What Are the Problems Facing Biotech Patents?

Biotechnology is the science of developing techniques for the application of biological processes and organisms to the production of materials of use in medicine and industry. Viewed from one perspective, biotechnology is no more than an aspect of chemistry in that the raw material of biotechnology and its products- most commonly DNA [1] and polypeptides, or proteins, for which these DNA sequences, or genes, code- are merely chemicals, albeit that many of them occur in nature [2] . Certain aspects of biotechnology law have become an especially controversial area of patent law, especially so in Europe, and particularly so in relation to patents on genes or on living organisms such as genetically modified animals. Much such controversy ignores the fact that the patent system has been protecting inventions in this field for many years, for example in relation to naturally occurring but newly discovered living organisms, such as certain yeasts [3] or microbes that have value as the source of medicinal products such as antibiotics, and that many patents with claims to genes in them, are now so old that they have now expired [4] . The consequences of the development in the 1970’s of recombinant DNA technology, a tool for genetic engineering have however posed problems for the patent system. Certain of these problems such as the ‘product of nature’ issue encountered by attempts to patent material of natural origin, are inherent in any patent system [5] , and it is those with which this paper is primarily concerned. In the latter part of the 19th century, new inventions in the field of art, process, method or manner of manufacture, machinery, apparatus and other substances produced by manufacturers were on the rise in India and inventors became very interested in getting their inventions protected [6] . Inventors were much concerned about the enforcement of their inventions that others should not copy or infringe their inventions. In this background the British rulers enacted the first ever patent law in India, i.e., Indian Patents Act, 1911 to offer patent protection to the inventions. Later, in the light of changing economic and political scenarios the Act was thought as not comprehensive and outdated. After independence, there were moves to consolidate the patent law by bringing up a new comprehensive legislation. At last in 1970, the government enacted the Patents Act, 1970 [7] . The Act highlights that an invention that satisfies universally accepted requirements of patentability such as novelty, inventive step and industrial application is patentable. The act defines invention to mean ‘any new and useful art, process, method or manner of manufacture, machine, apparatus or other articles produced by a manufacturer and includes any new and useful improvement on any of them’. [8] The Act does not specify the inventions which are patentable, but it illustrates subject matters that are not patentable [9] . The Act however did not mention anything about biotechnology inventions and the reason for such was that at that time the biotechnology industry was not developed in India and was in a nascent stage the world over as well. Once patents were granted for different biotechnology inventions in the US as well as in the European Union the demand for adopting the same approach gained significance throughout the world including India. The judiciary has been responsible for the evolution of patent law on biotechnology inventions in the US as well as in the European Union. Following such intervention patent laws were suitably amended and efforts were made to grant patents on biotechnological inventions. This momentum set new trends in the history of patent law and influenced the adoption of international conventions like Trade Related Intellectual Property Rights [10] (TRIPS) [11] . The agreement states that patents shall be made available to all types of inventions in all fields of science and technology. The agreement mandates patenting of biotechnology inventions in the member states. [12] After ratifying TRIPS, India modified all its intellectual property laws including patents law [13] and started marching towards patenting of biotechnological inventions [14] .

Chapter I

TRIPS and Indian Patent Law-

India has amended the Patents Act, 1970, three times in a span of five years. The first was in the year 1999, to give effect to the provisions of the TRIPS and thereby meet the first deadline, and some of these provisions were made retrospective from 1995. The second amendment was made in 2002 and brought the Indian law in substantial compliance with the Agreement. The third amendment was brought about in December 2004, which came into force from 1 January 2005 to make the Patents Act fully TRIPS compliant [15] . The deletion of Section 5 of the Indian Patents Act, 1970 was important to allow product patents in the area of biotechnology, chemicals and pharmaceuticals.

Article 27(1) of the TRIPS Agreement clearly states that patents should be granted for inventions in any field of technology without discrimination, subject to certain clauses. This implies that biotechnological inventions are patentable subject matter [16] . The patenting of genes or DNA sequences is popular in the US, the EU and Japan. However, patenting of genes or DNA sequences per se was not allowed in India until January 2005, but processes involving recombinant DNA technology to produce proteins involving a gene or a DNA sequence was patentable subject matter. Product patents for DNA, RNA or genetic inventions are patentable subject matter from January 2005 following the third amendment [17] .

The basic criteria for a patent to be granted are novelty, non-obviousness (inventive step) and utility. For a patent to be granted in India it should not be covered in the negative list in Section 3 which provides an extensive list of what are not inventions under the Indian Patents Act. The inventions related to DNA molecules or sequences must not be contrary to public order and morality [18] .

An important exclusion in Section 3 (c) [19] of the Indian Patents Act is that the discovery of an invention is not patentable subject matter. Therefore, the question of whether a DNA sequence is a discovery or an invention must be addressed first. This is based on an assumption that genes are naturally occurring, these are discoveries, and not inventions [20] . There are no case laws in India regarding discovery. In Europe also ‘discoveries’ are not patentable subject matter [21] . There are not many case laws in Europe either. The EC has however, issued directives and guidelines regarding discoveries [22] . The guidelines and rules of the European Patent Office clarify that DNA or gene sequences are patentable subject matter as these are considered synthetic molecules isolated from the organisms and characterized and produced as recombinant molecules or synthetic molecules containing the information as in the natural genes. [23]

The position in the US regarding discovery is different as compared to India and Europe [24] . Under the US law , Section 101 reads- “Whoever invents or discovers and new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent there for, subject to the conditions and requirements of this title.” In the case of Funk Brothers Seed Co v Kalo Inoculant Co [25] , the patent involved a process for inoculating leguminous plants with strains of naturally occurring bacteria to allow the plants to fix nitrogen from the air. Wherein the Court laid down that, the claimed inventions are a ‘discovery of the phenomena of nature’, and therefore genes should not be patentable. A gene is not an ‘invention.’ However, while the Court never explicitly overrules Funk Brothers, it limited its holding in a subsequent decision [26] .

In Diamond v Chakrabarty [27] , the Court held that bacteria, which had been genetically modified to degrade oil, could be patented. The distinguishing factor in Chakrabarty, as compared to Funk Brothers, appeared to be that in Chakrabarty, the bacteria had been altered by human intervention, furthermore the bacteria was considered to be an invention as it had two energy generating plasmids which is quite different and uncommon for the existing bacteria [28] . The Court in this case stated that a gene isolated for patenting is not altered in the same way as the bacteria in Chakrabarty, but it is purified and amplified. The court has never answered whether this distinction is sufficient to qualify a human gene as patentable subject matter. However, the 35 USC 101 [29] , is the pertinent statute which allows grant of a patent to a person who ‘invents or discovers’ a new and useful composition of matter, among other things. Thus, an inventor’s discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it [30] .

Chapter II

Patentable Subject Matter in India-

The biotechnology industry is devoted to the development of commercially valuable therapeutic, biochemical and pharmaceutical products and processes among others. Many of these products and processes revolve around the manipulation of DNA molecules and their encoded proteins. In the last thirty years, great strides have been made in the field of biotechnology and particularly recombinant DNA research. However with this progress has come a degree of uncertainty regarding the obviousness of certain biotechnological inventions. For example, methods of cloning genes and shuttling them between organisms have become common place. The ready availability of these methods coupled with the central dogma of molecular biology [31] , i.e., DNA is transcribed into RNA which in turn is translated into functional or structural protein molecules, has created a somewhat muddled legal structure.

In India only inventions are patentable but not discoveries. There is a clear distinction between inventions and discoveries as the law specifies that only inventions constitute patentable subject matter [32] . The Indian patent law does not provide for subjects that are not patentable, instead it does provide what is not patentable. Indian patent law provides for an illustrative list where it has mentioned the subjects that are not patentable [33] . Any subject matter, which does not fall within the purview of the illustrated list, does constitute a patentable subject matter. The list has been updated and modified to comply with the provisions of the TRIPS Agreement [34] . However, micro-organisms and such other inventions of biotechnology, both products as well as processes, do constitute patentable subject matter [35] . India has amended its patent law in 2002 to bring life and living beings created through biotechnology within the purview of patentable subject matter. The term chemical process is redefined through amendments to include biochemical, biotechnological and microbiological process. [36] As per the modified definition of the chemical process it is implied that biotechnological processes and products of such processes are unambiguously patentable. However, there are no decided case laws in India on the patentability of biotechnological inventions [37] .

After the Chakrabarty decision in the US, throughout the world living beings were recognized as patentable subject matter. The TRIPS provisions of the WTO Agreement make it mandatory to the member countries to provide protection in the area of living materials for the new plant varieties and for new micro organisms. The member countries can decide as to whether to grant protection for other living things or not. In the case of grant of protection for new Plant Varieties the TRIPS provides two options for the member countries- namely either to grant the protection by way of patents or to have a separate legislation called sui generis system. India has opted for a sui generis system for the grant of protection for new plant varieties.

Micro-organisms-

The legal framework of patenting micro-organisms in most countries was that though they are not specifically excluded from patentability, micro-organisms were not granted patent protection on the ground that it was contrary to natural laws [38] . Section 3(j) of the Patents Act allows for patents for micro-organisms. It is worded in the form of an exception to an exception [39] . The permissibility of patenting micro-organisms was considered in Dimminaco AG v Controller of Patents and Designs [40] , a case which involved an invention relating to a process for preparation of infectious Bursitis vaccine for protecting poultry. The Assistant Controller of Patents and Designs rejected the application on the ground that it did not constitute an invention under S 2(1)(j) of the Patents Act, holding that the process of preparing the vaccine which contains a living virus cannot be considered as ‘manufacture’ under the old definition of invention [41] . The Assistant Controller further held that the vaccine with living organisms cannot be considered a substance. An inanimate object can be described as a thing or item but not as a living one. Micro-organisms cannot be considered an inanimate substance as it cannot be converted physically or chemically to any other product. On an appeal preferred under S 116 of the Patents Act to the Calcutta High Court, the court took into account the practice of the Patent Office in granting patents for end products containing living virus and quashed the order of the Controller and directed the reconsideration of the patent application.

The case was decided under the provisions of the Patents Act before the Patents (Amendment) Act 2002 came into force. The said Amendment introduces S 3(j) which allows patents for micro-organisms. The decision in the Dimminaco case considers the practice of the Patent Office in granting patents for end-products containing living virus and arrives at its conclusion to allow patents for micro-organisms on the basis of such practice [42] .

The controversial question pertains to how micro-organisms are to be defined. By a broader definition, it will include any microscopic organism. A narrower definition of the word would limit the definition to only unicellular organisms [43] . The narrow definition of micro-organism confines the application of the definition to organisms such as viruses, algae, bacteria, fungi and protozoa. It would exclude cell lines, genes and gene sequences. [44] Since the TRIPS Agreement approves patents for micro-organisms, member countries of the WTO have shown a tendency to expand the scope of the micro-organism and microbiological process to include genetic material and plants and animals [45] . However, the TRIPS Agreement does not define the term ‘micro-organisms’, leaving the member countries with the necessary flexibility to decide the kinds of micro-organisms that will be entitled to protection. The Patent Office is unlikely to grant protection for micro-organisms which are living entities of living origin [46] .

Conclusion

A steady progression of case law marks the way by which patent protection has been expanded to include living organisms. While formal patent law is about 500 years old, it is only in the past 130 years that it has begun to enter the area of biotechnology [47] . The first step in the expansion of patent law turned out to be something of a false start. In 1873, Louis Pasteur received a patent for his claim to a yeast free from organic germs of disease, as an article of manufacture [48] . This was the first patent on a micro-organism and the first patent on a living organism. It took over 100 years for the next patent on a micro-organism to be granted.

In 1980, the US Supreme Court ruled in Diamond v Chakraborty [49] that living organisms are patentable so long as they fit within the definition of ‘invention’ in the patent legislation. Chakraborty’s application for a patent on a genetically modified organism had been rejected by the US PTO on the grounds that living organisms were not patentable [50] . Ultimately, the US Supreme Court, in a 5/4 split decision, reversed this policy and found that ‘anything under the Sun made by man’ is patentable [51] . In its decision, the Court adopted expansive interpretations of the terms ‘manufacture’ and ‘composition of matter’ in the definition of invention.

Patents are a form of reward for human ingenuity in the form of monopoly rights. Biotechnology inventions, a result of human ingenuity to the biological processes too deserve patent protection. The law relating to patenting of biotechnology inventions could be traced to the Supreme Court of America. In 1980 in the Chakrabarty case, the Supreme Court of America had laid the foundation for the evolution of biotech patent law. Indeed the Chakrabarty decision had a great impact on the traditional patent laws, which were against patenting living beings. The decision opened the doors for the patenting of living beings and signaled a new era in the history of the patent law. However, the ethical and moral standards of society objects to the patenting of living beings. Almost all religious groups are against patenting of living beings, but the same is not being considered in the light of the enormous potential of living beings fetching benefits to the society. Living beings are considered as the creation of God and patenting of the same is considered unethical and immoral. The approach is that human beings cannot create living beings and cannot own living beings through patents. Morally speaking, a living beings life cannot be monopolized and living beings cannot be treated as market commodities through patents. Patenting living beings amounts to slavery and such is against the dignity of living beings. The law relating to morals and ethics has strong foundations in Europe and India when compared to the USA. [52] While European and Indian patent laws have specific statutory provisions relating to morality and public order in determining patentability of a gene based invention, the US patent law does not have any such provisions. So the chances of a gene based invention being rejected based on moral and ethical concerns is very high in Europe and India when compared to the USA [53] . The general public play a very important role in defining patent principles based on their perception of morality in granting patents on biotechnology and specifically gene-based inventions.