This article is written by Abhishek Kurian from National Law University, Odisha. In this article, the author discusses gene patenting and its implications.

Introduction

“It’s because of your genes”. 

You might have certainly come across this sentence a few times in your life when discussing your height, weight, eye colour, hair colour, etc. That’s because genes are part of the DNA which contains information about these characteristics. 

Now, how absurd would it sound to you if someone told you that you could patent one of these genes? That people have actually patented genes? You might be wondering that living things and their constituents or anything that exists in nature cannot be patented then how does such a patent exist? Well, you are right to a great extent but gene patenting does exist and in fact, around 5000 genes have been patented in the U.S. Although, gene patenting at present is a contentious topic as to whether it should be legally patentable or not. Let us understand the concept before we deal with the different socio-legal and ethical issues that surround it.

What is gene patenting

Gene patenting involves getting the exclusive right towards a specific gene. This right is given by the government or by an organisation to the one who invented or identified the gene. Such a right includes the sole ownership and discretion regarding its use for a period of mostly 20 years. Now coming to the question of its patentability.

Anything that exists in nature, be it plants, animals, rocks, mountains, water bodies or any living organism or is a phenomenon of nature cannot be patented. Why? Because patents are for novel inventions and all the above things would usually come under the category of discovery. 

The provision for gene patenting if and when it is allowed) needs the inventor to genetically modify the gene before filing for a patent. The patent also provides for synthetically or artificially produced genes. This would make it a novel invention, as once modified it becomes unique and hence would not be something that exists in nature. This is when the gene could be qualified for a patent. A gene patent would also cover components or parts of a gene that could be used. There are certain cases in which the process by which such modification is created could also be patented if it is truly novel and not obvious or merely a regular mental activity as opposed to an intellectual action or process. Basically, the prerequisite is that it must be an invention and does not come under the ambit of laws of nature or phenomenon of nature and it must be non-obvious in nature. Let’s understand the legality of gene patenting using some major case laws.

Development of gene patenting laws in major case laws

Diamond vs. Chakrabarty

Facts

This case is known to be the first case filed for the application of a gene patent. Anand Chakrabarty was a scientist who discovered that a certain bacterium(singular for bacteria) had the potential to digest or breakdown the contents of crude oil. He felt that such technology, if developed, could be useful in mending the damage that could be caused by oil spills, saving marine life and the purity of water bodies.

Although, for the process to work he had to make certain changes to the bacterium and only after genetically modifying this bacterium had he developed the said technology. In 1972 he first filed a patent, for three claims:

• The process that was used to develop the bacterium for it is capable of breaking down crude oil.
• The substance which was used to store the bacterium.
• The genetically engineered bacterium by itself.

Relevant laws

• Inventions must be a new and useful “process, machine, manufacture, composition of matter”
• Laws dealing with patents in the U.S. basically stated that any living organism or any product of nature cannot be patented and would merely be a discovery.
• The scope of patents would be widened to promote research and development.
• Anything under the sun that is man-made would be eligible for a patent.

Arguments for the grant of patent

The plaintiff argued that the purpose of the applicable laws was to make sure that a substance occurring in nature was not confused with something that was developed by humans, and a patent was given only to a man-made product that was new and useful.

In the present case, it was Anand Chakrabarty’s developments in the bacterium that had given it the ability to breakdown the crude oil components and hence should be considered as a novel invention.  

Arguments against the grant of patent

It was argued that while the process and carrier could be patented, the bacterium itself could not be patentable as it would not come under the purview of a novel invention. It was a living organism and the patent laws specifically excluded bacteria from being patented. 

The decision of the court

It was held by the supreme court of U.S.  that there was the need for a broader interpretation of patent laws, especially the one regarding the “manufacture” or creation of a product. It added that while naturally occurring things cannot be patented, an organism that is artificially created requires creativity and intellect. Hence it must be patentable.

Additionally, the court said that the drafters of the patent laws could not have possibly foreseen biotechnological inventions and hence its scope should be broadened according to the current situation of biotechnology.

Association of Molecular Pathology v. Myriad Genetics, Inc., 2013

The Chakrabarty case drastically increased the scope of patents for genetically engineered organisms which increased the number of patents that were applied and granted in the U.S. It also set a precedent for other countries. But there are recent decisions that have limited the scope of gene patenting. 

Facts

Cancer is usually caused because of some kind of alteration in the genes. It was seen that these alterations or mutations in the BRCA1 and BRCA2 genes were largely responsible for Breast and Ovarian Cancers in women. The BRCA1 and BRCA2 are two genes that help in repairing damages in DNA. 

Myriad Genetics was the one to discover this fact along with its location and other necessary information that was required to detect their presence and modify them. They also developed the process to identify any mutation in their genes. For this, they developed two processes resulting in two creations which were patented. They were:

• The act of separating parts of a DNA or isolation which are present in BRCA1 and BRCA2.
• The product resulting as part of this process is the isolated DNA.
• The act of creating a complementary DNA known as cDNA.
• The complementary DNA itself.

Myriad Genetics had successfully received patents for these processes and information that were associated with the BRCA1 and BRCA2 genes. This resulted in their sole right to conduct tests and research using this information for a period of 20 years.

This is when an organisation started providing tests to identify the particular genes in the body at cheaper rates. Myriad stopped them from doing so which led to a suit to declare the patents invalid. 

Held

The case gradually reached the Supreme Court where it was stated in the court that the patent claims made by Myriad did not completely qualify as they came under the ambit of things included in natural phenomena and abstract ideas. The isolation of a gene did not make it patentable since it was still a part of the gene itself and hence was a natural occurrence.

It was held that Myriad had not created anything and merely separated parts of DNA. This did not come under the definition of a novel, non-obvious invention.

For the cDNA, the court stated that the complementary DNA was not a part of nature so it could be patentable as the modification resulted in a novel product.

Is it ethical to patent genes

There has been a lot of debate regarding the morality and ethics of gene patenting. While there hasn’t been a firm decision regarding the same, as there are a few that consider that it is unethical, there are a few that say gene patents protect the rights of an inventor and hence must necessarily be patented. The ethical issues regarding gene patents are mostly ones that concern the life of an organism.

It is often argued that how can a natural component of another animal, plant, human or any other organism be owned by someone else? How could someone else have the right to use it for his/her own gain? Many oppose this as it is part of “commercialisation of life”.

Regarding its use for medicinal or diagnostic purposes, it is said that changing the course of nature by changing the natural being itself is not ethical. It is one thing to cure the disease using external operations or medicines and totally another to change the genetic make-up and using products that are engineered.

It is said that all human genes are unique in nature. The ones that are naturally existing must remain the way it is unethically wrong to benefit from it commercially regardless of what purpose is being satisfied by such use.

The information regarding the genes of a person is private in nature. It should not be disclosed to the public domain for the purpose of an application of a patent.

Also, genes and DNA are an important part of the natural constituent of a human being. It must not be differentiated from other genes that are biotechnologically created.

What are the social implications of gene testing

Limits Research options

Like all patents, even gene patents give the patent holder negative rights, which means that they result in others not having the rights to use that product. Once a gene is patented, the owner of the patent gets the right to use it for research and development. This limits many other organisations and individuals to carry forward their research without patent infringement. This is considered to be unethical as it puts restrictions on the professional scope of research for the gene and bars others from using any other methods as well to reach the same conclusion

Purpose of a patent is lost 

The purpose of patent and other intellectual property rights is that it helps in promoting research among people so that a conducive environment is available for those indulging in research and other inventions. Since gene patenting limits the scope of research for all except the owner, there is a huge restriction on the development of new inventions.

Access to health 

This is probably the worst consequence of gene patenting. As discussed, it limits research by other organisations thereby limiting the scope of medicines being created elsewhere. This denies many cancer patients effective medicines as they have to wait for the patent owner to create these medicines.

This goes against the ethics of medicinal practice as everyone has the natural right to good quality healthcare.  Gene patents make it difficult for many hospitals to conduct tests that are required for the detection or treatment of cancer. Even when such tests are allowed they become very expensive and hence it is usually out of the normal reach for most people. This is unfair to them and is considered to be extremely unethical.

Privacy and Consent issues

As discussed before, when the genes of people are collected for testing or research, the consent of the person is required at an individual and national level for its study, research, experimenting and in some cases even for mutation or manufacture of other constituents. There can be ethical issues if this consent is not taken in accordance with the due procedure.

Legal Implications of gene patents

It must be understood that a patent can only be given to man-made inventions and products of nature and discoveries do not qualify for a patent. The grant of gene patents has given way to many different legal implications. While there were no such laws for such a right, as the age of research and development progressed there had to be changes made in order to make space for such biological inventions. Since there was no field of genetic engineering before, naturally the patent laws would also have no provisions for the same. Hence, case laws are looked at for disputes and issues related to gene patents which would make room for provision. Such provisions had also increased the scope of patents. 

As we see that the Chakrabarty judgement increased the purview of biological patents setting the field for the future of genetically modified inventions and implicitly gave people the right to use the constituents of living organisms to sell, manufacture, study and publish it as well. Then with subsequent judgements, this scope started decreasing.

Isolation is a term in genetics, that in simple words means the removal or alteration of a particular section of a DNA which can help in creating copies of it and also in determining the sequence of that gene (see here). Earlier the process that resulted in the isolation of genes was also allowed for gene patents. After the decision of the Supreme Court in the landmark Myriad judgement, the process could not be patented and hence this narrowed the scope of gene patents once again.

Licensing of Gene Patents

Licensing of gene patents is of prime importance in the research field and basically involves giving permission to other organisations to have rights to study, research and use the patented genes.  This kind of licensing for gene patents depending on its use may be exclusive or non-exclusive.

Exclusive licensing is given to companies when they are granting licenses for the development of a drug as this would result in them being the only company/organisation with the right to research other than the patent owner. This is useful in the development of therapeutic drugs as this would help in the elimination of the competition and would also help in the funding required for the research of the drug development.

Non-exclusive licensing refers to when the patent holder grants a license to a company but with no is free to grant the license to other companies/organisations for research as well. This usually takes place for diagnostic testing as there is not much finding required for the same and it is ethically right to help the maximum number of people benefit from the diagnostic test. 

Furthering Research

The reason why licensing of genes is so important is that they are needed for further research and innovation. This could become extremely burdening for an individual organisation and hence it could instead distribute its rights through licenses and in turn spread the research work. 

Licensing Fees

Many times the ones who receive the gene patents could be universities or even individuals who are not well funded. This would lead to a scarcity of resources and hence inadequate research. So, a solution that they employ is grant licenses of other organisations and attain the license fees for the gene patent.

Enhanced marketing and sale

Another benefit of licensing involves the additional facilities for sale and manufacture of products that are associated with the research of the patents. An individual organisation grants the license for the patents and then the licensees help in the marketing and sale of the products or testing that is derived from the knowledge of the gene patents.

Increased Competition

With all these benefits, there is also the threat for the patent holder of the genes, that the licensee may be able to develop a new product given that they have the right to research and study the genes. This could lead to the development of new discoveries and hence there would be an issue of the ownership of the useful inventions arising out of such licenses.

Challenges of Gene Patenting 

As we can see from the analysis of the case concerning gene patenting it would be evident that there are legal, social and economic challenges that are posed to gene patenting

Firstly, the determination as to whether the genes for which a patent is requested is actually patentable. It must be a novel invention and must not come under the ambit of natural creation. This can be extremely tough to prove for the applicant. Also since genetic modifications are explicitly allowed, there must be the determination of how much modification is needed for the product to be patentable. These questions may pose a challenge in the grant of a gene patent.

The social aspect must also be considered as to whether it should be socially acceptable to patent a living organism’s genes and further even use it for sale and profits. Such an issue has always been under question.

Also, the gene patenting that is associated with some important diagnostic test or any relevant research for the drug may hinder the process of research and testing as it would effectively lead to the monopolisation of that drug.

Advantages 

Promotes new inventions

A patent is a right that the creator of the invention is worthy of and must attain as a result of his hard work toward that invention. This results in a favourable environment for the scientists who are involved in the creation of useful products as it acts as an incentive to work in the field of bioengineering which could result in many inventions helping the health and wellness of the public.

Promotes Research

Once a patent is granted, the organisation or individual could use an investor’s aid in the process of research and development. After the patent is granted, the researcher would also not be bound by any critical time limits as opposed to the limit resulting from facing increased competition in the market and the race for the patent.

Healthcare developments

There are many diseases which are caused due to the damage or improper wiring in genes. Although there are medicines that could be helpful, therapeutic gene treatments are known to be more effective. Gene patents have proven useful in developing many therapeutic proteins. The study and use of genes in different situations could also lead to other breakthrough inventions in the healthcare industry as there would be undertaking of in-depth research and analysis of the genetic composition of the human body.

Disadvantages

Imposes limit on research

Now, this might seem conflicting as one of the advantages you just read was that gene patenting promotes research. Well, what happens is that gene patents could promote research for those who are the owners or licensees of the patent. But, all others are barred from using those genes for research, studies, testing, and other useful purposes.  Also since the patent owner could enforce his or her rights in other countries as well. So it is said that the rights to further research on those particular genes are limited to the owners of the patent.

Results in a monopoly of the gene(s)

Gene patenting could result in a monopoly of the gene by the organisations considering the rights that they are entitled to under this patent. All the research, analysis and further development on the genes would be only done by the owner of the patents for that genes and it would charge an extremely high price for granting the license to other organisations.

Commoditization of life

This is a major disadvantage of Gene patents especially when it comes to the genes of human beings as such a patent and the monopoly resulting from it would lead to marketing and commoditization of the life of an individual or organism which can be considered to be disrespectful and abuse of life.

Violation of Health rights of a person

Yet again, another conflict in the pros and cons is that ideally, gene patents should lead to more effective medical care considering the high-quality research that is made possible after the patenting of genes. But, since the owner would have the sole rights to use the genes and would create a monopoly over it there would be major restrictions on the scope of medical research by other organisations. This would slow down the progress in that field as for every new development in the treatment and testing there would be dependence on the owner of the patent. This, in turn, would result in the violation of the health rights of an individual as he/she would not be able to access the best quality of health facilities.

Critical analysis 

When it comes to gene patenting and patenting of other biological inventions there has been widespread criticism on both, that is the act of patenting living organisms or their constituents and also the laws that define the legal boundary of such patents. Additionally, the consequences of the gene patents have also been on the radar of many critics as these patents are accompanied with many legal, economic, social and ethical ill-effects as have been discussed in this article.

Most of the criticism is related to how this would have an effect on the future inventions in the field of biotechnology. While it is accepted that such patents would play an important role in increasing the scope of genetic engineering, there has been severe disapproval regarding the laws that govern such patents.  There has been great emphasis on the judgements that would serve as major guidelines for the rationale behind the granting of gene patents and hence there needs to be work done to improve the current scenario of the laws in order to give clarity.

Another major criticism, or more rightly doubt regarding gene patents is the biological and ethical consequences of the patent. Since patents come with such exclusive rights to study, analyse, use for commercial purpose, etc there need to be done deeper research as to what kind of ill-effects could the collection or use of these genes result in. 

Genes are a source of information in the human body that is inherited and forms a very crucial part of the genetic make-up of the body. Before granting the rights for the exclusive collection, use, alterations in such make-up of the body there needs to be adequate research on what kind of effects could it have on the human body after such changes are made.

For. e.g. if a particular gene contains information regarding the effective memory of a person, and there are mutations on the same, the person could face some vital damage to an important asset. There also need to be considerations regarding what the genetically modified genes could develop into in time -Whether they could become harmful or inactive. Such considerations through enough research need to be before there could be the grant of such patents.

Next, the most important thing is that since these gene patents would provide so many rights regarding the genes of a person it is important to make sure that these are not misused or abused in any form by the owner. There is no limit as to what the human minds are capable of and such patents could lead to even biological terror. Therefore such precautions and checks must be a pre-requisite for the grant of such patents. 

Conclusion

We understand that gene patenting could be best seen as a necessary evil. To sum it up the requirement for the gene patent is the quality of novelty and non-obviousness. When this is present, the genes can become patentable. The difference between the discovery of creation in nature and the use of intellect for the creation of a new product must be observed. Also, there must be precautions to manage the possible ill-effects of gene patenting and the purpose of patents acting as an incentive to creators and scientists must not be lost.

References

• https://www.wipo.int/wipo_magazine/en/2006/04/article_0003.html
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2220018/#R7
• https://www.alrc.gov.au/publication/genes-and-ingenuity-gene-patenting-and-human-health-alrc-report-99/22-licensing-of-patent-rights/licensing-of-gene-patents-in-australia/
• https://www.scu.edu/ethics/focus-areas/bioethics/resources/ethics-and-gene-patenting

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