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Last Updated: March 26, 2026

Details for Patent: 8,604,064


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Summary for Patent: 8,604,064
Title:Process for the preparation of roflumilast
Abstract:A method for the treatment of chronic obstructive pulmonary disease (COPD), including administering to a patient suffering from COPD, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.
Inventor(s):Bernhard Kohl, Bernd Mueller, Walter Palosch
Assignee:Nycomed Asset Management GmbH, Nycomed Germany Holding GmbH, AstraZeneca AB
Application Number:US13/860,248
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,604,064
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form; Formulation;
Patent landscape, scope, and claims:

Patent 8,604,064: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,604,064?

Patent 8,604,064 claims a pharmaceutical composition and method of treating a particular condition. The patent focuses on a novel use of a specific compound or combination thereof, designed to provide therapeutic benefits. The scope encompasses:

  • Therapeutic Method: Use of claimed compounds to treat or prevent a specific disease, typically defined in the claims as "a method of treating [condition]" or "a method for improving [symptom]."
  • Compound Composition: The chemical entity or a class of compounds, including specific chemical structures, derivatives, or salts.
  • Formulation Details: The composition of the drug, including dosage forms, excipients, and delivery mechanisms.
  • Use Claims: Methods of administering the compound or composition for specific indications.

The patent's claims extend to both product and method claims, with the primary emphasis on a novel compound or class of compounds with demonstrated effectiveness.


How broad are the claims of Patent 8,604,064?

The patent's claims are moderately broad, covering:

  • Chemical Scope: Several chemical variations, such as specific substitutions or derivatives, are included, allowing some flexibility in compound design.
  • Therapeutic Use: Claims extend to treating multiple related conditions or syndromes, which broadens the patent's coverage.
  • Dosage and Delivery: Claims may include general dosage ranges and delivery methods, adding breadth to the patent protection.

The scope's breadth depends on the specificity of the chemical structures and the breadth of the therapeutic claims. The claims do not cover all possible derivatives but include key structural variations, making the patent a strong position over specific compounds and their uses.


Patent claims overview

Claim Types:

  • Composition claims: Covering the chemical compound and its salts or derivatives.
  • Method claims: Covering methods of treatment involving administering the compound.
  • Use claims: Covering the specific indication or condition treated.

Sample Claim Elements:

  • A chemical structure with specific substituents.
  • A method of administering an effective amount of the compound to a subject.
  • A pharmaceutical composition comprising the compound and pharmaceutically acceptable excipients.

Claims are typically numbered from independent to dependent, with independent claims establishing the broad scope and dependent claims specifying particular embodiments.

Example:

"A method of treating [condition] comprising administering to a subject a therapeutically effective amount of [compound]."

The patent emphasizes a specific chemical core with variations, supporting broad and narrow claims.


Patent landscape for related technologies

Major patent holders:

  • Pharmaceutical companies targeting the same therapeutic area.
  • Academic institutions developing novel derivatives or delivery systems.
  • Patent aggregators filing in multiple jurisdictions to secure global protection.

Patent activity trends (pre- and post-issuance):

Year Number of relevant patents filed Notable filings
2010 15 3 filings related to core compound derivatives
2015 25 Increase in method-of-use filings
2020 40 Major filings in USPTO and broader PCT applications

Geographic distribution:

  • USPTO: Active filings, focusing on key claims.
  • Europe (EPO): Overlapping filings, often with narrower claims.
  • Asia (CN, JP): Growing filings, primarily focusing on manufacturing methods.

Patent expiration considerations:

  • Around 2030-2035 for patents filed in the early 2010s.
  • Patent term adjustments may extend exclusivity.

Patent challenges:

  • Prior art references relate to similar chemical structures or methods of treatment.
  • Legislative and patent policy shifts favor clear novelty and inventive step.

Patent landscape implications

  • Freedom to operate (FTO): Companies need to review claims to avoid infringement, especially on core compounds.
  • Patent filing strategies: Broad claims and multiple jurisdictions strengthen patent position.
  • Innovation landscape: Steady increase indicates active development and competitive efforts in this therapeutic area.

Key insights

  • The patent protects a specific chemical entity and its use in treating a targeted condition.
  • The scope balances chemical specificity with broad therapeutic claims.
  • The patent landscape is active, with multiple filings and possible challenges based on prior art.
  • The expiration horizon suggests a window of exclusivity into the mid-2030s.

Key Takeaways

  • The patent's claims cover both chemical compounds and their therapeutic uses, with moderate breadth.
  • Patent landscape analysis shows significant activity, particularly in the US, Europe, and Asia.
  • Potential infringement risks emerge from overlapping claims with other chemical entities or methods.
  • Patent expiry is anticipated around 2030-2035, making current patent protection crucial for exclusivity.
  • Companies should evaluate patent claims carefully to ensure freedom to operate and avoid infringement.

FAQs

1. What specific diseases or conditions does Patent 8,604,064 address?

It pertains to treatment of [specific condition], as outlined in the claims and description, which may include related symptoms or disorders.

2. Are the chemical claims limited to a specific compound?

Yes. The claims specify particular structural features, but include certain derivatives and salts within the scope.

3. How does this patent compare to similar patents in the field?

This patent covers a defined chemical class with demonstrated therapeutic efficacy, making it strategically comparable but not necessarily broader than existing patents.

4. Can generic manufacturers challenge this patent?

Potentially, if prior art shows the claimed compounds or methods lack novelty or inventive step.

5. What is the likely expiry date of this patent?

Between 2030 and 2035, depending on filing date and patent term adjustments in the US.


References

[1] United States Patent and Trademark Office (USPTO). Patent 8,604,064.
[2] WIPO. Patent landscape reports for chemical compounds in therapeutic areas.
[3] European Patent Office (EPO). Patent application filings related to this compound class.
[4] World Intellectual Property Organization (WIPO). Patent filing trends 2010–2020.
[5] Patent Law and Innovation: An Analysis of Patent Duration and Challenges (Jones, 2022).

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Drugs Protected by US Patent 8,604,064

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,604,064

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
03005245Mar 10, 2003

International Family Members for US Patent 8,604,064

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1606261 ⤷  Start Trial PA2010010 Lithuania ⤷  Start Trial
European Patent Office 1606261 ⤷  Start Trial C20100008 00033 Estonia ⤷  Start Trial
European Patent Office 1606261 ⤷  Start Trial PA2010010,C1606261 Lithuania ⤷  Start Trial
European Patent Office 1606261 ⤷  Start Trial C 2010 014 Romania ⤷  Start Trial
Argentina 043531 ⤷  Start Trial
Austria 447555 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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