Tag: clinical trials
January 21, 2021
Intellectual Property | Patent
Intellectual Property | Patent
Filing data after applying for an Indian patent: Drafti...
Applying for a patent is a race against time to secure the earliest priority date (i.e., the date of the first filing of a patent application). As a result, patent applications are often filed with accompanying data that do not always capture all the facets of the invention. In such cases, using post-filing data to support the applications is often the only course available. ......
April 21, 2020
Intellectual Property | Other | Pharmaceuticals
Intellectual Property | Other | Pharmaceuticals
Changes to the Regulatory Framework for Clinical Trials...
The total cost for bringing a new prescription drug to market is about USD 2 to 3 billion (DiMasi et al.). A significant portion of this cost is incurred in conducting clinical trials. The global clinical trials market size is expected to reach USD 69.8 billion by 2027, exhibiting a 5.1% compound annual growth rate (‘CAGR’) during the forecast period. ...
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....
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.
India upgrades its guidelines for computer-related inventions
India's new 2025 CRI Guidelines clarify patentability for computer-related inventions, which will impact applications in cutting edge areas, including AI, ML, and Blockchain technology.
Of informed users and dissected designs: The Delhi High Court clarifies essentials of desi...
What is the standard that decides whether a design is novel or not? The Delhi High Court clarifies that instructed eye or informed user test remains the primary standard in Indian design law.
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