UNLOCKING INDIA'S HEALTHCARE FUTURE BY NAVIGATING THE PATENT EXCLUSION

By Saloni Rani

[Keywords] Medical Drones, Computer “perse”, CRI Guidelines, Software, IP case analysis

INTRODUCTION

‘Medicine from Sky’ type initiative highlights the growing importance of drones which could reduce the time delivery from 8 hours by road to mere 22 minutes. The drones can support the neglected rural clinics by creating reliable supply chains for medicines and diagnostic samples. Their range of temperature-controlled drones can preserve vaccines and blood products so that resulting spoilage is reduced and cold chain reliability is improved. The full set of positive features of medical drones, including operational costs and integration into healthcare, agriculture, and logistics, has the potential to positively impact India's economy up to USD 1.6 billion in GDP by 2030 as it crosses the overall Drone Integration into the economy. In India specifically, it will create over 100,000 jobs in direct/indirect job roles for manufacturing, assembly, AI Software creation, data analytics, and aviators. The operation of drones depends on algorithm and data system embodied in aircraft.

This paper advances the core thesis that the software used in drones is legally and normatively distinct from a simple computer program perse algorithm and thus, needs to be protected under Patent Act,1970. The commercial logic of Patent Act, which except mathematical or business method or a computer programme per se or algorithms, breaks down when applied to operation of drones especially in medical sector.

Building on this, the blog critically examines the conflict between software that runs sophisticated AI drones and the exception governing them under Patent Act. It argues that the software cannot be included in the exception under Section 3(k) of Patent Act, because of two compelling reasons, firstly per constitutional principles, secondly, due to interrelation with hardware controlling the drones. The analysis provides plausible recommendations for governance and patentability in India’s digital age.

2. UNDERSTANDING THE NATURE OF SOFTWARE: BEYOND THE SECTION 3(K)

Section 3(k) of the act explicitly excludes the ‘computer program perse’ from ambit of ‘invention’ which has been reiterated by court in various judgements. In Open tv Inc vs The Controller of Patents and Designs, the Delhi High Court ruled that merely inventing a business method in computer will not make it patentable. To be patentable under Section 3(k), as ruled in Microsoft Technology Licensing LLC v. Assistant Controller of Patents, an invention must demonstrate a specific enhancement to existing functionality which must be clearly defined, distinct and innovative in nature. According to 2017 Computer Related Invention Guidelines (hereinafter, CRI), examiners ought to focus on ‘underlying substance’ of the invention.

While the Indian Judiciary has laid down the guidelines to address what constitute a “technical effect” capable of crossing the Section 3(k) bar. However, the phrase ‘per se’ creates an ambiguity in governance. CRI guidelines too attempt to operationalise Section 3(k), but ends up in further deepening ambiguity. Para 4.5.1 and 5.4.4 direct officers to regard invention as ‘whole’, still Para 5.4.3 instruct any claim ‘in any form’ falling within an, excluded category must be denied. Thus, it reinstates the exclusion without adequately defining it leaving the gateway for judgements on ‘technical effects’. As evident, Indian courts have always grappled with distinction between a mere computer program or algorithm (excluding part); and a computer implemented invention that produces a technical effect (including part). The Supreme Court in Ferid Allani v. Union of India, held that an invention could not be explicitly ignored because it merely involves a computer programme and all those inventions involving a solution to technical problem must be included; thus the court clarified the bar under Section 3(k).

THE CONSTITUTIONAL DIMENSIONS

The Court in Consumer Education and Research Centre v. Union of India, elevated the imperative of public health under Right to Life. Medical drones are directly correlated with health and life of a patient. State has an obligation to ensure access to health technologies to everyone as reiterated by court in Mohd. Ahmed v. Union of India. Exclusion of software program in patent indiscriminately rope the innovation due to lack of initiative, thereby the lifesaving drones indirectly limit the state ability to deploy them. Furthermore, absence of a specific legislation opens the gateway for interpretation of phrase ‘computer per se’ which could lead to subjectiveness in determination of patentability of drones. Thus, it violates the Right to Equality as Supreme Court ruled in E.P. Royappa v State of Tamil Nadu that arbitrariness is antithesis to equality.

Any statutory reading of the Patent Act, that enables the patentability of software with new invention is vulnerable to challenge. Therefore, the constitutionally coherent interpretation of Section 3(k) requires harmonisation of patent law with fundamental rights.

INTERRELATION WITH HARDWARE OF DRONE

Software used in drones produce a technical effect by directly having control over hardware. This are deployed to resolve the real time outcomes, making it distinct from ‘computer program per se’. Temperature-controlled delivery in drones too relies on software. If it cannot be patented, foreign players with excellent IP portfolios would take that position. This would hamper the development in this sector in our own nation. Indian economy is estimated to generate $1.6 billion as discussed, out of which majority composition consists of software developments for example, jobs in AI, data analytics, etc. Non-patentability of these again risk the employment in these sectors. A close interplay between the physical and digital component of drone places the regulation of software outside the ambit. Thus, the court’s emphasis on ‘technical-effect’, if incorporated in the legislation, could integrate and harmonise the functioning of a medical drone. Adopting this framework will favour innovation in the sector. This will help India stand out in international sphere in terms of medical facilities and drones in rural and underdeveloped areas.

WAY FORWARD

Despite the judicial attempt to liberalise Section 3(k) from any subjective approach, there remains a legal lacuna in governance of software involved in assessment of medical drones. The way forward is the incorporation of functionality-based patent test. The genesis of test lies in comparative patent jurisprudence where the concept of ‘technical effect’ gained prominence. This effect is used to distinguish between the patent eligible computer inventions from the mere programs per se.

This test is used to analyses whether an innovation is mere addition or does it truly contribute to something innovative. It is not explicitly defined in either of the statue, but the Indian Judiciary has adopted this approach inspired from the European Patent Office (EPO) and U.S. Jurisprudence. The word ‘technical effect’ as discussed, finds mention in CRI guidelines which must be followed while granting patent. A functionality-based test here, would assess whether the claimed software produces a technical contribution with objectivity. In this case, a drone algorithm which operationalize the flight direction in order to maintain requisite temperature required for vaccine is patent-eligible. To implement this approach, the CRI guidelines must be revised. Further, the clarification on exception (Section 3(k) must be provided by the legislature to avoid misunderstandings.

These reforms will align with the judicial reasoning and harmonize India’s frameworks on governance of patents with international frameworks. This can be evident from the Parliamentary Committee which in 161^st report expressed the concerns regarding the patentability on this issue whereby the committee in Paragraph 8.7 recommended “The approach in linking the mathematical methods or algorithms to a tangible technical device or a practical application should be adopted in India for facilitating their patents.’’

CONCLUSION

The same rationale must be applied in governance of medical drones whereby denying them protection under Section 3(k) will disregard them from contributing in public health. To maintain legal and constitutional integrity, the word computer ‘per se’ should explicitly be explained and secondly, right based framework must be adopted in regulation of algorithm. It is only through this that India’s Patent law can achieve the objective to regulate the emerging innovation in operation of medical drones. Therefore, the patent framework of Inda must move from rigid exclusions towards functional evaluation which will serve as an economic and technical imperative to set the country as an exemplary in globe.