“The response of the Hungarian physicist Leo Szilard to my cold spring harbour talk on the double helix was less academic. His question was, “Can you patent it?”...But then as now patents were given only for useful inventions and at the time no one could conceive of a practical use of DNA. Perhaps then, Szilard suggested, we should copyright it.”
-James D. Watson, DNA: The Secret of Life (2003)
Genetics has been identified as one of the technologies most significant to the developing countries. In the past two decades scientists have unravelled the entire genetic sequence of hundreds a organisms including a representative human. This eventually resulted in a stampede of the commercial firms to the US, European and other patent offices around the world to stake claims on the ownership of DNA.
It goes without saying that patented items should amount to an invention. Therefore, opponents of genetic patenting often argue that, legally, genes are not inventions, but discoveries. Though the UNESCO General Assembly adopted a Universal Declaration on the Human Genome and Human Rights, in 1997 which categorically states that no part of the human being can be subject to profit in its natural state, scientists have been able to isolate and purify genes. The UNESCO Declaration does not dispute the existing patenting of isolated sequences. This raises a question whether such modified genes be considered as patentable? This leads us to explore the legal facets of genetic patenting.
Living organisms were not patentable as life forms were considered a “product of nature” and not a human invention. The non-patentable status of living organisms changed with the 1980 landmark United States Supreme Court case Diamond v. Chakrabarty. The court decided in a narrow 5-4 decision that a strain of bacteria that had been modified by the insertion of new genes was patentable because it was not naturally occurring and was modified. This was a defining moment in advance of Genetic Patenting
The components of life forms that are patentable and patented under existing patent laws are:
o An invention regarding plants or animals if the implementation of the invention is not limited to a particular species of plant or breed of animal.
o Microbiological procedures and the products of such a procedure.
o An isolated or synthesized part of the human body even if it is identical with the natural part.
o A gene found in the body that is speculated to have a particular function is not an invention but a discovery and hence not patentable. But if function of the gene is studied and it is isolated from its normal environment in which it functions and give it a new task by making alterations in it as a medicinal product or a diagnostic instrument, it is an invention that can be protected by a patent. The industrial use of a gene sequence must be clearly stated in a patent application, if it is a subject matter for an invention.
The patentability of genes and other nucleic acid sequences is justified on the ground that they have been subject to gene sequencing, a microbiological or nonbiological process, which is itself a standard process which is patentable. So, nucleic acid sequence itself and its function are actually patented.
The International Approach
Patenting of genes is permitted in many countries around the globe including, United States, Japan, Germany, and France. In U.S As per law, in order to receive a patent on a gene sequence, the patent application must satisfy the requirements of novelty, utility, and non-obviousness.
The landmark decision by the U.S. Supreme Court in Diamond v. Chakrabarthy laid down the law on patenting in 1980. In this case, Chakrabarty sought a patent for a genetically engineered bacterium that could break down oil and thus help to clean oil spills. The basic question facing the court was whether living organisms can be patented. The court ruled that genetically modified organisms will be considered living matter. Prior to 1980, life forms were considered a part of nature and were not patentable. However, in this case, the Supreme Court granted patenting of human-made, genetically engineered bacterium which is capable of breaking down multiple components of crude oil. This decision by the US Supreme Court heralded a new era in which living organisms could be patented. Amgen Inc. v. Chugai Pharmaceutical Co. became the second case to confirm the patentability of living organisms. In this case, the United States court confirmed that isolated genes should be considered in patent law like other chemical compounds
American courts usually uphold the patentability of genes if an inventor isolates and purifies the substance, given that it meets other patentability criteria. As well, it appears that adding commercial or therapeutic value to an isolated and purified naturally occurring substance increases its patentability. About about 3,000 to 5,000 patents on human genes have been granted in the United States. At first blush it seems odd to patent a gene, which is why the practice has been controversial since it began nearly three decades ago.
In general, raw products of nature are not patentable. DNA products usually become patentable when they have been isolated, purified, or modified to produce a unique form not found in nature. The Unites States Patent Office (USPTO) has 3 years to issue a patent. In Europe, the timeframe is 18 months. The USPTO is adopting a similar system. Patents are good for 20 years from filing date. Most DNA-related patents are issued by the USPTO, the European Patent Office, or the Japanese Patent Office.
The Indian Approach
In 1995, India joined the World Trade Organization (WTO) and automatically became a signatory to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The Indian Patent Act excludes a definition for micro organism thus not clarifying whether human genes, such as DNA, may be patented. Therefore, the term microorganism needs to be defined. A number of jurisdictions considered the issue, allowing for the opportunity to examine their precedents in search of a variable definition. Europe, the United States, and Japan hold well-developed patent laws regarding genes, providing an available review. Like Article 27.3(b) of TRIPS, sections 3(j) of the Indian Patent Act provides that: 3(j) : plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. The Act excludes plants and animals, in whole or any part thereof, including seeds, varieties, species, and biological processes for production or propagation of plants and animals, but not including microorganisms, from the list of patentable inventions.
India debated the patentability of microorganisms until the judgement of the Calcutta High Court, in Dimminaco AG v. Controller of Patents. This case supports microorganisms as patentable subject matter. Here the Court held that the law did not bar the processes ending in the creation of a living thing. The world community generally accepts the landmark Indian judgment as in consonance with world patent practice. Hence, it can be safely concluded that microorganisms are patentable subject matters in India as long as they meet the patentability criteria.
Coming to Genetic Patents or DNA Patenting, the word gene or DNA does not appear anywhere in the Indian Patent Act nor there is any special directive issued by GOI for according legal protection to Biotechnology related inventions. The only reference for the same can be found in the Examination Manual Chapter 8 which deals with Examination and Grant of Patent applications.
In Manual of Patent Office Practice and Procedure as modified on March 22, 2011, Chapter 8 which deals about Examination & Grant, Under the head Unity of Invention it is said that Independent claims of different categories may relate to a single inventive concept. For example: In case of a genetically modified Gene Sequence/ Amino Acid Sequence claims may be directed to a Gene sequence / Amino Acid sequence, a method of expressing the sequence, an antibody against that protein / sequence, a kit containing such antibody / sequence.
The manual is not a binding document as it is not issued under any provisions of the Patent Act, but serves as an informal written guidance for the Examiners at the Patent office.
Concerns and Solutions
Patenting of genes clearly continues to be the most controversial of all kinds of patenting. Research scientists who work in public institutions often are troubled by the concept of intellectual property because their norms tell them that science will advance more rapidly if researchers enjoy free access to knowledge. By contrast, the law of intellectual property rests on an assumption that, without exclusive rights, no one will be willing to invest in research and development. Numerous ethical and legal arguments discourage patenting of genes. Some experts hold that patenting of genes offends morality and that, in any case, genes do not qualify, legally, for patenting. Another argument against genetic patenting is that ownership of genes by one party may discourage investment in research on the same gene by another party. Genetic patents may also result in a situation private laboratories may be unable to offer diagnostic tests due to costly licence and royalty fees. It might also result in high production costs which may pass on to the consumer, thereby making genetic drugs and tests unaffordable and inaccessible. As the genetic research is in its nascent stage, granting patents to fragmented genes ultimately limits access to genetic information for further research. Patents are meant to "promote the progress of science," but patents on human genes arguably do the opposite. Genetic patenting has both positives and negatives. It can be summarised as follows.
o Researchers are rewarded for their discoveries and this will be beneficial for further research.
o Attracts investors to invest in research and development.
o Duplication of effort can be prevented.
o Research is forced into new, unexplored areas.
o Reduction of Secrecy which eventually results in advancement of research
Disadvantages of Genetic Patents:
o Will result in monopolising of research and development.
o Limits Access to Genetic information and further research.
o The possibilities of Genetic information are still unexplored to a large extent.
o The costs associated with diagnostics and therapeutics is likely to go up which can squarely affect the common man as well.
o Lenient rules may lead to frivolous patenting and ever greening of the inventions.
o Such patents make important products more expensive and less accessible.
The Patents Act allows compulsory licence to be granted when the reasonable requirements of the public with respect to the patented invention have not been satisfied or when the patented invention is not available to the public at a reasonably affordable price. Provisions of the Competition Act, 2002 can be invoked when an enterprise abuses its dominant position in the market. India should soon adopt guidelines similar to those of the USPTO, ensuring a strict vigilance of the utility criteria, preventing frivolous patenting. There are genes with unknown functions and this will help in preventing patenting of genes with unknown functions.
India being a developing country, the Government should ensure that a balance is created between public access to the pharmaceutical inventions and innovations with that of an incentive driven system of patent protection that would ensure continuing investment in such fields. A comprehensive Patent Act which ensures that both public interest and patent holders will go a long way in this exercise.
Well, if you want to know more on DNA Patenting all I want to say as of now is D.N.A~ Do Not Ask. ;)
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