== The next speaker was John Doll, Director of Group 1800. He talked about 35 USC 112 First Paragraph, "Enablement Obviousness". He passed out two sets of materials - one being the training manual for 1800 examiners for 35 USC 112 First Paragraph Enablement, the other being tons of statistics on Group 1800. One complaint that his group had been hearing was that examining were using 101 rejections but disguising them as 112 rejections. Doing something that Groups 2300/2400 should have done years ago, Group 1800 did a sampling of the file wrappers of issued biotech patents where there were 112 rejections, and found that 41% should have been scope rejections and 27% where the rejections were not clearly explained. Thus the creation of these training materials for First Paragraph Enablement. Another complaint he is hearing is that examiners are doing searches to question enablement, not prior art. They also prefer that applicants use pharmaceutical language like in vivo and in vitro, that lack of working examples is not necessarily grounds for rejection if you have in vivo models, also that FDA approval is not enough for enablement - you must submit the data the was submitted to the FDA, and that it is not improper for an examiner to make a 102/103 rejection and a 112 rejection over the same claim (but you can complain if the reasons are unreasonable). He also said that they are ignoring In Re Duell (DNA in claims is ground for rejection. There is interesting because of a comment recently posted on one of the net patent law lists: I have continued to hit resistance in the Examining corp with respect to adhering to the (fairly clear, I believe) holdings of these cases: that the disclosure of a protein in a prior art reference would not have made the DNA sequence obvious -- obviousness of a chemical (DNA) should be analyzed as to whether the STRUCTURE is obvious, not the method of production. One interesting conversation I had with an Examiner in Group 1804 indicated that he would not follow Deuel or Bell in a general sense but would narrowly construe the findings to the specific facts (and therefore generally find factual distinctions to rely upon) unless the Applicant showed that there was something unusual or unexpected in the cloning that needed to be overcome. Some statistics as October 1, 1996: PE = Primary Examiners, JE = Junior Examiners UNEX = new unexamined applications, GATT = pre-GATT applications Group 1801: 2 PEs, 8 JEs, 284 UNEXs, 70 GATTs Recombinants Group 1802: 1 PEs, 9 JEs, 315 UNEXs, 152 GATTs Bacterial immunology Group 1803: 6 PEs, 4 JEs, 559 UNEXs, 52 GATTs Recombinant plants Group 1804: 3 PEs, 6 JEs, 245 UNEXs, 112 GATTs Animals / Gene therapy Group 1805: 3 PEs, 9 JEs, 577 UNEXs, 32 GATTs Gene expression Group 1806: 1 PEs, 9 JEs, 584 UNEXs, 135 GATTs Antibody engineering Group 1807: 2 PEs, 11 JEs, 270 UNEXs, 39 GATTs Nucleic acid assays Group 1808: 5 PEs, 11 JEs, 579 UNEXs, 121 GATTs Fermentation Group 1809: 1 PEs, 9 JEs, 85 UNEXs, 62 GATTs Antisense nucleic acids Group 1811: 3 PEs, 12 JEs, 813 UNEXs, 293 GATTs Proteins/peptides Group 1812: 3 PEs, 10 JEs, 450 UNEXs, 154 GATTs Receptors and cytokines Group 1813: 3 PEs, 10 JEs, 656 UNEXs, 143 GATTs Viruses Group 1814: 2 PEs, 11 JEs, 742 UNEXs, 99 GATTs Enzymes and toxins Group 1815: 2 PEs, 8 JEs, 224 UNEXs, 116 GATTs Viruses Group 1816: 4 PEs, 5 JEs, 200 UNEXs, 100 GATTs Cellular immunology Group 1817: 2 PEs, 7 JEs, 237 UNEXs, 109 GATTs Bacterial immunology Group 1818: 4 PEs, 9 JEs, 396 UNEXs, 109 GATTs Immunoneurology Group 1819: 3 PEs, 6 JEs, 489 UNEXs, 349 GATTs Animals / Gene therapy In Fiscal Year 95, hired 35 examiners, lost 30. In Fiscal Year 96, hired 82 examiners, lost 18. 124 examiners have PhDs, 40 examiners have Masters. 12941 patents filed for this group in 1994, 17318 in 1995. 4082 issued in 1994, 4875 issued in 1995. 22307 pending applications. 29 animal patents ==> 23 mice, 1 rat, 1 rabbit, 1 sheep, 1 bird, 1 fish and 1 worm, with 1 chicken SIR. 1200 animal patents on file. Over 5000 applications have been filed for entire human, animal or plant genes. Much like Groups 2300/2400/2600, Groups 1200/1500/1800 have a combined Matrix Management process in place. ==== The next speaker was Christian Gugerell, Director of the EPO Biotechnology Unit in Munich. While he talked about many things, he expressed confidence that in 1996 the European Parliament will finally pass directives to update the biotech patenting laws in Europe. For years, such attempt have been frustrated by environmentalist groups, though apparently this time around parliamentary maneuvers will limit their abilities to do so. His handouts included the full text to the proposed directive plus some commentary. The new directives still have the morality clauses in Article 9: 1. Inventions shall be considered unpatentable where exploitation would be contrary to public policy or morality, provided that the exploitation is not deemed to be so contrary merely because it is prohibited by law or regulation. 2. On the basis of paragraph 1, the following shall be considered unpatentable: (a) methods of human treatment involving germ line gene therapy; (b) processes for modifying the genetic identity of animals which are likely to cause them suffering or physical handicaps without any substantial benefit to man or animal, and animals resulting from such processes, insofar as the suffering or physical handicaps inflicted on the animals concerned are out of proportion to the objective pursued. Indeed, last month at the International Bar Association meeting in Berlin, a draft treaty Convention on the Human Genome included a ban on "germline" gene therapy, though it left the door slightly open for such techniques so long as "there is indisputable proof of the benefits and safety of such therapy". In general, I got the impression that Mr. Gugerell and his colleagues really don't like having do deal with these morality questions, something examiners really aren't trained to deal with (how is an examiner supposed to determine if a patent application will lead to suffering in an animal?), especially as there are no similar rejection ground in the United States where such patents will issue and affect European activities anyways. Besides, in a real, real subtle way, in the future this ban will be looked at as a form of homosexual bashing. 41% of the biotech EPO applications are from the United States, 40% from Europe, and 12% from Japan. 40% of the issued biotech patents go to US companies, 36% to European companies, and 22% to Japanese companies. ==== At this point, the conference broke for a nice lunch, and the luncheon speaker was Judge Pauline Newman of the US Court of Appeals for the Federal Circuit, who gave a talk "Biotechnology Patents: A View from the Bench". Unfortunately, I really didn't take any notes because I was just enjoying her talk. At one point, she did express her wonder that patent law really hasn't changed that much over the decades despite tremendous evolutions in technology. She also said that science has had the biggest social impact. ==== After lunch, the first speaker was Michael Yates of Pioneer Hi-bred International of Des Moines, Iowa, who talked about Protecting Plants Worldwide. Pioneer is 70 years old, $1.5 billion 1995 sales, 71 million acres corn 1995 in United States. Also involved with soybeans, sorghum, sunflower, alfalfa and canola seeds. Their competitors are DeKalb, Novartis, Mycogen and others. Their R&D budget is $130 million. He thinks utility patents for plants in Europe unlikely in near future. Pioneer dropped one seed line because farmers were saving and selling seeds. One of the dangers of marketing genetically engineered seeds. Believes that ag-biotech patent litigation could provide the forum for significant, ground-breaking paetnt law precedents, given the number of potential interferences (for example 200+ pending/issued patents relating to Bt genes and their agricultural use) and stakes worth hundreds of millions of dollars. "Now utility patent protection should not be considered 'perfect' either, but given the state of our knowledge of RFLP maps of our germplasm base, we believe we can detect most misuse of patented imbred lines, and therefore we believe the benefits of having utility patent protection in the U.S. far outweigh the risks of both patenting and not patenting." ==== Next speaking with Helga Kolb, a lawyer with the firm of Hoffman, Eitle and Partner in Munich Germany, who talked about biotechnology patent enforcement in Europe. In short, much like the language translation problem, each country has a different system for patent enforcement, multiplying the amount of time and effort and cost needed to enforce a patent. Her advice was to choose those countries with the highest payoff to protect your patent. As an example of the complexity, in the UK there is the Patent Court and the Patent County Court; in Germany there are 11 patent courts; in the Netherlands there is the District Court in the Hague; while in Italy there are 160 courts that hear patent cases, the Tribunale court in Milano preferred (as is the Dusseldorf and Munich courts in Germany). In the UK, DE, FR and ES it is rather difficult to obtain a preliminary injunction in a complex patent case. There is a greater chance of success in NL, IT and CH. The Dutch courts are granting cross-border injunctions in patent infringement matters in order to avoid contradictory decisions; this has upset other countries who believe such actions are premature until everyone agrees upon some cross-border system. Chances for interlocutory injunction: UK very difficult, DE difficult, NL fairly easy, FR difficult, IT possible, ES difficult, SE no, and CH possible. ==== The next speaker was Alan Kowalchyk, a lawyer with Merchant and Gould, who spoke about options for biotechnology patent enforcement in the United States. He talked about the four main options: lawsuits at the US District Court (seeking damages and injunctions), filings with the International Trade Commission (seeking import bans), filings at the Patent Office (reexaminations and interferences), or some combination of these three options. With regards to District Courts, he discussed the impact of the recent Markman v. Westview Instruments decision specifying that the court must interpret claim issues. With regards to the ITC, an ITC Commission finding of infringement and failure to prove invalidity, even if affirmed by the Federal Circuit, has no resjudicata or collateral estoppel effect in court proceedings involving the same patent. He ended with examples of uses of more than one option, for example, Amgen versus Genetics Institute, which involved the District Courts and interference proceedings at the PTO. ==== The next speaker was James Darnley, patent counsel with Pharmacia & Upjohn in Kalamazoo, Michigan, speaking on industry's view of biotech patents. He had some neat observations: less than 1% of issued biotech patents protect commercially valuable products; that despite the many thousands of new drug patents each year only 30 new drug families are approved by the FDA each year; that marketing is more important for positioning, for example Capoten was out 7 years before Vasotec but Vasotec had clinical studies marketed better so that now Vasotec is #1 though both equally effective and patented; that some drugs survive without patent protection because the risks involved mean that few want to be involved; generic drugs drop prices 80%, though good marketing by the original manufacturer can preserve market share; drug patents protect narrow domain - rarely give broad protection - and only a time limited exclusivity; health needs met in different ways - for example in 1996 there are 25 drugs for rhuematoid arthritis but still there is an unmet need while in 1986 27 companies were chasing TPA but only Genentech really selling anything today. In his handout he mentions one point some lawyers like to deny in public. He quotes part of an article written about the E-data mess: The author concluded with the following comments: "So where do these patents come from anyway? For years, the US Patent Office granted overly-broad and vague patents on technologies, especially software, because it had no technically competent patent examiners. That has changed in the last few years as the office hired technical experts in fields ranging from software to biotechnology. Still the industry [software] is likely to labor under the onus of broad patents for years to come". Darnley then comments: I believe these observations are also applicable to the drug/biotech industry which will also labor under the onus of broad patents for years to come. The royalties charged for access to these technologies could become so burdensome that development of useful and necessary products using biotechnology could become stalled and prehaps wane. He felt that there was one fundamental problem with biotech patents: the stacking royalty problem, that is newer biotech patents run into earlier patents teaching "fundamental" techniques, all of which have fees and royalties that add up to significant levels for the newer biotech patents. In fact, to inflame a pissing contest on one of the patent law mailing lists, he labels some of the "fundamental" biotech patents as "submarine" patents. ==== The last speaker was David Hricik, of the Houston office of Baker & Botts. He talked about the ethical issues in the practice of intellectual property law, in particular, communicating with clients over the Internet and other channels (cellular telephones, cordless phones) where there is a possibility of third party interception (though interestingly it hadn't occurred to him to think about the problems of PTO examiners using the Internet to do prior art searching). The other topic he talked about was the problems in-house counsel face when they provide legal advice to affiliated entities. It was an interesting talk but I don't pay too much attention to patent lawyers talking about ethics. The unaddressed impotence of rule 56 for a system where undersupported/underresourced examiners award monopoly IP rights makes a mockery of ethics. ==================== In general it was a nice conference to attend. If MIPLA and Merchant and Gould hold such conferences again in the future, it is worth attending. I think they have extra copies of the proceedings for sale. I should be getting some followup information from them to pass on. Greg Aharonian Internet Patent News Service From elastic!lethe!abyss!news2.compulink.com!news3.idirect.com!n2tor.istar!tor.istar!east.istar!news1.hotstar.net!winternet.com!www.nntp.primenet.com!nntp.primenet.com!news.bbnplanet.com!cam-news-hub1.bbnplanet.com!news.idt.net!feed1.news.erols.com!phase2.worldnet.att.net!netnews.worldnet.att.net!uunet!in1.uu.net!world!srctran Wed Nov 20 20:40:26 1996 Xref: elastic misc.int-property:828 misc.legal.computing:2629 sci.econ:16472 Newsgroups: misc.int-property,misc.legal.computing,sci.econ Path: elastic!lethe!abyss!news2.compulink.com!news3.idirect.com!n2tor.istar!tor.istar!east.istar!news1.hotstar.net!winternet.com!www.nntp.primenet.com!nntp.primenet.com!news.bbnplanet.com!cam-news-hub1.bbnplanet.com!news.idt.net!feed1.news.erols.com!phase2.worldnet.att.net!netnews.worldnet.att.net!uunet!in1.uu.net!world!srctran From: srctran@world.std.com (Gregory Aharonian) Subject: PATNEWS: Shame on Commissioner Lehman Message-ID: Organization: The World Public Access Internet, Brookline, MA Date: Mon, 18 Nov 1996 02:01:19 GMT Lines: 18 The November 11th edition of Interactive Week, page 61, has an article about Patent/Trademark Commissioner Lehman's controversial involvement with efforts to amend global Copyright laws to deal with machine-readable database protection. A quote from the article: "Everybody has their own parochial interests", Lehman says. "There are people who would just as soon not have an intellectual property system. That's the information-should-be-free crowd. Well, how do they suppose [we'll] have capitalism if there's no property? What do they want to go to, socialism? Communism? McCarthyistic-bashing in the 1990s? Greg Aharonian Internet Patent News Service From elastic!lethe!geac!onramp.ca!news2.insinc.net!news.iosphere.net!news.supernet.net!news.magicnet.net!feed1.news.erols.com!howland.erols.net!newsfeed.internetmci.com!uunet!in3.uu.net!world!srctran Wed Nov 27 20:57:08 1996 Xref: elastic misc.int-property:876 Newsgroups: misc.int-property,alt.inventors,sci.bio Path: elastic!lethe!geac!onramp.ca!news2.insinc.net!news.iosphere.net!news.supernet.net!news.magicnet.net!feed1.news.erols.com!howland.erols.net!newsfeed.internetmci.com!uunet!in3.uu.net!world!srctran From: srctran@world.std.com (Gregory Aharonian) Subject: PATNEWS: Economics and IP of cDNA sequences; Monsanto's soybeans Message-ID: Organization: The World Public Access Internet, Brookline, MA Date: Mon, 25 Nov 1996 02:26:28 GMT Lines: 805 The Summer 1996 edition of Human Genome News (a DoE publication) has an article by Rebecca Eisenberg, a professor of intellectual property law at the University of Michigan. The article is about the patenting aspects of partial cDNA sequences (expressed sequence tags), where you have a DNA sequence you know has some function, but not knowing what the function is. You won't be able to work with anyone to discover the function without publicizing the DNA sequence, but if you do so, you could lose patent protection. But many object to awarding a patent for something for which the utility is unknown, causing the controversy, a controversy made very public in 1991 when the National Institutes of Health filed a massive number of applications on such sequences (an act with its own stories). In the following article, Prof. Eisenberg analyzes the different cDNA database-usage strategies undertaken by Merck, Incyte Pharmaceuticals and Human Genome Sciences. Dr. Eisenberg's article is followed by four documents distributed at the Third Conference of the Parties to the Convention on Biological Diversity in Buenos Aires raising many concerns with Monsanto's genetically engineered soybeans. The articles are the price the biotechnology industry pays for a generally inept-to-total-lack-of public education, a price that is going to increase in time as even more socially troubling genetic innovations become public (and the biotechnology industry has lucked out that no one in these environmental/third world movements ever reads PCT applications). These controversies are just one more reason why the full text of patents belong on the Internet - the texts of biotechnology patents provides the best starting points for discussing the social implications of such innovations. And I would be glad to get in the middle with help from BIO :-) Greg Aharonian Internet Patent News Service (for info on free subscription, send 'help' to patents@world.std.com ) (for prior art search services info, send 'prior' to patents@world.std.com ) ==================== Commercial strategies aim to spin DNA threads into gold Rebecca Eisenberg, University of Michigan Intellectual property issues have been unusually conspicuous in the recent history of genomic advances, even by the standards of the patent-weary genetics and molecular biology communities. Controversy has been particularly acute over intellectual-property rights in the results of large-scale cDNA sequencing. Beginning in 1991 with NIH's filing of patent applications on the first batch of Expressed Sequence Tags (ESTs) from Craig Venter's laboratory, each new development has been met with lively speculation about its strategic significance from an intellectually property perspective. Are cDNA fragments of unknown function patentable, or must they undergo further research or characterization before they satisfy patent-law standards? Will patents on such fragments promote commercial investment in product development or interfere with scientific communication and collaboration and retard the overall research effort? In the absence of patent rights, how might the owners of private cDNA sequence databases earn a return on their investment while still permitting other investigators to obtain information access on reasonable terms? What are the rights of those who contribute such resources as the cDNA libraries that are used to create the databases and of those who formulate appropriate queries to identify interesting sequences from the morass of information? Will the disclosure of ESTs in the public domain preclude patenting of subsequently characterized full-length genes and gene products. And why would a commercial firm invest its own resources in generating an EST database for the public domain? Two factors have contributed to the fascination with intellectual property issues in this setting. First is a perception that some pioneers in large scale cDNA sequencing have sought to claim intellectual property rights that reach far beyond their own actual achievements to cover the future discoveries of others. For example, the controversial NIH patent applications claimed not only the ESTs for specified sequences by also the corresponding full length cDNAs and smaller portions that might not even include the disclosed ESTs. More reecntly, private owners of cDNA sequence databases have conditioned data access on advance agreements offering either a license or right of first refusal to any resulting intellectual property. These actions raise questions about the fairness and efficiency of the system to protect intellectual property. Such concerns are particularly compelling to research scientists, who have more than commercial interests at stake. Second is the surprising alignment of interests in the data. NIH, a public institution, initially took an aggressive position in favor of patenting discoveries that some industry representatives thought were unpatentable and should remain unpatented. Merck ultimately took on the quasigovernmental function of sponsoring a university-based effort to place comparable information in the public domain. These topsy-turvy positions raise intriguing questions about the proper roles of government and industry in genomics research and about who stands to benefit - and to lose - from the private appropriation of genomic information. Promoting R&D Through Exclusive Rights Research scientists who work in public institutions often are troubled by the concept of intellectual property because their norms tell them that science will advance more rapidly if researchers enjoy free access to knowledge. By contrast, the law of intellectual property rests on an assumption that, without exclusive rights, no one will be willing to invest in research and development (R&D). Patenting provides a strategy for protecting inventions without secrecy. A patent grants the right to exclude others from making, using and selling the invention for a limited term, 20 years from application filing date in most of the world. To get a patent, an inventor must disclose the invention fully so as to enable others to make and use it. Within the realm of industrial research, the patent system promotes more disclosure than would occur if secrecy were the only means of exclusing competitors. This is less clear in the case of public-sector research, which typically is published with or without patent protection. The argument for patenting public sector inventions is a variation on the standard justification for patents in commercial sectors. The argument is that postinvention development costs typically far exceed preinvention research outlays, and firms are unwilling to make this substantial investment without protection from competition. Patents thus facilitate transfer of technology to the private sector by providing exclusive rights to preserve the profit incentives of innovating firms. Nonpatent Strategies For Commercial Exploitation No patents have been issued so far on cDNA fragments of unknown function, although a number of private firms have pending patents applications that claim thousands of such fragments. Meanwhile, three firms - Human Genome Sciences (HGS), Incyte Pharmaceuticals, and Merck - are pursuing different non-patent strategies for exploiting the value of these sequences as unpatented information. These strategies are exclusive licensing, nonexclusive licensing, and dedication to the public domain, and it is still too early to tell how each will pay off. We can see, however, how different firms are placing their bets, and we also have some idea of the sizes of those bets. HGS and Incyte are exploiting their databases commercially by controlling access to them, in effect using contracts and trade secrecy to protect their intellectual property. The viability of these strategies may be limited by Merck's sponsorship of a competing cDNA sequencing effort at Washington University dedicated to the public domain. The commercial value of the private databases is likely to decline as public-domain information increases. Although public-domain databases are growing rapidly, the private ones remain larger at this point and claim to offer superior products. These products include longer sequences of contiguous cDNA fragments; more complete sequence annotations, including information about expression in different types of tissues; high-powered bioinformatics capabilities; and user-friendly software. A significant limitation on the value of public domain databases is the pending patent applications of private database owners. If these applications ripen into issued patents, they could preempt the use of any covered sequences, even if those sequences were disclosed publicly before the patent was issued, as long as the patent applicants are able to establish their priority. U.S. patent applications are confidential until a patent is issued, so determining which sequences are the subject of patent applications is impossible. Those who use sequences from public databases today risk facing a future injunction if those sequences turn out to be patented by HGS or Incyte on the basis of previously filed patent applications. The same uncertainty applies to sequences obtained from private databases; for example, sequences that are obtained from the Incyte database may turn out to be covered by a previously filed HGS patent. Because the Merck initiative got off to a late start, its sequences are more likely to be covered by other firms' prior patent applications. Exclusive Licensing For $125 million over a 3 year period plus royalties on product sales, HGS has licensed exclusive rights to access its database to SmithKline Beecham (SB). SB also gained the right of first refusal to develop and market protein therapeutic and diagnostic products from information in the database. HGS has entered into separate collaborative agreements with other research partners for gene-therapy and other DNA-based product development. During the period of SB's exclusive license, investigators in academic and nonprofit institutions may obtain access to some of the same sequence information through a separate database maintained by The Institute for Genomic Research (TIGR) under the terms of a Database Access Agreement. The TIGR database includes sequences that are similar to previously published sequences and accessible to nonprofit investigators with minimal restrictions on use. It also includes proprietary sequences that are accessible only to those who sign more restrictive agreements giving HGS rights to prepublication review and an option to negotiate a license to any resulting inventions. Some academic investigators also have obtained access to sequences in the separate HGS proprietary database by signing a Materials Transfer Agreement granting HGS "a sole and exclusive worldwide right and license" to develop any resulting products on terms to be negotiated in the future. An obvious advantage of this exclusive licensing strategy for HGS is that it has generated a lot of revenue; SB placed what appeared to be a very large bet 3 years ago. An obvious concern is that restricting database access to such a degree may limit the value that can be extracted during the term of the license. Perhaps this concern motivated SB and HGS to enter into collaborative agreements announced this past summer to share the database with four additional firms {Takeda Chemical Industries, Merck KGaA, Schering Plough, and Synthelabo}. With the signing of these agreements, SB appears to have made its money back even before bringing any new products to market - the agreements call for payments totalling $140 million plus royalties on product sales. Nonexclusive Licensing Incyte has offered nonexclusive licenses to as many firms as will take them, at a much cheaper price than SB paid for its exclusive deal with HGS. So far ten pharmaceutical firms have signed on as subscribers, including Pfizer, Pharmacia & Upjohn, Novo Nordisk, Hoechst, Abbott Laboratories, Johnson & Johnson, BASF AG, Hoffman-La Roche, Zeneca and Schering AG Berlin. Financial terms for most of these agreements have not been disclosed, but press accounts report that they total more than $160 million, excluding contigent payments such as milestones and product royalties. Although each Incyte subscriber has placed a smaller bet than SB did, in the aggregrate they may well provide more funds for the development of Incyte's genomic databases. From a broader social standpoint, of course, the more interesting question is not the size of the bets but the ultimate payoffs. Which approach will yield more discoveries or more commercial products? Public Domain The Merck strategy of putting sequence information into the public domain is the newest approach and, at first glance, the most puzzling. How does this strategy advance Merck's own interests? By placing data in the public domain, Merck can generate the sequence information more cheaply - indeed, almost unbelievably cheaper. Merck is placing a very small bet, somewhere under $10 million, but by positioning itself as a public benefactor, the company is able to take advantage of existing infrastructure at Washington University, put in place with public funds, for its sequencing efforts. Apart from generating sequence information more cheaply, Merck expects to promote research and derive more benefit by distributing the data widely. As Merck sees it, sequence information will not yield products for commercial development until further fundamental research is done to understand functions and biological pathways associated with the partially sequenced genes. Merck's interest is in developing specific drugs at a later stage in the R&D process. Nothing obligates researchers to bring any potential products to Merck for commercial development, but Merck is confident that it can capture an adequate share of resulting products to justify the company's modest investment in generating the database. Some observers have suggested the more cynical possibility that Merck may seek to undermine the value of its commercial competitors' investments in existing sequence databases. HGS and Incyte will be dependent on patents to protect their proprietary positions in the long run, and Merck may be betting that the two companies will not obtain much in the way of patent rights. Preliminary indications suggest that the public data is generating considerable interest, with EST-database accessions showing a dramatic increase. A big part of the increase has come in daily anonymous FTP downloads of the entire database, a form of query likely to be popular with commercial users who do not want to leave an electronic record of what they are looking for. The most obvious benefit of disseminating information in the public domain is that free availability encourages widespread use of information, minimizes transaction costs, and makes R&D cheaper and faster. Of particular relevance to research science, a vigorous public domain can supply a meeting place for people, information, and ideas that might not find each other in the course of more organized, licensed encounters. Finally, information in the public domain is accessible to users who otherwise would be priced out of the market. In emphasizing intellectual property rights in the past, we may have underestimated the value of a rich public domain to private as well as public sectors. We may need now to reconsider the limits of private appropriation of new information as a means of promoting commercial development. ============================================================================== Dear Friends, The Conference of the Parties to the Convention on Biological Diversity met at Buenos Aires 4-15 November 1996. I was at the Conference as an NGO observer representing Ecoropa (coordinating their biodiversity/biotechnology/biosafety programme). I worked in close cooperation with many other NGOs, especially with Third World Network. This autumn, the US company Monsanto tried to forcefully flood the European market with its herbicide-resistant transgenic soybeans. Many delegates and NGOs felt that they did not have enough information neither on the scientific findings concerning potential health and environmental impacts nor on the very successful public action taken by European consumers and environmentalists for keeping these gene-beans out of the European market and their shopping baskets and meals. Dr. Beatrix Tappeser (Eco-Institute,Freiburg) and I wrote the following documents which were published in Third World Network Briefings (document 1-3) and in "ECO 4" (doc. 4). I hope that some of you will find this information useful. Feel free to reprint any of the papers but please let me know that you intend to do so and, on publication, send me a copy of the reprint (to: Ecoropa, attn. Christine von Weizsaecker, Postfach 130165, 53061 Bonn/Germany). You may want to have a look at our web-page "Everything you never wanted to know about biosafety": http://slc.p2p.de/~franz/biosafety. With best regards, Christiane von Weizsaecker Tel: +49-228-9181033 Postfach 130165 Fax: +49-228-9181034 53061 Bonn, Germany Email: cvw@isd.de ============================================================================== Document #1 Published as Third World Network Briefing No. 4, 8 November 1996 at the Third Conference of the Parties to the Convention on Biological Diversity in Buenos Aires Monsanto's Genetech-Soybeans Safe for Consumers? SAFE FOR The Environment? Gap Analysis and Flaw Identification in Monsanto's Testing by Beatrix Tappeser and Christine von Weizsaecker The US company Monsanto applied for a permit to introduce genetically engineered soybeans into Europe. The application has been approved by the European authorities. The first cargo ship with Monsanto's genetically engineered soybeans have already crossed the Atlantic. Possible Human Health Impacts of Monsanto's Transgenic Glyphosate-Resistant Soybeans Numerous studies have been carried out by Monsanto on the transgenic soybean and its potential impact on human health. However, going through the reports, one can easily identify a blatant scientific omission in the design of these tests: Consumers will ingest transgenic soybeans that will be grown on glyphosate-sprayed fields. However, the tests were done on transgenic soybeans that were grown without the application of glyphosate. This is a scientific error of major proportion which makes the results void. The beans tested are not the transgenic beans from glyphosate-sprayed fields which will be consumed. Four problem areas associated with the use of glyphosate on legumes and with the impacts of transgenic food crops in general have already been identified: 1. Glyphosate was ranked third worst among all pesticides causing severe health problems among those working in agriculture in the State of California. 2. The application of glyphosate causes the production of phyto-estrogens in legumes. These phyto-estrogens mimic the role of hormones in the bodies of mammals who ingest them. Hence, they may cause severe reproductive system disruptions. The data on estrogen-content of the plants submitted by Monsanto does not reflect the real scope of this problem, because the tested plants were grown in a glyphosate-free environment (see above). 3. The adequacy of Monsanto's testing for allergenic potential is questionable. Rendering a plant herbicide-resistant, as in the case of the glyphosate resistant bean, means that a new protein (or enzyme) is introduced into the plant. The presence of a new protein in the plant and in the foods the plant produceshas potential for causing allergic reactions. Monsanto only tested people known to be allergic to soybeans. However, they cannot test for the reaction to new proteins with the test design they used. Everyresearcher active in the field knows that you cannot adequately test in advance for allergic reaction to proteinsnever before consumed by humans. Moreover, recent studies published by Swiss scientists have evaluated the differences in allergy potential between traditionally bred and genetically engineered crops. The scientists concluded that the use of genetic engineering techniques causes a higher incidence of allergy problems. 4. A further problem consists in the fact that genetic engineering produces "position effects". In living organisms, genes are intricately linked in finely balanced networks. The introduction of new gene constructs (often consisting of parts of genetic material of 4 to 5 different types of organisms) at a random place on the long stretch of the DNA-molecule is known to change the fine-tuning of the balanced network. The "position effect" may lead to unintended shifts in the concentration of plant metabolic products. This seems to be the case in Monsanto's transgenic soybeans. The beans show some differences in oil-composition compared to non-transgenic beans, but not all data has been included in Monsanto`s European application file. There are also differences in the level of trypsin-inhibitors, proteins that inhibit the degrading activities of proteases - the first step in the digestive pathway. Trypsin-inhibitors have been characterized as anti-nutritive. Again however, figures given in the application file are incomplete. Governments, farmers and consumers should consider these problems carefully. They may not want to take a course of action which turns people into experimental Guinea pigs. Possible Environmental Impacts of Monsanto's transgenic Glyphosate-Resistant Soybeans Glyphosate, like other herbicides, is meant for weed control, i.e. it is meant to reduce biological plant diversity in and around fields. Herbicides do so with devastating success. Unlike other herbicides, glyphosate could not be used in fields with growing crops since it kills not only a selected group but all green plants. The introduction of a glyphosate-resistance-gene now allows a widened range of application. A very different aspect of herbicide use should also not be forgotten: Many plants that are called "weeds" by those promoting high-input monoculture for the worldmarket are called "salad", "medicine", "animal feed", "compost" and "flower-bed" by many farmers in the world. Loss of plant diversity also invariably means loss of animal diversity and diversity of soil organisms. Herbicides are known to be self-abolishing technologies: Invariably, weeds learn to cope, and the herbicide has to be replaced by yet another one. Rye-grass in Australia already has asserted its weedy vitality by becoming glyphosate resistant. Transgenic soybeans, like all other transgenic plants, are associated with a specific biosafety risk if planted in centres of origin. Scientific studies have shown that transgenes are transmitted to wild relatives with potentially disruptive effects on the endemic flora and on agriculture. Besides its plant killing potential, glyphosate was shown to have other direct impacts on biological diversity: It is poisonous to fish. It persists in the soil for long periods of time: Salad, barley and carrots planted on soil one year after the application of glyphosate have been shown to have incorporated small quantities of this chemical. The degradation of glyphosate leads to metabolites like AMPA (amino-methyl-phosphonic acid) which can persist in the soil for 3 years. Governments, farmers and consumers should consider these problems carefully. They may not want to take a course of action which - causes an increase in the use of the herbicide glyphosate - which may add to biosafety problems - and which are associated with the accumulation of largely unstudied metabolites with have already demonstrated some toxic effects in our soils and waters. Dr. Beatrix Tappeser is Head of Department on Risk Assessment in Genetic Engineering at the Institute for Applied Ecology, Freiburg, Germany. Christine von Weizsaecker is Head of Ecoropa's Biodiversity/Biotechnology/Biosafety Programme, Vice-Chair of the Advisory Council of the German Consumer Testing Group ============================================================================== Document #2 Published as Third World Network Briefing No. 5, 11 November 1996 at the Third Conference of the Parties to the Convention on Biological Diversity in Buenos Aires MONSANTO'S GLYPHOSATE-RESISTANT TRANSGENIC SOYBEANS 77% of German Consumers refuse to eat them. *** 94% of German Consumers want them labelled. *** Scientists can identify them in processed foods. *** Greenpeace "labels" and blocks ships carrying them. *** Food processing companies promised not to use them. *** Food Chains will exclude them or at least label them. *** Worldmarket prices reward soybean farming areas which were kept free of them. by Christine von Weizsaecker and Beatrix Tappeser The German word for soybean is Soja. The word has a very positive connotation: So-Yes. Why is it that "SO-Yes turned into SO-NO" for German environmental groups like Greenpeace and Friends of the Earth, Germany, for the German Consumers' Organisation, for Health Food Stores Associations and other Food Chains, and for practically all companies specializing in foods for babies? The NO is addressed to a very special company: Monsanto, USA. The NO goes to a very special soybean: a soybean that has been genetically engineered to be resistant to the herbicide Roundup/Glyphosate, produced by the same company. Monsanto applied for a permit to introduce genetically engineered soybeans into Europe. This application has been approved by the European authorities. Soon after this year's harvest, the first cargo ships with Monsanto's genetically engineered soybeans began to cross the Atlantic. Yet, these specific soybeans had no clearance from environmentalists and from consumers. CONSUMERS' OPINIONS AND MOTIVATIONS: In Germany - as in many countries of Europe - more than 90% of consumers want the general labelling of genetically engineered foods. Why do they want them labelled? Because 77% of consumers definitely do not want to eat them, and do not want to offer them to their families and friends. The results of a recent Emnid opinion poll show that amongst those who do not want the gene-bean 45% will avoid them as best as possible and a further 28% will, additionally, consistently boycott every food that may has a trace of gene-beans in it. More than 50% will boycott products from firms that bring these products to market without labelling them. Only 5% think Monsanto's transgenic soybeans may taste better or be healthier. Although consumers are not aware of much of the scientific data on health and environmental risks they have a very keen commitment to the precautionary approach and they insist on prior informed consent. Consumers want food-sovereignty. And they want the right to influence the choice of public research priorities and technological and agricultural pathways. These priorites have traditionally been determined, top-down. But citizens with their shopping baskets are now giving a strong message that they want bottom up decision-making. The growth of civil society and the environmental debate of the last decades has had some success. Many people actively strive for participation and sustainable consumption patterns; they see their responsibility for the whole life cycle of products including socio-economic and environmental impacts. These people cannot at all see that Monsanto's gene-beans produced in the United States and consumed by German cattle and people are a contribution to solving the World Food Problem, an aim often invoked by genetic engineers. Some are even aware of the fact, that capital-intensive globalized technologies have demonstrably not been Pro-Poor in the past. About half of all consumers are fully aware of potential negative environmental impacts of releases of living modified organisms into the environment. They are convinced that Monsanto's beans mean high-input, pesticide-dependent agriculture. And lastly, they noted that Monsanto's transgenic Bt-cotton failed in the field, thereby throwing doubt on the benefits derived from gene technology and on the predictive capacity of scientists. THE EU-DEBATE ON "NOVEL FOOD": Many European women and men were made very angry when a member of the European Commission said "We cannot have hysterical and panicky European consumers not eating what the European Commission considers safe". Their anger increased when a European Novel Food Directive was submitted which does not guarantee general labelling of genetically engineered foods. Monsanto's transgenic soybeans were on their way. The strategy of the managers of Monsanto, of the oil-mill in Hamburg and of some major food processing companies was to mix genetically engineered soybeans with all other soybeans. This strategy made consumers angrier. They felt that this plan was obviously designed to produce individual and public confusion and resignation in the face of a large and complicated task. They were faced with governments that did not adequately protect their citizens against forced consumption of genetically engineered foods and that had approved of Monsanto's application. FIGURES ON SOYBEAN PRODUCTION AND TRADE: According to a Monsanto spokesperson "at the moment only one to two percent" of soybeans in the US are genetically engineered. How much is that? Monsanto's transgenic soybeans have been planted by 8 000 of the 300 000 soybean farmers. Next season, more transgenic soybeans and other transgenic crops are expected. US soybean production is expected to reach 62 million tons of the 135 million tons worldwide. Two percent of US production is nearly one percent of world production, i.e. roughly 1 million tons. Europe only has minor soybean production in France and Italy. European oil-mills processed 15 million tons of soybeans in 1995. They import 60% of these beans from the US. Germany imports 10% of US production. Approximately 30% of European imports come from Brasil and Argentina. Argentina - by the way - already started seed-production of Monsanto's glyphosate-resistant transgenic soybean. However, beans have not yet come to market. HOW MANY AND WHICH FOODS CONTAIN SOYBEANS? The German Consumers Initiative has calculated that approximately 20 to 30 thousand foods contain processed soybeans. Soybean-oil can be found in mayonnaises, breadspreads and salad sauces. Soybean-meal is used in tinned and deep-frozen foods. Lecithin from soybean can be found in chocolates and ice-cream. 80% of all soybeans imported into Europe is fed to cattle and other animals. IDENTIFICATION OF TRANSGENIC SOYBEANS IN FOODS: A small German research company named "Hydrotox", situated in Freiburg/Breisgau, developed a testing system which allows identification of lecithin derived from transgenic soybeans, a scientific achievement that Monsanto's huge laboratories had declared impossible. The ability to differentiate between Monsanto's transgenic bean and all non-transgenic soybeans lays the technological ground for targeted consumer boycotts. FINDING ALLIES: In Germany, the environmental movement and consumers joined forces in an unprecedented way. A very wide alliance was formed. Large environmental groups like Greenpeace Germany and Friends of the Earth Germany joined with hundreds of local environmental groups. The German Consumers' Organisation with all their local branches and infrastructure became active. ASSERTING CONSUMPTION ALTERNATIVES: Groups and associations of health food stores and other smaller food producers and traders organized ways by which to guarantee that no transgenic soybean entered the products they sold. A Swiss oil-mill guaranteed genetech-free soybean products. PUBLIC CAMPAIGN: The Soybean-Campaign started in September 1996. At this point more than 100,000 German Citizens have signed onto it. Press conferences and web-sites have spread the information and further increased public awareness. On 5th November, the cargo ship "Ideal Progress" with Monsanto's transgenic soybeans on board was "labelled" by Greenpeace activists on entering Hamburg harbour. The label read "No Gene-Soybeans in our Foods". Two days later, November the ship "Ziemia Zamojska", registered in Poland, tried to unload its gene-beans at Cargill's site in Amsterdam harbour. Greenpeace activists blocked the entrance to Amsterdam harbour and unrolled a banner "Genetic experiment - Don't buy it". MARKET IMPACT: But even before these events, nearly all major food processing companies serving the German market -- Unilever, Nestle, Jakobs/Kraft/Suchard -- had already been forced by public opinion to guarantee to exclude Monsanto's beans from their products. One after the other they realized that these soybeans would destabilize the market for processed foods in a very decisive but unpleasantly unpredictable way. Major food chains in Germany and Switzerland committed themselves to gene-bean-free food. Even Dr. Ruettgers, German Minister for Research, a stark supporter and funder of genetic engineering, now argues that labelling is advisable because it would mellow the debate on modern biotechnology in food and agriculture and reconciliate consumers. The world market for soybeans has had to adapt and change its prices. Traders who can offer soybeans from areas that do not use Monsanto's glyphosate-resistant transgenic beans are making now profits far beyond expectations. NEXT STEPS: A worldwide coalition of women has gathered at the Word Food Summit in Rome. They call for food sovereignty and for general labelling of genetically engineered food. The signatures gathering for the Soybean Campaign in Germany is still snowballing. Corresponding initiatives are under way in the United States. Citizens in many countries will demand general labelling, strict liability, appropriate biosafety regulations and practices. Most urgently, they want freedom to say no to foods that they neither consider safe nor necessary. Christine von Weizsaecker coordinates Ecoropa's Programme on Biodiversity/Biotechnology/Biosafety and is Vice-Chair of the Advisory Council of the German Consumer Testing Group Dr. Beatrix Tappeser is Head of Department on Risk Assessment in Genetic Engineering at the Institute for Applied Ecology, Freiburg, Germany. ============================================================================== Document #3 Published as Third World Network Briefing No. 9, 12 November 1996 at the Third Conference of the Parties to the Convention on Biological Diversity in Buenos Aires Addendum on European Public Opinion and Genetically Engineered Food: A Lay People's country report from Norway Paying due respect to socio-economic impact assessment by Beatrix Tappeser and Christine von Weizsaecker The Norwegian National Committee for Research Ethics presented the results of Norway's First Lay People's Conference on Genetically Modified Food in a press release of 1 November 1996 and will make the full report available on request. The results of this conference can be condensed into one single sentence: "No Way for genetically modified food into Norway." The lay people's conference was organised jointly by the National Committee for Research Ethics and the Norwegian Biotechnology Advisory Board. The conference was designed along the lines of thirteen People's Conferences organized by The Danish Board of Technology. The lay panel consisted of eight women and eight men from different parts of Norway, who differed in age, education and occupation. They had one thing in common, however: They were chosen for having no close connections to any biotechnology stakeholder group and no special knowledge on the topic. After questioning a wide range of experts, made available to them, the lay panel issued recommendations to Norwegian politicans and the food industry. The lay panel - anticipating the necessity to react to potential introduction of genetically engineered foods into Norway, recommended that all foods containing genetically modified organisms and/or derived from a manufacturing process using gene technologies be labelled. - rejected the introduction of genetically modified food stuffs into Norway. - insisted that environmental and ethical concerns be prominent in the decisions on genetically modified foods. - called for adherence to the precautionary principle. - recommended research programmes on long term health and environmental effects of genetically modified foods. - recommended to attribute greater credibility to ecologists than to biotechnologists. - applauded the clauses in the Norwegian Gene Technology Act which preclude genetic engineering unless proven to be "of benefit to the community" and "a contribution to sustainable development" and called for applying these clauses to prevent all imports of genetically engineered products into Norway. "This is a historic occasion and perhaps a small victory for democracy," said Professor Reidar Almas, Head of the Centre for Rural Research, as the document was presented to the experts. He added that the conference has proven that ordinary citizens are capable of understanding complicated processes and of producing valuable advice. ============================================================================== Document #4 Buenos Aires, 13 November 1996 Article by Christine von Weizsaecker, Bonn, and Beatrix Tappeser, Freiburg published in "ECO 4" at COP3 of CBD, Buenos Aires, 14 November 1996 Citizens' Guide to successful action against Genetically Manipulated Foods The application of gene technology in the field of food and agriculture is an arena in which public opinion and private and public investment policies collide. A vast and stable majority of European citizens prefer their foods not to be genetically engineered. They consider gene-food to be unnecessary and hazardous to health and to biological diversity. In Norway, The Lay People's Conference on Genetically Manipulated Foods firmly reasserted citizens' NO. The lay panel was complimented by scientific and other experts on its excellent grasp on the complex and interrelated legal, socio-economic, ethical, environmental and health issues involved. In Germany, 77% of consumers do not want to eat genetically manipulated foods; 94% want them strictly labelled to allow identification and choice. More than 50% of citizens intend to boycot firms that bring these products to the market unlabelled. The private sector and governments have heavily invested in modern biotechnology in the field of food and agriculture. Consistent intellectual efforts and financial investments went into the promotion of public acceptance for genetic engineering. These efforts have demonstrably failed. Economists tell us that market mechanisms are fastest and best suited to respond to and cater for consumers' choices. One would therefore expect that such severe mis-allocation of funds be identified and immediately redressed. In reality, however, a cynical alliance between European authorities and the US firm Monsanto has been formed with the intent to force down genetically manipulated foods into unwilling and angry German consumers' mouths. European legislation does not ensure strict labelling of such foods, thus not allowing identification and avoidance. A member of the European Commission said "We cannot accept hysterical and panicky European consumers not eating what the European Commission considers safe." Monsanto applied for and attained permission to introduce its herbicide-resistant transgenic soybean into Europe, in spite of the fact that independent scientists identified a blatant scientific omission in the design of Monsanto's tests concerning health effects and in disregard of obvious hazards to the environment: e.g. increased herbicide-dependence and biodiversity reduction which goes with it, additional biosafety problems, accumulation of largely unstudied metabolites in the soil. Monsanto, in alliance with large oil-mills and food processing companies, designed a strategy to successfully flood the German market with 30 000 different food products processed from its gene-beans - ranging from oil to ice-cream. Only 1-2% of this year's US soybean production consists of Monsanto's gene-beans, however, these were strategically mixed with the rest of the harvest. 60 000 tons of this mix already reached German oil-mills. According to Monsanto, science has not tests which might tell whether its transgenic soybeans were used in the processing of a given food. Did citizens accept the role they were cast for: victims of unavoidable forced consumption of genetically engineered foods? No! Since September 1996 German citizen activists successfully defended their food sovereignty. What were the main elements of their successful struggle? 1. Alliance of Environmentalist and Consumers' Organisations joining their multifacetted talents: Greenpeace and Friends of the Earth, Germany, The German Consumers Organisation and many small initiatives joined forces. 2. Collection of signatures and initiation of opinion polls: 180 thousand signatures by 12/11/96). 3. First allies in the field of food producers, processors and food chains, willing to guarantee gene-bean-free food alternatives: organic farmers associations, a Swiss oil-mill, baby food firms and some food chains. Recently, the Speaker of the German Farmers' Association called for labelling so that farmers have a choice in animal feeds. 4. Independent scientific expertise and a testing system that allow the identifation of Monsanto's gene-bean in the processed foods: such a testing system was developped by the Freiburg based research company "Hydrotox". 5. Public visibility and press work: On entry into Hamburg Harbour Greenpeace activists "labelled" the cargo ship "Ideal Progress" carrying Monsanto's gene-beans (5/11/96); others blocked access of the freighter "Ziemia Zamojska" into Amsterdam Harbour (7/11/96); and yet another group demonstrated citizens' protest in front of Hamburg oil-mill (12/11/96). 6. Persuasion of food processors and food chains: by now, all major food processing companies (Unilever, Nestle, Danone, Jakobs/Kraft/Suchard, Schwartau) and many of the major supermarkets and food chains (Edeka, Karstadt) serving the German market somewhat reluctantly gave in to public opinion and promised to keep shelves gene-bean-free. 7. Impact on the world market: Traders who can provide soybeans from areas that can guarantee a gene-bean-free cargo of soybeans are now making profits far beyond expectations. Ships carrying gene-bean-free soybean cargo are on their way. 8. Finding international allies: A Soybean-Campaign is on its way in the US; a worldwide Coalition of Women for Food Sovereignty has gathered at the Food Summit in Rome. Women say NO to genetic engineering in their fields, gardens and foods. They call for strict labelling as a minimum rule of decency paying due respect to their judgement and choice.