The fear that natural products would be privatised soon, or one cannot study a product of nature and benefit from it if another legally possesses it, is always in the minds of all stakeholders. D. Calab Gabriel and Maria Gabriel of Lex IP Care discuss the patenting of natural bio-materials in India

Patenting of life has been debated since 18th century. In fact, Louis Pasteur was granted a patent in 1873 for purified yeast, which is a living organism, by the US Patent and Trademark Office (USPTO). Several other patents were granted for microorganisms that were part of fermentation processes such as bread or wine-making in the US. The USPTO then changed its view due to public policy until the US Supreme Court decided in 1980 that a recombinant bacterium made by humans was patentable as a composition of matter in Diamond v Chakrabarty. Therefore, patentable merit was imparted to living product, which could be seen as a man-made invention rather contemplating it being animate or inanimate.

This was eventually followed by patenting of higher forms of life that do not occur in nature, such as genetically engineered oysters, oncomouse (Harvard Mouse),cows, dogs and crops, in the US. However, the question of whether a naturally occurring product such as an isolated DNA sequence or isolated microorganism is patentable was not clearly answered by these cases.

Myriad case

The Myriad case eventually decided by the US Supreme Court provides clarity regarding patenting of naturally occurring DNA sequences. This case involved the challenging of patents owned or controlled by Myriad Genetics that cover isolated DNA sequences with mutations, methods to diagnose predisposition to cancer, and methods for screening drugs using such DNA sequences. This case was originally filed at the US District Court for the Southern District of New York and it was held that all of the challenged claims were not patentable. While rejecting the claims to isolated DNA sequences, Judge Robert Sweet held that DNA’s existence in an isolated form alters neither its fundamental quality as it exists in the body or the information it encodes.

Therefore, the patents at issue directed to ‘isolated DNA containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C §101. In addition, this decision found that differentiating and analysing of DNA sequences involved in these patents are abstract mental process as held under the Bilski decision in 2010, and hence not patentable. Regarding the drug screening claims, these were rejected as claiming mere basic scientific principles .

Myriad appealed against this decision before the US Court of Appeals for the Federal Circuit. The Federal Circuit overturned the earlier decision and held that the isolated DNA is patentable since it does not exist alone in nature. Against this decision, the plaintiffs took their appeal to the Supreme Court, which admitted the case but remanded it back to the Federal Circuit. However, in spite of this remand, the Federal Circuit did not alter its original findings.

Therefore, the US Supreme Court eventually heard the appeal and passed a unanimous decision pointing out that merely isolated sequence or genes that are found in nature are not patentable.

Furthermore, the court observed that Myriad did not create or alter the genetic information encoded in BRCA1 and BRCA2, or the genetic structure of the DNA, and athough it found very useful information, even such brilliant discovery does not satisfy the test of 35 USC §101. However, cDNA comprises of an exons-only sequence and was not considered as naturally occurring isolated DNA sequence and so not a product of nature.

Indian context

The issues in the Myriad case could be co-related to the artificial exclusions prescribed under Section 3 of the Indian Patents Act 1970, as follows:

  • Section 3(c): discovery of any living thing or non-living substance occurring in nature.

  • Section 3(d): mere discovery of new form of known substance that does not result in enhancement of known efficacy or mere discovery of any new property of a new use for a known substance.

  • Section 3(i): any process for the medicinal, surgical, curative, prophylactic (diagnostic, therapeutic) or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.

  • Section 3(j): plants and animals in whole or any part thereof other than microorganisms, but including seeds, varieties and species, and essentially biological processes.

  • From the above, it is clear that any methods of treating human beings and animals, and higher forms of plants and animals, are not patentable. Regarding section 3(c), though it says discovery of any living thing occurring in nature is not patentable, the Indian Patent Office (IPO) still grants patents for isolated sequences and microorganisms with new or better functionality, and they are patentable so long as they satisfy the test of novelty, inventiveness and utility. The reason for granting patents for isolated DNA is that it is chemically distinct from the natural state of a gene in the body and the fragmented gene does not exist as such in nature. Further, the isolated/fragmented sequence imparts a better/enhanced/different property. Also, there is a considerable amount of human effort and involvement and other factors contributing to the new product. In fact, if such products are not granted in India then there would be literally no residual protection available since any treatment, including diagnosis and any new use of a known substance (second medical use), is not patentable.

    According to current Indian interpretation, the distinction between discoveries and inventions is no more and both are used interchangeably. However, a mere discovery is not patentable but the question of what is mere, trivial and obvious regarding a discovery/invention is quite subjective and difficult to resolve. Meanwhile, two tests, one being the utility/usefulness of an invention and other being the human efforts/involvement put in that invention, need to be satisfied. Both of these tests could be critical, and if both are present in an invention, it is surely patentable subject matter. But in the absence of both, at least the human effort and involvement should be satisfied and clearly emphasised and exemplified in the specification to get the benefit of patentability.

    Unfortunately, according to the Biotechnology Guidelines for Examination of Patent Applications issued by the IPO: “As per Section 3(c), products such as microorganisms, nucleic acid sequences, proteins enzymes, compounds, etc, which are directly isolated from nature, are not patentable subject matter. However, processes of isolation of these products can be considered subject to requirement of Section 2(1)(j).”

    Regarding the isolated microorganism, the current Indian practice is that if the organism is isolated from nature, characterised and its properties are identified/discovered, its utility established and it can be clearly described, or deposited in an international depository, then the isolated microorganism becomes patentable subject matter. The reason for granting patents for isolated versions is that the isolated organism per se does not exist in nature but is always available in agglomerates of microorganisms. In addition, there is human involvement or effort involved, not only in the isolation/making a pure culture by chemical process (the isolated version is a product of chemical process), but also in meeting all of the requirements mentioned above.

    Most importantly, the exclusion of microorganisms from non-patentable items under Section 3(h) is absolute and is also sanctioned under Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights and it shuns discrimination between different areas of technologies. Therefore, patentability of a microorganism will have to be tested only under Section 2(1)(j), ie, novelty, inventiveness and utility. However, as opposed to the above practice, the biotechnology guidelines state: “Although microorganisms are excluded from non-patentability list, a conjoined reading with Section 3(c) of the Act implies that only modified microorganisms, which do not constitute discovery of living thing occurring in nature, are patentable subject matter under the Act.” The examples provided in the guidelines emphasise that if an organism in nature and is isolated from soil, it is treated as a discovery of a living thing and so is not patentable.

    The guidelines indicate that a claim to a polynucleotide sequence that was available, for example, as part of a library before the priority date, lacks novelty, even if the activity or function of the sequence of the polynucleotide has not been previously determined. Here, we are of the view that the biotechnology guidelines talk about the entire gene or whole DNA sequence present in the library. With regard to a claim for a specific fragment of polynucleotide, it may be considered to be novel and its patentability is subject to the fulfillment of inventive step and exclusion under the relevant clauses of Section 3 of the Indian Patents Act. If any sequence of a polynucleotide/polypeptide from prior art does not exactly match with the claimed sequence of polynucleotide/polypeptide, then the subject matter of such claims cannot be said to be anticipated by the prior art sequence.

    Still, the examples in the guidelines mention that the isolated sequence should be modified/altered/deleted and not merely made free from components normally found/accompanying in their native state. The above has been reiterated in the Guidelines for Examination of Pharmaceutical Application and the Guidelines for Patenting Traditional Knowledge and Biological Material. Nevertheless, the authors are of the view that interpreting which microorganism, ie, isolated or modified, is patentable according to the guidelines is ultra vires, improper and against the current practice of granting patents for isolated microorganisms. Although there is a disclaimer that these guidelines do not constitute law making, it would definitely confuse and prejudice the minds of the patent examiners. The interpretation of the Patents Act is vested with the courts and not through guidelines issued by the IPO.

    The fear that natural products would be privatised soon, or one cannot study a product of nature and benefit from it if another legally possesses it, is always in the minds of all stakeholders. Unlike the present position in US due to the Myriad case, in India the guidelines for examination issued by the IPO create the artificial exclusion from patentability of isolated DNA sequences/microorganisms. The authors are of the view that if an isolated sequence is to be a new biological material that does not exist as such in nature and is not part of common natural heritage, and if this material shows enhanced/better efficacy, then it should be patentable in India. This exclusion by the guidelines is yet to be tested by the due process of interpretation/law as there is no case law so far in this regard, and until such a time, the ambiguity regarding patentability of isolated DNA sequences/microorganisms will remain.

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