Ethics in DNA patenting
Author: Swetalika Das
Introduction
The concept of DNA patenting has improved in recent times because the application of the patent system in biotechnology mainly aims at a balance between the inventor’s rights and the interest of the public. There is a concern in every sector whether it is ethical, legal, or scientific. Therefore, it creates a platform for discussions.
A patent is an intellectual property right is for technical inventions which allow you to prevent others from using someone’s inventions for their commercial use. This right has a time limit of upto 20 years[1].
Patenting DNA which can also be known as the patents that asserts rights over DNA which has raised various ethical issues like the legal status of DNA patenting as well as the scientific use of DNA Patenting. As there are so many issues regarding DNA patenting. Therefore, it becomes important to discuss more the application and value of the system of Patenting concerning DNA sequence.
It has been seen that there is a relation between law and DNA sequences. There are many cases where the DNA patents were granted and in the end, it received all protection about the use of DNA which also includes the protein produced by DNA. The patents were granted after examining the creativeness and the utility of the particular invention.
In this paper, we will analyze the four applications of DNA sequences about patent claims and the ethics related to DNA patenting.
The Patent system and Its History:
The patent system aims to raise innovations and give specific rights to the inventors with a defined time limit. A patent owner can permit anyone to use his/her inventions. The concept of DNA patenting started with the case of Diamond v. Chakrabarty[2] 1980, in the U.S. Supreme Court it was held that living organisms or man-made substances could be patented because they don’t form naturally. After this, there was an opportunity for the field of biotechnology companies to grow regarding patent DNA or human genes. Earlier, the patents were granted on the whole gene after observing the known function. Then, the inventors started to ask for the patent for a DNA sequence which isn’t a whole gene whose functions were unknown. The researchers stated that the gene discoveries in the future would take over the rights of previously patented gene discoveries. Therefore, they applied various limitations on gene patenting and made sure that it would continue if there would be yearly investments of hundredsof millions of dollars after a proper examination of whether a gene sequence fits the patenting criteria.
After all the discussions and valid points, the United States Patent and Trademark Office determined the validity of DNA sequences rights which requires at least one particular utility and credibility. If there is no such utility or credibility then the patent rights could be rejected.
What are the four applications of DNA sequences in the patent claims?
The four applications are:
1. Research tools
2. Gene therapy
3. Diagnostic testing
4. Therapeutic proteins
Research Tools:
Research tools are the DNA sequences. There are two types of research tools such as Expresses sequence tags(ESTs) and Single Nucleotide Polymorphisms(SNPs).
The patent holders usethese research tools in commercialization by licensing them for a particular sequence
In which case patent should be granted or discouraged:
1. If the rights are asserted to cover all the sequences containing ESTs, only those which are the subject of the original part then no patent shall be granted.
2. Generally, granting of patents is discouraged in case of the rights over DNA sequences as research tools.
Gene Therapy
This therapy also involves the use of DNA sequences. Gene therapy is considered when a disease is caused by different mutations in the same gene. So, when there will be any kind of disease caused by mutation the person would need gene therapy. In this case, if the gene is patented then the treatment gets dependent on the availability of license of patent from the patent holder. Therefore, it becomes important to understand that in this type of case treatment through gene therapy by the use of DNA sequences is relevant and the protection by patents should be discouraged.
Diagnostic Testing:
It is mainly based on the identification of DNA sequences. In this case, the DNA sequence in the gene and mutation-related diseases are applied to detect and characterise the gene in human beings. The concept of patenting DNA sequences should be given less concern than inventiveness.The patent rights in DNA sequences don’t provide sufficient ways to cure the disease instead it increases the number of different tests.
Therapeutic Problems:
In this case, the patents not only assert rights over DNA sequences but also on the protein characterization process as well. As in this case the patent rights on DNA sequences help in making new medicines related to therapeutic problems, it is acceptable and it suggests that the rights on DNA sequences should only be limited to the protein manufacturing process.
Ethics in DNA patenting:
Generally, patents on human genes are morally not acceptable and get objected to by society. By patenting it is assumed that Human genes are not only but a machine for profit which is discouraged by many people. Patents are the concept of innovation and ownership but here, the main question develops regarding the ownership rights and innovations as there were so many infringement cases arise due to the innovations.
The patent system is applicable in biotechnology as it makes a balance between the owner's rights and the interest of the public[3].
Conclusion:
The patent system on DNA sequences has both advantages and disadvantages, but due to some disadvantages banning the whole DNA patenting would be an impractical decision. In recent times, it can be seen that there are certain products that can be patented. If the product is giving some type of benefits then it can be patented and that same goes for DNA patenting because we get benefits from the genetic code.
References:
[1] What is a patent?,https://www.ige.ch/en/protecting-your-ip/patents/patent-basics/what-is-a-patent.html, (28.03.2021) [2] 447 U.S. 303 (1980) [3] The ethics of DNA patenting, Available at http://www.legalservicesindia.com/articles/dna.htm, last seen on 30.03.2021