Patentability of transgenic & genetically modified plants in India

INTRODUCTION

A transgenic plant is a modified organism where genes are transferred from one organism to another through genetic engineering techniques. Maize, rice, brinjal, cabbage, cauliflowers, potato and tomato are a few examples of transgenic plants. A transgenic plant is a GMO and indicates that genes from either an unrelated plant or a microbe have been transferred artificially, using rDNA technology into a plant of interest.

Selecting plants during cultivation is not a new phenomenon. For many years plant breeding entailed the selection of the elite plants for higher yields and tolerance to biotic and abiotic stresses. Earlier, variation occurred through induced mutation or hybridization where two or more plants were crossed. Selection occurred through breeding process, and only the seeds with the best traits were selected. Even before the creation of a transgenic, the alteration of crops to improve their production had been performed through selection for thousands of years, becoming a science onto itself in recent centuries. However, to manipulate plants through selection takes many generations and does not always work due to randomness in the natural selection process. By using transgenic technology, which involves the use of genetic engineering techniques, one can control the process better and produce crops that are resistant to biotic and abiotic stresses. With recent developments in genetic engineering techniques, scientists can now identify, manipulate, and exploit genes responsible for specific traits.

Creating a transgenic plant involves modifying the plant genome for expressing the desired trait(s). The steps involved in developing a transgenic plant as illustrated in Fig. 1 include:

1. Step one. Synthesizing a DNA construct for a gene of interest under the control of a promoter (regulatory element) to express the gene and thus leading to the production of a desired protein in a host organism (recombinant host cell). In addition, the DNA construct could have DNA for selection markers for antibiotic or herbicide resistance, transit peptides that can localize its expression into organelles, and other transcription factors that function like an on/off switch.

2. Step two. Transformation of plant cells by insertion of the recombinant DNA construct using genetic engineering methods. However, this technique may lead to the insertion of the gene of interest at any random location in the chromosome of the plant, leading to the production of several transgenic plants. It is possible that the transformation method can result in insertion of one copy to several copies of the recombinant DNA construct carrying the gene of interest.

3. Step three. It is possible that not all the insertions from the aforementioned transformation led to the expression of the gene of interest. Therefore, the next step is to screen and select for the desired transformants expressing the gene of interest. Screening of these transformants involves identification of the most advantageous insertions, namely, the elite transformants, which are named as “events.” In other words, when the gene of interest is located at different locations in the plant genome, each constitutes a different “event.” Thus, this step entails selecting one or more elite event(s) with the desired expression of the gene of interest in the transgenic plant.

There are applications for patents that comprise of the first two steps as described above (e.g., Indian patent no. 214436, where claims 1–24 relate to the transformation process or step 2 and claims 25–27 relate to recombinant DNA construct carrying the modified bacterial gene of interest or step 1). There are also patent applications that pertain to specific events and their screening such as Indian patent no. 232681, for Bt gene associated with Bg II (more specifically the cotton event is named as MON 15985).

Finally, the elite transgenic event obtained from the transformation process is used to transfer the desired trait(s) (e.g., insect resistance) to different varieties of a plant. This can be done by using conventional crossing techniques like backcrossing, hybridization, etc. to produce new plant varieties expressing the desired gene of interest.

Usually, companies or research entities develop proprietary technologies for making the gene construct, transforming plant cells, and screening for the elite “events.” These events are licensed out as donor seeds in the exchange for licensing fees and royalties for the use of the GM technology in plants. The licensees (commercial seed growers/breeders) use the donor seeds for introgression of the desirable genetic trait developed by the licensor into their own specific varieties by backcrossing breeding.

The status of patent protection for Transgenic/GM plants is presently uncertain in India and is a debate rife with economic and ethical considerations. It is relevant to note the legislative intent of the Patents Act and follow the history of its revisions to become TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights) compliant to understand the issues surrounding the patentability of plant-related inventions in a broader context (Declaration on Patent Protection – Regulatory Sovereignty under TRIPS 2014).

INDIAN PATENT ACT, 1970

A patent in India is a statutory right given to an inventor once the invention is registered with the Indian Patents Office, excluding all others from using or benefiting from the invention for a limited time period of twenty years. The Indian Patents Act grants the same patent rights to both domestic and foreign inventions. However, patent protection is “territorial in nature,” and therefore, patents granted in India are only valid in India. The “fundamental principle” of the Patents Act is that subject matter can only be patentable if it is an invention. An invention under the Act is “a new product or process involving an inventive step and capable of industrial application”.

NON-PATENTABILITY

The Patents Act has explicitly excluded certain items and processes from the definition of invention, thus making them unpatentable. Under the Act, mere discovery of “any living thing or non-living substance occurring in nature” is not an invention. Further, if the intended use of an invention causes conflict with public order or morality, or causes “serious prejudice” to humans, animals, plant life, health, or the environment, the invention is unpatentable.  This includes “method[s] of adulteration of food.” Under the Act, any “method of agriculture or horticulture” is not an invention.  For example, inventing a method to produce “a new form of a known plant,” which involves modifying the “conditions under which natural phenomena would pursue their inevitable course” is unpatentable. Moreover, one Indian Court held unpatentable a “method of producing improved soil from soil with nematodes by treating the soil with a preparation containing specified phosphorothioates.”  Courts have found that a method for producing algae and mushrooms is analogous to agriculture because mushrooms and algae belong to the plant kingdom and, therefore, are not inventions for purposes of the Patents Act. Any treatment of animals “to render them free of disease or to increase their economic value or that of their products” is not an invention. Treatment and diagnosis methods performed on “tissues or fluids, which have been permanently removed from the body,” however, may be patentable. Treatments to plants are no longer excluded from the invention definition after the 2002 amendment omitted “and plants” from this section.

The 2002 amendment adds a section specifying that plants and animals and any part of a plant or animal, excluding microorganisms but including seeds, are not patentable. Likewise, varieties, species, and essentially biological processes used for production or propagation of plants and animals are unpatentable. These areas are protected, however, under the Protection of Plant Varieties and Farmers Rights Act (Act 53 of 2001) (India), which complies with TRIPS by protecting plant varieties through a sui generis system of protection. Even if the subject matter is an invention, the Patents Act may still exclude the invention from patentability. Certain substances are excluded from patent rights, and only the process to create the substance is patentable. This limitation applies to any substance where the use is intended for, or capable of being used as, food, medicine, or drug. Under the Act, food is “any article of nourishment for human consumption,” which includes all food or drink intended for the use of infants, invalids, or convalescents.

Finally, any substance that is prepared or produced by a chemical process cannot be patented–only the process itself is patentable. A chemical process includes biochemical, biotechnological, and microbiological processes.

The Ayyangar Committee Report of 1959, based on which the Patents Act was enacted, expressly clarified that the prohibition under Section 3(h) of the Patents Act, excluding “methods of agriculture or horticulture” from patentability, was intended to apply to “inventions in the field of plant propagation by asexual methods.” Presently, the Indian Patent Office tends to consider every conventional practice that is carried out in an open field as a method of agriculture. Consequently, any claim in a patent application that refers to terms like germinate, seeds, hybrid, variety, etc. is objected to under Section 3(h) by the Indian Patent Office and deemed to be excluded from patentability. Prior to being amended in 2002, Section 3(i) of the Patents Act read as:

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 “(i) any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products;”

Section 3(i) of the Patents Act was amended in 2002, and the words “or plants” were omitted by the Patents (Amendment) Act, 2002. Thus, the treatment of plants to render it free of disease or to increase its economic value no longer falls under the scope of the existing Section 3(i) nor under any of the other exclusions specified by Section 3 of the Patents Act.

Further, Section 3(c) of the Patents Act excludes the “discovery” of naturally occurring living things or non-living substances from patentable subject matter. This means inventions such as isolated DNA or protein molecules are non-patentable subject matter. On the other hand, recombinant DNA constructs, modified DNA, and modified protein molecules developed in the laboratory and involving substantial human intervention qualify as patentable subject matter as these cannot be considered as discovery.

Furthermore, Section 3(j) of the Patents Act excludes “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” from patentable subject matter. The Indian position on plants or animals and on conventional methods of production and propagation of plants and animals is that they do not fall under patentable subject matter.

PATENTABILITY

The Indian Patents Act does not describe, in an inclusive manner, what is patentable; rather, omissions of subject matter from the non-patentable sections clarify what subject matter can be patented. As indicated in the above section, the process of creating biochemical, biotechnological, and microbiological processes is patentable. Therefore, patents are available for “processes or methods of production of tangible and non-living substances” like enzymes, hormones, and vaccines. Furthermore, processes using bioconversion, microorganisms, biologically active substances, biotechnology, microbiology, and/or chemical substances produced by using genetically engineered organisms are patentable. Moreover, the Patents Act explicitly excludes microorganisms from the invention exemption, making them patentable. The mere discovery of organisms, however, is not patentable. Finally, although the Act does not allow patents for a method of horticulture, as noted above, the Act does explicitly specify that any method relating to the treatment of plants is patentable. Therefore, the Act allows an invention to be patented that is merely a method of making plants free of disease.  Also, a process for improving the plant’s value or increasing the value of the plant’s products is patentable. Upon being issued a product patent, the patentee has the exclusive right to prevent third parties, who do not have the patentee’s consent, from “making, using, offering for sale, selling, or importing” the product in India. If the patent is for a process, however, the patentee has an additional right to prevent third parties, who do not have the patentee’s consent, from using the process. The exclusive right to prevent third parties from using, selling, importing, or offering for sale a product that was directly obtained by the patented process in India is still applicable.

A process patent is not allowed for methods and processes of horticulture and agriculture, including food. Also, cells, cell lines, and cell organelles cannot be patented.

An isolated sequence inserted into a vector and then placed into a host cell to express desired characteristic/trait would be a patentable gene. These recombinant genes are considered “chemical compositions” and thus are considered “incremental innovations.

India has not fully complied with Article 27(1) of TRIPS, which requires protection of all inventions of both products and processes, except plants and animals. India has only fully provided patent protection for processes or methods for chemical processes, excluding the resulting product from patentability. Furthermore, processes intended for or capable of use as food, medicine, or drug are patentable, but the product itself is unpatentable.

The gray area lies in the interpretation and implication of what is covered under “any part of a plant” – is it limited to organs such as leaves, roots, stems, and flowers, or can this term “any part thereof” extend to plant cells as well? The Indian Patent Office’s position at present does not allow claims directed to eukaryotic cells that include plant cells and animal cells as these are objected to under Section 3(j) of the Patents Act. The Indian Patent Office considers cell as a part of a plant even though it uses transgenic technology to produce transformed, recombinant plant cells. In contrast, all microbial cells (prokaryotic) are patentable under Section 3(j) of the Patents Act, as long as these do not fall under discovery and meet the criteria of novelty and inventive step. While many patent applications for method of transforming plants have been allowed by the Indian Patent Office.

Few examples of Patents: IN2013CH05384A, IN2009CH00476A, IN2012DE01103A, IN2013DE00539A.

PROTECTION OF PLANT VARIETIES AND FARMERS RIGHTS ACT, 2001

The Protection of Plant Varieties and Farmers’ Rights Act (PPV&FR Act), 2001, is a sui generis legislation formulated by India to fulfil its obligation under TRIPS for providing effective intellectual property right protection for plant varieties. This Act defines variety to include its propagating material (i.e., seed) and this includes transgenic varieties. Hence, the exclusions under Patents Act are covered under PPVFR Act. Further, the Act also provides for ‘researcher’s rights’ which allow a breeder to license their variety to a local source as an initial source to create new varieties without any authorization. The researcher company has rights only on the transgenic seed. Once the transgenic seed is sold to the local companies as an initial source for producing further hybrid varieties, the company does not patent rights on the subsequent varieties. Under the PPVFR Act, such companies have rights of benefit sharing. The company is allowed to have a share in the benefit accruing to the breeder from such varieties.

However, one is to note here that the PPV&FR Act awards protection to the commercial growers/breeders/seed companies for specific varieties in terms of Distinctness, Uniformity and Stability (DUS) testing to distinguish and identify a new, extant, essentially derived variety and farmer’s variety. Moreover, Section 2(za) of the PPV&FR Act defines a “variety” as “a plant grouping except microorganism within a single botanical taxon of the lowest known rank, which can be:

  1. defined by the expression of the characteristics resulting from a given genotype of that plant grouping;
  2. distinguished from any other plant grouping by expression of at least one of the said characteristics; and
  3. considered as a unit with regard to its suitability for being propagated, which remains unchanged after such propagation, and includes propagating material of such variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety.”

“Section 2(j) of the PPV&FR Act defines “Extant Variety” as “a variety available in India which is— (i) notified under section 5 of the Seeds Act, 1966 (54 of 1966); or (ii) farmers’ variety; or (iii) a variety about which there is common knowledge; or (iv) any other variety which is in public domain.” Section 2(i) of the PPV&FR Act states that an “Essentially Derived Variety” in respect of a variety (the initial variety) “shall be said to be essentially derived from such initial variety when it— (i) is predominantly derived from such initial variety, or from a variety that itself is predominantly derived from such initial variety, while retaining the expression of the essential characteristics that results from the genotype or combination of genotype of such initial variety; (ii) is clearly distinguishable from such initial variety; and (iii) conforms (except for the differences which result from the act of derivation) to such initial variety in the expression of the essential characteristics that result from the genotype or combination of genotype of such initial variety.”

Section 2(l) of the PPV&FR Act defines a “Farmers’ Variety” as “a variety which— (i) has been traditionally cultivated and evolved by the farmers in their fields; or (ii) is a wild relative or land race of a variety about which the farmers possess the common knowledge.”

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Considering the aforesaid, a gene can never be equated to be a variety, wherein a trait is determined by the expression of one or more genes. Thus, a gene made of nucleic acids is a chemical compound within a plant which may confer a specific trait or characteristic to a plant but cannot be considered a variety under PPV&FR Act. Moreover, when a gene or DNA molecule is inserted into a plant species through the transformation method, such method cannot get protection under PPV&FR Act. Such methods can only be protected under the patent regime, since there is no provision of protecting a method of transforming a plant or regeneration of plant using tissue culture methods under PPV&FR Act. It is further important to note that a trait for resistance to biotic and abiotic stress may be a distinct characteristic under the PPV&FR Act regime. However, the protection under this regime is for all the characteristics of a plant variety and not for a specific distinct trait which differentiates this variety from other closely related varieties. Therefore, genes, proteins, promoters, enhancers, and traits in plants cannot get specific protection under PPV&FR Act and need to be protected under the patent regime. Thus, a recombinant DNA construct, which is neither a plant or part thereof, nor a variety, can be protected under the patent regime and not under the PPV&FR Act regime.

IMPORTANT JUDGEMENTS

1. The Indian Patent Office found Section 3(j) of the Patents Act to be applicable in case of transgenic plants in the case of Monsanto Technology LLC. v. Controller General of Patents. In this case, the Controller of Patents refused Monsanto’s patent application claiming an invention titled “A method for producing a transgenic plant with increased heat tolerance” as non-patentable subject matter falling under the scope of Section 3(j) of the Patents Act, among others. Monsanto challenged the Controller’s order before the Intellectual Property Appellate Board (IPAB). The IPAB accepted Monsanto’s argument that since the production of the transgenic variety being claimed involved substantial human intervention, it could not be considered as an “essentially biological process” and, thus, was not hit by Section 3(j) of the Patents Act. The IPAB held as follows:

“…The plant is modified by the introduction of known recombinant DNA into its genome, thereby causing the said predisposition. The specification also teaches how the known regeneration and screening technique can be used to screen the transformed plant with heat, salt or drought tolerance. The appellant has given up all claims relating to recombinant DNA, plant cell, progeny, plant, crop plant, propagule, seed etc. [claims 1–15] and also claims 17 [transgenic plant,19 [Isolated protein] and 20 [a field crop].

 Let us see amended Claim 1 [claim16 amended]. It relates to a method that requires several steps that together provide claimed solution. The method here is best considered as a series of individual steps. It is a method that includes an act of human intervention on a plant cell and producing in that plant cell some change. Therefore, the respondent erred in finding this method as essentially biological process and excluded under section 3(j). We set aside his findings to that extent.”

Following the above interpretation of the IPAB, there have been many decisions by the Indian Patent Office, wherein the objection under Section 3(j) of the Patents Act has been set aside on account of the inventions having a substantial human intervention and tissue culture steps such that they no longer constituted essentially biological processes for the production or propagation of plants and animals, thereby allowing the patent grant. This has been especially true and applicable to method of transformation in plants involving recombinant DNA constructs. While the IPAB ultimately rejected Monsanto’s application on grounds of lack of inventive step and non-patentability under Section 3(d), it set aside the Controller’s order on the issue of non-patentability under Section 3(j) of the Patents Act.

2. In a differing interpretation of Section 3(j) of the Patents Act, the Division Bench of the Delhi High Court in the case of Nuziveedu v. Monsanto vide judgment dated April 11, 2018 invalidated Monsanto’s patent no. 214436, holding that the subject matter of the patent was non-patentable under Section 3(j) of the Patents Act. First, the judgment does not address the question of whether DNA should be considered as a part of a plant or not and is further unclear with regard to the interpretation and applicability of Section 3(j) of the Patents Act. This is especially relevant to an otherwise patentable subject matter concerning isolated, modified genes, i.e., modified DNA molecules, to create DNA constructs for transformation of plants. Claims 25–27 of the Monsanto’s impugned patent no. 214436 pertains to a DNA construct where the gene of interest encodes for Bacillus thuringiensis (Bt.) toxin. Claim 25 of the said patent is reproduced below:

“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 8-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.”

Such a DNA construct comprising a promoter sequence, transit peptide, and a gene of interest expressing the Cry2Ab protein is a synthetic molecule called as recombinant DNA construct and considered a patentable product under the Patents Act in India. Such a DNA construct was never a part of a plant and further did not occur in nature. Therefore, the product claims for the recombinant DNA construct cannot be considered a plant or part thereof and thus should be excluded from falling under the purview of Section 3(j) of the Patents Act. This is the view taken by the Indian research institutes and the scientists’ community. The question to be asked is can and should DNA, proteins, RNA, cDNA, etc., which are chemical molecules, and although may be present in the plant cells, fall under the scope of the term “any part thereof” or the expression “parts of a plant”? Recombinant DNA constructs cannot fall under Section 3(j) of the Patents Act, even if these constructs’ function, or express genes in plant species. Since, recombinant DNA technology used in the construction and synthesis of such recombinant DNA constructs has been singularly practiced in the laboratories requiring human intervention and manipulation, these cannot fall under Section 3(j) of the Patents Act. It is to be emphasized that “plant” under the meaning of Section 3(j) of the Patents Act is a “living organism,” while “DNA” or a gene or a DNA construct are inanimate molecules, not a living entity, which merely code for production of a protein in a living organism. Hence, it is erroneous to focus on the “application” or “use” of such an inanimate product, when used in a plant to conclude it as a part of a plant. Thus, to consider an artificial DNA construct as a part of a plant is scientifically incorrect. In fact, Section 3(j) of the Patents Act nowhere mentions “use” of a product as a basis for non-patentability of inventions; it only covers product (plant or parts thereof) or process (essentially biological process). DNA constructs inserted into a plant using recombinant DNA technology cannot be interpreted as falling under the definition of plants or parts thereof.

3. However, in contrast to the aforementioned IPAB order for the process of generating transgenic plants by transformation, in Nuziveedu v. Monsanto, the Delhi High Court inferred that claims 1–24 of the patent no. 214436 that are directed to a method of transformation of plants fall under Section 3(j) of the Patents Act. Claim 1 of the said patent is reproduced below:

 “A method for producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence comprising a plant functional promoter sequence 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 said plastid transit peptide functions to localize said δ-endotoxin protein to a subcellular organelle or compartment.”

 Transformation is the method by which a recombinant DNA construct is inserted into a plant system, which has been equated to a microbiological process and, thus, is patentable. Transformation creates hundreds or thousands of possibilities, i.e., gene insertion can take place at any location in the plant genome, and there can be multiple insertions as well. Thousands of plants having the DNA construct at various locations in the plant genome can be produced by transformation methods. The recombinant DNA constructs, such as the construct of claims 25–27 of the patent no. 214436, has a gene of interest encoding for Cry2Ab protein. Similarly, any gene of interest can be introduced into a plant species. Importantly, the gene of interest expressed by such a recombinant DNA construct (as claimed in patent no. 214436) is a protein of bacterial origin, which cannot be considered as a part of a plant. This process is carried out in a laboratory under strictly controlled tissue culture conditions and thus, under no stretch of imagination, can be said to be either a “conventional method of breeding” or an “essentially biological process” for the production of plants. In fact, it is to be considered as a microbiological process, where the transformation occurs, which is an insertion of a recombinant, synthetic DNA construct into a plant species mediated by Agrobacterium tumefaciens, microprojectile bombardment, etc., and cannot be equated to an essentially biological process. The Delhi High Court has overlooked the claims directed to the process of transformation of plants (using the recombinant DNA construct) to express the Bt toxin and rather focused on post-invention, conventional breeding methods for introgression of desired traits into plants and not on the claimed transformation method, which does not involve any conventional method of breeding. Transformation can neither be considered a conventional breeding method nor an “essentially biological process” for the production of plants as it is carried out in the laboratory, involving tissue culture techniques in the laboratory which are results of human ingenuity, and, therefore, cannot fall under Section 3(j) of the Patents Act. It must be understood that transformation is in no way even similar, to any conventional means of breeding such as hybridization or introgression. While transformation is not considered as an “essentially biological process” (since it is performed using DNA constructs in the laboratory), hybridization/introgression, on the other hand, falls under essentially biological process involving crossing, backcrossing, selfing, etc. of plant varieties to transfer the genes or genetic material conferring the traits from one plant to another; and these are carried out in the fields or greenhouses and constitute conventional methods of breeding.

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4. The European Enlarged Board of Appeals, in its decision of Plant Bioscience Limited v. Syngenta Participations AG Groupe Limagrain Holding while expanding the definition of an “essentially biological process,” has held that:

“A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.

Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.

If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC. 4. In the context of examining whether such a process is excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.”

Since, transformation has introduced a recombinant DNA construct conferring a trait in the genome of the plant species; and this introduction of the trait is not the result of the mixing of the genes of the plants, but rather a process carried out in the laboratory under strict supervision and with ample human interference; it is not an “essentially biological process” for production of plants and thus ought not to fall under the ambit of Section 3(j) of the Patents Act. The confusion arises due to the use of the terms, transformation and hybridization, but it is pertinent to distinguish them and to emphasize that the initial transformation process forms part of the patentable subject matter in India, which cannot be equated to an “essentially biological process” for the production of plants.

5. In the case of Plant Genetic Systems v Greenpeace, the European Enlarged Board of Appeals has held that insertion of the relevant DNA sequence into the genome of a plant could not occur without human intervention, and consequently, this step is an important technical step which has a decisive impact on the desired final result. Such a process is not “essentially biological” by any definition and thus not excluded from patentability. Moreover, the first plant directly obtained by such a transformation process is to be considered as a product of a microbiological process. In contrast, the subsequent generations obtained using the first transformed plants by conventional breeding them to other plants to obtain subsequent transgenic plants would constitute an essentially biological process.

Claims 25–27 of the patent no. 214436 pertains to a recombinant synthetic DNA construct where the gene of interest encodes a bacterial protein, Bt toxin, while claims 1–24 pertain to a transformation method for insertion of the recombinant DNA construct into the plant species. Clearly, the said patent is directed at a method of transformation. Therefore, neither the product claimed in claims 25–27 can be considered as a plant or part thereof, nor can the transformation method of claims 1–24 be considered an “essentially biological process” under Section 3(j) of the Patents Act. Therefore, in our view, neither the product, nor the process claimed in the patent no. 214436 falls under the scope of Section 3(j) of the Patents Act.

CONCLUSION

In case of transgenic plants developed using recombinant DNA technology, such as those having a trait for insect resistance, the flow of innovation, inter alia, requires the synthesis of a recombinant DNA construct, followed by the transformation of a plant cell by insertion of the recombinant DNA construct. Due to fundamental differences in biology, if the gene is obtained from a completely unrelated species (e.g., a bacterium), it cannot be successfully inserted into a plant with any success. Significant human intervention in the form modifying the gene for it to be suitable for a plant genome and adding several other components is required. Further, the insertion of the DNA constructs into the plant can occur at different locations in the plant genome, but not all of them will result in a desired trait. Only through significant human intervention can one select one of these “events” that will result in the transgenic plant expressing the desired trait at the optimal level. The recombinant DNA constructs developed in vitro, the method for developing the genetically modified plants using that gene, and the integration of the DNA construct into the plant genome at a specific location in the plant genome cannot be termed as “essentially biological processes” and should be considered as patentable subject matter. Such recombinant DNA constructs, recombinant DNA sequences, and methods of developing a transgenic plant are per se not a subject matter of protection under the PPV&FR Act because none of them can be considered as a “variety.” A variety as defined under the PPV&FR Act only refers to a plant grouping within a given species of plants and does not cover such recombinant DNA constructs. A plant variety being registered under the PPV&FR Act could also be a variety which was developed by backcrossing/breeding/hybridization of the transgenic plant – the “event.” The PPV&FR Act also does not deal with granting any form of intellectual property rights to plant breeding methods. Effectively then, rights under the PPV&FR Act and the rights granted under the Patents Act operate in completely different spheres. What is protected under the Patents Act cannot be protected under the PPV&FR Act, and the vice versa holds true as well.

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