Introduction:

The World Intellectual Property Indicator Report, 2024 shows the 15.4 % growth in patent application in year 2023. It marks countries increasing role of a global innovation hub. With this the Indian MedTech market has been projected to reach US $ 50 billion by 2030 due to rapid growth in biomedical sector. For this we need to update our Intellectual Property Rights as these regulatory framework deals with the traditional innovations but lacks the ability to deal with the newer technological innovation. The transformative development and intersection of Brain-Computer Interface (BCI) technology in Neuroprosthetics (an area of neuroscience concerned with neural prostheses) presents unique legal challenges and opportunities regarding the intellectual property rights in India. This blog explores India’s patent law concerning BCI technology, the regulatory hurdles and balance approach of privacy, safety within the biomedical patent landscape.

I. The Emergence of Brain-Computer Interface Technology:

Brain-Computer Interface (BCI) is a computer-based system that directs communication link between the brain’s electrical activity and an external device, most commonly a computer or robotic limb. It acquires brain signals, analyzes them and translates them into commands that are relayed to an output device to carry out the desired action. It's application spans different domains such as: Healthcare, Gaming and Entertainment, Education and Assistive Devices. As companies like Elon Musk’s Neuralink is advancing towards human trials and others developing different solutions, India faces critical regulatory challenges and issues related to patent rights of such technologies or devices.

II. Intellectual Property (Patentability) Challenges:

The patent law is governed by the Patents Act, 1970, it possess a unique challenge for BCI innovators. These include:

1. Patent Eligibility Criteria

India’s patent framework requires that inventions fulfill the following criteria:

a). Novelity: The invention must be new.

b). Inventive Step: The invention must not be obvious to someone skilled in the art.

c). Industrial Applicability: The invention must have a practical application.

While these criteria are often met by the BCI, issues occur due to certain exclusions: Excluded Subject Matter:

Section 3(k): The Section 3(k) of Patents Acts, 1970 excludes algorithms, mathematical methods and computer programs per se from patentability. As BCI technology often involves coplex algorithms and nural network systems, innovators may face reection under this clause.

Section 3(i): It exludes the methods of treatments or diagnosis, or any process for the medicinal, surgical, or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value. This medical exclusion can negatively effect the patentability of BCI devices.

The classification of neural signal processing methods as their patentable technical processes or non-patentable mathematical methods requires careful consideration. While physical components generally qualify as patentable subject matter, the integration of biological interfaces with electronic systems raises novel question about the boundaries of patentable innovations.

2. Ethical and Social Concerns:

Patenting neural innovations raises ethical such as : Should monopolies be granted for life altering technologies? Can’t it lead to further medical issues. There are also cultural or human value issues for such technologies where a person is becoming the slave of this technology.

III. BCI Regulatory Challenges:

1. Medical Device Rules, 2017:

In India, currently the legal framework regarding medical devices is regulated by Medical Device Rules, 2017 under Drugs and Cosmetics Act, 1940. While these rules provide the basic framework for medical device regulation, however, they fail to address the BCI. It becomes evident when the nature of this device is considered as it involves both the medial and complex data-processing system.

2. Digital Personal Data Protection Act, 2023:

The implementation of Digital Personal Data Protection Act, 2023 again leads to a new regulatory complexity. While this regulates crucial data privacy protection, it fails any direction for neural data in mind. The question of how to classify and protect signals- which could reveal not just the medical information but thoughts, emotions and memories- presents new challenges for patent rights.

IV. Global Comparisons: Lessons for India:

The western and European countries are way ahead in regulation of the BCI technology and India can draw valuable lessons from these jurisdiction regarding their regulation and property rights.

USA: In United States of America the Food and Drugs Administration encourages innovation by expenditure on regulatory approvals for these devices and they allow for patenting of algorithms and software when integrated with hardware, which provides protection to innovators for their invention.

European Union: The Medical Device Regulation categorizes BCI under High-risk medial devices which ensures the clinical evaluation and safety protocols for any such devices and for the issue of privacy right the General Data Protection Regulation extends its protection for neural data also.

[Image Sources: Shutterstock]

V. Enhancing Prospects for the Grant of BCI Patents in India

With BCI technology rapidly growing around the world India is yet at the cross road to growth of Intellectual property regime that will support innovation while protecting public and ethical use. The current system is sound for applying regulation on traditional technology but this raises major challenges that can only be addressed with major modification for application on neurotechnology. It identifies critical moves India needs to make to become a world centre for neurotechnology development and deployment while ensuring the right protection is in place.

a). Patent Law Modernization

It raises the need for adjustments in India’s patent regulation to make it suitable to the kind of BCI know-how. The greatest challenge today is on the definition of Section 3(k) of the Patents Act under which computer programmes per se are not deemed patentable. As much as current BCI designs depend on advancements in both the software and the devices, this provision requires special attention when restating. It is therefore imperative that the Patent Office establish coherent rules with respect to the patenting of innovations the use of algorithms on BCI hardware systems. Further, Section 3(i) that prevents grant of patents in methods for medical treatment should further be amended where it clearly is not warranted in order to except life saving Neurotechnological devices while at the same time making medical inventions on par with global standards.

b). Improving the Status of Research and Development

Since the growth of a BCI innovation ecosystem in India requires reliable support infrastructure for futuristic R & D, it is mandatory that the country must meet the following needs. It remains the responsibility of the government to provide particular tax incentives to companies seeking to invest in neurotech R&D, strategies used in biotechnology domains. Moreover, enforcing dedicated innovation centres through cooperation of the government with representatives of the private sector and academic community would supply effective infrastructure for new ventures. These centres should therefore enable knowledge exchange, host expensive tests equipment and allow for niche mentorship opportunities. Academician and industry Interaction can help India for the early development of the indigenous BCI Systems that efficiently match the need and constraint of the nation.

VI. Further Implications and Consequences and their Ethical Prospects

Such steps, however, must be weighed against a more comprehensive social context in which the measures are effectuated. Thus, accessibility remains the major issue; however, the role at which socioeconomic differences of people in India will come into focus. It has to be founded how policies will provide fair access to BCI technology by way of healthcare insurance or public programmes. Responsibility for errors and adverse consequences and in case of a faulty functioning of a device is a subject to determination with the responsibility distribution between the manufacturers, medical establishments, and customers.

Therefore, issues of human rights require special consideration in the Indian situation. BCI technology must be protected from possible misuse for surveillance or coercion; rules concerning vulnerable people have to be especially stringent. This entails special precautions when designing and obtaining consent, limitations concerning the disclosure of data and the periodic ethical review of BCI uses.

Conclusion

Indian journey toward the global domination in BCI technology has always been tipped with concern as the novelty in any field is always followed by strict governmental regulation. With these advances today India has squeezed levers that can spur meaningful technological development while harbouring ethical protection for people and the society at large through enactment of these extensive measures ranging from patent law reforms to ethical frameworks. The performance of this framework will not only define India’s place in the world neurotechnology map but also help in establishing several precedents for new age technologies in developing countries.

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

References:

1. Medical Device Rules, 2017, Ministry of Health and Family Welfare, Government of India

2. Digital Personal Data Protection Act, 2023, Ministry of Electronics and Information Technology, Government of India

3. Patents Act, 1970, Ministry of Commerce and Industry, Government of India

4. EU Medical Device Regulation 2017/745

5. FDA Guidance for Brain-Computer Interface Devices, 2021

6. World Health Organization Guidelines on Human-Computer Interfaces, 2023

7. Indian Journal of Medical Ethics, Special Issue on Neurotechnology, 2024

8. The Neurorights Foundation Policy Guidelines, 2024