Gene
A gene is the basic physical and functional unit of heredity and are made up of DNA that encode proteins
Gene Patents
A gene patent is the exclusive rights and ownership to a specific DNA/RNA sequence by an individual, organization, or corporation, who claims to have originally isolated a natural gene sequence and altered through gene engineering technologies to obtain a known function.
Well-known examples of gene patents include those covering genes implicated in treating cancers such as breast cancer (BRCA1 and BRCA2), hemochromatosis (HFE), etc.
Which Genes are Patentable?
The 2013 Association for Molecular Pathology v. Myriad Genetics case clearly stated that human genes cannot be patented in the U.S. because DNA is a “product of nature”i.e. any naturally occurring gene is not patentable.
However, any gene/nucleotide sequence which has been manipulated in the lab can be still patented, because this brings the sufficient human intervention factor into the gene/nucleotide sequence. Hence, synthetically mutated or genetically modified genes which do not occur naturally in nature and their products are patentable, example:
- Gene sequence / Amino Acid sequence (Polynucleotides) (product);
- A method of expressing Gene sequence / Amino Acid sequence (Polynucleotides) (process);
- Vectors (e.g., plasmids) (product and/or process);
- Gene constructs or cassettes and gene libraries;
- An antibody against that protein / sequence, and
- A kit made from the antibody / sequence.
When a genetically modified Gene sequence/ Amino Acid sequence are novel, involve an inventive step and have industrial application, the following can be claimed.
Genes Patenting in India
Indian Patent Act 1970 specifies the following sections for Patentability of Genes:
- Section 2 (1) (j): Novelty, inventive step & industrial applicability of products or processes,
- Section 3 (b): Inventions contrary to morality or which cause serious prejudice to human, animal or plant life or health or environment,
- Section 3(c): The mere discovery of scientific principle or the formulation of an abstract theory, discovery of any living thing or non-living substance occurring in nature would not patentable,
- Section 3(j): Plants or animals in whole or any part thereof, other than microorganisms but including seeds varieties and species and essentially biological processes for production and propagation of plants and animals cannot be patented.
- Section 10 (4): Sufficiency of disclosure and the best method of performing the invention, and
- Section 10 (5): Unity of invention and clarity, succinctness and support of the claims.
A gene is product which naturally occurs and hence under Section 3(c) of Indian Patent Act, a gene is not patentable. Thus, merely isolated naturally occurring genes are considered a discovery and not an invention and are therefore deemed to be not patentable as per sub-Section 3(c).
The Indian Patent practice shows an approach which is broad and assimilating in nature. Moreover, the draft manual 2005 and “Guidelines for Examination of Biotechnology Applications for Patent” had an annexure specifically dedicated to invention related to biotechnology and pharmaceutics.
This gave a clearer picture of kind of gene related inventions which are and are not patentable. It clarified that though natural origin plants, animals, their varieties and species are not patentable but recombinant DNA and plasmids are patentable if there is substantial human intervention.
CONCLUSION
Therefore to sum up the findings a gene is patentable in India only when it is recombinant with sufficient human intervention and has an industrial application.
A Gene patent can be granted for the isolated DNA sequence corresponding to the coding region of a gene only if the sequence is new and was isolated by a method that would be considered non-obvious by a skilled person, and if it presents unexpected, surprising properties.
Hence, the sequence function must be disclosed in the patent application and should meet the industrial applicability requirements.
How Videaim IP can help you regarding your Gene invention?
We at VideaimIP, have a team of professionals lead by Dr. MADHAVI MUPPIRALA, a patent agent and Ph.D holder from CSIR-CCMB, Hyderabad. She has helped multiple companies in understanding their IP potential followed by IP generation and protection.
Do you want to discuss more about Gene Patent and want to know the opportunity of intellectual property (IP) you can acquire, Please feel free to contact us or Email your queries at info@videaimip.com and videaimip@gmail.com
INTERESTING CASE LAW ON GENE PATENT IN INDIA
One such gene patent giving a functional use of the gene in the engineered plant is the “BT_COTTON patent” – IN/PCT/2001/603/CHE (Patent No. 214436) entitled “METHODS FOR TRANSFORMING PLANTS TO EXPRESS BACILLUS THURINGIENSIS DELTA-ENDOTOXINS” filed by Monsanto Technology LLC.
INDEPENDENT CLAIMS
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 5-endotoxin protein, wherein said plastid transit peptide functions to localize said 5-endotoxin protein to a subcellular organelle or compartment.
The method of claim 1, wherein said second polynucleotide is operably linked to a plant functional 3′ end transcription termination and polyadenylation sequence, wherein expression of said nucleic acid sequence in said plant yields a fusion protein comprised of an amino-terminal plastid transit peptide covalently linked to said 5-endotoxin protein, and wherein said plastid transit peptide functions to localize said 5-endotoxin protein to a subcellular organelle or compartment.
DEPENDENT CLAIMS
Some of the dependent claims which protect the gene sequences encoding Cry2Ab Bacillus thuringiensis 5-endotoxin protein are as follows:
The method of claim 1 or 2, wherein said polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 5-endotoxin protein is selected from the group consisting of SEQ ID NO: l and SEQ ID NO: 17.
The method of claim 1 or 2, wherein said Cry2Ab Bacillus thuringiensis 5-endotoxin protein is selected from the group consisting of SEQ ID NO:2 and SEQ ID NO: 18.
This patent protected a novel method to control plant pests using Cry2Ab Bacillus thuringiensis 5-endotoxins. Nucleic acids encoding Cry2Ab Bacillus thuringiensis 5-endotoxins were used to make transgenic plants. Said nucleic acids, the vectors to transform plant cells comprising said nucleic acids, and method to transform plants using said vectors were claimed in the patent. Such transgenic plants produced the insecticidal endotoxins resulting in effective control of susceptible target pests.
VERDICT
Monsanto Technology LLC v. Nuziveedu Seeds Ltd is one of the landmark cases in India which decides the fate of patents claiming recombinant genes. Monsanto had come into an agreement with Nuziveedu where the license to use the brand names “BOLGARD” and “BOLGARD II” brand cotton technology, and the seeds of the BT-cotton under the above patented claims were provided to Nuziveedu Seeds Ltd. with a certain royalty payment.
The agreement entitled the defendants to develop “Genetically Modified Hybrid Cotton Planting Seeds” with help of the plaintiffs’ technology and to commercially exploit the same subject to the limitations prescribed in the agreement.
However, the State Govt. fixed the MSP and introduced a trait value that was significantly lower than that agreed by contract between Monsanto and its subsidiaries. Seeking this argument Nuziveedu refused to pay the extra amount to Monsanto., following which the plaintiff filed a suit for an ad interim injunction to restrain Nuziveedu and its subsidiaries from using its trademarks “BOLGARD” and “BOLGARD II”, and from marketing and selling the GM hybrid cotton seed patented by the Plaintiff.
The defendant contended that their rights were protected under the Protection of Plant Varieties and Farmers’ Rights Act, 2001, and the defendant also field for revocation of the patent under Section 64 of the Act, as being in violation of Section 3(j) of the Patents Act. Delhi High Court instructed the plaintiff to supply the GM hybrid cotton seeds according to the initial sub-license agreement in 2004, however the license fee payable by the Respondents would be governed by the laws in force.
The counter claim of the Respondents was not considered. This was a clear violation of the agreement. Appellants and the Respondents appealed before a Division Bench against the said order. The Division Bench dismissed the Appellant’s appeal by upholding the Respondents’ contention with respect to patent exclusion under Section 3(j) of the Patents Act. Consequently, the Respondents’ counter claim was allowed by the Division Bench.
The Bench, however, directed that the suit continue in respect of the claim for damages and other reliefs. The Appellants approached the Supreme Court of India against the decision made the Division Bench. The Supreme Court, inter alia, found / held that the nature of the injunctive reliefs granted by the Single Judge was in order and merits no interference during the pendency of the suit. The Supreme Court set aside the order of the Division Bench.