Science and technology has witnessed prodigious advancements which have led to modern evolution and discoveries in the field of medicine. One of such revelations would be the discovery of Genes, the basic physical and functional unit of heredity, made up of deoxyribonucleic acid (DNA). Scientist are now capable of extracting DNA from cells to isolate specific segments for the purpose of research and can also synthetically create DNA by extracting only particular strands from the DNA and omitting the rest.

Such a break-through or revelation in the field of science and medicine is nothing short of an invention per se. So are such inventions patentable and can someone own these genes? Gene patentability has been a controversial issue for quite some time and genomics industry and the Courts have witnessed various litigation related to genetics DNA research.

Let’s first get an international view on this subject matter and refer to a recent judgment by the United States Supreme Court where the validity of gene patenting was challenged.

Association for Molecular Pathology vs. Myriad Genetics, Inc.

Facts: The human DNA contains of innumerable strands of nucleotides. These nucleotides contain exons (which contains protein-coding information/ amino acids) and introns (which does not contain the said coding information). With the advancements in scientific technology, scientists are now capable of isolating the exons segments from the DNA to synthetically create exon-only strands of nucleotides leaving behind the introns, and it is known as complementary DNA (cDNA).

Myriad Genetics, the respondent company, discovered the precise location and sequence of particular genes called the BRCA1 and BRCA2 genes, whose mutations can increase the risk of developing breast and ovarian cancer, a medical breakthrough, for which patent protection was claimed. Given the circumstances that the claimed patent protection was granted to the respondent company, they would enjoy exclusive right to not only isolate the BRCA1 and BRCA2 genes, but also the exclusive right to synthetically create BRCA cDNA, which will contribute towards the development of medical tests for detecting mutations of these two genes in patients and enabling an assessment on their risks of developing breast and ovarian cancer.


  • Whether an isolated DNA or naturally occurring segment of the DNA is patent eligible?
  • Whether a synthetically created cDNA is patentable?

Naturally occurring DNA not patentable: As far as the first contention is concerned, the Court held that a DNA or its constituent naturally occurring segment is a product of nature and thus is not patent eligible merely because it has been isolated from the remaining DNA segments.

Synthesized DNA patentable: The cDNA although retains the naturally occurring exons of DNA, but it is discrete from the DNA from which it was derived and the nucleotide sequence in the cDNA is dictated by man rather than the nature. Hence is not a “product of nature”, thereby is patent eligible.

The U.S. Supreme Court in the present case somewhat ended up giving a tentative ruling and the ambiguity still remains as to what is the reasonable test to determine if the synthesized DNA is inventive enough to be granted patent protection and are all synthesized DNA patentable?

What does the Indian Patent Act say?

Section 3 (c) of the Indian Patent Act, 1970 very clearly states that “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature” is not an invention and hence is not patentable. Accordingly genes, which occur naturally cannot be patented under the Indian Patent Act.

But what about the isolated synthesized DNA sequences?

Unfortunately, there is a lacuna in judicial decisions with respect to this subject matter so let us analyze a few examples of gene patents granted by the Indian Patent Office.

Position before 2013:
  • Genetically Stable JEV cDNA based on Japanese Encephalitis Virus (Patent No. 243799)

The IPO in this particular application has granted protection to a cDNA sequence though it is not synthesized or a recombinant and a mere derivative of the exiting natural sequence.

  • An Expression Vector or Cloning Vector Encoding Filarial Parasite Polypeptide (Patent No. 246865)

In a similar cDNA patent application, the Patent Office took a different view and objected to the cDNA sequence stating that it was obtained from what was already existing in nature. But ultimately these objections were withdrawn and the patent was granted.

The actual practice adopted by the IPO hasn’t been much consistent due to lack of guidance in the patent manual and the Act and even though naturally occurring gene is not patentable under Sec. 3 (c), there have been cases where naturally occurring isolated gene sequences have also been granted with patent protection.


Considering these irregularities in patent grant for genes, the Guidelines for Examination of Biotechnology Applications for Patent was issued to the IPO in March 2013. These guidelines are a welcome step towards generating a uniform and consistent pattern for granting patents for genes.

The Guidelines explicitly states that isolated gene sequence occurring in the nature will be treated as a discovery of a living thing occurring in nature and therefore not capable of patent protection under Sec. 3 (c) of the Act.

Having said that, what is the position of a cDNA that is, an exon-only genetic sequence in which the introns have been removed by man? There seems to be a lack of useful guidance on this specific subject matter but judging by an illustrative example in the guidelines it can be inferred that an isolated gene sequence would not fall under the scope of Sec. 3 (c) if the claims indicate modification or alterations or deletions. Unfortunately, no guidance is provided on the extent of modification that is required.

An inconsistent and unsettled criteria for granting gene patents

To an extent it seems clear that the mere identification of the location of a human gene, or part of a gene, as it exists in nature is not patentable under Sec. 3 (c). What is vague is whether isolated synthesized cDNA would fall within the scope of the exclusions under Sec. 3 (c).

Tracing through the history of gene patents granted by the Indian Patent Office, one can’t help but notice the extreme level of inconsistency involved in the reasoning for granting various gene patents. Although the 2013 Guidelines seems like an optimistic start, yet many questions are left unanswered and hence it is for the time to tell as to how IPO will be dealing with complications in granting gene patents.

Definitely with the ongoing developments in genetic technology one can expect continued litigations and oppositions with respect to granting gene patents, unless there is a uniform and comprehensive practice. The Indian Patent Office must be cautious while dealing with biotechnology patent applications as patents incorrectly granted will only hinder development and innovation.

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