Introduction

Biotechnology is the process of using biological science to create new ways, products, or goods that are useful for living organisms and contribute to the health and technology advancement of society. The most common application of biotechnology involves the development of medicines or proteins through genetic engineering.

What is a patent?

A patent is a legal right that grants exclusive right to sell or use an invention. Patents are important in biotechnology because they grant exclusive rights that promote collaboration, attract capital, and incentivize innovation. Patents give businesses an advantage in international markets, protect intellectual property, increase transparency, and help biotechnologists navigate regulatory processes, resolve disputes, and facilitate technology transfer.

Overview of CRISPR Technology

CRISPR (pronounced clustered regularly interspaced short palindromic repeats) is a cutting-edge gene-editing technique that enables the precise alteration of DNA in living organisms. CRISPR was originally derived from the immune system of bacteria and has since been adapted for a variety of biotechnological applications. CRISPR has completely revolutionized genetic engineering and provides a powerful tool for precise DNA alteration with broad applications in fundamental science, medicine and agriculture.

Importance of Patents in Biotechnology

The patentability of biological materials is a matter of debate; Some see them as inventions, while others see them as discoveries. A specific and useful application of a biological invention in a patent application is necessary to address issues such as industrial applicability and adequate disclosure. Licensing and exploitation aspects are also highlighted, underscoring the need for multifaceted patent claims, especially in the early stages of discovery.

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Protection of Intellectual Property in Biotechnology

In the biotechnology industry, intellectual property (IP) protection is essential for promoting innovation, drawing capital, and ensuring fair competition. The following methods are used to protect the rights of biotechnology innovators and businesses:

1. Patents:

Gene Patents: Genetically engineered organisms, isolated genes, and genetic engineering techniques are frequently the subject of patent applications.

Process patents: It is possible to obtain a patent for processes used in the production of biotechnological goods such therapeutic proteins or vaccines.

2. Exclusive Regulation: To stop rivals from using the same data to get market approval, regulatory bodies in the pharmaceutical and biopharmaceutical industries may grant the original data submitter data exclusivity for a predetermined amount of time.

3. Agreements and Licencing: In order to transfer technology, businesses frequently enter into licence agreements that permit third parties to use, produce, or market biotechnology inventions in return for royalties or other forms of payment..

4. International Accords and Treaties: The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes basic requirements for IP protection worldwide and contains clauses pertaining to biotechnological inventions.

5. Trademark: Names, logos, and other identifiers connected to biotechnological products are protected by trademarks. This promotes brand recognition and aids in product differentiation in the marketplace.

6. Copyright: Programmes utilised in biotechnological research and development may be subject to copyright laws. Databases, software codes, and other unique creative works are all protected.

Evolution of CRISPR Patents and the Legal Battle:

The development of CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) patents has been a complex and dynamic process, characterised by court cases, ownership disputes, and continuous advancements. Genetic engineering has been transformed by the discovery of the CRISPR-Cas9 gene-editing technique by Emmanuelle Charpentier and Jennifer Doudna.

Initial Patents was filed by Doudna & Charpentier, but Broad/MIT's application for eukaryotic cell use (demonstrated in mammals) was granted priority in the US. USPTO initially favored Broad/MIT in 2017, but the US Court of Appeals reversed in 2018.

Global Variations: Patent rulings differed outside the US (e.g., China upheld Broad/MIT, Europe favored Doudna & Charpentier).

Patent Expansion: Field widened to different CRISPR systems and used it in agriculture and medicine.

Licensing: Broad/MIT licensed patents for commercial use, increasing licensing agreements.

Ongoing Developments: Patenting landscape is constantly changing due to new technologies and legal challenges.

Later on there were ethical considerations due to the commercialization of biotechnology for responsible research and regulatory frameworks.

Challenges

1. Complexities: Legal battles and varying rulings create confusion and uncertainty for research and development.

2. Access and Affordability: Broad patents could limit access and affordability of CRISPR technology, especially in developing countries.

3. Ethical Considerations: Debates exist on responsible use, editing germline cells, and potential unintended consequences.

4. Regulatory Frameworks: Need for clear and harmonized regulations to ensure safety, ethical use, and accessibility.

5. Environmental Impact: Release of genetically modified organisms raises ethical questions about ecological disruptions.

6. Dual-Use Concerns: Concerns about CRISPR's potential use for harmful purposes, like bioweapons development

Future Possibilities and the way forward:

1. There can be collaboration between patent holders and researchers to facilitate innovation and access.

2. The world can look forward to the development of open-source platforms and non-profit initiatives to increase CRISPR availability.

3. International agreements and harmonization of regulatory frameworks for ethical and responsible use of biotechnology can help clear the air of paranoia around it.

Overall, the CRISPR patent landscape is dynamic and complex, posing challenges for research, development, and responsible innovation. Addressing ethical concerns and establishing clear regulatory frameworks are crucial for the future of this transformative technology.

International Cooperation and Standards

The World Intellectual Property Organisation (WIPO) maintains the International Patent Classification (IPC) system, which is used to identify patents in biotechnology.

Many other property rights forms were developed during the subsequent periods in different countries all over the world. The most important treaties for Europe are the Paris Convention (PC) stipulated in 1883, the European Patent Convention (EPC) stipulated in 1973 and the Patent Cooperation Treaty (PCT) stipulated in 1970.

Legal Framework in India

The Patents Act, 1970 and the Patents Rules, 2003, set the legal foundation for biotechnology patents.

The Guidelines for Examination of Biotechnology Applications for Patents, 2016 offer guidelines for the examination of patent applications in the biotechnology. These rules address a number of topics, such as the conditions for patentability, the sufficiency of disclosure, and the patentability of biological material.

In general, India's biotechnology patent laws are intended to promote creativity while striking a balance between the public interest and the need to safeguard intellectual property rights.

Conclusion

The world benefits greatly from biotechnology. We therefore owe it to the inventors to give them the same opportunities to profit from their ideas that we have. Consequently, patenting is crucial since it grants inventors twenty years of exclusive rights to create, utilise, and promote their discoveries.

Compounds in biotechnology would be treated more like trade secrets if patents were not allowed; only the proprietor would be aware of how something is created or carried out. This can create a hindrances in the future developments and inventions in biotechnology. We can do a lot more when we collaborate and exchange knowledge. The development of novel, highly effective medications will come from biotechnology, particularly genetic engineering.

The patent system serves as both a potent tool and an excellent source of knowledge.

Additionally, the patent system is constantly evolving to keep up with emerging biotech technology.

Author : Barira Parvez, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

 References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3815763/

2. https://www.wipo.int/patents/en/topics/biotechnology.html

3. https://ukhumanrightsblog.com/2020/02/21/the-importance-of-patents-in-biotechnology-john-butcher/

4. https://healthcaremba.gwu.edu/blog/why-patents-matter-in-biotech