Biotechnology is one of the most advanced and burgeoning fields in technology. It refers to the process of altering living organisms that make them beneficial for humankind. Every biotechnology company has a patent, one of its most valuable assets, and a utility patent covers biotechnology inventions.

Orange juice could now be consumed as part of a regular breakfast, thanks to the pasteurization procedure. Microbiologist Louis Pasteur patented a new yeast-making process at the French Patent Office in 1873, and numerous commercial orange juice enterprises employed this unique biotechnology approach.

Myraid Genetics holds patents on two genes involved in breast cancer development, giving the business exclusive rights to research and diagnostics concerning these genes. By stating that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” the United States Supreme Court has prevented companies from patenting human genes, preventing scientists around the world from conducting potentially life-saving research.

However, the court also held that “manipulation of a gene to create something not found in nature could still be eligible for patent protection.” This leads to a gene-editing tool such as CRISPR-Cas9.

CRISPR is a powerful gene-editing technique that has transformed agriculture and human medicine. CRISPR-related breakthroughs have already resulted in improved crops, a revolutionary notion for human medicines, and the eradication of vector-borne diseases. This technology, on the other hand, is a double-edged sword. Biosafety of the invention, biosecurity, Intellectual Property ownership, patent process, and regulation of its use are all negative aspects. CRISPR has a promising future if protected from competition, has a good patent environment, and is appropriately regulated.

The obstacles that the biotechnology industry faces in patent processing are the subject of this article.

Patents are the most powerful of all intellectual property rights, and it allows the patentee to utilize their invention for 20 years with complete exclusivity.

Article 27 of the TRIPS Agreement states that any novel product or technique, requires an inventive step and has an industrial application is eligible for a patent. According to Articles 27.2 and 27.3 of the Agreement, an innovation that incorporates medicines, diagnostics, or surgical treatments does not meet the standards for patentability because it is against morals or causes substantial prejudice to plant, animal, or human lives. This raises further perplexing concerns, such as whether microorganisms that exist freely in nature have the right to be patented. Is it possible to patent a product made by a well-known microorganism?

Suppose the biological material used in the invention is not available to the public or not adequately described as per the provision of the Act, then as per Section 10(4) Rule 13 (8). In that case, the applicant must deposit with an International Depository Authority under the Budapest Treaty. The international depository authorities in India are the Microbial Culture Collection, Pune and Microbial Type Culture Collection, and Gene Bank, Chandigarh.

The sequence listing is an essential part of the invention, and the sequence listing is the nucleotide and related amino acids and should be filed electronically. Among all types of Intellectual Property Rights, Patent is the strongest, and it gives the patentee to exploit their invention for 20 years with complete exclusive rights to use it.

The main problem with patenting biological material is that it is extracted or produced from a naturally occurring live organism, making it merely “discoveries.” If the innovation is still in its early stages and the gene’s future utility is unknown, to justify based on industrial applicability, and disclosure sufficiency would be a matter of debate.

To be patentable, an invention must meet the criteria of novelty and inventive step. However, in the case of biotechnology invention, the majority of the subject matter already exists in nature and thus contributes nothing new. Because the subject matter is natural, it is unethical and against the public interest to transform them into private holdings.

Another challenging issue in biotechnology patenting is the ability of biological materials to reproduce. As a result of reproduction or change in morphology with time, the one that is currently patented may change in the future.

Scientists commonly employ the same procedure to isolate gene sequences, making the invention non-obvious. Because human genes are found in nature, it is considered a discovery rather than a creation.

It’s challenging to describe genetically engineered inventions because they’re so complicated accurately. As a result, biotechnology inventions are not adequately protected by the present patent system.

Given the preceding, even though biotechnology inventions confront numerous challenges, they must overcome them in order to address the world’s most vexing productivity, health, and environmental issues. Biotechnology is a rapidly expanding science that involves human lives. Understanding the complexities and limitations of patents connected to biotechnology is critical to ensuring that it saves lives and makes the world a disease-free environment.

Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.

Author

  • Title

    Meenakshi Lal is a biotechnologist and patent professional. She assists organizations or individuals in patent searching & analysis with expertise in patent drafting according to Indian Patent law, European Patent law and USPTO for their exciting new inventions and processes.