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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.   

Continue Reading The Great Reset: What Lies in Store for Targeted Advertising?  
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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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‘Technical Breach’ not a contravention of Section 39 of the Patents Act?

In Selfdot Technologies (OPC) Pvt. Ltd. v. Controller General of Patents, Designs & Trademarks, [order dated November 28, 2023],the Madras High Court has adjudicated on Section 39 and 40 of the Indian Patents Act and held that the breach committed by the appellant was a technical breach and cannot be considered a contravention of Section 39 of the Patents Act, 1970, and hence cannot trigger deemed abandonment under Section 40.

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Court interprets “known substance” in respect of Section 3(d) of the Patents Act

In an important decision, Justice Senthilkumar Ramamoorthy, discussed Section 3(d) of the Patents Act, 1970.[1] The case involved a patent application no. 7096/CHENP/2015, which claimed priority from the US application number 61/815,502 dated 24 April 2013. The patent application claimed two polymorphic forms—A and B—of a compound RTA-408. Compound RTA-048 was claimed and granted in the Indian Patent Application No. 8486/DELNP/2014.[2] The patent application 7096/CHENP/2015 was refused essentially on the grounds of being not patentable under Section 3(d) of the Indian Patents Act.

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Substantial Issues in Defining “Substantially the Whole of the Undertaking”

Section 180(1)(a) of the Companies Act 2013 (“2013 Act”) requires a company to obtain prior approval by a special resolution to sell, lease or dispose of the whole or substantially the whole of the undertaking of the company or, when the company owns more than one undertaking, of the whole or substantially the whole of any of such  undertakings.

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Summary of the Draft Trade Marks (1st Amendment) Rules, 2024

The Draft Trade Marks (1st Amendment) Rules, 2024, introduced by the Department for Promotion of Industry and Internal Trade under the Ministry of Commerce and Industry, represent a strategic modification to the Trade Marks Rules, 2017. This regulatory endeavor is conducted under the delegated powers provided for in Section 157[1] of the Trade Marks Act, 1999 (“the Act”). These rules create a unified adjudication process which is carefully planned to ensure consistency. This effectively streamlines the Act’s execution by strengthening the Adjudicating Officer’s capabilities. The aim of this comprehensive approach is to optimise and refine the adjudicative framework, thereby fostering a more robust and coherent administration of trademark-related matters.

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Declaration of Dividend: Interplay of law and business dynamics

Context

The aim of any business organisation is to earn profit and distribute it among the owners. In case of a company, such distribution of profits is connoted as Dividend. The Companies Act, 2013 (“the Act”), inter alia provides for declaration of dividend out of profits. Profit here is the net profit of a company, as determined for preparing financial statements, as per the provisions of Section 129 of the Act and after complying with all the applicable accounting standards notified under Section 133 of the Act.

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Cause of action for a Writ Petition in Patent Suit stands independent of “Appropriate Patent Office” Determination under Patent Rules

In University Health Network v. Adiuvo Diagnostics Pvt. Ltd.[1], Madras High Court has held that it shall have territorial jurisdiction to entertain the writ ‘irrespective of the location of the appropriate patent office’[2], which was Delhi. At the time of filing of a patent application, “appropriate office” for that application is ordinarily frozen, i.e. decided based on the place of residence or domicile or business of the applicant(s); or where the invention originated; or based on the address of service of the applicant in India, in case of a foreign applicant.[3] Section 2(1)(r) and 74 of the Patents Act 1970 (“the Act”), Rule 4 of Patent Rules 2003 (“Patent Rules”), and Clause 3.02 of Patents Manual indicate the immense significance of ‘appropriate office’ in the process of prosecution and grant of patent application in India. For instance, all proceedings are conducted from the appropriate office, all communications related to the proceedings are addressed to the concerned appropriate office, among others.

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