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A Comprehensive Analysis of Patent Invalidation System in India: Legal Framework, Procedural Changes, and Practical Challenges
The patent invalidation system in India is centered around the 1970 Patent Act, which features a balance between innovation incentives and public health (especially drug accessibility). Through strict patentability standards (such as Article 3 (d)) and unique post grant opposition procedures, India stands out in the global intellectual property system. This article combines legal provisions, case evolution, and procedural changes to systematically analyze the key rules and practical strategies of India's patent invalidation system.
PART .01
Legal Basis:Legal grounds for patent invalidity (Article 64 of the Indian Patent Act)
According to Article 64 of the Indian Patent Act, the circumstances in which a patent may be declared invalid include:
Core Features:
Article 3 (d): India's unique "efficacy threshold" was established in Novartis v. India (2013) as the main basis for invalidation of drug patents.
Compulsory licensing association: Patent invalidity is often linked to compulsory licensing procedures (Article 84) to promote the production of generic drugs.
PART .02
Invalid program:Dual track system of objection and revocation of litigation after authorization
Time limit: Submit to the Indian Patent Office (IPO) within one year after the patent authorization announcement.
Subject qualification: Any interested party (including competitors, NGOs, individuals).
core process
Features:
Low cost and efficient: The cost is about 2000-5000 US dollars, and the average processing time is 12-18 months.
Evidence flexibility: New evidence can be submitted, including experimental data and expert opinions.
Jurisdiction Court:
High courts of various states (since the abolition of IPAB in 2021).
Applicable situation:
Challenge the validity of the patent after the objection period expires;
Presented as a counterclaim in infringement litigation.
Program features:
Strict rules of evidence: all evidence must be listed in the complaint (Order VI Rule 2 of the Civil Procedure Law);
High cost and long cycle: The litigation cost is about 50000 to 200000 US dollars, with an average time of 3-5 years.
PART .03
Program Reform: Judicial Adjustment after the Abolition of IPAB
Function transfer of IPAB:The 2021 Tribunals Reforms Act abolished the Intellectual Property Appeals Board (IPAB) and transferred its jurisdiction over patent invalidation appeals to the High Court.
Practical impact:
Decentralization of jurisdiction: Different higher courts may make different judgments on similar cases;
Decreased professionalism: The court lacks technical expert support from IPAB and relies more on external expert testimony.
PART .04
Rules of Evidence and Focus of Attack and Defense
Burden of proof:The burden shall be borne by the invalid requester, who must meet the "preponency of probability" standard.
Core evidence type:
Time limit for evidence submission: In court proceedings, a list of evidence must be submitted within 30 days after filing (Article 137 of the Patent Rules).
PART .05
Typical Cases and Rule Evolution
1 Novartis v. Union of India（2013）：
The Supreme Court cited Article 3 (d) and determined that the patent for the new crystal form of Imatinib is invalid, establishing the examination standard of "efficacy improvement".
2 Bayer v. Natco（2019）：
The Delhi High Court revoked the patent for the liver cancer drug sorafenib due to lack of creativity and adopted a combination of existing technical literature.
3 Lee Pharma v. AstraZeneca（2016）：
The patent controller revoked the patent of diabetes drug Shagliptin on the grounds of insufficient disclosure of the specification.
PART .06
Practical Strategies and Industry Guidelines
Quick decision priority: For high-risk patents (such as drugs), priority should be given to raising objections within 1 year after authorization.
Infringement countermeasure: file a counterclaim to withdraw within 30 days after receiving the infringement complaint (Article 107 of the Patent Law).
Article 3 (d): Collecting and comparing data on the bioavailability and stability of drugs to demonstrate no significant improvement in efficacy;
Compulsory licensing linkage: promoting patent invalidity through public interest defense (such as Natco v. Bayer).
Localized evidence: Prioritize the use of Indian journals and clinical practice guidelines as existing technologies;
Notarization and authentication: Overseas evidence must be authenticated by the Indian embassy or consulate abroad, and non English documents must be accompanied by translated copies.
