While researching for a paper that I am currently writing, I stumbled along a rather strange issue regarding the patentability of microbiological processes. The root of the issue traces back to Article 27.3 of TRIPS. This provision allows member-states to exclude from patentability certain subject matter such as plants, animals and essentially biological processes, with the caveat that member-states will still have to protect micro-organisms and microbiological processes under their national patent laws. The relevant wording of Article 27.3 reads as follows:
“plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.”
Going by the wording of the provision, “micro-organisms” are an exception to “plants and animals” and “microbiological processes” are an exception to “essentially biological processes”.
The requirements of Article 27.3 of TRIPS were incorporated into the Patents Act, 1970 via the Patents (Amendment) Act, 2002. This amending legislation incorporated Article 27.3 into two different provisions: The first amendment was Section 3(j) of the Patents Act which reads as follows:
“plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”
The second amendment was in the form of an “explanation” to Section 5. This “explanation” used to read as follows “Explanation.- For the purpose of this section, “chemical processes” includes biochemical, biotechnological and microbiological processes”. Section 5 at the time allowed for the patenting of chemical processes.
The insertion of Section 3(j) and the explanation to Section 5, ensured that India was in compliance with Article 27.3 of TRIPS because it had ensured the patentability of micro-organisms and microbiological processes. An important side-note here is the demand by CPI(M) to exclude micro-organisms from patentable subject matter. The government of the day referred the issue to the Mashelkar Committee which concluded that India would be violating Article 27.3 of TRIPS if it prohibited the patenting of micro-organisms.
In 2005, during the last set of amendments to the Patents Act, Parliament simply deleted Section 5, including the explanation inserted in 2002. Clause 4 of the Patents (Amendment) Act, 2005 read as follows: “Section 5 of the principal Act shall be omitted”. That Section 5 itself was deleted is not surprising given that the provision prohibited the grant of product patents for food, medicine, metals, alloys etc. Since the main text of Section 5 went against the very essence of Article 27 of TRIPS it had to be deleted. However the “explanation” to Section 5, especially the express mention of “microbiological processes” should have been incorporated elsewhere in the law. Surprisingly this wasn’t done and the last I checked, the phrase “microbiological processes” is not to be found anywhere in the Patents Act.
Since the prohibition against patenting of “essentially biological processes” continues to exist in Section 3(j) of the Patents Act does it follows that microbiological processes will also be un-patentable? And if microbiological processes are un-patentable in India is the country in violation of TRIPS and has the Patent Office wrongly granted patents for biotech inventions that are basically microbiological processes? More importantly what are the ramifications for the Monsanto patent currently the subject of the patent litigation? In a previous post by Nuziveedu’s lawyer, he had mentioned that the main claim being asserted by Monsanto in its litigation against Nuziveedu is as follows:
“Claim 25: A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis δ-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said δ-endotoxin protein, and wherein said fusion protein functions to localize said δ-endotoxin protein to a subcellular organelle or compartment.
Is the invention that is the subject of Claim 25, a microbiological process?
Good one
Its a vector (plasmid construct based claim) encompassing nucleic acid sequence capable of expressing a fusion protein by a plant cell wherein the said fusion protein functions to localize said δ-endotoxin protein to a subcellular organelle or compartment.
Hence not to be confused with the plant cell based claim neither with the microbiological process.
The said plasmid is eligible for patent protection.
Very good observation indeed, Prashant. That’s the way it is, hamara India!!
Please read Section 3(j) of The Patents Act
(j) plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;
All biological processes are not prohibited, only the biological processes for production or propagation of plants and animals are prohibited. Microbiological processes are NOT biological processes for production or propagation of plants and animals.
essentially biological processes are always understood to involve conventional techniques of asexual and sexual methods of propagation, for example, grafting, breeding etc….generally used by farmers and breeders
The Monsanto claim is a genetic engineering method
Its a vector (probably a plasmid) construct that is being claimed herein (Claim 25) which is capable of expressing the fusion protein when introduced within a plant cell wherein said fusion protein functions to localize said δ-endotoxin protein to a sub cellular organelle or compartment.
Hence its not a genetic engineering method based claims either instead it claims a construct which can be used in genetic engineering.
Its a vector (plasmid construct based claim) encompassing nucleic acid sequence capable of expressing a fusion protein when introduced within a plant cell wherein the said fusion protein functions to localize said δ-endotoxin protein to a subcellular organelle or compartment.
Hence not to be confused with the plant cell based claim neither with the microbiological process nor with the genetic engineering method.
Yes the claimed construct can be used further in the genetic engineering process to transform the microorganism.
Transformation of the micro-organism would be referred as genetic engineering method.
Section 3(j) clearly and explicitly excludes microbiological processes my reciting ‘essentially biological processes for production or propagation of plants and animals’ which means the biological processes pertinent to production or propagation of plants and animals.
firstly, the claim is for a vector and the protection afforded will be limited to the technical features of the vector, and not what it does or how it does. what it does or how it does does not define the vector characteristics.
secondly, the “process” may be validly claimed in a separate “method’ claim as it involves a synthetic vector, thus falling outside the ambit of Section 3(j).