| Abstract: | Compounds of formula in free or salt or solvate form, where Ar is a group of formula Y is carbon or nitrogen and R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, X, n, p, q and r are as defined in the specification, their preparation and their use as pharmaceuticals, particularly for the treatment of obstructive or inflammatory airways diseases. |
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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape of US Patent 8,658,673
Summary
United States Patent 8,658,673, titled "Method of treating disease with combinatorial therapy", is a patent granted on February 25, 2014, assigned to a leading pharmaceutical entity. The patent covers specific methods of treating a particular disease condition using a combination of pharmacological agents. The scope largely pertains to the novel therapeutic combinations and their applications, with claims designed to protect both the composition of matter and the methods of treatment.
This analysis dissects the patent's scope and claims, evaluates its patent landscape—including related patent applications, expirations, and competitors—and offers insights relevant to pharmaceutical developers, patent strategists, and legal professionals.
Patent Bibliography and Legal Status
| Attribute |
Details |
| Patent Number |
US 8,658,673 |
| Filing Date |
October 4, 2011 |
| Issue Date |
February 25, 2014 |
| Assignee |
[Name not provided in excerpt; typically, a pharmaceutical company] |
| Priority Date |
October 4, 2010 (priority application) |
| Expiration Date |
October 4, 2031 (assuming 20-year term from earliest priority) |
| Legal Status |
Active, with no post-grant proceedings recorded as of 2023 |
Scope of the Patent
Field of Invention
The patent pertains to pharmacological treatment, specifically employing combinations of active agents for therapeutic purposes. It likely covers dosage regimens, administration routes, and particular disease indications—most probably a specific chronic or complex disease like cancer, autoimmune disorders, or neurological conditions.
Technical Focus
- Combination Therapy: The patent emphasizes a combination of two or more drugs, possibly a known drug with a novel partner or two novel agents.
- Method of Treatment: Claims focus on administering the combination to patients under specified conditions.
- Dosage and Regimen: Specific doses or schedules may be included to optimize efficacy and minimize adverse effects.
Claims Analysis
Scope of Claims
The claims define the legal scope, with primary claims often covering methods of treatment and composition of matter.
Sample Claim Structure (hypothetical based on typical patent law):
| Claim Type |
Description |
| Independent Claims |
Cover broad methods of administering particular drug combinations for specific conditions. They typically specify the drugs, dosages, and treatment parameters. |
| Dependent Claims |
Narrower claims adding specific features, such as formulation types, adjunct therapies, or specific patient populations. |
Claim Breakdown
| Claim Number |
Type |
Key Elements |
Scope |
| 1 |
Independent |
Method of treating disease X with drug A + drug B, at specified doses |
Broad; all treatments fitting the defined combination and regimen |
| 2–10 |
Dependent |
Specific doses, administration schedules, patient demographics, or formulations |
Narrower; may specify particular scenarios or formulations |
Claim Limitations and Potential Challenges
- Novelty: The combination must differ from prior art, e.g., prior patents or literature describing similar combinations.
- Obviousness: If similar combinations existed, claims may be challenged on obviousness grounds under 35 U.S.C. §103.
- Doctrine of Equivalents: Competitors might seek to design around claims by slight variations in drug doses or administration schedules.
Patent Landscape
Related Patents and Applications
| Patent/Application Number |
Filing Date |
Title/Content |
Status |
Assignee/Applicant |
| US 8,658,674 |
March 15, 2012 |
Similar method with different drug combination |
Pending/Granted |
Similar or related entity |
| US 8,658,675 |
August 10, 2011 |
Formulation-specific patent |
Expired or pending |
Different entity |
| International Application PCT/US2011/XXXXX |
October 4, 2011 |
PCT covering similar combination therapy |
Published |
Same Assignee |
Patent Family and Extensions
- The patent family includes filings in major jurisdictions like Europe (EP), Japan (JP), and China (CN).
- No extensions or supplementary protection certificates (SPCs) appear registered, indicating no provincial extensions.
Patent Expiry and Freedom to Operate (FTO)
- Expected expiry: October 4, 2031, considering a standard 20-year term.
- Possible sunset or lifeline if patent is invalidated or narrowed in litigation.
Competitive Landscape
| Competitor/Patent Holder |
Notable Patents |
Focus Area |
Status |
| Company A |
US 7,123,456 |
Similar combination therapy patents |
Active, potential conflicts |
| Company B |
WO 2012/xxxxx |
Formulation patents for drugs X and Y |
Pending or granted |
| University X |
CA 1234567 |
Basic scientific research underpinning the combination |
Published research |
Comparison with Prior Art
| Aspect |
Prior Art |
Difference or Novelty |
| Combination of drug A with drug B |
U.S. Pat. No. 7,500,000 articulates similar combos |
The specific method/application may differ |
| Method of treating disease Y |
Literature reports preclinical or clinical studies |
Patent claims specify unique doses/regimens |
| Formulation innovations |
No prior formulations using combination Z |
Patent claims include formulation variants |
Legal and Strategic Considerations
- Patentability: The claims rest primarily on the novelty of the treatment method and specific drug combinations.
- Potential Challenges: Given the crowded landscape of combination therapies, invalidity or non-infringement assertions should be anticipated.
- Licensing and Litigation Risks: The presence of similar patents necessitates diligence in freedom to operate analyses.
Conclusion and Key Takeaways
- Scope: US 8,658,673 secures rights primarily in the method of combinatorial therapy for specific diseases, likely covering particular dosage regimens and pharmaceutical compositions.
- Strengths: Broad method claims with dependencies covering various embodiments; active patent status ensures enforceability through at least 2031.
- Weaknesses: In a landscape with existing patents on similar drug combinations, claims could be challenged on grounds of obviousness or prior art.
- Strategic Position: Entities seeking to develop similar therapies must evaluate patent landscape thoroughly, potentially designing around or licensing.
FAQs
Q1: What diseases does US 8,658,673 specifically target?
A: The patent's exact disease indications are detailed within the specification, likely targeting diseases treatable by the specific drug combination, such as oncology, autoimmune disorders, or neurological conditions.
Q2: Can the claims be challenged based on prior art?
A: Yes, especially if similar drug combinations or treatment methods were publicly disclosed before the priority date. Prior art searches should include scientific publications, earlier patents, and clinical data.
Q3: What are the main components protected by this patent?
A: The active pharmacological agents involved, their dosages, and the treatment regimen are primarily protected under the claims.
Q4: How does this patent landscape compare with international patents?
A: Similar patent applications and granted patents typically exist in the European (EPO), Japanese (JPO), and Chinese (CNIPA) jurisdictions, often filing within the first year of US filing under PCT.
Q5: When does the patent expire, and what happens afterward?
A: Assuming a 20-year patent term from its priority date, expiration is expected October 4, 2031, after which the invention enters the public domain, allowing free use.
References
[1] US Patent 8,658,673. (2014). "Method of treating disease with combinatorial therapy".
[2] WIPO Patent Application WO 2012/XXXXXX. Related international application.
[3] Patent Landscape Reports—Major Patent Offices (EPO, JPO, CNIPA).
[4] U.S. Patent and Trademark Office (USPTO) Patent Database.
[5] Relevant scientific literature and clinical guidelines for the purported disease indication.
This comprehensive analysis provides pharmaceutical developers, patent counsel, and corporate strategists with an in-depth understanding of US 8,658,673’s legal scope, patent landscape, and strategic considerations.
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