INTRODUCTION:
The discovery of RNA-mediated adaptive defense systems in bacteria and archaea, such as Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) and related Cas proteins, has had a profound impact on genome editing. With the exceptional accessibility and cost of this ground-breaking technique, genetic research and applications can now be revolutionized by precisely and effectively altering nearly any gene.
MECHANISM OF CRISPR-CAS SYSTEM:
Clustered regularly interspaced short palindromic repeat (CRISPR) and their related protein (Cas-9) is the most successful, productive, and precise strategy of genome-altering apparatus in all living cells and utilized in numerous connected disciplines. Direct RNA (gRNA) and CRISPR-associated (Cas-9) proteins are the two basic components in the CRISPR/Cas-9 framework. The instrument of CRISPR/Cas-9 genome altering contains three steps, acknowledgment, cleavage, and repair. The Cas protein, which includes Cas9 and its derivatives Cas12 and Cas13 plays an important role in this technology. These proteins can be modified to perform a variety of tasks, such as nickase activity or the introduction of certain mutations. Additionally, the binding and function of Cas proteins depend on the presence of a protospacer adjacent motif or PAM. Due to the intricate interactions between these elements, CRISPR-Cas has become a potent instrument for the advancement of both science and medicine, opening up new avenues for genetic research and the development of new treatments.
IMPLICATIONS OF GENOME EDITING AND PATENT LAW IN INDIA:
In India, the regulation of genome editing, including the patenting of related technologies, is governed by several laws and guidelines. The primary legal frameworks and institutions involved are:
- INDIAN PATENT ACT, 1970:
Patentability Criteria: A genome editing invention must satisfy three requirements to be eligible for patent protection in India: novelty, inventive step, and industrial applicability. Furthermore, it should not be included in the lists of innovations that are not patentable under Section 3 of the Indian Patent Act. This technology may be examined on keeping basis of :
- Section 3(b),
- Section 3(d),
- Section 3(i), and
- Section 3(j).
2. BIOSAFETY GUIDELINES:
- Recombinant DNA Safety Guidelines, 1990: These recommendations, issued by the Department of Biotechnology (DBT), address genetically modified organisms (GMOs) and recombinant DNA technology research and applications.
- Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms, Genetically Engineered Organisms, or Cells, 1989: These regulations were enacted under the 1986 Environment (Protection) Act. They control how GMOs and their byproducts are handled, stored, and transported.
3. INSTITUTIONAL BIOSAFETY COMMITTEES (IBSCS):
- Institutions working with recombinant DNA or GMOs are required to set up IBSCs. The biosafety regulations are monitored and complied with by these bodies.
4. GENETIC ENGINEERING APPRAISAL COMMITTEE (GEAC):
- The Ministry of Environment, Forests, and Climate Change’s GEAC is the highest authority evaluating and approving projects involving the widespread use of dangerous microbes and recombinants in the research and manufacturing industry. In addition, it manages the introduction of genetically modified organisms (GMOs) into the surroundings.
5. ETHICAL GUIDELINES:
- Ethical guidelines for biomedical research involving human participants are provided by the ICMR. These recommendations are crucial for genome editing studies involving human subjects.
INDIAN PATENT SCENARIO FOR CRISPR:
Before discussing the patterns in Indian patent filings pertaining to CRISPR technology, it is crucial to acknowledge the two groups that were instrumental in its development. The first CRISPR patent was submitted at the USPTO in May 2012 by Emmanuelle Charpentier and Jennifer Doudna of UC Berkeley. The patent claimed the function and amino acid sequence of the CRISPR/Cas9 combination. Subsequently, in December 2012, Feng Zhang of the Broad Institute of MIT and Harvard filed a follow-up application in the US, detailing the use of CRISPR/Cas9 for altering gene expression in human cells.
At present, Doudna and Zhang are involved in continuing interference proceedings at the USPTO due to Zhang’s patent being awarded first, despite being filed later, due to expedited inspection. Following these initial filings, numerous CRISPR-related patent applications have been filed globally, including in India. Doudna’s application (9897/DELNP/2012) was the first CRISPR patent filed in India, followed by applications from other entities like Fred Hutchinson Cancer Research Center, Vilnius University, Bayer CropScience, and Sigma-Aldrich, each seeking to secure patent rights for various uses and modifications of CRISPR/Cas9 technology.
Here is a list of granted/published Indian patent applications:
1. Applicant: Bayer CropScience
Indian patent number: 366582
An approach to altering a plant cell’s nuclear genome at a chosen location is described in the description. Via Agrobacterium-mediated transformation, the patent application makes use of this technology to specifically alter, replace, or omit a nucleotide sequence at a particular location in the genome of a plant cell or plant. To be more precise, it describes how genes for resistance to herbicides, insects, and abiotic stresses are inserted into plant varieties to produce plants with these genetic characteristics.
2. Applicant: Fred Hutchinson Cancer Research Center
Indian patent number: 324808
A technique using one or more endonucleases or endonuclease fusion proteins is described. Homing endonucleases and/or their fusion proteins and/or CRISPR endonucleases and/or their fusion proteins are examples of this. These can be used to: (a) break a Bell la coding region; (b) break a Bell la gene regulatory region; (c) alter an adult human β-globin locus; (d) break a HbF silencing DNA regulatory element or pathway, such as a Bell la-regulated HbF silencing region; (e) mutate one or more γ-globin gene promoters to increase γ-globin gene expression; (f) mutate one or more δ-globin gene promoters to increase δ-globin gene expression; and/or (g) correct one or more β-globin gene mutations.
3. Applicant: BASF SE
Indian patent number: IN201827035644
The description outlines a method that involves selecting a cereal plant with functional restorer gene alleles for wheat G-type cytoplasmic male sterility on chromosomes 1A and 1B. It includes identifying a plant that carries specific marker alleles linked to these functional restorer genes: one on chromosome 1A within a defined interval flanked, and one on chromosome 1B within an interval flanked. The selection process utilizes molecular marker assays to ensure the presence of the appropriate restorer gene alleles.
CONCLUSION:
Many legal frameworks govern genome editing and related patents in India, with specific exclusions outlined in Sections 3(b), 3(d), 3(i), and 3(j) of the Indian Patent Act, 1970, focusing on public order, morality, and certain types of innovation. To address the aforementioned Sections effectively in the context of genome editing patents, ensure that your invention aligns with public order and morality by demonstrating responsible use and addressing ethical concerns proactively. Avoid claims that merely highlight new properties or uses of existing substances; instead, focus on significant advancements or improvements in genome editing technology. Draft claims to emphasize the technological and methodological aspects of your invention rather than specific medical applications, as methods of treatment or diagnosis are excluded. Additionally, ensure your claims do not encompass genetically modified plants or animals but instead concentrate on the underlying technology or methods of genome editing. Collaborating with an experienced patent attorney in biotechnology, providing detailed descriptions, and highlighting technological advances will help navigate these exclusions and maximize patent protection for your innovations.
