The ethics of DNA Patenting

The study of biology was radically transformed by the discovery of the double helical structure of DNA, which is the genetic material of living organisms. Since then, scientists have made considerable advances in understanding how DNA works, and how differences in DNA lead to differences between people. But rapid developments in biotechnology during the past decade have enabled corporations , scientists and "bioprospectors" to alter nature's handiwork for commercial profit. A major strategy for private exploitation in this area is to obtain the patent rights to an organism or its component parts. As these developments affect all of society, we need to decide whether any corporation, institution, or individual should have the right to private ownership of life.

It is commonly accepted that benefits that have accrued to society from the patent system cannot be ignored, but the question remains whether the application of the patent system to DNA sequences is achieving its goals, namely the stimulation of innovation for the public good, and the rewarding of people for useful new inventions.

We know that many patents that assert rights over DNA sequences have already been granted but are of doubtful validity. The effects of many of these patents are extensive as well as controversial , because inventors who assert rights over DNA sequences obtain protection on all uses of the sequences which has generated a lot of controversy as they directly come into conflict with many moral and ethical questions. In the light of this controversy we have attempted to examine various aspects relating to DNA patenting.

The patent system

Before turning to the question of patents involving genes, it is important to discuss the patent system in general.

Patents are exclusive rights granted for a limited period of time by states through their legal systems to inventors to prevent others from exploiting the patent holder's invention. Patent applications contain claims which set out the precise nature of the protection.. Patent claims are normally drafted to ensure that they cover more than exact duplication of the inventor's work.

Patents can be broadly divided into three categories, though these categories are not formally distinguished under the patent system. A product patent is a patent on the product itself. The term 'product' normally means a mechanical, chemical or biological entity, substance or composition (as distinct from a device or electrical circuit). A patent that asserts rights over a product itself covers all uses of that product.

A process patent is a patent on a method or process. This covers a process, and may also include what is directly produced from the process. If a product is made by another process, not covered by the patent, it does not infringe it. A use patent is a patent on the use of the product for a specific purpose; only the specified use is covered.

An important feature of product patents is that they extend to new uses of the invention that may develop subsequently, even if these uses were not anticipated or predicted by the owner of the patent.

Of the three main kinds of patent i.e. product, process and use patents, only product patents can assert rights over DNA sequences themselves. Use patents only extend to the use of the sequence. In practice, use patents may also restrict access to the DNA sequence itself.

Ethical issues relating to DNA patenting

Exciting invention in the field of bio technology have been made in recent years following the examples of the owners of bio tech patents companies with high investment in the field of bio technology now recognized the advantage of protecting and enforcing their intellectual property rights and in relatyion to this a series of ethical questions relating to the patent aspect has emerged. In the middle of this debate are ordinary citizens, often uncomfortable with the idea that something as fundamental as a gene can be patented but at the same time eager to see new medicines.

The objection which is forwarded against genetic patenting is that genes are "products of nature" and therefore ought to be off-limited. The courts have recognized a "products of nature" doctrine and used it to reject some patent applications.

However a counter-principle has also evolved : Even a product of nature can be patented if a inventor has devised a new process of purification or collection that makes a substance available in previously unknown quantity or purity. Examples patented in this century include adrenaline and purified Vitamin B1. The most well-known example of a living organism which was granted a patent is the genetically engineered bacterium that was the subject of litigation in America, in the case of Diamond v Chakrabarty_ftn3[3] . By a 5-4 decision, the U.S Supreme Court allowed the grant of the patent to stand, US Chief Justice Burger famously remarking that in principle 'anything under the sun that is made by man is eligible for patenting.'Other living organisms that have been patented include yeasts, viruses, and cell lines. This case sent a crucial signal to the world that patenting must be made available in any country which sought to join the race for commercial returns on bio technological research and made it easy for the courts to extend the doctrine to genes.

One reason is that isolating a gene for medical use is not simply a matter of plucking it out of the body. The "genes" that researchers patent barely resemble genes as they exist in nature'.

Advocates of gene patents cite the sophistication of this work (i.e. gene patenting) in arguing that ownership rights are not being granted to scientists simply because they stumble on an aspect of nature, but rather because they are deploying complex techniques to manipulate nature in the service of human goals.
The next argument that is forwarded against D.N.A patenting is that such patents make important products more expensive and less accessible. The biotech industry claims that patents are necessary so that innovative, life-saving technologies can be developed. In actuality, patents enable companies to create a monopoly on a product, permitting artificially high pricing. As a result, products such as drugs are often priced out of reach for many of those who need them.
There are 3.5 billion bases in the human genome. The human genome is, in effect, a single sentence: .. and so on it would fill 500,000 pages various aspects of a telephone directory. Once the human genome is decoded, it will begin to transform various aspects of human life including medicine, science, human fertility, archaeology, genealogy, the insurance trade and the whole of human society. Knowledge of the human genome, the code of life, will allow us to determine exactly what it is that makes us human. The code may give us the cure for cancer, heart disease and a thousand genetic human frailties.

Decoding human genome will be of great benefit to human race, a cure for AIDS or maybe eventually all of the diseases that afflict humanity can be wiped off. So we can say Genomic is the future of a whole new set of pharmaceutical industries that will create thousands of individually tailored drugs and consequently billions of dollars would be needed to invest in these complex researches. Where will this money come from? Obviously from the people, who will in turn benefit from this research. And regarding the high pricing of life saving technologies, it is it has observed that many of the pharmaceutical companies sell these drugs at a much lower rate than feared.

Patents on living organisms are morally objectionable to many people. Patenting organisms and their DNA promotes the concept that life is a commodity and the view that living being are "gene machines" to be exploited for profit. If it is possible to consider a modified animal an invention, are patents and human reproductive cells and their marketing far behind? Patents derive from concepts of individual innovation and ownership, which may be foreign to cultures which emphasize the sharing of community resources and the free exchange of seeds and knowledge. Many disputes involving patent infringement cases emerged because of question related to obviousness, enablement or the priority of invention that had to be decided by the courts. More difficult were the questions about the ownership rights and privileges.

For example, in the patent 'Unique T-lymphocyte line and products derived therefrom', the inventors used the spleen of a patient Mr. John Moore who suffered from hairy cell leukemia and came for treatment to Dr. David Golde at UCLA. As part of the treatment, his spleen was removed and Dr. Golde developed a cell line with enriched T-lymphocytes that produced large amounts of lymphocytes useful for cancer or AIDS treatment. Without Mr.Moore's initial knowledge or consent, but requiring his repeated visits to the hospital, Dr. Golde and the University of California applied for a patent on the cell line derived from Mr. Moore's spleen which was granted in 1984. Mr. Moore subsequently sued Dr. Golde and the University supreme Court. Both the Appeals Court and the Supreme Court recognized the novelty of Mr. Moore's claim Mr. Moore on the issue of conversion (unauthorized use of his body part), but recognized his right to be informed of what the physician was doing involving his health and well being. It's as irony that a person is not given any benefit of the substance which he himself had produced, and at the same time others are minting money from the same substance.

Defenders of such patents such as biotechnology firms, joined by some researchers in academia and the pharmaceutical industry argue fiercely that without patents society won't benefit from revelations about the molecular roots disease. Moreover the arguments that patenting DNA promotes the view that life is a commodity, cannot be accepted because it is not that the main aim of the DNA patenting to earn profit or to use it for someone personal interest, on the contrary the overall aim of the patent system is to promote the public interest and to provide a fair reward to inventors. The patents system is said to be justified because it provides an important incentive for the development or new products and technologies related to healthcare.

One of the most coveted argument which is vociferously put forward against the patenting of life forms is that the First World patenting of Third World genetic resources represents theft of community of biological resources. Patents held by the industrialized world on biological resources from the developing world will serve as a tool for the North to accumulate more wealth from the already impoverished south. Microorganisms, plants, animals and even the genes of indigenous people have been patented for the production of pharmaceuticals and other products. Requiring developing nations to pay royalties to the wealthy industrial nations for products derived from their own natural resources and innovation in robbery. Moreover the developing world has never received compensation or recognition for these intellectual and technological contributions. Patenting life forms will exacerbate this inequality. This "bio-colonialism" will continue the pattern of a few transnational corporations profiting at the expense of genetic resources of the third world countries.

But biocolonist have their own defence; they argue that "Decoding the human genome will increase our knowledge a thousand fold times a thousand fold of the nature of Homo sapiens. And with that knowledge will come immense power. Before we create, we will almost certainly destroy, committing a new form of human selection, genomecide. Through systematic but simple foetel genetic tests in the next decade, we will ruthlessly search out and eradicate those human genes we regard as inferior, Trisonomy 21 or Down's Syndrome, Turner's Syndrome, Huntingdon's Chorea, Cystic Fibrosis; the list is as long as we want to make it. Certainly there will be great benefits a cure for AIDS malaria, maybe eventually nearly all of the disease that affect humanity. Genomics is the future of a whole new set of pharmaceutical industries that will create thousands of individually tailored drugs.

But the question is where to draw the line? Will one abort multi-celled fetuses because the tests show genes that code for Alzheimer's in later life? Would we now eradicate the former US President Ronald Reagan, whose Alzheimer's is genetically inherited, just after conception? What is the definition of an acceptable genetic human being? What is a valid human life?

Some legal and technical concern
The application of the patent system in the field of biotechnology and biomedicine is justifiable as a way of striking a reasonable balance between the right of inventors and the public interest.

But such patents involve some legal and technical issues which are as follow:
The first concern is that patents which assert right over DNA sequences in particular human DNA sequences, should not be allowed by virtue of the special status or nature of DNA. While dealing with this question we have to draw an important distinction between the acquisition of knowledge about the nature and functions of a DNA sequence, and the information contained within that sequence. Although we think that the judgment that isolated DNA sequences are eligible for patenting, is based on questionable extrapolation to the case of genetic information from the case of the isolation of chemical compounds, we accept that a limited number of the early patents granted on that basis need not now be called into question in view of the inventiveness required to isolate the DNA sequences.

Since the early days of the pioneering experiments using positional cloning techniques patents have been field on many DNA sequences, which were mass-produced by a mixture of computational and cloning techniques. Even if it can be convincingly argued that these sequence were eligible for patenting, the patents should be examined in the light of the criteria for inventiveness and utility. we note that as techniques have advanced, and in particulars as the use of computers to identify genes has become more widespread the eligibility of DNA sequences for patenting should have diminished.

The second concern is that patents which asserts rights over DNA sequences should not be allowed because they do not meet the legal criteria for patenting. With regard to the legal criteria for assessing patents with claims to DNA sequences, while the test of novelty can be met, the tests of inventiveness and utility are more problematic. In the case of inventiveness, we hold that as the use of computational databases becomes the standard way of identifying genes, it is difficult to see how the test can be met, despite current US practice. In the case of utility, we argue that the standard of credibility required for a claimed utility needs to be set higher than the mere theoretical possibility of this utility; some positive evidence that the DNA sequence has the claimed utility should be required.

Some glaring questions relating the Patentability of genes or nucleic acid

There is a current debate on the inherent dangers of the process of creating transgenic organisms, which is why UK and many countries in Europe are banning transgenic crops or imposing a moratorium.

Transgenic DNA has the potential to generate new viruses and bacteria that cause diseases, and may also cause cancer by integrating into mammalian cells. The transgenic DNA from terminator or GURT technologies involve even greater risks, as they contain dangerous genes that prevent germination, which can nonetheless escape into other species. Furthermore, the technologies depend on gene-splicings that have to be engineered and regulated very precisely, but those requirements are beyond the capability of the genetic engineer. The hazards of the transgenic DNA resulting from GURT technologies are much greater, because the imprecisions of inserting multiple gene-constructs are multiplied, and because of the gene-splicing sequences and genes deliberately introduced. Gene splicing has the potential to create new combinations of genes and to scramble genes and genomes when it is imprecise.

How can we regard this as a patentable invention when it is so hit or miss and unreliable? It is both scientifically flawed and ethically unacceptable to create so much suffering.

The patentability of genes and other nucleic acid sequences is justified on the ground that they have been subject to a microbiological or nonbiological process, i.e, gene sequencing, which is itself a standard process patentable and patented under existing patent laws for invention. So, the actual patented entity is the nucleic acid sequence itself and its putative function.

However, the DNA or RNA sequence is subject to change by mutation, deletion, insertion and rearrangement. Does it mean that, for example, if the sequence patented is, ATCCAGAACCTA, then variously mutated sequences such as:
AACCAGGAACCTA (single base substitution), ATAGGAACCTA (deletion of two bases), ATCCATCGGAACCTA (insertion of two bases), AGACCTGAACCTA (inversion of 5 bases) are no longer covered? The confusion is multiplied when single nucleotide polymorphisms (SNPs) are ruled to be independently patentable by the US Patent Office. Thus, the patent for the gene and the patent for the gene variant will legally clash.

The same arguments of mutability of entire genomes raise the question as to which genome is being patented. If the patent is on one DNA base sequence, does it cover genomes differing in DNA base sequence?
For a DNA sequence of 10000 bases, the possible number of variants is 410000

The "industrial application" stated in the EU Directive Article 5.1 involves the functional side of the gene sequence, and presumably qualifies it as an invention. It is important to realise, however, that the nucleic acid molecule by itself can do nothing. It can only have a function in a living cell or an organism. However, its function depends on which kind of cell it is in, where in the genome it is inserted (not under the control of the human genetic engineer), in what kind of genome and in which environment. In other words, its function is uncertain and unpredictable. For example, the acetyl-CoA carboxylase gene, which confers herbicide resistance in monocots, is claimed primarily for regulating oil content in a patient. Under some circumstances, again beyond the control of the genetic engineer, the gene is silenced, so it has no function whatsoever. Thus, the patentability based on function is equally unscientific.

The patenting of genomes raises the question of the function of the genomes. Again, the isolated genome can do nothing by itself while its 'function" in the organism cannot be considered separately from the totality of the organism.

Conclusion
A ban on patenting genome sequences would be both impractical and unrealistic and tighter rules are needed on the conditions under which such patents are granted.

As already referred, the most commonly heard refrains from those critical of the private sector's control over biotechnology is that no patents should be granted on DNA sequences because such stretches of DNA are 'natural', and therefore cannot qualify as inventions (which is what the patent system was set up to protect). On ethical grounds, an equally strong argument is made that if the human genome - and all its contents - belongs to anyone, it should be commonly owned by all mankind. Staking claims to the sequences that make up individual genes, even if previously unknown is portrayed as the ultimate form of "biopiracy".

Unfortunately, perhaps, such a viewpoint appears somewhat utopian. We live in a world where society, through its patent laws, has already agreed that certain kinds of products can be patented. A likely candidate, for example, would be a gene sequence that forms an essential element of a novel diagnostic test for a disease.

But that does not mean that nothing can - or should - be done about DNA patents.

In future, a patent should only be granted on a gene if the social benefit likely to emerge from knowing the genetic code for that gene can be clearly defined. Patents on gene sequences should no longer cover all possible uses of that sequence, some of which may be unknown. In this regard it is submitted that patents must satisfy the condition of not being contrary to morality or 'ordre public' and suggest that patent offices should seek general ethical guidance, as necessary, from relevant bodies.

As the Nuffield panel6 concludes, DNA patents should be "the exception rather than the rule".

It is not as simple as, 'Patents, good or bad?' or 'Licensing, good or bad? "The mission should be to make sure that all this research benefits people".

Also Read:
Patenting of Micro-Organisms in India: The fact that the subject matter of many products of biotechnology is incredibly complex, particularly where the subject-matter is a living organism.

Patentability: What Is Patent?
A patent an exclusive right granted to a person who has invented a new and useful article or an improvement of an existing article or a new process of making an article ensuring that no other person may make, use, distribute or sell any commodity which uses this product or process.

Patent & Its Effect In India:
Though India was not a member of Paris convention, but having signed the TRIPS agreement, India is now obliged to recognise and implement the provision of national treatment to nationals of other members as has been incorporated in the TRIPS agreement.

Challenges to India Patent Regime:
The new patent regime in India touched the hornets' nest and has raised several contentious issues relating to right to health of the people, which is in conflict with the economic right of patent holders.

Whether Patent Law Protects Biotechnological Inventions:
William Heseltine (President, Human Genome Science) has interestingly noted that trying to patent a human gene is like trying to patent a tree. You can patent a table that you build from a tree, but you cannot patent the tree itself. By signing Budapest Treaty on the International Recognition of the Deposit of Micro organisms for the Purposes of Patent Procedure, India can assist in the standardization process of biotechnology pate in the country.

Software Patenting:
With respect to computer software, in Patents (Amendment) Act, 2002, the scope of non-patentable subject matter in the Act was amended to include the following: "a mathematical method or a business method or a computer programme per se or algorithms".

Pharmaceutical Product Patents:
The monopoly granted by patents to the Drug companies should not be exercised without responsibility. Hence it can be safely said that India having rushed through with the third amendment of 2005 to the patents act without proper parliamentary scrutiny and without having tactfully dealt with issues relating to food, health and technology was not in public interest.

Patenting Recent Biotechnological Inventions:
Patenting within the biotechnological sphere and the subsequent opposition proceedings which have been undertaken by NGO's such as the Greenpeace, which have become worried by prospects such as the patenting of life, have led courts to highlight the relationship between patents and morality.

Patent Regime And Right To Health:
Patents are not a gift for drug companies to exercise power without responsibility. Given the importance of the issues at stake, the debate concerning the impact of medical patents on access to drugs is unlikely to subside in the near future even though the Patents (Amendment) Act, 2002 has just been adopted.

The author can be reached at:dwivedianu@legalserviceindia.com / Print This Article

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