Tag: generic drugs
October 14, 2019
Intellectual Property | Patent
Intellectual Property | Patent
Bolar provision remains standing after Bayer challenge
The Delhi High Court recently adjudicated on the issue of whether generic companies can export patented products for experimental purpose, in an expansive interpretation of Section 107A of the Indian Patents Act, 1970 (the ‘Act’). Section 107A, which relates to what is referred to as ‘the Bolar Provision’, was introduced via the Patents Act (Second Amendment) Bill, 1999. The provision sought to ensure the prompt availability of patented products, particularly generic drugs, immediately after the expiry of the patent term....
September 13, 2019
Intellectual Property | Patent
Intellectual Property | Patent
Delhi High Court stops AstraZeneca’s attempts at evergr...
In a major decision that is likely to impact evergreening of pharmaceutical patents in India, the Delhi High Court vacated interim injunctions granted to AstraZeneca, a big pharma multinational, against three generics manufacturers, Micro Labs, Natco Pharma, and Dr. Reddy’s Laboratories. The case involved allegations of infringement of AstraZeneca’s three patents, for offering a generic version of AstraZeneca’s drug-TICAGRELOR for sale under the brand name BRILINTA....
Formulation fight: Amgen case tests patentability of biopharmaceuticals in India
In a high-stakes case, the Madras High Court examines whether Amgen's specific formulation is non-obvious and patentable, and whether the prior art guides...
Implementation of India’s Four Labour Codes: Key Changes and the Road Ahead
On November 21, 2025, the Ministry of Labour and Employment issued notifications operationalizing substantial portions of India's four labour codes...
The Digital Personal Data Protection Rules, 2025: A New Digital Frontier
The Ministry of Information and Technology (“MeitY”) on Thursday, November 13, 2025 notified the Digital Personal Data Protection Rules, 2025 (the “DPDP Rules”), framed under the Digital Personal Data Protection Act, 2023 (the “DPDP Act”).
Indemnity and Limitation of Liability Clauses: Strategic Risk Allocation in Commercial Con...
In the world of commercial contracts, astute risk management is paramount. Among the arsenal of legal tools and safeguards available to parties, the indemnity and limitation...
RBI Opens the Doors to Bank-Funded M&A’s: Boosting Domestic Acquisition Financi...
Recently, the Reserve Bank of India ("RBI") Governor, Mr. Sanjay Malhotra underscored the importance of enabling Indian banks to finance acquisitions by domestic corporates...
Government Sahyog in Tightening Takedowns
In 2021, the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021 ("IT Intermediary Rules") were notified in furtherance of the Central Government's power to make rules...
Data Clean Rooms: The Future of Privacy-Compliant Data Collaboration
As organisations grapple with increasingly stringent privacy and data protection laws, the concept of the Data Clean Room (“DCR“) has emerged as a transformative solution that enables collaboration without compromising compliance.
The power of transition phrases in Indian patent drafting: the ‘Frimline’ Ruli...
Transition phrases are crucial in patent drafting for they define the scope of a claim. Choosing the correct phrase can impact what rights an applicant can enforce, as determined by the Delhi High Court recently, in Frimline v. K-Smatco
Representations, Warranties and Covenants: What are the consequences of breach?
Representations, Warranties and Covenants clauses are included in all commercial contracts. Traditionally, the nomenclature has not been clearly delineated, and representation and warranties are grouped together in a manner that often led them to be viewed as synonymous terms.
Pharmacyclics Continues the Divisional Applications Debate in India
In 2024, the Indian Patent Office (“IPO”) issued the Patents (Amendment) Rules, 2024 (“Rules”), which, among other things, amended the rules relating to filing of divisional applications.
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