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Regulating Software as Medical Devices – Navigating Hurdles One Byte at a Time

Transitioning Regulatory Landscape

Dynamic progress in healthtech and medtech has led to a transformative surge of the medical devices landscape, propelling the rise of new and innovative medical devices. However,  preceding the amendments to the Medical Devices Rules, 2017 (“MD Rules”), only a handful of medical devices were regulated, with software escaping regulatory scrutiny. Recognising the myriad instruments affecting individual and animal health, the Government found it imperative to extend regulations to this rapidly evolving realm.

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Scope of business method inventions under Section 3(k)

In Priya Randolph Vs Deputy Controller of Patent and Design,[order dated December 20, 2023],the Madras High Court set aside a refusal order passed by the Deputy Controller of Patents and Designs in appeal proceedings. The Court held that mere involvement of a business method in an invention doesn’t render it unpatentable under Section 3(k) of the Indian Patents Act, 1970. The Court observed that the invention involved hardware, software and firmware and that all these components put together, improve data privacy and protection mechanisms.

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Global Capacity Centres (GCCs) take centre stage in fuelling global growth

Emergence and Transformative Evolution of GCCs in India

Global Capacity Centres (“GCCs”) started as offshore global in-house centres (“GICs”) in the Indian  banking industry to help cut costs and provide operational support to the service offerings of a foreign entity (“Foreign Entity”). India has gained credence as a favourable destination because of its skilled human resources (wide talent pool) and competent operational costs. As of FY 2022–23, India’s approximately 1,580 GCCs have 1.66 million employees,[1] and this number is rapidly increasing.

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Overview

As envisaged in the IT Policy of 2023[1] (2023 IT Policy), Maharashtra Government, in accordance with the powers vested in it under Section 9 of the Maharashtra Stamp Act on February 1, 2024[2], issued the much awaited notification (2024 Notification) on full or partial waiver of stamp duty available to eligible new and expansion diversification units or projects, relating to Information Technology (IT), Information Technology Enable Services (ITES), Animation, Visual Effects, Gaming and Comics (AVGC) units, Data centres and Emerging Technology Units, (collectively IT/ITES Unit). The 2024 Notification is valid from June 27, 2023, to June 26, 2028, (both days inclusive) or for the currency of the 2013 IT Policy.

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Employer safeguards in the wake of ‘Loud Quitting’

In the ever-evolving landscape of professional dynamics, a recent trend has emerged where employees have been publicly expressing their dissatisfaction and grievances with their employers after resigning from their jobs, often through social media platforms. This phenomenon has been termed as ‘loud quitting’. This practice marks a stark shift from the previous subtle ways that employees chose to express dissatisfaction about their work environments.

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DB of DHC sets the contours of Pre-grant opponent in an examination process

In a recent case[1], Novartis AG[2] v. Natco Pharma Ltd.[3], the Division Bench (DB) of the Delhi High Court (DHC) adjudicated on the extent of engagement a pre-grant opponent should be allowed under the Patents Act, 1970, in the course of proceedings initiated by the Controller, requiring the patent applicant to amend or modify the patent application.

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Linking Patents to Pills: Unravelling the Patent Linkage Framework for Pharmaceutical Products in India

A patent grants the patentee exclusive rights, title, and interest in an invention. This creates a right in rem – a right to restrict a third party from making, using, offering for sale, selling, or in any manner commercializing the invention (as claimed in the patent)[1] for a period of 20 years[2]. In case of drugs, grant of patent, does not give the patent owner an automatic right to market the product. Such additional right in the form of a marketing approval/ license/ registration is granted by the concerned drug regulatory body acting under the auspices of the relevant legislation that regulates the import/ manufacture/ sale/ marketing of the drug in the relevant jurisdiction.

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Institutionalising public consultations: A step towards building a stakeholder-friendly regulatory threshold

Introduction

 The ‘Draft Policy for Pre-Legislative consultation and comprehensive review of existing Rules and Regulations’, released by the Ministry of Corporate Affairs (“MCA”), became effective from January 1, 2024 (“MCA-PLCP”). This move complements the increased focus on improving the ‘ease of doing business’ across regulators in India[1] and will also help address the inherent non-uniformity in the consultative mechanisms and processes employed by various MCA-formed/governed regulatory bodies.

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Background

The European Court of Justice (“CJEU”) in mid-2023 passed a landmark judgment in Meta Platforms Inc. v. Bundeskartellamt[1], by imposing strict restrictions on social media entities using personal data of consumer’s for targeting them with personalised advertisements through their platforms. This ruling struck at the core revenue model of many big technology organisations.   

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FIG Paper (No. 34 – Data Law Series 5) Balancing Sectoral Regulation and DPDP Act Compliance by NBFCs & Fintechs

Background

Indian regulators in recent times have shown a keen interest in monitoring the intersection between data, information technology, and cybersecurity with regulated entities—more so in relation to Non-Banking Financial Companies (“NBFCs”) and ‘fintechs’. With the expected enforcement of the Digital Personal Data Protection Act, 2023 (“DPDP Act”), and the promulgation of its rules, it becomes imperative for NBFCs and fintechs to map their journey of compliance from legal and regulatory perspectives.

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