By Smita Chaudhry
Biotechnology is a rapidly growing field in which new products and services are developed from an increasingly complex and cumulative set of underlying technologies. The sequencing of genes, identifying their functions and mutations, creating systems to selectively express, regulating or silencing genes, predicting protein structures and expressions, mapping the influence of genetic make-up on metabolism and analysing the vast amounts of genetic data has been dubbed as the ‘genomics revolution’. These technologies have contributed to the rapid pace of advancement in life sciences. They offer tremendous promise for improving human health.
Genetic tests are slowly but steadily emerging as an important component of health care services as they provide means to establish difficult diagnoses and detect persons at risk before expressing the disease. Such tests are of immense benefit to the public.
Unfortunately, patenting of genes has raised genuine concerns pertaining to the future of the genomics revolution and its potential benefits for public health. The legality of gene patents is a contentious debate. On one hand, it may be argued that the isolation of a gene amounts to ‘discovery’ and not ‘invention’ and hence not patentable.
On the other hand, it may be argued that the subject matter is not the isolated gene per se but the purified gene which comes under the realm of “invention” and not “discovery” and hence patentable. Further, it is debatable whether purified gene is a “part thereof” of human body.
This debate has intensified in the light of the judgment by the District Court of the Southern District of New York which invalidated seven of twenty-three patents on BRCA1 and BRCA2 genes. The judgment, in effect, undermined the very idea that DNA sequence can be patented.
Gene Patents Under Patents Act, 1970
As per Section 3(c) of Patents Act, 1970, discovery of any living thing or non-living substance occurring in nature is precluded from patentability. As per Section 3(i), plants and animals, where it is a genetically modified gene, would be considered as new, inventive, having industrial application and hence patentable.
Considering Section 3(i) of the Act which prescribes patenting of diagnostic methods, the Draft Manual of Patent Practice and Procedure, 2008 excludes methods of diagnosis practised on the human or animal body. However, it includes methods of diagnosis performed on tissues or fluids which have been permanently removed from the body and henceforth diagnostic methods having DNA are patentable.
Patentability Requirements: Novelty
Taking the viewpoints of gene patentability, the novel requirement encircles around whether naturally occurring genes can come under the purview of newness. Previous courts have excluded them from being patentable subject matter because they lack invention and are naturally occurring phenomena.
Therefore, a plant, animal or microbe newly found in the wild, or a mineral or chemical newly discovered in the earth, or any part of a plant, animal, microbe, mineral or chemical is not patentable subject matter; such discoveries are “manifestations of nature, free to all men and reserved exclusively to none.”
The US Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 (1980), made a distinction between living organisms as they exist in nature and things isolated as a result of human intervention. This isolation makes the information in the gene available in a way that is not in nature, and thus considered a novel product.
Although Article 27.3(b) of TRIPS allows governments to exclude plants, animals and essentially biological processes from the requirement of Article 27.1 that patents be available in all fields of technology, isolated organisms are unlikely to fall within the exception.
Inventive Step
The requirement of Article 27.1 of TRIPS agreement states that inventions must involve an inventive step. This means that comparison of what is already known (prior art) should show that the invention would not be obvious to a skilled person working in the area.
The Patent Office seems to be reluctant to deny legal protection where a significant investment of time and effort has been made and more Intellectual Property protection should be available.
With the advent of computer technology, gene identification has significantly improved, making it much easier and speedy. Moreover, in the US, the inventive step requirement focuses on the invention itself rather than the techniques for its production. It simply concentrates on whether the gene sequence is obvious, not whether the method used to obtain it was obvious to try.
For example, in In Re Bell, 26 U.S.P.Q.2d 1529, DNA and RNA sequences coding for “human insulin-like growth factors” were claimed. The Court of Appeals held that the degeneracy of the genetic code meant that there are vast numbers of DNA sequences that might code for a specific protein and concluded that prior disclosure of amino acid sequences and general sequencing methods did not render the claimed sequences obvious.
Utility
Article 5(3) of the Biotechnology Directive requires that industrial applicability for gene patents is disclosed in the patent application. This requirement was introduced relatively recently in the US, and was a key recommendation of the Australian Law Reform Commission Report into gene patents.
In Brenner v. Manson, 383 U.S. 519 (1966), it was observed that inventions must have substantial utility — a specific benefit — and not merely be capable of some beneficial use to society.
In Parke-Davis & Co. v. H.K. Mulford & Co., 95 (C.C.S.D.N.Y. 1911), the court observed that patentability is not denied merely because products of nature are involved.
This suggests that if there is sufficient reason for granting a patent, then the subject-matter requirement will be satisfied even if the subject matter claims product of nature. It has been said that the difference between a discovery and invention is a difference in degree rather than its kind.
It was also held in Diamond v. Chakrabarty by the United States Supreme Court that genetically manipulated organisms are subject matter under Section 101. In light of the “product of nature” theory, the Court’s reasoning can be accepted, as there was no corresponding organism in nature as claimed. The Court further said that statutory subject matter includes “anything under the sun made by man” is patentable.
Critical Analysis with India’s Patent Law
India has emerged as the hub for biotech research and commercial market. This and the revised patent law have encouraged patent filings in the biotech field in India.
The Indian Patent Law has defined what is an invention under Section 2(1)(j) and has also stipulated under Section 3 what inventions are not patentable. Section 3 of the Indian Patents Act categorizes what are not inventions within the meaning of the Act. There are specific categories which are applicable for biotech inventions, including those relating to genes and diagnostics. The relevant sections include Section 3(c), 3(i) and 3(j).
According to Section 3(c) of the Patents Act, “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living or non-living substance occurring in nature” is not an invention.
Thus, merely isolated naturally occurring genes are considered as discoveries and not inventions and are therefore deemed to be not patentable as per Section 3(c).
Further, under Section 3(i) of the Patents Act, diagnostic methods are not patentable inventions. However, in the Patent Office’s Draft Manual of Patent Practice and Procedure 2008, it is stated that while methods of diagnosis practised on the human or animal body are excluded from patentability, methods of diagnosis performed on tissues or fluids which have been permanently removed from the body are not excluded. Thus, diagnostic methods employing DNA primers and probes would be considered as patentable inventions.
According to Section 3(j), plants and animals as a 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 are not patentable.
Under Section 3(j), animals, plants or part thereof, not only of the natural origin but such living entities of artificial origin such as transgenic animals and plants or any part thereof are also not patentable. Microorganisms may be construed as being patentable as per Section 3(j), however Section 3(j) read together with Section 3(c) makes it clear that naturally occurring isolated microorganisms are patentable subject matter in India. Nonetheless, genetically engineered or modified micro-organisms of artificial origin and vaccines are considered patentable.
One may wonder whether genes are considered as biological or chemical material, whether they would be interpreted as part of plants or animals and if they can be patented or not. The Indian Patent Office’s Draft Manual 2008 does not explicitly elucidate the same, but under the guidelines for the unity of invention, the following example is included: when a genetically modified gene sequence/amino acid sequence is novel, involves an inventive step and has industrial application, the following patents can be claimed:
- Gene sequence / amino acid sequence.
- A method of expressing the above sequence.
- An antibody against that protein/sequence.
- A kit made from the antibody/sequence.
Conclusion
The link between intellectual property rules and ethical regulations over genetic research should be institutionalized. Human genetic research is highly international and interactive in character; hence agreeing on standards for informed consent and benefit sharing presents a regulatory challenge akin to those that deal with genetic resources under the Convention on Biological Diversity.
There is ambiguity and uncertainty, particularly with regard to the ambit of the inventive step, utility and disclosure test, the distinction between inventions and discoveries, property rules and ethical considerations.
Biotechnology law is mostly considered to be judge-made law or court-established law. Therefore, efforts of harmonizing all the patent laws under the TRIPS agreement have failed particularly in respect of gene patents, which is one of the main causes for the ongoing debate.
Hence, strict application of the requirements is the need of the hour and a proper balance should be maintained between the public and private interest, keeping in mind that the development of science and technology should not disturb society.