Patenting of Human Genes: Moral and Ethical Issues

INTRODUCTION

“If you have got at least one kidney, a company called biogen owns the patent for atleast one of your genes, it’s called the KIM gene, and the kidney uses it in the process of self-repair. And if we can taste things with our tongue, the university of California owns the rights to three of our genes, called TCP-1, 2 and 3: it’s not clear in the patent application what the owners plan to do with their rights to these genes”.

The conflicts between science and the law prevails from centuries and have greatly intensified with rapid progress and  has shaped our world  reliable on technologies to make our lives more efficient. In the early days, science and law came into conflict because scientific theories and the prevailing concepts of law were highly divergent and different. The conflict we face today is not whether scientific postulates that are contrary to rule of law should prevail, but it’s whether and to what extent law, or government, should or should not influence scientific progress. People, in their mind need to keep society under control, and this will continue to strive towards establishing a balance between the extremes of scientific innovation and the established rules of law.

Of all the areas of modern science and technology that involve intellectual property protection, it is the patenting of biotechnology inventions, and specifically genes that has captured the greatest public attention and controversy. The coverage of these patents and their enforcement has global implications, between the private and public sector and between rich and poor countries. Like the technology that intellectual property (IP) protection is applied to protect, IP protection is a system that needs to be subjected to ethical analysis and examine whether it is suitable for a moral society. While there are many controversial areas of biotechnology regarding IP protection, like stem cells, this paper focuses on Human Genes because, the criteria of human DNA, or human experiments, are objective selection criteria that can be used for ethical review in a patent application. Patent protection on a large number of genes has broad socio-economic impact because few companies are dominating genomic sequencing. The extent of this expansion of patents made people ask what are the limits for commercialization of the human body, and some has suggested that our species name be changed to ‘Homo economicus’?.

PATENT LAW AND BIOTECHNOLOGY

Patent law, the oldest and strongest form of intellectual property; is also a primary way by which the biotechnology companies recoup a return on their investment. Biotechnology is a popular term for the generic technology of the 21st century. Although it has been utilized for centuries in traditional production processes, modern biotechnology is only about 50 years old, and in the last decades it has witnessed tremendous developments. Since Research & Development in biotechnology is extremely time consuming and requires huge investment, granting Intellectual Property Rights (IPR) is an effective tool to protect. The reasons for controversy are not hard to identify. Life sciences research literally touches on issues of life and death.

Biotechnology aims to serve basic human needs such as

• Human health, food and a safe environment,
• Touches on fundamental values, such as human dignity, the genetic integrity of humanity,
• Can raise human rights issues such as access to health and benefits from scientific progress,
• Raises concerns over equitable access to the fruits of new technologies, the consent of those involved in research, and protection of the environment.

Biotechnology has been defined, as “being any technique that uses living organisms, or parts of organisms to make or modify products, to improve plants or animals or to develop micro-organisms for specific uses”. The biotechnology industry has led to infinite progress such as treatments to people’s individual genetic makeup, developing new vaccines, and preventing disease by intervening in the genome . The issues that affect the biotechnology industry include inter alia discoveries, and related to genetics, such as the patentability of genetic information, the conduct of clinical research involving gene therapy, the approval process for new drugs, proteins and other biological components, genetic testing and cloning. The biotechnology industry has certain unique aspects that distinguish it from other sectors, such as lengthy product development lifecycles, significant financial resources, and complex intellectual property issues.

Although deciphering human gene sequences is very time-consuming, the deciphering process is advancing at a surprisingly fast rate because of cutting-edge information technology, and especially computer technology supporting it. As a result, information taken from the human genome (DNA information) is being transacted as it has economic value. Western countries own the majority of this DNA information. Patent law is being utilized for legal protection of such DNA information. Pharmaceutical companies, then, endeavor to develop innovative drugs using  DNA information.

Under Article 27.1 of TRIPS, ‘patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application’.

Patent laws provide the protection checking the key characteristics of novelty, non-obviousness, utility and sufficient disclosure. The grant of a patent confers a civil right on the patent owner to prevent others from exploiting what is claimed in the patent, excluding the use for scientific research purposes. Of all the present issues in biotechnology patenting, the main problem is that, attempts to harmonize the existing patent laws and practices internationally have not yet fully succeeded. For e.g. In US patent law,  the term “invention” means invention or discovery. In European law  “discovery” is distinguished from “invention” and is unpatentable. The distinction is not easy to define. “A discovery involves new knowledge whereas an invention is a practical application of knowledge”.

DEFINITION OF GENE AND ITS RELATED TERMS

Gene:

Genes are the physical units of hereditary that the parents pass down to their children. They are made up of tightly coiled threads or polymers called as deoxyribonucleic acid (DNA). DNA is an informational molecule and is made up of four distinct nucleotides – deoxyadenosine (A), deoxyguanosine (G), deoxythymidine (T), and deoxycytidine (C) that forms the base of each DNA molecule.

However, DNA has no functional property. Genes are considered to be fundamental as they contain the blueprint for the body to make proteins. Actually it is the proteins that do the actual work in our bodies. It is a chemical that, when placed in an appropriate environment, will direct the synthesis of particular and specific proteins, which make up the structural components of cells, tissues and enzymes (molecules that are essential for biochemical reactions). This environment is known as the cell. A DNA molecule may contain one or more genes, each of which is a specific sequence of nucleotide bases. It is the specific sequence of these bases that provides the exact genetic instructions that provides an organism with its own unique traits.

DNA (deoxyribonucleic acid):

It’s a double-stranded molecule within each cell that encodes hereditary information; also the template for RNA molecules that turn genes on and off.

RNA (ribonucleic acid):

It’s a molecule within each cell that determines protein synthesis and transmits hereditary information.

Recombinant DNA:

Artificial DNA made by splicing DNA strands from different organisms. It is used for many purposes, such as replicating DNA for research, producing important proteins, and devising gene therapies.

Expressed Sequence Tag:

An EST, or “expressed sequence tag,” is a DNA sequence of several hundred nucleotides. As the name implies, ESTs are DNAs that code for a particular protein. An EST is a convenient means of identifying a specific gene in the context of a single chromosome, a complete genome or a collection of genes (often termed a “library”). Because the sequence information contained in an EST is enough to distinguish one gene from all others.

Genetic Testing:

A variety of tests now make it possible to examine a person’s DNA. The DNA is typically obtained from a blood sample. Genetic tests provide physicians with information about that DNA sequence and with this information, a physician can prescribe drugs, special monitoring or preventive measures to treat the disease or reduce the risk. This is the subject of a new area of medicine called pharmacogenomics.

Gene Therapy:

Gene therapy can be achieved by replacing, augmenting, or eliminating absent or defective genes, as well as by providing genes encoding therapeutic or immunogenic  proteins. One method of gene therapy works by replacing a patient’s ineffective or absent gene with a therapeutic gene (e.g. a replacement gene).

Different between human genome and gene:

A ‘genome’, on the other hand, is the complete set of genetic instructions carried within a single cell of an organism. A gene is a small subunit of the genome which in general ‘codes for’ – contains the information necessary for constructing – a single protein, or protein subunit. The human genome is estimated to comprise more than 120,000 genes.

CONCEPT OF GENE PATENTING

Besides all these befits to the society the first question that arises  in our mind is that, if all this helps the humankind then why is this concept is so controversial? And to seek the answer, we must first know actually what is gene patenting?

“Gene patenting” is a broad term referring to the “patenting of either a process that involves isolation of DNA (where DNA refers to either DNA or associated materials such as RNA) as well as to a chemical substance related to DNA”.  A patent is not received on just a gene. A patent is received on a gene, gene sequence, or gene fragment based inventions. DNA products usually become patentable when they have been isolated, purified, or modified to produce a unique form not found in nature. Therefore, Isolated and purified genes are patentable. Moreover gene or gene product should have real world applicability.

CONFLICT OF DISCOVERY OR INVENTION:

Regarded with the patentability of biotechnological matter, the patent law first should first distinguish between invention and discovery.

Buckley J. explained the distinction between a discovery and an invention in Reynolds –vs. – Herbert smith & Co. Ltd  in the following terms:

“Discovery adds to the amount of human knowledge, but it does so only..by disclosing something..Invention also adds to human knowledge, but not merely by disclosing something. Invention necessarily involves also the suggestion of an act to be done, and it must be an act which results in a new product, or a new process, or a new combination for producing an old product or an old result”

DOCTRINE OF PRODUCT OF NATURE:

According to the “product of nature” theory, “any kind of structure made by a human hand” is patentable, but things that exist in nature as it is (that is, not made or intervened by human hand), namely “products of nature” are not patentable.

Judge Hand’s opinion in the case of Parke-Davis & Co. v. H.K. Mulford & Co   illustrates that patents are not denied merely because products of nature are claimed. 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 the well-known case of 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 in this case that statutory subject matter includes “anything under the sun made by man” is patentable.

It is said that an isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because;

(1) An excised gene is eligible for patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, and

(2) Synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.

The position in the European Union Directive on the Legal Protection of Biotechnological Inventions, 1998  is given under Article 5 and is as follows-

1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence of a partial gene, cannot constitute a patentable invention.

2. An element isolated from the human body or otherwise produced by means of a technical process, including the structure or partial structure of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

PATENTABILITY REQUIREMENTS

NOVELTY:

In the context of gene patents, the novelty requirement centers around whether genes, which already exist in nature, can be truly said to be new. Traditionally, courts have interpreted the requirement of newness as excluding from patentable subject matter certain discoveries that lack invention, such as laws of nature  and, most importantly for purposes of the naturally occurring products, processes, and other phenomena. Thus, 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.

However, the US Supreme Court in Diamond v Chakrabarty  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) the invention would not be obvious to a skilled person working in the area. This element has received little judicial consideration in the context of genetic materials and technologies. In practice this makes it very difficult to oppose the grant of a patent because the opposing party must prove that the selection of particular choices, preferences, techniques, and probes etc., actually made was obvious. The Patent Office’s seems to be reluctant to deny legal protection where a significant investment of time and effort has been made. The argument is that the easier it gets, the more IP protection should be available. “If a little bit of protection is good, then a lot is better”. The traditional balancing act between the rights of the inventor and the public interest has been mostly considered in favour of the inventor.

Arguably, the techniques used to isolate and characterize genes are now so common that very little inventive ingenuity is required to describe a new gene. In particular, the use of computer technology has dramatically improved the ease and speed of gene identification. However, in the US, the inventive step requirement has been interpreted liberally for gene sequences. The focus is placed on the invention itself rather than the techniques for its production. This means that the focus of inquiry for gene patents is whether the gene sequence is obvious, not whether the method used to obtain it was obvious to try. For example, In Re Bell , 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”. Similar findings were made In Re Deuel . Since Genentech , other decisions in Europe have confirmed that a recombinant DNA sequence will be obvious if it can be shown that all the techniques needed. The criticism arises and it means that any invention disclosing a gene sequence will satisfy the inventive step requirement, and that gene patents are per se non-obvious.

Many suggestions have been made as to how to protect the patent system from itself. A stricter application of the inventive step requirement will play an important role in ensuring vital access to information. However, this increased stringency only goes a part of the way to dealing with the problem. This highlights the inherent difficulty in coming up with an acceptable definition which will work with the case-by-case approach taken by the Patent Office.  The patent system when applied to truly non-obvious inventions is effective in redirecting the flow of investment to solving new problems, but the strong protection patents afford will always be a problem when applied to incremental innovations.

UTILITY:

Article 5(3) of the Biotechnology Directive requires that industrial applicability for gene patents is disclosed in the patent application. With no need to demonstrate utility, there is nothing to encourage innovators to complete a commercial realization of their research. This requirement was introduced relatively recently in the US, and was a key recommendation of the Australian Law Reform Commission Report into gene patents

Prior to Brenner v. Manson , inventions were useful if capable of some beneficial use to society. The aforementioned case changed this view and required `substantial utility` and `specific benefit…in currently available form’. The requirement of utility provides important way to distinguish between inventions consistent with commercialization of technology and innovations which, if useful, are really useful for further research, and should be protected through compensatory liability rules, requiring ‘specific, substantial and credible utility’ is a step in the right direction. However, UK have raised concerns that a ‘credibility’ test may be not be going far enough, as it may be satisfied by a mere ‘theoretical possibility,’ which still sets the bar too low. Given that the implementation of this requirement will require new legislation, the possibility of adopting the stronger standard legislation, ‘capability of industrial application’  would be a preferable criterion.

Finally, adding a utility requirement puts an additional burden on patent examiners. But this is a good idea anyway; it is to some extent dependant on reducing the number of patent applications by increasing the threshold of other criteria.

In addition to these three requirements, the application must describe the invention in sufficient detail to inform the public on how to make and use the invention. The inventor must teach or “enable” other persons skilled in the technological area of the invention to use the invention described by the inventor. This is known as the `enablement` requirement

LEGAL FACTS AND QUESTIONS REGARDING GENE PATENTING

The idea that a patent on human genes is immoral exits because of it is indistinguishable from the claim to own other people. And this rests on two confusions about patent law.

• The first, confusion is over what is patented by a human gene patent;
• The second, there is confusion over what a patent enables one legally to do.

Patent rights are different from ownership rights, and do not confer ownership on anything, patenting must be distinguished from owning.

Though the genes in our body are not patentable, the degree of manipulation and alteration that is required to isolate and identify a human gene scientifically means that genes so altered and manipulated can gain a legal patent. There are several methods of sequencing DNA; all of them require at least some of the following:

• Isolating DNA,
• Purifying DNA,
• Removing a small segment of the DNA from its place in the genome and connecting it to bacterial DNA (apparently doing this is called “cloning” DNA),
• Chemically unwinding DNA, and
• Constructing radioactive or florescent copies of the genomic DNA fragment.

In Parke –Davis and Co. v. H. K. Mulford and Co.,  a lower Court held that purified human adrenaline was patentable because, through purification, it became “for every practical purpose a new thing commercially and therapeutically.”  Hence, scientifically isolating and identifying a gene, and the changes in the properties of the gene that involves treating human genes as patentable inventions does not, in and of itself, threaten the bodily integrity of human beings.

This consideration raises some significant doubts about the morality of patenting human genes.  Perhaps patentable genes do not differ as greatly from naturally-occurring human genes as do oil-eating bacteria from naturally occurring bacteria as held in the famous Diamond –vs. – Chakrabarthy case, However, it is clear that, legally, patents on human genes are on genes that are scientifically and legally distinguishable from the genes in our bodies, or from natural genes taken out of our bodies.

THE MORAL AND ETHICAL CONSIDERATIONS

Moreover, the difficulty with the main moral objections to human gene patents is not simply that they confuse legally patentable genes with naturally occurring genes.  In addition, they confuse patenting with owning. Thus, the Courts failed to see that whatever the complexity involved in legal ownership, a patent does not confer legal ownership of anything.  This is because the only legal right conferred by a patent is the right to prevent others from using or possessing one’s invention. So, the legal facts about human gene patents remove the most serious doubts about their moral justification. But still these patents are necessary to promote research and investment in biotechnology, or in the prevention and cure of human suffering.  Nevertheless, doubts on this score hardly imply that human gene patents are essentially immoral, as they prevent people from using their genes to live or to reproduce.

Moreover, while these legal features of human gene patents do not lessen the concern that patenting may worsen existing inequalities between rich and poor countries, or between rich and poor people in the same country, they suggest that there is nothing about a legal patent that precludes government regulation of licensing agreements with these worries in mind.  For example, governments might require patent holders to license the use and manufacture of human genes for some purposes (right to exclude is not absolute), prohibit their use for others, and limit how much they can charge for their use or manufacture by poor countries or poor people.  In these ways any morally objectionable consequences of human gene patents could be met, and even preempted, while acknowledging the legality of these patents.  Yet this, too, would be impossible, where human gene patents are considered to be the moral equivalent of slavery.

HUMAN DIGNITY AND HUMAN VALUE ANALYSIS

The threat to human dignity because of gene patenting originates not in the said unlikely scenario of a patent conferring complete ownership on a human being alone, but in the narrower ability of the patentee of an isolated and purified biochemical or tissue found in the human body to prevent any individual who produces that biochemical or tissue

• From commercializing it (or choosing not to commercialize it), and
• Possibly from transmitting the cells to third parties for noncommercial purposes.

The problem of monopolization of naturally occurring human tissues presented itself most severely in the much-discussed case Moore v. Regents of the University of California.  In this case a biotechnology firm took cells from a hospital patient for commercial use without the patient’s consent and refused to accept a legal challenge to its right to patent the patient’s cell line. The necessary consequence is that the patient, Moore, was not allowed from commercializing his cell line or preventing the patentee and any licensees from doing so, or donating his cell line to a less mercenary biotechnological use. The analysis leads to another disturbing conclusion. Under the Moore majority’s reasoning, a patient whose cells have been patented would be prohibited from donating or selling any patented part of his biochemical self, such as his plasma, blood, or sperm, to other scientists without first obtaining a license from the patentee, as these other scientists would be obtaining

from Moore his cells in their patented form. The patentee could also theoretically prohibit Moore from undergoing a leukemia test with a group of physicians not approved by the patentee because, again, an isolated and purified version of Moore’s genome would be transmitted to a third party without a license . These limitations on the rights of individuals to transfer, donate, or control commercialization of their genetic material and, possibly, to seek some kinds of medical care, clash with the constitutional right to privacy.

The view that a cell line patent does not confer ownership of the genetic material contained in that cell line is intended to soothe concerns over infringements on human dignity, but overlooks several important facts. The widespread international antipathy generated by National Institute of Health and Department of Commerce patents attests to a prevalent popular belief that ownership of another person’s genetic material invades that person’s privacy; violates his or her bodily integrity, often for purposes of economic exploitation; and offends his or her human dignity.

Another issue linked with human dignity and gene patents is genetic discrimination. Although genetic tests provide valuable, and often life-saving medical information, some people fear that if the result of a genetic test indicates that they either have a genetic disease or have an increased risk of developing a disease, employers, insurance carriers, schools and others may discriminate against them. This is one reason some people prefer not to take tests that may indicate they could develop a serious disease in the future, especially if there are at present no effective preventive measures or treatments. The Biotechnology Industry Organization has long advocated legal protections to prevent genetic discrimination against individuals. UNESCO sought to bring some level of international consensus on how information about the human genome should be handled. The Universal Declaration on the Human Genome and Human Rights was adopted unanimously by the General Conference of UN

ESCO at its 29th session on November 11, 1997, refers to the human genome as the heritage of humanity in a symbolic sense. It is the first universal instrument in the field of biology. It aims to strike balance between safeguarding respect for human rights and fundamental freedoms and the need to ensure freedom of research. The Declaration states that “no one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity” . It also states in Art 4 that the “human genome in its natural state shall not give rise to financial gain”.

There are other issues linked with human dignity, among them is the issue of cloning. There exist numerous controversial issues involved with human cloning such as the possibility of malformed offspring, designer babies and the rights and legal protection for cloned humans. However, on the other hand there exist concerns in certain scientific communities that the extent of legislation against human cloning might result in stifling research into human embryology that could lead to new treatments for disease .

Universal Human Heritage:

The Human Genome Diversity Project (HGDP) was considered to be the VAMPIRE PROJECT by many biologists and social philosophers.

Eminent scientists and many governments have taken the position that the human genome and other naturally occurring genomes are res communis–the common heritage and inheritance of mankind–and, therefore, should not be subject to patents. Genes are inherited from previous generations, “not invented by scientists or corporations,” patenting them is a “profound misuse of the patent system and represents the privatization of the common heritage of all humankind.” For example, the French Minister of Science, in 1991, rejected the notion of gene patents in absolute terms: “A patent should not be granted for something that is part of our universal heritage.” UNESCO itself has adopted the principle that the “human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.” The gene map “should be available for all to use” with “equal and free access.” Many others have expressed similar views on the public ownership of the genome. The opponents of gene patents are varied but share an idea of naturally occurring genes, and the human genome in particular, as something larger than personal property. Moreover, an invention must be distinguished from a discovery.

Some of the important international laws for protection of the human community upholding both the human value and technology advancements are:

• Article 53(a) of the European Patent Convention specifically stipulates that patents should not be granted for inventions relating “the publication or exploitation of which would be contrary to ‘ordre public’ or morality.”
• International Covenant on Economic, Social and Cultural Rights (the ICESCR) is the major international human rights instrument addressing these issues.
• The UNESCO Declaration on the Protection of the Human Genome and Human Rights adopted by the UN General Assembly in 1998 recognizes the common heritage principle. It states that: “The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity”.

The Council for Responsible Genetics issued a Genetic Bill of Rights, which contends that “all people have the right to a world in which living organisms cannot be patented, including human beings, animals, plants, and all of their parts.”

MYRAID GENETICS- THE TWIST

Gene patents have recently attracted the attention of researchers, industrial persons and legal fraternity around the globe. The reason for this is the recent invalidation of gene patents belonging to Myriad Genetics by a federal court in the US.

Myriad Genetics, based in Salt Lake City, Utah, along with the University of Utah Research Foundation holds several patents on two breast cancer genes, BRCA1 and BRCA2 and is the sole provider of the full sequencing of BRCA1 and BRCA2 genes in the US on a commercial basis. The Association for Molecular Pathology along with individual patients, medical organizations and others challenging Myriad’s gene patents filed a complaint alleging violations of 35 USC S 101, Article I, section 8, clause 8 of the United States constitution. It was contested that the patent claims covered products of nature, law of nature and/or natural phenomena and abstract ideas or basic human knowledge or thought.

Other arguments included that: Myriad’s patents and its position as the sole provider of BRCA1/2 testing has hindered the ability of patients to receive breast cancer genetic testing; it has impeded the development of improvement to BRCA1/2 genetic testing; and that the human genes are the common heritage of mankind whose use should not be restricted by patent grant. Myriad contested that patenting is a quid pro quo system and gene patents are essential for obtaining capital investment in the development and commercialization of technology breakthroughs. Myriad disputed the idea that patenting of isolated human DNA conflicts with the advancement of science and asserted that it allowed scientists to conduct research studies on BRCA1/2 freely; further patents on isolated DNA actually promoted research and advanced clinical development to the benefit of patients.

THE US COURT DECISION:

Judge Robert Sweet found that the challenged patent claims are directed to:

• Isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence and
• Methods of comparing or analyzing BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer.

He noted that the claims-in-suit directed to isolate DNA containing human BRCA1/2 gene sequences reflect the US Patent and Trade Mark Office’s (USPTO) practice of granting patents on DNA sequences so long as those sequences are claimed in the form of isolated DNA. This practice is premised on the view that DNA should be treated no differently from any other chemical compounds and that its purification from the body, using well-known techniques render it patentable by transforming it into something distinctly different in character. However, it was held by Judge Sweet that DNA’s existence in an isolated form alters neither its fundamental quality nor the information it encodes. In invalidating the patented claims, he concluded that because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 USC S 101. Similarly with regard to the method claim, he held that because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under S 101.

Myriad with others have already filed a notice of appeal with the United States courts of appeal for the federal circuit. Only time will tell what will happen in future and whether the decision of the district court will be overturned at the federal circuit or the case will go up to the US Supreme Court. Many however, believe that the district court’s decision, if not in entirety but in part, is likely to be overturned by the federal circuit. At least for now the invalidation of gene patents and the underlying reasoning for doing so has generated concern and curiosity about the patentability of isolated genes not only in the US, but also around the world. It would be interesting to consider the patentability of isolated genes in different parts of the world and how this case when decided ultimately will have an impact on the patenting of isolated gene patents in those geographies. However, we shall limit ourselves to India.

CRITICAL ANALYSIS WITH INDIA’S PATENT LAW

India has emerged as one of the best suited place for biotech research and commercial market for biological therapeutics and diagnostics for its population of more than one billion people. This and the revised patent law have encouraged patent filings in the biotech field in India. In the US, 35 USC 5 101 defines what inventions are patentable. What is not covered under the meaning of 35 USC 5 101, can be construed to be not an invention and therefore patent ineligible. 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 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 discovery 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 states “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 practiced 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, the diagnostic methods employing the 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 not 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 above sequence
• An antibody against that protein/sequence
• A kit made from the antibody/sequence.

This makes it evident that the genetically modified gene sequence is patentable and so is such a sequence.

Additional clarification can be found in the draft manual of 2005 in annexure-I, which provided examination guidelines for patent applications relating to inventions in the field of chemicals, pharmaceuticals and biotechnology. Annexure-I listed the patentable and non-patentable biotechnological inventions. It is mentioned that biological material such as recombinant DNA, plasmids and the processes of manufacturing thereof are patentable provided that they are produced by substantive human intervention. Further, it is mentioned that gene sequences and DNA sequences with unidentified functions are not patentable due to lack of inventive step and industrial application. Thus as per the Indian patent practice DNA, plasmids are biological material; and DNA or nucleic acid sequences which are modified or made recombinant by significant human involvement and with identified functions are patentable. The draft manual of 2005 also states that the living entities of natural origin suc

h as animals, plants, in whole or any parts thereof, plant varieties, seeds, species, genes and micro-organism are not patentable and any process of manufacture or production relating to such living entities is also not patentable. Thus mention of genes is found amongst the living entities of natural origin which are not patentable. In this way, section 3(c) and the draft manuals of 2008 and 2005 clarify that the isolated naturally occurring DNA would be considered as discovery and is not patentable in India.

OVERCOMING OBJECTIONS:

It is observed that during prosecution, in the examination report for claims directed towards isolated DNA, genes etc. objection is often raised stating under section 3(c). Nonetheless, such objection can be dealt with based on the facts of the individual case by submitting that claimed isolated DNA sequences are recombinant, modified or not identical to those occurring in nature. However, it is believed that isolated gene; DNA for which the claims have been granted may not always be substantially different from the naturally occurring ones. These patents with claims on isolated genes, DNA or nucleic acid sequences may have been granted based on the earlier precedence of such issued claims.

Given such circumstances, if Judge Sweet’s decision is upheld in further proceedings asserting that isolated genes are a product of nature and therefore not patentable, it is likely that it may impact Indian patent practice to the extent that it would further affirm the rejections of claims directed towards isolated genes, DNA etc under section 3(c) of the Indian Patents Act.

Despite the advantages of the biotechnology revolution, serious issues and concerns are raised which are legal, ethical, social, moral, economic, and sociological. With regards to India, there exist a large number of issues that need to be dealt with. There is a need to be educated in the markets and the technologies and also develop a clear understanding of the importance of intellectual property protection in biotechnology. There have been no clear policies on the patenting of genes, and DNA sequences in India, even though Indian inventors working in these areas have been applying for patents in India and abroad.

Currently, the manufacture, import and storage of genetically modified organisms in India are regulated by the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/Genetically Modified Organisms or Cell Rules, 1989 . These Rules are made under delegated powers given by the Environment Protection Act. The rules are framed by the Ministry of Environment and Forests with the objective of protecting the environment, nature and health during the various applications of gene technology and micro-organisms.

The biotechnology industry in India has suffered from the inconsistent scope of legal protection available for biotechnology inventions and there is lack of a regulatory framework in this sector. India needs to prepare to meet the opportunities and challenges by thoroughly debating the ethical issues. Stringent laws need to be framed to meet the needs of the biotechnology industry as well as society. The Government has been encouraging in this regard, by taking appropriate steps to provide for biotechnology patents. This is reflected in the Government’s decision to sign the Budapest Treaty on Micro-organisms on July 20, 2001, which will give the country the advantage of depositing patentable micro-organisms for protection. The establishment of an international depositary in India will help facilitate the patenting of micro-organisms that are new and are created using inventive steps. Sensible regulatory requirements and expeditious product review by regulatory agencies, can

lead to new applications, products, and processes that will improve human health and welfare, enhance environmental and agricultural quality, strengthen the Indian economy and accompany in the biotechnology revolution while at the same time protecting the ethical issues involved.

THE UNCERTAIN FUTURE OF GENE PATENTING

The first genes were patented in the early 1980s, and the practice has been controversial from the start. They are brightly illustrated in the case of BRCA1 and BRCA2 genes which belong to a class of genes known as tumor suppressors and were found that certain harmful mutations of these genes linked to an increased risk of breast and/or ovarian cancer.

On March 29, the court invalidated seven of Myriad’s 23 patents associated with the genes. Not surprisingly, the decision will cause confusion in industries associated with gene patenting. Although it is possible that the decision will be overturned on appeal, a large number of questions require thoughtful examination. For instance, if the decision is upheld, we can expect to see changes in the business practices of firms and universities engaged in genetic research, which in turn may affect commercial and clinical development. If they can no longer apply for patents, researchers are likely to feel increased pressure to protect their inventions through competition and secrecy, which would slow the overall pace of research.

Moreover, a 2005 essay in Science¬ estimated that about 20 percent of human genes are associated with at least one United States patent.  The research associated with these patents, as well as the diagnostic tools made available as a result, represent billions of dollars. How will the industry’s ability to raise capital be affected? How will the direction of research be affected? Will competition mean lower costs to eventual consumers? The answers to these questions will affect all of us as actual and potential consumers of health care tests and products associated with gene patents.

CONCLUSIONS AND SUGESSTIONS:

“We shall not cease from exploration. And the end of all our exploring will be to arrive where we started, and know the place for the first time.” T. S. Eliot

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 present a regulatory challenge akin to those that deal with genetic resources under the Convention on Biological Diversity. There is still ambiguity and uncertainty, particularly with regard to the ambit of the inventive step, utility and disclosure tests and the distinction between inventions and discoveries.

Biotechnology law is mostly considered to be the judge made law or courts established law. Therefore despite the efforts of harmonizing all the patent laws the TRIPS has failed particularly in respect of gene patenting which is the main cause for the ongoing debate over gene patenting. Hence, strict application of the requirements of patentability is 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 the society in which we live.

BIBILOGRAPHY:

1. Australian Law Reform Commission, “Genes and Ingenuity: Gene Patenting and Human Health,” ALRC 99, June 2004, Recommendation 6-3

2. Christopher Arup –“The new WTO Agreement globalizing law through services and I.P”

3. Directive 98/44/EC of the  European Parliament  and of the Council of 6 July 1998  on the legal  protection of biotechnological inventions

4. Li Westerlund, Biotech Patents- Equivalency and Exclusions under European and US Patent Law, 1st Ed., Kluwer Law International, 2002.

5. Peter K.Yu “Intellectual property and Information wealth –issues and practices in the digital age patents and trade secrets” pg.no:317-376

WEBILIGRAPHY:

1. eubios.info/UNESCO/ibc2002ip.pdf.

2. biotechnology.com/humangenome.law

3. Law Versus Science: the HGP, bae.ncsu.edu/research/biotech/law.html.

4. genomicglossaries.com/content/ex bio.asp

5. geneontology.org/GO.doc.shtml

6. lawgenecentre.org/

7. science.com/discovery/biotechnology.html

8. biospectrumindia.com

ARTICLES REFERRED:

1. Akimitsu Hirai, Biotechnology and Legal Protection-Current Issues, CASRIP Newsletter, Vol.8, Issue 1, Autumn   2000.

2. Genomics, Ethics, and Intellectual Property. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at ipHandbook.org.

3. Nuffield Council on Bioethics. 2002. The Ethics of Patenting DNA: A Discussion Paper.

4. Stephen A. Merrill and Anne-Marie Mazza, eds., Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (Washington, D.C.: national Research Council, 2006).

5. Timothy Caulfield, Tania bubela, and C J. Murdoch, “Myriad in the Mass Media: The Covering of a Gene patent Controversy,” Genetics in Medicine, December 2007.

Patent on Genes – An Ethical and Moral Issues

By

N. V. Rangantha

Email: ranganath06.adv-at-gmail.com