In Synthetic biology researchers actively design biological components to create new configurations that may include generating biofuels, production of medical biomolecules, synthetic gene networks for sensing or diagnostics, and more .
For instance - CRISPR allow scientists to make precise alterations to an organism's DNA, which can lead to improvements such as disease resistance in crops or the production of therapeutic proteins in microorganisms; creation of bio factories that include engineered microorganisms that can produce valuable chemicals, such as pharmaceuticals and biofuels. Thebaine, Codeine, Taxadiene, Dencichine, engineered probiotic L. gasseri ATCC 33323, probiotic L. paracasei ATCC 27092, engineered E. coli Nissle 1917 (EcN) and Genetically encoded click chemistry (or Spy chemistry) are some of the examples of the same.
EXAMPLES RELATED TO PATENT/PATENT APPLICATIONS FOR SYNTHETIC BIOLOGY IN US, EP, IN -
- Biological tools and methods- Claims can be covered with aspects of tools and methods used in synthetic biology for examples- Crispr-CAS, method of synthesizing DNA or techniques for assembling synthetic genomes.
- Genetically Modified Organisms: Claims can be made for genetically engineered microorganisms, such as bacteria or yeast, that have been modified to produce specific compounds or perform certain functions. For example, a patent might cover a genetically modified bacterium designed to produce biofuels or pharmaceuticals.
- Synthetic Genes and Pathways: Patent applications may be written and grants can be obtained for synthetic genes or metabolic pathways that have been engineered to enhance or introduce new functions in an organism.
- Bioprocesses: Patent applications may be written and grants can be obtained for processes that use synthetic biology to produce chemicals, pharmaceuticals, or other value-added processes.
FEW LANDMARK CASES -
- Dimminaco A.G. v. Controller of Patents and Designs (2002): This landmark case involved the patentability of a live vaccine for poultry.
- Monsanto Technology LLC v. Nuziveedu Seeds Ltd. (2019): This case revolved around the patentability of genetically modified (GM) cotton seeds.
- Kibow Biotech Inc. v. The Controller General of Patents (2019): This case involved a dietary supplement aimed at aiding kidney function.
JURISDICTION WISE SPECIFICITIES -
India: Assessing the patentability of synthetic biology innovations in India is complex. The patenting of naturally occurring genes, including those in the human genome, is a highly contentious issue.
FEW PATENTS/PATENT APPLICATIONS INVOLVED-
- Recently patent IN501662B granted on January 22, 2024 in IPO, discloses a method for producing specially modified immune cells through advanced genetic engineering. The process utilizes a gene-editing tool derived from Streptococcus pyogenes, known as the Cas9 protein, along with guide RNA that directs the editing to precise sequences within two key genes: Dgkα and Dgkζ. The targeted sequences are identified using unique identifiers, allowing for precise modifications that can lead to more effective immune responses.
- ERS Genomics Limited ('ERS') got grant for Indian Patent No. 397884 on May 27, 2022. This patent. This patent covers methods and compositions for use of CRISPR/Cas9 and chimeric Cas9 in all cell types including eukaryotic cells.
- IN289454B – titled- METHODS FOR IN VITRO JOINING AND COMBINATORIAL ASSEMBLY OF NUCLEIC ACID MOLECULES claims
An in vitro method of joining a set of two or more double-stranded (ds) or single stranded (ss) DNA molecules.................to form a first assembled dsDNA molecule in a one-step reaction.
- IN235338B - A method for making a recombinant DNA claims
- A double-stranded DNA vector useful for directed cloning or subcloning of a target DNA molecule of interest.............................the first target DNA strand.
- A kit useful for directed cloning or subcloning of a target
DNA molecule .......:
...................... on the first target DNA strand; and
B) a cell containing a bacterial recombinase.
USA: During the 1970s and 1980s, the U.S. Supreme Court along with the European Patent Office's Board of Appeal tackled the contentious topic of patenting genetic materials, which stirred significant political debate among citizen groups.
FEW PATENTS/PATENT APPLICATIONS INVOLVED-
- US11352619B2 - Method for synthesis of polynucleotides using a diverse library of oligonucleotides claims-
- A method for synthesizing a target double stranded (ds) polynucleotide having a predefined sequence, ........................
- An oligonucleotide library provided within an array device comprising a diversity of library members, wherein the library members are single stranded oligonucleotides (ss oligos) and double stranded oligonucleotides (ds oligos) ....................
- US6355412B1 - Methods and compositions for directed cloning and subcloning using homologous recombination claims
- A method for introducing a double-stranded target DNA into a vector comprising .......
- A cell comprising a double-stranded DNA vector useful for directed cloning or subcloning of a target DNA molecule of interest.............. .......
- A kit useful for directed cloning or subcloning of a target DNA molecule comprising in one or more containers......
EUROPE: The European Parliament adopted Directives to regulate the legal protection of biotechnological inventions, establishing additional criteria for their patentability.
FEW PATENTS/PATENT APPLICATIONS INVOLVED-
- EP3694994B1 - A novel method for synthesis of polynucleotides using a diverse library of oligonucleotides claims
- A method for synthesizing a target double stranded (ds) polynucleotide having a predefined sequence, comprising...........
- Use of an oligonucleotide library which is provided within an array device comprising a diversity of library members that covers at least 10.000 pairs of matching oligonucleotides ............. ...........
- In the case involving -The Howard Florey/Relaxin Case -
The Howard Florey Institute successfully isolated the relaxin hormone from human tissue samples and characterized its chemical structure. Their research revealed an unexpected form of human relaxin, distinct from that of other species, necessitating the development of synthetic relaxin for therapeutic use. This innovation was achieved through novel gene cloning methods using recombinant DNA techniques, leading to a patent application that claimed both the gene encoding the unexpected form of human relaxin and the synthetic hormone produced.
RISK ASSESSMENT FOR SYNTHETIC BIOLOGY INVENTIONS -
- Ensuring that synthetic organisms do not pose risks to human health or the environment.
- Monitoring the health of individuals working with synthetic biology to detect any adverse effects early.
- Assessing the potential impact of synthetic organisms on ecosystems.
- Considering the broader ethical and social impacts of synthetic biology.
- Ensuring that all synthetic biology activities comply with relevant laws and regulations.
- Implementing design principles that inherently reduce risks.
- Engaging with a diverse range of stakeholders, including scientists, policymakers, and the public, to ensure that risk assessments are comprehensive and inclusive.
OPINION
In summary, synthetic biology encompasses multiple crucial areas that are essential to the ongoing public debate about patents. While there are no simple solutions, every Patent office adheres to its ethical guidelines when making decisions on a case-by-case basis. The intellect and logical reasoning play an important role specifically when the subject inventions are related to biotechnology, microbiology and nanotechnology, that is, when genes, DNAs etc. are the raw material used in the inventions. The exclusion of the non-patentability laid by the Indian Patent law should be closely studied based on subject invention at its every stage both at the Applicant's and Patent office's end. Along with the afore mentioned- ethical and legal issues must also be checked upon carefully to ensure that the inventions comply with national and international regulations and ethical guidelines. This would lead to a better way to draw out the conclusion for any subject invention related to synthetic biology.
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