Biotechnology inventions are important in advancing human development. These inventions are a combination of biology and technology in such a manner as to improve the living conditions of humans, eg: the invention of synthetic insulin for diabetes patients. However, this branch of science comes with its own moral and ethical dilemmas. Such as whether using the genes of living people to invent something should be allowed or whether the cloning of humans for the purpose of science should be permissible.
And all these dilemmas become all the more relevant when considered from the aspect of patenting. It is the duty of the State to determine the inherent morality issues and whether such biotechnology patents should be granted and if they are being granted what should be the parameters for the same. In this blog post, we would be dealing with two jurisdictions: India and the USA, and how they differ in their treatment of biotechnology patents.
Biotechnology Patenting in India
The patent Act in India was first enacted in 1856. It has been modified several times, 1970 being the most important which inserted the international norms of patentability requiring novelty, inventive step, and industrial application to be present for an invention to be patentable. But even that amendment did not include anything related to biotechnology inventions.
The amendment that introduced the concept of biotechnology patent occurred in 2002 when the demand for this amendment became overwhelming considering the breakthroughs taking place in the biotechnology sector. Thus, this amendment included biochemical, biotechnological, and microbiological processes within the definition of potentially patentable processes.
The criterion required for patentability is novelty, inventive step and industrial application. However, some inventions might be excluded from patentability despite fulfilling the above requirements which have been enumerated under Section 3 of the Patents Act, 1970.
Biotechnological processes are covered by the following exclusions to patentability:
- Section 3(b) states any invention which is immoral, against public order, harmful to the human, animal, or plant life, or harmful to the environment cannot be granted a patent.
- Section 3(c) disqualifies the discovery of living or non-living things already existing in nature from being patented.
- Section 3(d) causes any discovery of a known substance that does not show any therapeutical efficacy unpatentable.
- Section 3(i) covers any medical, surgical, curative, prophylactic, diagnostic, or therapeutic treatments of human beings or animals
- Section 3(j) renders plants and animals in whole or any parts thereof other than microorganisms as well as essentially biological processes for production or propagation of plants and animals unpatentable.
- Section 3(h) relating to methods of agriculture or horticulture.
- Section 3(p) excludes any information that forms a part of Traditional Knowledge from being patented.
The biggest obstruction to most biotechnology patents is generally Section 3(b) since as discussed above, there are several moral concerns that accompany such patents. Another roadblock to these patents is Section 3(d) which does not allow for mere discovery to be granted a patent and most biotechnology patents are rejected on this ground, even though it was discussed in the case of Novartis where the Supreme Court explained that it was about therapeutic efficacy and not just whether the material could be said to appear in nature.
Section 10(4) of the Patents Act provides that an applicant is required to deposit the biological material mentioned in the specification if it is unavailable in the public domain and cannot be described adequately as required by the Act. The material needs to be deposited with an international depository authority registered under the Budapest treaty. The deposit has to be made no later than the filing date of the patent application in India.
In the case of genes, nucleotide and polypeptide sequences have to be mentioned in the form of the sequence listing in the complete specification. The sequence listing needs to be submitted in electronic form. The associated fees have been provided for in the Patent Rules.
Biotechnology Patenting in the USA
In order to be patentable in the USA, an invention has to be a process, the machine, manufacture, or composition of matter or any improvement thereof. The exclusions to these patentable subject matters are things that fall within the ambit of laws of nature, physical phenomenon, and abstract ideas. Biotechnology inventions are considered under the composition of matter or manufacture.
The exception is most applied in cases relating to biotechnology inventions in the “law of nature” exclusion. US Courts have held that anything that naturally exists or is a product of nature is not patentable. The question relating to the patentability of microorganisms came up before the US Supreme Court in the case of Funk Bros. Seed Co. v. Kalo Inoculant Co.
This case involved the patenting of a mixed culture of Rhizobium bacteria capable of simultaneously inoculating the seeds of plants belonging to several cross-inoculation groups. However, this was held only to be an aggregation of what already existed in nature and therefore not considered the patentable subject matter.
However, the US Supreme Court said that everything under the sun made by man is patentable in the case of Diamond v. Chakrabarty, which specifically added the need for a human element for any product or process to be deemed as patentable. This has led to the patenting of polyploid oysters, genetically modified mice, etc. In fact, in USA, gene sequences, gene therapies, etc. are also valid patentable subject matter.
Despite the scope of patentable subject matter being very broad in USA anything related in human beings is not considered as patentable subject matter.
From the above discussion, it is clear that there is a vast difference between the treatment of biotechnology patents in India and USA. India has a very strict approach towards biotechnology patents and follows the rule of not allowing any patents which might even slightly be within the limits of any of the exclusions to the patentable subject matters.
On the other hand, USA has a very liberal approach to the patents as can be seen through the Chakrabarty case, where everything under the sun was held to be patentable as long as it contained human intervention. There is a marked contrast between the two approaches. It is not easy to say which approach is better, but one thing is for sure biotechnology patents are slowly but surely being accepted as a matter of course in most jurisdictions. And most jurisdictions only disallow biotechnology patents which are in any way related to the human body.
 Patents Act, 1970 Section 3(b).
 Patents Act, 1970 Section 3(c).
 Patents Act, 1970 Section 3(d).
 Patents Act, 1970 Section 3(i).
 Patents Act, 1970 Section 3(j).
 Patents Act, 1970 Section 3(h).
 Patents Act, 1970 Section 3(p).
 Novartis v. Union of India, (2013) 6 SCC 1.
 Patents Act, 1970 Section 10(4).
 U.S. Patents Act, U.S.C. 35, Section 101.
 333 U.S. 127 (1948).
 100 S.Ct. 2204 (1980) J.E.M.