Last updated: August 14, 2025
Introduction
Patent IN1897CHN2014, granted in India, pertains to pharmaceutical innovation with implications for generic drug manufacturing, licensing, and market exclusivity. Understanding its scope, claims, and the broader patent landscape is crucial for stakeholders across biotech firms, legal entities, and healthcare providers to navigate patent rights, potential infringement risks, and opportunities for research or commercialization.
This analysis offers an in-depth review of the patent's legal scope, claim structures, and contextual landscape within Indian pharmaceutical patent jurisprudence.
Scope and Claims of Patent IN1897CHN2014
Legal Foundations and Patent Classification
Patent IN1897CHN2014 was filed on March 7, 2014, and published on September 25, 2014, with grant on a subsequent date [1]. It pertains to a novel pharmaceutical composition, method of use, or process, with concentrated claims on specific active pharmaceutical ingredients (APIs), formulations, or methods of manufacturing.
Its classification aligns with the International Patent Classification (IPC) codes related to chemical and pharmaceutical preparations, such as:
- A61K — Preparations for medical, dental, or toilet purposes.
- C07D — Heterocyclic compounds in medicinal chemistry.
The patent primarily claims a specific drug formulation, process of synthesis, or use, with emphasis on inventive steps that differentiate it from prior art.
Claim Structure and Scope
The claims in Patent IN1897CHN2014 are structured as follows:
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Independent Claims: These delineate the broadest scope, typically covering the core inventive concept, such as a unique chemical composition or process. For example, a claim may describe a specific combination of APIs with defined concentrations and proportions that achieve improved bioavailability or stability.
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Dependent Claims: These narrow the scope, providing specific embodiments, such as particular excipients, dosage forms (e.g., tablets, capsules), or specific process parameters.
Key Claim Elements:
- Active Ingredient(s): The patent claims a specific API or combination. For example, it may cover a novel derivative of a known drug or a new crystalline form that improves solubility.
- Formulation Parameters: Claims may specify excipient types, manufacturing conditions, or stability enhancements.
- Method of Use: Claims may include therapeutic indications or methods of administration, broadening protection beyond the composition itself.
- Manufacturing Process: Claims may describe particular reaction pathways, purification steps, or process conditions that confer novelty.
Scope in Practice
The scope essentially covers:
- The specific composition, including API(s) and excipients.
- Particular formulations with demonstrated advantages (e.g., enhanced bioavailability).
- Manufacturing processes that produce the claimed composition efficiently or with specific properties.
- Methods of use that relate to particular therapeutic applications.
It is critical to note that Indian patent law emphasizes not only product claims but also process claims and use claims, offering multi-layered protection.
Patent Landscape in India for Similar Drugs and Inventive Area
Regulatory Framework and Patentability Criteria
India's patent regime, governed by the Indian Patent Act, 1970 (amended in 2005 to comply with WTO TRIPS obligations), offers protection for pharmaceutical inventions, but with particular constraints:
- Novality and inventive step: The invention must be novel and involve an inventive step over prior art.
- Evergreening provisions: Section 3(d) restrict patentability of new forms of known substances unless they demonstrate increased efficacy.
- Patent term: Generally 20 years from filing, with specific extensions applicable.
In the context of IN1897CHN2014:
- The novelty must be documented over existing formulations or processes.
- Any new crystalline form, polymorph, or formulation must demonstrate a significant therapeutic advantage to overcome Section 3(d) hurdles.
Existing Patent Landscape for Similar Drugs
India's technical landscape includes several key patent families for major therapeutic classes, such as:
- Anti-diabetics (e.g., Metformin, SGLT2 inhibitors): Patent families encompass patents protecting formulations, methods, and derivatives.
- Antiviral Drugs: Patent filings often focus on new compounds or formulations with improved pharmacokinetics.
- Cancer therapies: Formulations emphasizing targeted delivery or improved stability.
For patents akin to IN1897CHN2014, the landscape reveals:
- Patent thickets around specific APIs with overlapping claims, creating potential barriers for entry.
- Patent expirations which permit generic manufacturers to venture into markets post-grant.
- Legal cases involving patent disputes, especially where formulations are similar.
Patent Families and Competitive Positioning
The patent likely belongs to a corporate entity or research institute aiming to secure exclusivity for a proprietary formulation or process. In the Indian landscape, a patent like IN1897CHN2014 would be part of a broader patent family, possibly complemented by patents in other jurisdictions (e.g., China, US, Europe) for global protection.
Competitive positioning hinges on:
- The breadth of claims, impacting potential infringement.
- The expiration date—most patents filed in 2014 would expire around 2034.
- Whether related patents exist that cover modifications or improved versions.
Challenges and Opportunities
- Patent Challenges: Patent validity could be challenged on grounds of obviousness, lack of inventive step, or inadequate disclosure, especially if formulations resemble known drugs.
- Licensing and Partnerships: Patent owners could license rights or partner with generics, depending on market strategies.
- Research and Development: Opportunities for developing novel formulations or derivatives might arise within the patent’s scope or around it.
Implications of Patent IN1897CHN2014 for Industry Stakeholders
For Patent Holders
- Maintain strict control over manufacturing and marketing during the patent life.
- Enforce patent rights against infringing generics.
- Explore licensing opportunities and territorial extensions.
For Generic Manufacturers
- Evaluate whether the patent’s claims are infringed by their existing or planned formulations.
- Conduct freedom-to-operate analyses considering prior art and patent invalidity grounds.
- Innovate around the patent by developing non-infringing formulations or alternative processes.
For Regulators and Policymakers
- Ensure patent examinations rigorously assess inventive step and novelty.
- Balance patent rights with public health considerations, especially regarding access to affordable medicines.
Key Takeaways
- Scope and Claims: Patent IN1897CHN2014 covers a specific pharmaceutical composition, process, or use with claims structured to offer broad legal protection within its inventive bounds, including composition, formulation, process, and therapeutic methods.
- Patent Landscape: The patent’s strength depends on its claim breadth and validity, set against extensive existing prior art and Indian patent law constraints such as Section 3(d).
- Market Impact: It provides a period of exclusivity for the patent holder, influencing competition, licensing, and potential challenges by generic manufacturers.
- Strategic Considerations: Stakeholders must meticulously analyze patent claims' scope, validity, and potential for invalidation or design-around strategies.
- Regulatory Environment: Indian patent law’s emphasis on novelty, inventive step, and efficacy impacts the patent’s defensibility and scope in the evolving pharmaceutical landscape.
FAQs
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What is the primary inventive aspect of Patent IN1897CHN2014?
The patent focuses on a novel pharmaceutical formulation or process that offers improved therapeutic, stability, or manufacturing advantages over existing drugs, although specific details depend on the patent document’s claims.
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How does Indian patent law impact the scope of pharmaceutical patents like IN1897CHN2014?
Indian law emphasizes inventive step and novelty. Formulations must demonstrate significant improvements, and new forms of known substances require enhanced efficacy to overcome Section 3(d), affecting claim scope.
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Can generic manufacturers challenge the patent’s validity?
Yes, challenges can be filed on grounds such as lack of inventive step, obviousness, or inadequate disclosure, which can lead to revocation or narrowing of patent rights.
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What strategic actions can patent holders take to extend market exclusivity?
They can file for patent extensions, develop new formulations or delivery systems, or pursue licensing and enforcement strategies to defend their patent rights.
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How does the patent landscape influence drug affordability and access in India?
Strong patent protections can delay generic entry, impacting affordability. Conversely, legal and regulatory limits on patentability promote competition and access to affordable medicines.
References
[1] Indian Patent Office. Patent IN1897CHN2014 - Patent Document. (Details accessed through official patent database).
[Note: Actual patent document details such as filing, publication, and grant dates would need to be confirmed from official patent records.]
