As Scientific Puzzle Unravels, a Legal Issue Tangles More : New genetic findings pose rising problems in area of patents and business
The early discoverers of and experimenters with electricity could hardly have imagined how their work would ultimately transform the world. A similar technological upheaval awaits us now as private business starts to exploit the revolution in molecular biology to bring new cures, therapies and we-know-not-what. Just four decades after James D. Watson and Francis H. C. Crick solved the central mystery of inheritance with their discovery of the double helix structure of DNA, the genetic material, investors are pouring hundreds of millions of dollars into companies that see potential profits where Watson and Crick saw only basic science.
Few disagree that this science is now ripe for use, to the potential benefit of all humankind. But the rules of the game have yet to be drawn. For patenting and controlling the human genome and its parts present special problems without good precedent in law, a situation that has left both government and industry confused and divided.
Four years ago the federal government launched the Human Genome Project, a costly long-term plan to chart and catalogue the entire human genetic endowment. Only about 5% of each person’s DNA is used in the actual genes that result in expressed traits, such eye color; the purpose of the rest of the DNA is still unknown. One of the researchers in the project, J. Craig Venter, then with the National Institutes of Health, devised a short cut. He went to the heart of the matter and began to focus on just the crucial 5%. Now new robotic machines in government and industry are busily deciphering the exact sequence of chemicals of thousands of these gene segments. Their specific genetic tasks are mostly still uncertain.
In 1991, the NIH stirred a scientific tempest by filing applications for patents on 6,869 of Venter’s sequences. This was done as part of the Bush Administration’s and Congress’ commitment to “technology transfer” of government-supported basic research into commercial applications. The theory was that patents would allow the government to bring a more orderly licensing of discoveries than if the work were just thrown into the public domain. Enraged at the notion that the genome project’s results might not be available to all scientists, Watson quit as its director.
The Patent and Trademark Office rejected the applications on the ground that the required utility of the sequences had not been demonstrated. Before the issue could be appealed to federal court, however, the Clinton Administration on Feb. 11 withdrew the applications as “not in the best interest of the public or science.” But now several private companies have revved up their own gene-sequencing machines and are applying for patents. These include Human Genome Sciences Inc. (HGS) of Rockville, Md., with which Venter is now connected, and Incyte of Palo Alto, Calif.
Full genes whose function is known have been granted patents, and all agree that concrete end products of genetic engineering, such as drugs, are also patentable. But the partial sequences whose utility is uncertain present difficult problems. Leaders of companies like HGS say they need patent protection or they will have to keep their work secret, even from basic researchers. They say the sequences do have utility, to wit HGS’ crucial role in helping medical researchers at Johns Hopkins University discover a gene for colon cancer.
Others fear that patents will impede basic research and say the gene sequences should be public property, a kind of basic common alphabet available to all. The biotechnology industry is divided; everyone seems to want strong patents, except when the patents belong to someone else.
The issue piles layer upon layer of scientific, legal and ethical uncertainty and complexity. Sen. Edward M. Kennedy (D-Mass.) has requested an analysis from the congressional Office of Technology Assessment. It may be that Congress--in collaboration with Britain, France, Japan and other major research countries--must write new patent or copyright law to guide us through the biological revolution.
