WHAT DOES A PATENT OVER A GENE MEAN?
A patent for a gene or gene patent means ownership and exclusive rights for 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. This means ownership of the specific nucleotide composition of the gene, its nucleotide sequence, the process for obtaining or using, or a combination of such claims.
It means exclusive rights of the owner of the patent to dictate terms for use or commercial exploitation of the gene for 20 years. This also implies that patent owner (founder individual or institutes or companies) has sole ownership of genetic testing for patented genes.
ARE NATURALLY OCCURING GENES PATENTABLE?
Until recently, in Untied States of America, a naturally occurring biological substance was patentable (falling under the category of utility patents) if they were sufficiently “isolated” from their naturally occurring states. The first human product to be patented was purified form of adrenaline in 1906. Then started the Cohen-Boyer patenting and licensing era in 1970s where patents for recombinant DNA and method for producing the same were given. These patents covered inventions for splicing genes to make recombinant proteins that are foundational to the biotechnology industry.
A landmark case in the field of biotechnology pertaining to organisms as a whole was made with the Diamond v. Chakrabarty case in 1980, wherein, it was upheld that a newly created living organism, a bacterium for digesting crude oil in oil spills, was patentable and the first patent for an organism as a whole was provided because the DNA of Chakrabarty’s organism was modified, and truly man-made. This started the era of patenting of genetically modified genes and organisms.
This was followed by several other patents in the field of monoclonal antibodies, transgenic mice, isolation of cancer-related genes and their usage and many more.
However, the 2013 case of Association for Molecular Pathology v. Myriad Genetics challenged the validity of gene patents in United States of America. Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. It was on 13th June, 2013 that the Supreme Court of the United States ruled that human genes cannot be patented in the U.S. because DNA is a “product of nature.” Prior to this ruling, more than 4,300 human genes were patented. The Supreme Court’s decision invalidated those gene patents, making the genes accessible for research and for commercial genetic testing.
WHAT IS PATENTABLE? 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
- 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.
Gene patents cover three distinct types of invention:
- diagnostics;
- composition of matter; and
- functional use.
Diagnostics: When an invention involves recognition of alteration in genetic makeup in disease associated locus for diagnosis and prognosis which generates statistical observation of genetic and phenotypic difference, then such a genetic makeup can be patented, e.g. breast and ovarian cancers (BRCA1 and BRCA2), colon cancers (HNPCC, FAP), cystic fibrosis (CFTR), hemochromatosis (HFE), spinocerebellar ataxia (SCA1–12) etc. This kind of recognition involves a detailed research over several years.
Composition of matter:This relates to chemicals and materials, including the isolated and purified gene (cDNA) and all derivative products (e.g., recombinant proteins or drugs, viral vectors and gene transfer ‘therapies’, transfected cells, cell lines and higher order animal models in which the patented gene has been inserted or knocked out).
Functional use:This relates to patenting a role that a gene(s) plays in disease or other bodily and cellular functions or pathways, and claim methods and compositions of matter (typically called ‘small molecule’ drugs) used to up- or down regulate the gene. For e.g. in the Viagra patent case, the patent claims any selective PDE5 inhibitor used to treat impotence.
PATENTABILITY OF GENES: INDIAN SCENARIO
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.
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. For example, a 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.