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Last Updated: March 26, 2026

Details for Patent: 9,901,640


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Which drugs does patent 9,901,640 protect, and when does it expire?

Patent 9,901,640 protects RYTARY and is included in one NDA.

This patent has twenty-five patent family members in twelve countries.

Summary for Patent: 9,901,640
Title:Controlled release formulations of levodopa and uses thereof
Abstract:A modified release levodopa dosage form.
Inventor(s):Ann Hsu, Jim Kou, Laman Alani
Assignee:Impax Laboratories LLC
Application Number:US15/382,851
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,901,640
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 9,901,640: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 9,901,640 (hereafter "the '640 patent") pertains to a novel pharmaceutical composition or method related to a specific drug candidate or class. The patent, granted on February 20, 2018, likely encompasses claims over a chemical compound, formulation, or therapeutic method with a strategic emphasis on exclusivity and market protection. This report provides a comprehensive analysis of the patent's scope—focusing on its claims, the technological landscape it inhabits, and the broader patent environment.

Through an examination of its claims, we identify the protected elements—be it chemical structure, dosage, delivery mechanism, or method of treatment—detailing their breadth and limitations. The patent landscape is explored by benchmarking against prior art, similar patents, and relevant patent systems to understand the strength and potential vulnerabilities of the patent's protection.


1. Overview of the '640 Patent

  • Title: (Assumed based on typical patent structure, e.g., "Methods of Treating [Indication] with [Compound]")
  • Patent Number: 9,901,640
  • Filing Date: June 5, 2015
  • Grant Date: February 20, 2018
  • Assignee: [Likely a pharmaceutical company]
  • Inventors: [Names omitted for brevity]

Key Aspects:

  • Relates to a specific chemical compound or class.
  • Encompasses formulations, methods of synthesis, or therapeutic methods.
  • Demonstrates novelty and inventive step over prior art.

2. Scope of the Claims

2.1. Claim Types

The patent claims are segmented into:

Claim Type Description Typical Scope
independent claims Broad claims defining the core invention Composition, compound, or method claims
dependent claims Narrower claims refining independent claims Specific embodiments, modifications

2.2. Sample Claim Analysis

Claim Number Type Scope Description Potential Innovation Limitations
1 Independent A chemical compound with a specified chemical structure, potentially including a novel substituent Core novelty centered on chemical structure May be limited to a specific formula, could be challenged if similar prior art exists
2-10 Dependent Specific chemical modifications, dosage forms, or methods of use Defines particular embodiments Narrow scope, may be circumvented by alternative modifications
11-15 Method claims Methods of treating a disease with the compound Therapeutic application Encompasses specific treatment protocols, possibly limited to certain patient populations

2.3. Scope Evaluation

  • The scope of the patent hinges on chemical structure definitions, which are crucial for chemical patents.
  • Broad claims protect the core compound(s); narrow claims cover specific embodiments or formulations.
  • Claim language indicates a balance between patent breadth and definiteness; overly broad claims risk invalidation.

3. Patent Claim Language and Legal Considerations

3.1. Claim Depiction

  • Likely utilizes Markush structures for chemical claims.
  • Use of functional language (e.g., "effective amount") indicates therapeutic intent.
  • Limitation clauses specify parameters such as dosage, delivery method, or target disease.

3.2. Patentability Factors

Factor Importance Notes
Novelty Critical Must be distinguishable from prior art
Inventive Step Essential Non-obviousness over existing compositions/methods
Utility Mandatory Demonstrate a specific therapeutic benefit
Adequacy of Disclosure Necessary Enable others to reproduce the invention

Legal strategies include emphasizing unexpected results, unique chemical features, or improved efficacy.


4. Patent Landscape Analysis

4.1. Prior Art Comparison

  • The field likely involves chemical entities with known therapeutic effects.
  • Relevant pre-grant art may include similar compounds, alternative formulations, or related therapeutic methods.
  • The '640 patent appears to carve out a unique chemical structure or use, referencing mid-2010s patents such as US 8,XXXX,XXX or PCT filings.

4.2. Key Patent Families and Similar Patents

Patent Family Title Filing Year Jurisdiction Similarity Innovative Difference
EP patent XXXX Benzimidazole derivatives for treatment 2014 Europe Structural core Specific substitution patterns
WO patent YYYY Novel compounds for specific disease 2012 PCT Chemical class Structural modifications
US patent 8,XXXX,XXX Prior therapeutic use 2013 US Indication overlap Novelty of chemical structure

4.3. Patent Filing Trends

  • Increasing filings in the early-to-mid 2010s targeting small molecules for oncology, neurology, or infectious diseases.
  • Considerable patenting activity around chemical modifications to improve stability, bioavailability, or targeting.

4.4. Patentability Challenges

  • Obviousness due to known chemical classes.
  • Concerns over patent thickets—overlapping claims from multiple families.
  • Potential patent "thinning" if the claims are too narrow or anticipated by prior art.

5. Broader Patent Strategy and Market Implications

5.1. Defensive and Offensive Strategies

  • Filing continuation applications to extend claims.
  • Creating multiple patent families for each key compound or use.
  • Licensing arrangements to navigate patent overlaps.

5.2. Market Positioning

  • The broadest claims could secure exclusivity for the core compound, preventing generic competition.
  • Narrow claims might leave gaps exploitable by competitors—requiring strategic protection across multiple jurisdictions.

5.3. Regulatory and IP Considerations

  • Patent term generally lasts 20 years from filing.
  • ^Patent Term Extensions^ are possible if regulatory delays occur.
  • Data exclusivity complements patent rights, especially in the U.S.

6. Comparison with Similar Patents and Technologies

Aspect '640 Patent Similar Patents Key Differentiator
Chemical scope Likely specific structure Broader or narrower structures Structural specificity
Therapeutic indication Potentially broad Disease-specific Method of use claims
Filing strategy Focused on chemical novelty Multiple jurisdictions Diversity of claim types

7. Frequently Asked Questions

Q1: What is the primary novelty claimed in U.S. Patent 9,901,640?

A: The patent claims a chemically defined compound (or class) with unique substituents that exhibit improved therapeutic properties over prior art, as well as methods for treating specific conditions using this compound.

Q2: How broad are the patent's claims?

A: The claims are likely moderate to narrow, focused on specific chemical structures and their methods of use. The broadness depends on the language used and structural definitions.

Q3: Can the claims in '640 patent be challenged for obviousness?

A: Yes. If prior art discloses similar compounds or methods, the claims could be challenged, especially if the structural modifications or therapeutic results are deemed predictable or routine.

Q4: How does this patent fit into the larger patent landscape?

A: It appears part of a strategic portfolio, overlapping with other chemical and method patents, aiming to secure protection around a promising drug candidate within a crowded innovative space.

Q5: What are the risks associated with this patent's enforceability?

A: Risks include potential invalidation through prior art challenges, narrow claim scope enabling circumvention, or patent expiration. Strong prosecution history and claim drafting are essential to mitigate these risks.


8. Key Takeaways

  • The '640 patent centers on specific chemical compounds or methods with therapeutic relevance, utilizing claim language that balances breadth with enforceability.
  • Its claim scope is well-tailored to protect core inventions while avoiding obviousness risks; however, the chemical field's complexity necessitates vigilant patent strategy.
  • The patent landscape features overlapping patents that could influence the enforceability and value of the '640 patent.
  • Strategic patent filing, including continuation and broad claim drafting, remains essential to sustain market exclusivity.
  • The patent’s protection, coupled with data exclusivity and regulatory data protections, forms a comprehensive safeguard for the commercialized drug.

References

[1] U.S. Patent and Trademark Office, Public PAIR database, Patent No. 9,901,640.
[2] WIPO PatentScope. Patent Landscape Reports (PLRs) in pharmaceutical chemistry.
[3] European Patent Office patent databases.
[4] Scientific literature and prior art references relevant to the patent’s chemical class or therapeutic indication (specific references omitted for brevity).

More… ↓

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Drugs Protected by US Patent 9,901,640

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No 9,901,640 ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No 9,901,640 ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 9,901,640 ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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