Genes in Private Hands

Biology’s Big Moment

 Many call it biology’s big moment — the equivalent of setting foot on the moon. In June, next year, after a decade of work by thousands of researchers across the globe, we will have a rough draft of the human genome: the blueprint for a human being.

Living beings are made of tiny building blocks, called cells. Depending on the size of the creature, the number of cells in a being may range from one (as in tiny bacteria), to millions (as in the case of complex beings like humans). These cells contain a central portion called a nucleus, and the nucleus is made of a complex molecule called DNA (Deoxy Ribonucleic Acid). All information of the living being is contained in the DNA molecule in a coded form — and a sequence of such codes that determine a particular characteristic in a being is called a gene. The human genome is comprised of the entire sequence of coded information that the human DNA molecule contains.

Unraveling the Genetic Code

 The human genome project was designed to unravel the codes, and consequently the genes which are a sequence of these codes, contained in the entire DNA structure of human beings. Such an endeavour can have enormous benefits for medical research. For it is this coded information in the DNA molecule that determines to a large extent whether a person will be black haired or blonde, blue eyed or black, tall or short — in other words, any imaginable feature that an individual can have. These codes also determine whether an individual is prone to many inherited diseases — including different kinds of cancers, and diseases where heredity plays a role, like diabetes and heart disease.

 Mapping of the human genome is a step towards predicting, and ultimately remedying the root of many human diseases. At this stage, though the genome has been mapped, in most cases scientists still do not know what the codes stand for. Added to this is the problem that the mapping is, as yet, imperfect, i.e. there are still gaps in the huge sequences of codes that have not yet been unraveled. Even more intriguing is the fact that about 97% of the DNA molecule appears to be junk — that is the coded sequences do not appear to serve any useful purpose. Scientists are not sure whether this “junk” actually contains valuable information, about which we are blissfully unaware.

 These problems, however, cannot detract from the central significance of the mapping of the human genome. Moreover, in the decades to come, it is likely that many of the answers to these difficult question will be available to us. What is however becoming an increasing source of concern has to do with turf battles being fought over who “owns” the information gleaned from mapping of the human genome. On the face of it, this may appear to be a foolish enterprise. For, it may be legitimately argued, that information contained in the human genome is the biological heritage of the entire human race, and hence the issue of proprietorship should not arise. But such are the large boundaries of Intellectual property rights today, that many private companies are set to establish their property rights over information contained in the human genome.

Who Controls the Information?

Biologists set out on the quest to sequence the genome with the aim of giving us all the knowledge of what lies at the heart of our own cells. But near the finish line it has turned into an unseemly race: publicly funded researchers trying to outpace the commercial upstart Celera Genomics of Maryland, which plans to complete its project in June. Academics had underestimated the commercial imperative for companies to get their hands on the sequence data in the human genome first.

A century from now, few will remember who won the race. But in the meantime, there are still plenty of questions to answer. Who controls this genetic information? Will researchers scanning our chromosomes for genes linked to inherited diseases be prevented by rival commercial interests from developing new tests and therapies?

Attempts to patent information contained in the human genome have already started. The New Scientist (May 20, 2000) reports about one such landmark case. Scientists working on AIDS research went through a whole gamut of reactions —  surprise, bewilderment, and finally outrage when Human Genome Sciences (HGS), a private company based in the U.S. issued a press release proudly proclaiming that it had been granted a patent “for a human gene that produces what is believed to be the critical entry point for the AIDS virus”. Knowledge about such a gene has enormous implication for AIDS research, as determining the entry point of the virus may be the first step towards finding means to blocking its entry into the human body.

The cause for concern arises from the simple fact that the company wasn’t responsible for showing that the product of this gene, CCR5, helps the AIDS virus to enter cells. In fact, HGS applied for the patent in 1995 — a year before several other groups published pivotal experiments showing that AIDS infection depends on CCR5. At that time the company was not even aware of the connection between the gene it wanted to patent and AIDS.

Reaping Profits from mere Speculation

HGS has been able to obtain a patent based simply on sequence information of a particular portion of the human genome that the Human Genome Project — which is an entirely public funded project, funded by a large number of public institutions across the globe — had made public. A computer program analysed the sequence and found that it looked similar to genes for a family of known cell receptors.

The DNA sequence itself occurs in nature and can’t be patented, but the company had enough information from the computer analysis and laboratory tests to speculate on ways that the gene could serve as a drug target, i.e. a target for anti AIDS drugs to work upon. It was this informed speculation on the gene’s function that turned a “discovery” into a patentable “invention”. Patent laws do not allow discoveries to be patented. So what the company has essentially done is to convert a discovery (that of the sequence which forms the gene) into an invention, purely on the basis of informed guess work.

The fancy bit of guess work by the company has turned out to be extremely profitable for it, after it was awarded a patent for the gene two months ago. Researchers are dismayed that  the combination of circumstances brought about by the availability of information on DNA sequences from the Human Genome Project and liberal patent requirements (especially in the U.S.) has enabled lots of companies to file a patent without doing any work. Patent lawyers gleefully retort that how one gets the information is irrelevant as long as the information is reliable and correct!

Companies such as HGS and Incyte Genomics, another U.S. based company, have filed thousands of applications based on little more than speculation and information gleaned from the Human Genome Project. Hundreds of such patents have already been awarded (see Table). The HGS case is just the beginning. As companies file thousands of such patents, the chance that they will have accidentally stumbled on an useful gene that has commercial application, is quite high. The enormity of what might ensue is frightening. Based on mere speculation and free information, many companies stand to make enormous profits. It is ironical that the same U.S. which regularly castigates countries like India for “copying” pharmaceutical inventions, awards patents so liberally to private companies that stand to make huge profits, merely by predating upon public funded research.

Retarding Vital Research

Even more than profits, granting of such liberal patents can also obstruct legitimate research and thus retard the progress in medical research that the human genome project is poised to open up. Granting broad patents for genes will prove a disincentive for scientists who don’t hold the patent. Their research would be immediately taxed if it shows up useful possibilities that can be commercially exploited. It is being predicted that a flood of gene patents will be granted in the coming months — there are already 20 000 applications pending at the US patent office. Mercifully, Europe is still some way behind with just a few thousand applications based on gene sequences, according to the European Patent Office in Munich.

Gene patents in private hands will also affect public funded research. It had been widely assumed that purely academic or non-profit research will be immune from patent squabbles. But the evidence suggests otherwise. The New Scientist reports two such instances, that may point to the dangers that will be faced by public funded research. Andrew Read, a geneticist at St. Mary’s Hospital in Manchester, U.K., who is involved in research in  cystic fibrosis (a life threatening, inherited disease) and breast cancer, has already had a demand for royalties from one company. In the US, Myriad Genetics, is making demands for licensing fees from laboratories testing for a breast cancer gene. These examples highlight the problems where a gene patent gives a company a monopoly on a single gene.

While its still not clear how far the boundaries of gene patenting will be stretched, patent lawyers are already rubbing their hands in glee. No one knows how many of these gene patents will hold up in a court of law — but the race to patent genes is on. The ultimate loser will, of course, be scientific research and the millions who stand to gain from such research.

Top Gene Patent Holders

Incyte                                               315

University of California                       219

US Health Deptt.                                183

SmithKline Beecham                          137

Genetech                                          136

Isis Pharmaceuticals                          116

Chiron Corporation                            111

Genetics Institute                               104

Eli Lilly                                              103

Novo Nordisk                                      99

Human Genome Sciences                     90

John Hopkins University                       88

Monsanto                                            84

University of Texas                              83

General Hospital Corp.                         80

Pasteur Institute                                  78