Gene Patents Across Borders: A Global Outlook

Gene Patents Across Borders: A Global Outlook

[This piece has been authored by Dhairya Kumar and Manas, students at the Dr. Ram Manohar Lohiya National Law University, Lucknow.]



The fundamental structural and operational component of heredity is a gene. DNA-based genes serve as instructions for creating proteins, which are molecules. Every gene is present in two copies, one from each parent, in every individual.

The evolving patenting system is facing enormous problems due to the developing biotechnology revolution, especially concerns over the patenting of the Code of Life, i.e., genes. The creation and delivery of medical services have significantly benefited from genetic innovations, but they have also raised a great deal of debate.

The US Approach on granting gene patents:

The Subject-matter of patentability in the United States is dealt with by Section 101 of the US Patent Act of 1952. The aforementioned provision states that:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Consequently, it might be stated that it emphasises the patent’s subject matter being “novel” and “useful.” So, the two key components that stand out are the inclusion of an inventive step and the potential to be industrially applicable. At this point, it is crucial to note that the Act is silent on the limitations imposed on the terms “invents” and “discovers” pertaining to the classification of patentable subject matter. Various legal precedents relating to biotechnology patents have developed over time, facilitated by the different courts.

The US Supreme Court made history on March 17, 1980, when it upheld the Court of Customs and Patent Appeals’ ruling in the case of Diamond v. Chakrabarty and granted the appellant a patent for a modified strain of bacteria that could break down crude oil. The important conclusion, in this case, is that, in the court’s view, whether or not something is alive has no bearing on the topic of patent law and that the focus is instead on whether it is a natural phenomenon or the result of human activity.

 This leads to the conclusion that the bacteria fell inside the statute’s definition of “manufacture” or “composition of substance.” It may also be described as a non-natural phenomenon and a result of “human inventiveness” simultaneously. This decision also ushered in a new era, paving the way for gene and biotechnology patents based on the idea that isolated DNA molecules were significantly cut off from their biological context.

The US Supreme Court abolished the practice of granting patents to isolated DNA sequences in the case of Assn. for Molecular Pathology v. Myriad Genetics, Inc. in 2009, presents another significant aspect of gene patenting. The gene patents that had been awarded before this judgement were significantly impacted by it.

This lawsuit challenged Myriad’s patents on diagnostic testing over two isolated human genes, BRCA1 and BRCA2, that company possessed. It was not until June 2013 that a nine-judge bench of the US Supreme court accepted the government of the United States’ position and held that only artificial synthetic DNA sequences were patent-eligible and that isolated DNA genomes were ineligible for patent eligibility because the order of nucleotides in the isoforms was random.

In its ruling, the court emphasised that genetic information stored in DNA remained substantially unchanged, negating the possibility of a separate genomic code. In light of this, it is crucial to recognise that the distinction between “finding” and “creation” becomes a crucial deciding factor.

Analysis of grant of Patent to Japanese Encephalitis Virus (JEV) cDNA by USPTO:

In the United States, the primary criteria for patent analysis are novelty, usefulness, non-obviousness, manufacture and composition of matter.

In the present case, a patent application was filed for the invention based on isolated DNA molecules encoding the genomes of mutant Japanese encephalitis viruses. The invention mentioned in the aforementioned case was majorly associated with protecting from virulent Japanese encephalitis viruses. The particular live attenuated JEV strain, which was subjected to patent, in this case, was produced empirically by serial passage in cell culture and laboratory. It had 57 nucleotide substitutions, resulting in 24 amino acid substitutions, which made it very different from the genome of wild-type JEVs naturally occurring in nature.

Thus, it satisfied one of the critical aspects of patentability, i.e., it was a composition of matter produced by human ingenuity under the ambit of the term ‘manufacture’ as mentioned in Section 101 of the US patent Act. Since such composition did not exist in nature before its creation as a product of human ingenuity having a distinctive name, character, and use, it also check-marked the criteria of ‘novelty’ and ‘non-obviousness’.

 According to the jurisprudence developed by the US Supreme Court, a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. However, cDNA was held to be patent eligible because it is not naturally occurring, as was the scenario in the present case. Thus, the distinction between discovering an unknown natural phenomenon and inventing a previously non-existent substance with a new and useful industrial application has also been recognised by US Patent and Trademark Office while granting a patent in the present case.

The present invention also had industrial application as it proposed developing a live attenuated vaccine for the JEV, a mosquito-borne disease that induces severe encephalitic and neurologic manifestations. The USPTO also seems to be one of the most liberal patent office’s opening gates for inventors compared to Europe and India, which follow a more stringent patentability criterion. The USPTO, in its gazette, held that there is no hard and fast rule for granting patents, and a decision on this aspect of patentability will be made on a case to case subject to the test of ‘inventive step’ and ‘non-obviousness.’

The TRIPS Approach:

There are various agreements pertaining to the enforcement of patents in the International Arena. The TRIPS agreement is one such effective regulation. Its main objective was to offer member states a certain level of protection for their intellectual property rights. The grant of patents for novel items and techniques that demonstrate creative steps and have the potential for industrial use is provided for in Section 5 of this Agreement. Here, we can see that the fundamental principles of what constitutes patentable subject matter remain constant and is comparable to the national and local legislation of the member nations.

The TRIPS agreement’s Article 27 discusses awarding patents to goods and processes in all technological disciplines. This would inescapably encompass biotechnology patents, bringing gene patents under its purview. Gene patenting is not expressly prohibited but is not officially permitted. Although it is mainly mute on this matter, it still serves as a significant persuasive authority and gives its member states much leeway in interpretation.

It does not define the standards for an invention or the range of inventions that fall under its requirements for patentability. Hence, a lot is contingent on how the member states interpret provisions. In conclusion, it is possible to determine a gene’s patentability based on the genetic alterations and valuable features placed into the structure that was not present in it in its naturally occurring condition.


The implementation of varying standards for patentability in the biotechnology sector will significantly affect investors and the sector’s future growth. Hence, it impacts the nation’s economic growth, scientific advancement, and the speed at which technology is developing. In contrast, providing patent protection to just technical advancements or enhancements made in the usual course of business without actual innovation slows development. For patents combining previously known parts, it may rob earlier innovations of their worth or utility. Hence, while resolving conceptual challenges in gene patenting, the patent office and judge must exercise extreme caution and diligence.

Many perspectives on how to strike a balance between the need to encourage innovation and maximise public access to stimulate more innovation and the interests of public health have value in this developing field of genetics. Nonetheless, it is necessary to recognise the advantages of convergence in certain areas of human gene patenting. Consequently, reaching an agreement on this particular element of patenting human genes deserves thought.

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