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LICENSING LIFE: THE BIOTECH BILLIONS are bound up in a web of alliances and interests. Research and On 14 March 1995, the United States Patent and Trademark development is concentrated in the hands of a few companies. Office issued the first patent on a human cell line to the US One example is the "superclub" set up by the France-based multi- National Institutes of Health (NIH). The unmodified cell line was national drugs company Rhéne-Poulenc Rorer, and operated by drawn from an indigenous person from Papua New Guinea. its subsidiary, RPR Gencell of Collegeville, Pennsylvania, USA. Human life is now officially a commodity whose ownership can The "superclub" is touted as an admirable venture because it be legally enforced by patents awarded to genomic corporations will accelerate the development of gene therapies for cancer, car- on human genes and their by-products. diovascular disease, obesity, etc., through the use of shared data Since this new and outrageous era in intellectual property was and technology. It will also accelerate the profits raked in by launched, the ‘life industries' have raced to identify and commer- RPR Gencell. One of the conditions of joining the "superclub" is cialise human genes and other human biological materials. that researchers should withhold publication of their findings for a The Rural Advancement Foundation International (RAFI) year until RPR Gencell files for patents to protect discoveries or describes the frenzied endeavours to profit from human biological inventions. This gives RPR Gencell a great deal of control over materials as a modern-day gold rush, a gene rush: researchers’ findings. .silent and reckless with incalculable stakes for The 14 "superclub" members include: humankind...the commodity they seek to exploit is not gold * CNRS (France's National Centre for Scientific Research) but biological information. The raw material they need is * Généthon, Paris human DNA: the blueprint of human life. * Gustave Roussy Institute, Paris Each human cell contains up to 100,000 genes. A single patent- « Transgéne, Paris ed cell line can be worth US$1.5 billion dollars per year to a com- ¢ Applied Immune Sciences, Santa Clara, California pany involved in the life sciences industries. Research conducted ¢ Darwin Molecular, Seattle, Washington by RAFI reveals that more than 1,000 DNA patents on sequences ¢ Genetix Pharmaceuticals, New York have already been issued to over 300 companies and government ¢ Introgen Therapeutics, Houston, Texas institutions. ¢ Lawrence Berkeley Human Genome Center, Berkeley, Just one small portion of the human biotechnology industry can California yield lucrative profits. The US consulting firm Frost and Sullivan * Virogenetics, Troy, New York estimates that the worldwide market for cell lines and tissue cul- Another example is the company Human Genome Sciences tures brought in US$427.6 million in (HGS) of Rockville, Maryland, which corporate revenues in 1996. Frost owns the details of DNA sequences and Sullivan predict that the market po aoe that could identify 35,000 human will grow at an average annual rate Human life Is NOW officially a genes—more than a third of the total of 13.5 per cent over the next seven i i thought to exist. years, to be worth US$914.1 million commodity whose ownership can In October 1994, HGS announced by 2002. be legally enforced by patents that any researcher who wanted to use Biotech companies are rushing to awarded to genomic corporations the information held by HGS could do isolate a plethora of disease-carrying so for free, on the basis that if the genes, including the genes that cause on human genes and their researcher came up with something by-products. that could be commercialised, such as a test or treatment for a disease, HGS would have the right to negotiate a marketing contract. HGS sees this seemingly modest demand as a way to colon cancer, lung cancer, prostate cancer, cystic fibrosis, heart disease and asthma. Once patented, these genes are worth billions of dollars in licensing fees and spinoffs from the manufacture of other pharmaceuticals and gene technology. pay back its investors, such as the pharmaceuticals company Some patents already awarded include: SmithKline Beecham which has poured US$100 million into HGS ¢ The hepatitis C virus sequence, patented by the US biotech and its non-profit arm, The Institute for Genomic Research company, Chiron Corporation. (TIGR). ¢ The gene for breast cancer susceptibility, patented by Myriad In biotechnology, as in many other fields, government agencies Genetics. are forming alliances with corporations. In 1995, the US Patent ¢ A European patent on the use of stored stem cells from umbil- and Trademark Office issued a patent to the US National ical cord blood, granted to the US company Biocyte Corporation. Institutes of Health, covering the principle of removing cells from Such cells are widely thought to hold considerable therapeutic a patient, altering their genetic makeup and returning them to the promise for bone marrow transplantation and gene therapy. body. Almost all gene therapy trials that have been approved so ¢ The gene for H2-relaxin, a protein produced within the ovaries far rely on this technique. The NIH has given GTI, of which relaxes connective tissue to allow a woman's pelvic girdle Gaithersburg, Maryland, exclusive rights to develop the technique to widen during pregnancy and while giving birth. commercially. Rival companies wanting to do research must now Once a company has a patent (say, on a gene-sequencing right), _ pay a licensing fee to GTI. it must be paid a royalty or licence fee by others using that Alleged industrial espionage is rife as biotech companies pro- sequence. Chiron claims that it invests more than five times its ceed with litigation against each other. One legal battle involves income from hepatitis C licensing in its research program—a total mice that have been 'developed' to secrete human antibodies of US$344 million in 1995. Thus, the income received from the which may help treat AIDS and cancer. The 'humanised' mice, hepatitis C virus sequence licensing fees would be valued at worth millions, were the subject of a bitter dispute between the US$68.8 million for that year alone. two US companies Cell Genesys and GenPharm. Cell Genesys Companies involved in human, plant and animal biotechnology withdrew its legal action upon learning that the US Patent and by-products. 32 ¢ NEXUS JUNE - JULY 1997 LICENSING LIFE: THE BIOTECH BILLIONS