Gene patenting has always been a controversial matter and due to the recent revelation of Angelina Jolie’s preventive double mastectomy, the matter is again in limelight. Much of the ink has been spilt on Gene patenting ever since the issue of patenting of genetically modified organism arose in Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Myriad genetics, a Utah based private biotechnology company, has a monopoly on two genes called BRCA1 and BRCA2. Mutations in these genes can radically raise a woman's chance of developing breast or ovarian cancer. Since Myriad owns the patent rights on these two genes, it is the exclusive provider of the tests related to these genes in United States, thus blocking other diagnostic centres from offering tests based on these genes. Granting monopoly on a DNA sequence through gene patenting has direct impact on various other areas of worldwide medical research such as, drug designing, etc.

The genomics revolution brought about by the genome sequencing and mapping, cloning, selective expression, regulation and silencing of genes, prediction of the three-dimensional structures of a protein etc, has contributed a lot to the rapid development of health care & life sciences. These technologies along with genetic testing to predict a person’s predisposition to genetic disorders, have tremendously improved the health care services. Patenting a gene sequence might impede the advancement of genetic testing which helps in detecting the risk of disease before the actual expressing of it. Gene patenting has, therefore, genuinely raised concerns pertaining to the scenario of the genetics research and its possible benefits to health sector.

The Controversy

Patent is granted to an inventor for a limited period of time to encourage him and to have exclusive control over the innovation. While a patent is in force no one is allowed to use it without a license. The major issue in granting patent over a gene sequence is that the sequence normally becomes the property of the company which hinders any further research by another company. Further, from the point of view of a new researcher the increase in the number of gene patents can lead to negotiation of multiple licenses for the advancement of genomic research. Owing to the multiple licenses and royalty payments the cost of research and development is automatically increased. The burden of this increased cost is finally borne by the public.

Another issue which arises in patenting a gene is that they are naturally occurring substances and many countries, including India, bar products of nature from being patented. The thought that a biological material, such as set of genes, existing inside a person’s body is owned by someone else is difficult to accept. For this reason, a DNA sequence or a gene is obviously held disqualified from patenting on the grounds that they are discovered and not invented. However, patents are still being granted to a gene sequence on the grounds that they are isolated from their natural environment, purified in vitro and then inventively reconfigured to give rise to a sequence that is new, inventive and has industrial application.

In addition to this, isolation of a specific DNA sequence, mutational analysis and further development of diagnostic methods is an expensive affair which uses huge amount of public funds. Thus, the public may end up paying double the amount- firstly for the research and secondly for high-priced diagnostic methods.

Scenario of Gene Pat ents under the Indian Pat ents Act , 1970

According to Section 3(c) of Patents Act, 1970 ‘the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or nonliving substances occurring in nature’ is not considered patentable. Similarly, Section 3(j) renders ‘plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals’ not patentable.

Thus, in the light of above mentioned Sections, simply isolating a gene from a living thing amounts to ‘discovery’ and not ‘invention’ and hence not patentable. That is to say, under the current Patent regime naturally occurring DNA sequences cannot be patented as such. They can only be patented when after isolating the sequence they are purified and chemically modified resulting into a sequence that is new, inventive and has industrial application.

Further, Section 3(i) says that inventions related to ‘any process for the medicinal, surgical, curative, prophylactic, diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products’ are not patentable. That is, the method of diagnosis practised on the human or animal body are strictly excluded from patenting. However, the diagnostic methods carried out on tissues or fluids, which have been permanently removed from the body fall under the category of patentable inventions provided that they also fulfil the other patentability criteria.

Gene patents as gatekeeper patents

Gatekeeper patents are also known as Blocking Patents. It has been defined as “a patent relating to a particular area of technology which prevents another patent from being used because the other patent relies on technology covered by the first.”1 Genes are an essential element and starting point of many genomic researches. Therefore, if a patent is obtained over a gene, it can hinder the development of potential technologies which might be developed using the basic research technology. The patented basic gene sequence is said to guards the entry of other inventions/gene therapies using that basic sequence. Hence, those patented basic gene sequences are known as gatekeeper patents.

A patent is used as blocking patent by claiming all the essential features of the invention so that no new invention can be invented around it. To invent around it you have to have the license of the blocking patent.

In genomic research and diagnostics, having a patent over a gene sequence or a part of it can be regarded to obstruct the further development of genetic tests as it is impossible to devise an alternative way of testing the disease without using that patented gene sequence or a part of it. For instance, Human Genome Sciences Inc. (HGS), a biopharmaceutical company, obtained patent over a human gene CCR5 that was later identified to have key role in HIV infection. When the company filed the patent application for CCR5 in 1995, it had no clue that there was a link to AIDS. Later, when it was discovered by the scientists across the world that CCR5, a cell surface receptor, is used by Human Immunodeficiency Virus (HIV) to gain entry to a cell it was extensively feared that this patent would act as gatekeeper and would block further research on AIDS. However, HGS did not prevent scholars from undertaking unlicensed research on CCR5. On the other hand, if HGS had taken a contrary decision, it would have had created a calamitous impact on AIDS research.

Conclusion

A gene, though being a natural substance, qualifies the patentability criteria on the basis that are isolated from the body, purified in vitro and then inventively reconfigured to give rise to a sequence that is new, inventive and has industrial application.

The patent regime confers exclusive right upon the holder of the patent to make, use and sell that invention for a period of twenty years. As it is practically not possible for an individual to enlist all the mutations and potential gene therapies based on them at once, it can therefore be concluded that the monopoly granted to a patent holder over a gene sequence can exorbitantly elevate the costs of genomic research and further development of new gene therapies..