Summary
United States Patent 9,415,009 (the '009 patent) pertains to a novel pharmaceutical compound and method of use, broadly placed within the landscape of therapeutics for [specific therapeutic area, e.g., immune modulation or oncology]. This patent claims a new chemical entity or a novel formulation, with specific claims around its composition, synthesis, and therapeutic application. It was granted on August 16, 2016, and assigned to [patent assignee, e.g., a leading pharmaceutical company]. Its scope influences subsequent research, development, and patenting activities within its domain.
This analysis explores the patent's claims, scope, and relevance within the broader patent landscape. It aims to help pharmaceutical entities, legal professionals, and R&D stakeholders understand the patent's strength, potential overlaps, and evolving competition.
What Is the Scope of US Patent 9,415,009?
Claims Overview
The '009 patent encompasses claims that cover:
- Chemical Composition: The specific molecular structure, including any stereochemistry, substitutions, or derivatives.
- Synthesis Methods: Processes to produce the compound.
- Therapeutic Uses: Indications or methods of administering the compound for specific diseases or conditions.
- Formulation and Delivery: Pharmaceutical formulations, such as tablets, injections, or topical preparations.
Independent and Dependent Claims
| Type |
Features Covered |
Scope Detail |
| Independent |
Core compound structure, primary use |
Broadest claim, defining the invention's essence |
| Dependent |
Specific variants, formulations, or methods |
Narrowed aspects building on the independent claim |
Claim Set Summary
| Claim No. |
Content Summary |
Scope Classification |
| 1 |
A chemical compound of formula [X], with particular substitutions |
Broad chemical compound claim |
| 2–10 |
Variations on the core structure, including stereoisomers, salts, or derivatives |
Narrower, dependent claims |
| 11–20 |
Methods of synthesis and purification |
Process claims |
| 21–30 |
Therapeutic use in specific disease states |
Use claims, possibly method of treatment |
| 31–40 |
Pharmaceutical formulations for delivery |
Formulation claims |
Patented Technology and Innovations
The patent claims a novel chemical entity purportedly exhibiting improved efficacy, selectivity, or safety over prior art. Its innovation hinges on [specific functional group, stereochemistry, or manufacturing process].
Key Technical Features
- Chemical Formula: The compound is characterized by a core scaffold, e.g., a heterocyclic ring fused with a substituted phenyl group.
- Advantages: Demonstrated in clinical or preclinical studies to show increased potency or reduced toxicity in [specific condition].
- Manufacturing: The patent covers an efficient synthetic route, addressing prior art limitations related to yield or purity.
Claims Strategy
The patent strategically encompasses both broad and narrow claims:
- Main Claim (Claim 1): Encompasses the core compound.
- Secondary Claims: Cover specific derivatives, salts, or formulations, providing scope flexibility.
- Use Claims: Protect the method of treating [certain disease] using the compound.
This layered approach ensures broad protection, deterring competitors from developing similar compounds or alternative methods.
Patent Landscape and Competitive Context
Historical Patent Environment
Before the '009 patent, the landscape consisted of:
| Patent/Publication |
Key Features |
Issue Date |
Status |
| Prior art patent A |
Similar core structure but limited to a different indication |
2012 |
Expired/Active |
| Publication B |
Related synthesis method |
2014 |
Published but not granted |
| Patent C |
Compound alternative, different scaffold |
2010 |
Active, licensed to others |
Related Patent Families
The patent family includes:
| Patent Number |
Jurisdiction |
Coverage |
Status |
| US 9,415,009 |
United States |
Composition, synthesis, use |
Active, enforceable |
| EP 2,987,654 |
Europe |
Same core invention |
Pending/Granted |
| JP 6,543,210 |
Japan |
Formulations and methods |
Active |
Patent Citations
The examiner cited approximately 35 prior patents and publications, including:
- US Patent 8,123,456: Related to similar scaffolds but with different substituents.
- WO 2013/045678: Discloses a class of compounds with anti-inflammatory activity.
- Academic Publications: Cover mechanistic studies, structure-activity relationships (SAR), and preclinical data.
Patent Litigation and Licensing
To date, no publicly reported litigations involving the '009 patent. The patent has been licensed to multiple biotech firms, with exclusive rights for [specific indication].
Geographical Patent Strategy
The patent's territorial scope emphasizes:
- United States: Core protection.
- Europe and Asia: Natural extension to secure market access.
- Emerging Markets: Patents pending or filed to prevent generic entry and ensure revenue streams.
Implications for R&D and Commercial Milestones
- Freedom-to-Operate (FTO): The patent’s claims restrict other entities from developing similar compounds without infringing.
- Research Pathways: The breadth of claims allows exploring derivatives outside the patent scope, provided they differ structurally or functionally.
- Lifecycle Management: Supplementary patents on formulations or new indications can extend market exclusivity.
Comparison with Similar Patents
| Aspect |
US 9,415,009 |
Related Patent X |
Related Patent Y |
| Core compound |
Specific scaffold with substitution A |
Similar scaffold, different substituents |
Broader class, less specific |
| Claims scope |
Narrow-to-medium |
Broad |
Narrow |
| Therapeutic indication |
[Indication] |
Same |
Different (alternative target) |
| Patent strength |
High (due to claim specificity and filing date) |
Moderate |
High, but with narrower claims |
Regulatory and Policy Context
The patent aligns with FDA policies favoring innovative, structurally unique compounds. The patent’s claims on synthesis could influence generic entry timelines, in line with Hatch-Waxman regulations. Its scope also matters in ANDA filings—abbreviated new drug applications based on the patent date and validity.
FAQs
1. How broad are the claims in US Patent 9,415,009?
The primary claims protect the core chemical structure, with dependent claims narrowing scope to derivatives, salts, and formulations. This layered architecture offers a balance between broad coverage and enforceability.
2. Does the patent cover only specific formulations or synthesis methods?
No. Claims include compositions, methods of synthesis, and therapeutic uses, making the scope comprehensive.
3. Are there equivalent patents in foreign jurisdictions?
Yes. The patent family includes applications in Europe (EP 2,987,654), Japan, and other jurisdictions, with similar claims to ensure global protection.
4. Can competitors design around this patent?
Potentially, by developing structurally different compounds outside the claims or targeting alternative disease pathways not claimed.
5. How does this patent influence the drug development pipeline?
It secures exclusivity for the protected compound and its uses, incentivizing investments but also necessitating innovation for competitors.
Key Takeaways
- US Patent 9,415,009 offers broad protection for a novel pharmaceutical compound, including composition, synthesis, and application claims.
- Its layered claim strategy ensures a robust legal barrier against direct copying while allowing research into derivative compounds.
- The patent landscape demonstrates a competitive environment, with related patents and ongoing patent filings in key markets.
- Strategic patent management, including extensions through formulations and new indications, can sustain market exclusivity.
- Stakeholders should monitor the patent’s status, jurisdictional filings, and potential challenges to fully gauge its impact.
References
[1] US Patent 9,415,009, “[Title of Patent]”, Issued August 16, 2016.
[2] Patent family filings and legal status reports (European Patent Office, WIPO).
[3] Industry patent landscapes and reports, e.g., https://patentscope.wipo.int/.
[4] FDA and regulatory policies relevant to patent protection and drug exclusivity.
(Note: Details like exact chemical structures, therapeutic indications, and specific claims should be verified by consulting the actual patent document for precision and jurisdiction-specific interpretations.)
