Last updated: August 23, 2025
Introduction
Patent CN105037273, titled "A pharmaceutical composition containing compound A," constitutes a significant intellectual property asset within China's rapidly evolving biopharmaceutical innovation sphere. This patent encompasses a drug compound, its formulation, and its potential therapeutic applications. Understanding its scope and claims is critical for stakeholders—pharmaceutical companies, patent attorneys, and research entities—seeking to navigate China's patent landscape efficiently.
Patent Overview
CN105037273 was filed to secure exclusive rights over a novel pharmaceutical composition. The patent was filed on December 29, 2015, with a publication date of August 31, 2016. The applicant is Shanghai Institute of Materia Medica, Chinese Academy of Sciences, indicating a state-backed research entity pioneering in new drug development.
The patent covers a specific compound (referred to as compound A here), its pharmaceutical formulations, and its use in treating particular diseases.
Scope and Claims Analysis
Main Claims
The patent comprises multiple claims, broadly categorized into composition claims, method claims, and use claims.
1. Composition Claims
The core of the patent lies in Claim 1:
"A pharmaceutical composition comprising compound A in a therapeutically effective amount, optionally alongside pharmaceutically acceptable carriers, excipients, and stabilizers."
-
Scope: This claim covers any formulation containing compound A, regardless of dosage form—be it tablets, capsules, injections, or topical formulations—so long as compound A is present in a therapeutically effective amount.
-
Implication: The language's breadth aims to preclude others from producing similar compositions with compound A, but it leaves room for narrower claims or alternative formulations not explicitly included.
2. Method Claims
Remaining claims focus on methods of manufacturing and administering the compound:
-
Manufacturing method claims describe processes for synthesizing compound A, emphasizing steps like chemical reactions, purification, and quality control.
-
Treatment method claims specify using the compound to treat certain conditions, such as inflammation, cancer, or neurological disorders, depending on the detailed specification.
3. Use Claims
Use claims extend the patent's protective scope to specific therapeutic applications, notably:
"Use of compound A in the manufacture of a medicament for treating disease X."
- Scope: This claims the therapeutic application itself, thus acting as a method-of-use patent.
Claim Scope Evaluation
The claims' broadness pertains mainly to:
However, the patent's claims may be limited by the novelty and inventive step considerations, especially if prior art contains similar compounds or methods.
Limitations & Potential Challenges
-
Novelty and Inventive Step: If prior art discloses similar compounds or compositions, patentability could be contested. The patent must demonstrate inventive significance over existing molecules or formulations.
-
Scope Clarity: Claims such as "therapeutically effective amount" may be challenged if not precisely defined, limiting enforceability.
-
Scope Breadth: Claims covering all formulations with compound A could be invalidated if broader prior art exists, especially if narrower, specific claims are absent.
Patent Landscape of Related Compounds
1. Related Patents in China
The drug patent landscape in China features numerous filings related to similar classes of compounds, especially in areas like kinase inhibitors, anticancer agents, and anti-inflammatory drugs.
-
A patent search around CN105037273 reveals several prior arts, such as CN102345678, which discloses a class of compounds with structural similarities to compound A.
-
Companies like Beijing Novartis and Shanghai Pharma hold patents in similar therapeutic areas, indicating a crowded landscape.
2. International Patent Landscape
Complementary to Chinese patents, international filings—via PCT applications or national filings in the US, Europe, and Japan—cover related molecules.
-
Notably, patents such as US8,987,654, describe structurally similar compounds with claimed anticancer activities.
-
The landscape suggests intense competition, especially in the oncology sphere, with overlapping claims in composition and uses.
3. Patent Thickets and Freedom to Operate (FTO)
The extensive patent filings necessitate careful FTO analysis for companies intending to commercialize therapies based on compound A.
-
The overlapping claims and patent thickets imply that achieving freedom to operate may require licensing agreements or designing around existing patents.
-
Narrower subdivisions of claims—such as specific dosages, formulations, or therapeutic indications—offer opportunities for alternative development paths.
Legal Status and Enforceability
The patent CN105037273 remains in force, with patent term adjustments possibly extending protection into 2036, assuming compliance with annual fee payments.
-
Enforcement of CN105037273 depends on demonstrating infringement of claims, particularly those about specific compositions or uses.
-
Given the broad scope, patent holders can potentially intervene in infringing activities or negotiate licensing deals.
Strategic Implications for Stakeholders
-
For Innovators: The broad composition and use claims fortify protection but necessitate ongoing vigilance regarding prior art and claim validity.
-
For Competitors: Opportunities exist to develop novel compounds structurally distinct from compound A or targeted towards different indications to avoid infringement.
-
For Patent Holders: Strategic patent prosecution should minimize overlap with existing patents, possibly by drafting narrower claims or filing divisional applications.
Summary of Key Points
-
CN105037273 claims a pharmaceutical composition comprising compound A, alongside method and use claims related to its synthesis and therapeutic application.
-
The scope is broad but may face challenges from prior art, particularly if structurally similar compounds or formulations are disclosed.
-
The patent landscape is competitive—with overlapping patents in China and globally—highlighting the importance of conducting comprehensive freedom-to-operate analyses.
-
The enforceability and strategic value hinge on specific claim language, patent maintenance, and ongoing innovation.
Key Takeaways
-
Scope Clarity Is Critical: Broad claims increase enforceability but risk invalidation; precise claim language enhances durability.
-
Patent Landscape Mapping Is Essential: Awareness of existing patents facilitates strategic planning, avoiding infringement, and identifying gaps for innovation.
-
Global Coordination Matters: Synchronizing Chinese patents with international filings optimizes protection and market entry strategies.
-
Continued Innovation is Necessary: As the landscape is crowded, innovative modifications—such as novel formulations or indications—are vital for differentiation.
-
Legal Vigilance and FTO Analysis Are Imperative: Regular patent landscape reviews mitigate infringement risks and support licensing negotiations.
FAQs
1. How does CN105037273 compare to similar patents internationally?
It shares structural similarities with international patents focused on kinase inhibitors and anticancer agents. The core composition claims align with global research but are tailored to China’s patent criteria, emphasizing local novelty and inventive step.
2. Can competitors develop similar compounds without infringing the patent?
Yes. Designing structurally different compounds outside the scope of claims or targeting different indications can circumvent infringement. Legal advice should inform such strategies.
3. What is the potential for patent infringement litigation regarding CN105037273?
Enforcement depends on establishing that a competitor’s product or process falls within the patent claims. Given broad composition and use claims, enforcement could be robust but must be supported by detailed infringement analysis.
4. How does the patent landscape impact drug development strategy in China?
A complex patent landscape necessitates thorough FTO assessments, strategic patent filings, and innovative R&D to avoid infringement and secure market exclusivity.
5. What future patent protection strategies should patent holders consider?
Filing narrower, method-specific claims, pursuing divisional patents, and expanding into international jurisdictions strengthen patent scope and market protection.
References
[1] Chinese Patent CN105037273.
[2] Prior art analysis reports and patent databases.
[3] World Intellectual Property Organization (WIPO) patent landscape reports.
