Tag: FDA
July 20, 2023
Intellectual Property | Patent
Intellectual Property | Patent
Experiments with Animals: The long road to preventing a...
Over 100 million animals are used in laboratory experiments worldwide every year. These are only estimates; the exact number is unknown and could possibly even be higher. These animals are either killed outright in scientific procedures, or used to assess the safety and efficacy of drugs and cosmetics. ......
July 3, 2023
Intellectual Property | Patent
Intellectual Property | Patent
When medicines are out of reach: Managed Access Program...
Before a new drug, biologic or medical device is approved and authorized for market launch, it has to undergo a long and complex process involving extensive testing and clinical trials to ensure its safety and efficacy. However, for patients who have exhausted all other options, sometimes an unapproved or pre-approved or investigational drug could be the only hope. ......
January 30, 2023
Intellectual Property | Patent
Intellectual Property | Patent
Exports under the Bolar Exception: A Key Arrow in the I...
India is the largest producer of generic drugs in the world, and thus, it is no surprise that a great deal of patent litigation in India has centred on the manufacture of generics. While there are provisions in the law that permit the use of patented drugs for research and development (“R&D”) and for obtaining regulatory approvals, permissibility around the export of such drugs for similar purposes can be in the grey. ......
Navigating Share Transfer Restrictions in Shareholders’ Agreements
Transfer restrictions in shareholder agreements ("SHA(s)") have come to play a critical role in shaping deal dynamics. With India reporting a steady growth in mergers and acquisitions ("M&A"), questions of control, transfer restrictions, ownership flexibility and exit options have become crucial for investors and companies alike.
The Infringer’s Burden in Process Patent Suits in India
Indian patent law contains a unique provision that shifts the burden of proof onto the accused / infringer in process patent suits. But this applies only if certain conditions are met.
NCLT’s Jurisdiction for Fraud in Oppression and Mismanagement Petitions: The Supreme...
The role of the National Company Law Tribunal ("NCLT") as a specialised forum under company law has often led to questions around the exact scope of its jurisdiction.
Can a Trade Mark be opposed in India before it is Advertised for Opposition?
In India, the law provides for formal opposition to a trademark application only after it is advertised, but can a third party intervene even during the pre-advertisement stage?
Essential Clauses in a Contract – Force Majeure in light of Regulatory Shifts and Co...
In August 2025, Dream11, an Indian fantasy sports platform, terminated its Rs. 358 Crore sponsorship agreement with the Board of Control for Cricket in India ("BCCI").
A New Era in Online Gaming Regulation: Introduction to India’s latest Gaming Act
On 20th August, 2025, the Ministry of Electronics and Information Technology (“MeitY”) announced the Promotion and Regulation of Online Gaming Bill, 2025 (“the Act”), a significant legislative milestone which has since received the President’s assent and become an Act.
Guide to the 13th Nice Classification (2025-26) for Trademarks in India
The updated 13th edition of the Nice Classification reclassifies goods and services to streamline the trademark application and registration process.
A Stitch in Time: Quia Timet and Trademarks in India
Brand owners can use quia timet actions in India proactively to stop trademark infringement before it even happens, but must be careful about how, when and before which forum they seek remedies.
May or Shall: A Curious Case of usage in Arbitration Clauses
In a recent judgment, the Supreme Court ("SC") in BGM and M-RPL-JMCT (JV) v. Eastern Coalfields Limited reiterated that not every inclusion of an arbitration clause in a contract would amount to a valid arbitration agreement...
E-Acceptance of Arbitration Agreements: Valid under Law?
The emergence of digital platforms catering to instant communication has transformed the structure and form in which business transactions are negotiated between the parties.
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