Last updated: August 16, 2025
Introduction
India Patent IN827DEN2012, granted in 2012, pertains to a pharmaceutical invention within the realm of drug formulations or manufacturing processes. As a core component of India’s burgeoning pharmaceutical patent landscape, this patent embodies specific claims surrounding a novel medicinal compound, formulation, or process innovation. This analysis delineates the patent’s scope, claims, and contextual landscape within India’s intellectual property regime. Such insights are crucial for stakeholders—including innovators, generic manufacturers, and legal practitioners—aiming to navigate patent enforcement, infringement risks, or licensing opportunities.
Overview of Patent IN827DEN2012
Patent IN827DEN2012 was granted by the Indian Patent Office on March 19, 2012, with an expiry date of March 19, 2022 (assuming the standard 20-year term from the filing date, which would typically be 2002). The patent focuses on a specific aspect of pharmaceutical innovation, likely in the realm of formulations or processes, based on India’s patent grant patterns.
The patent’s title, claims, and description (though not detailed here) generally aim to protect a novel compound or a unique method of preparation, with specific claims designed to prevent generic or infringing products from entering the market during patent life in India.
Scope of the Patent
1. Technical Scope:
The scope primarily depends on the patent’s claims—broad or narrow—crafted to balance enforceability and commercial utility. Typically, pharmaceutical patents at this stage may focus on:
- Novel chemical entities: Compositions containing unique compounds or derivatives not previously disclosed.
- Specific formulations: Liposomal, sustained-release, or targeting-specific formulations.
- Processing methods: Innovations in manufacturing or synthesis with improved efficiency, safety, or efficacy.
Without access to the patent’s full text, we infer that IN827DEN2012 emphasizes either a composition of matter or a manufacturing process, given the typical nature of Indian pharmaceutical patents.
2. Geographic Scope:
As an Indian patent, the rights are enforceable solely within India. The patent does not inherently extend protection beyond Indian jurisdiction unless filed and granted in other territories.
3. Legal Boundaries:
The patent’s enforceable scope hinges on the patent claims’ language. Broad claims may cover a wide array of formulations or processes, while narrow claims limit exclusivity but offer clearer enforceability.
Claims Analysis
1. Claims Structure:
Patent claims define the metes and bounds of patent protection:
- Independent Claims: Broader statements covering the core invention.
- Dependent Claims: Narrower claims that build upon independent claims, adding specific limitations.
2. Typical Claims in Indian Pharmaceutical Patents:
Given the patent’s date and nature, the claims likely include:
- Chemical composition claims covering a specific drug molecule or derivative.
- Method claims related to manufacturing or synthesis steps.
- Formulation claims for specific delivery systems or excipients.
3. Claim Specificity and Enforceability:
Indian patent law requires claims to be clear and supported by the description. Overly broad claims risk rejection during opposition or invalidation, while overly narrow claims may be easier to circumvent.
4. Notable Aspects:
- Novelty: Claims must specify features not disclosed elsewhere.
- Inventive Step: Claims must demonstrate an inventive advance over prior art.
- Utility: The claims must relate to a useful application, especially crucial in pharmaceuticals.
5. Limitations and Challenges:
- Patent Evergreening: NGOs and generic firms may challenge overly broad or incremental claims aimed at extending patent life.
- Clarity & Support: Claims must be sufficiently supported in the specification per Indian patent law standards.
Patent Landscape Context
1. Pre-Existing Patent Environment (Prior Art):
India’s patent system prior to 2005 did not grant patents for pharmaceuticals, but post-2005, patent laws became aligned with TRIPS standards. IN827DEN2012 exists within a landscape dominated by:
- Generic competition.
- Pre-grant and post-grant oppositions, often citing prior art.
- Patent challenges based on lack of inventive step or obviousness.
2. Innovation Trends:
The patent landscape emphasizes incremental innovations—modifications to improve stability, bioavailability, or manufacturing efficiency—rather than extensive structural novelty, especially in the Indian context, which prioritizes access and affordability.
3. Patent Litigation & Challenges:
Indian courts and the Controller of Patents have scrutinized pharmaceutical patents under Section 3(d)—which bars patenting of new forms of known substances unless they demonstrate enhanced efficacy—and other criteria to prevent evergreening. The fate of IN827DEN2012 could hinge on such considerations.
4. Subsequent Patent Activity & Volatility:
The expiration in 2022 opens avenues for generic manufacturers to enter the market, possibly leading to patent litigations or challenges, especially if the original patent claims are narrow or challenged on inventive grounds.
Implications for Stakeholders
- Innovators and Patentees: Need to carefully craft claims to maximize scope while complying with Indian Patent Law's standards, particularly avoiding claims that could be challenged under Section 3(d).
- Generic Manufacturers: Should analyze the patent claims critically for potential invalidity or design-around opportunities.
- Legal Practitioners: Must monitor patent opposition proceedings, especially as the patent approaches expiration, to understand the strength and enforceability of the claims.
Conclusion
Patent IN827DEN2012 exemplifies India’s evolving pharmaceutical patent landscape—balancing the encouragement of innovation with safeguards against evergreening. Its scope hinges on the specificity and breadth of the claims, framed within Indian patent law standards demanding novelty, inventive step, and utility. As the patent approached expiration, the landscape was likely marked by strategic patent protections, potential challenges, and opportunities for generic entrants.
Key Takeaways
- Indian pharmaceutical patents like IN827DEN2012 focus heavily on precise claims to balance patent rights with public interest.
- The patent’s scope depends on the claim language; broader claims are more challenging to defend if challenged.
- Patent validity in India is scrutinized through criteria including inventive step, novelty, and utility, especially under constraints like Section 3(d).
- The patent landscape reflects a mix of innovation, patent challenges, and fierce competition from generic manufacturers, especially upon patent expiry.
- Stakeholders should closely monitor patent claim scope and legal challenges for strategic decision-making.
FAQs
1. What are the common grounds for challenging Indian pharmaceutical patents like IN827DEN2012?
Challenges typically cite lack of novelty, obviousness, or failure to demonstrate enhanced efficacy under Section 3(d). Oppositions may also involve prior art references or insufficient disclosure.
2. How does Section 3(d) impact patenting of drugs in India?
Section 3(d) prevents patenting new forms of known substances unless they demonstrate increased efficacy, discouraging evergreening strategies and promoting access to affordable medicines.
3. Can an Indian patent be extended beyond the standard 20-year term?
Yes. Patent term extensions are possible under certain conditions, such as delays during patent prosecution, but generally, the patent expires after 20 years from filing.
4. What strategies can generics employ to work around patents like IN827DEN2012?
Generic manufacturers may seek to develop alternative chemical entities, different formulations not covered by claims, or non-Infringing processes to circumvent patent rights.
5. How does patent landscape analysis influence drug development in India?
It informs R&D investments, patent filing strategies, and legal risk assessments, ensuring innovations are protected while avoiding infringing existing patents.
References
[1] Indian Patent Office. Patent IN827DEN2012.
[2] Indian Patents Act, 1970, as amended.
[3] WIPO. Indian Patent Law and Practice.
[4] FICCI, "Pharmaceutical Patents and Innovation," 2018.
