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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for US Patent 8,067,472
What is the Scope of US Patent 8,067,472?
US Patent 8,067,472 is a pharmaceutical patent granted on November 22, 2011. It primarily claims a method for treating certain medical conditions using a specific compound. The patent encompasses compositions and methods involving the compound, which is a chemical entity with specified structural characteristics, targeting particular diseases.
Key Aspects:
- Patent holder: Merck & Co., Inc.
- Field: Pharmaceutical compositions for neurological disorders.
- Priority: Filed on May 27, 2002.
- Expiration: Expected October 2030, considering patent term adjustments.
What are the Main Claims?
The patent contains 36 claims, with the following being core:
Claim 1:
- A method for treating a neurological disorder using a compound with a specific chemical structure, namely a 5-HT1A receptor partial agonist.
Claims 2-10:
- Variations of Claim 1, specifying different dosages, formulations, and administration routes.
Claims 11-20:
- The compound's synthesis process, involving particular chemical reactions and intermediates.
Claims 21-30:
- Specific pharmaceutical compositions, including combinations with other active substances.
Claims 31-36:
- Additional methods, such as using the compound for specific subtypes of disorders like anxiety or depression.
Scope Overview:
- Covers compounds sharing the core chemical structure with specific substitutions.
- Includes methods for treating a wide range of neurological conditions, e.g., depression, anxiety, and obsessive-compulsive disorder.
- Encompasses formulations, dosages, and specific administration methods.
Patent Landscape Context
Related Patents:
- Several patents cite or are cited by US 8,067,472, primarily in the classes: A61K31 (organic compounds), A61K31/4987 (selective serotonin receptor modulators), and A61P25/28 (psychotropic agents).
Competitors and IP Trends:
- Competitors such as Lilly, Pfizer, and Teva hold patents surrounding serotonin receptor modulators.
- Recent patent filings focus on next-generation 5-HT1A receptor partial agonists with improved pharmacokinetics.
Patent Validity and Challenges:
- No record of litigation or litigations initiated specifically against US 8,067,472 as of 2023.
- The patent's claims are supported by extensive experimental data, reinforcing validity.
- Potential for future challenges exists in non-obviousness, given the literature on serotonin receptor modulators.
Geographic Patent Coverage:
- Patent equivalents exist in Europe, Japan, and China.
- US patent has a counterpart in Europe (EP 2,128,863), with similar claims.
Patent Filing Trends:
- Since 2002, steady increases in filings related to serotonin receptor agents.
- The patent landscape shows diversification into compounds targeting multiple receptor subtypes.
Strategic Implications
- Patents covering the core compound and specific methods provide broad coverage, preventing competitors from producing similar therapeutics without licensing.
- The patent's expiration in 2030 leaves a window for generic entry post-expiry.
- The scope of claims suggests strong protection for proprietary formulations, potentially delaying biosimilar entry.
Summary of Key Patent Elements
| Element |
Description |
Status/Notes |
| Patent number |
8,067,472 |
Issued in 2011 |
| Priority date |
May 27, 2002 |
Critical for patent term calculations |
| Expiration date |
October 2030 |
Potential extension via patent term adjustments |
| Core compounds |
5-HT1A receptor partial agonists |
Broad chemical scope |
| Diseases targeted |
Depression, anxiety, OCD |
Wide therapeutic coverage |
Key Takeaways
- US 8,067,472 claims methods, compositions, and synthesis steps of specific serotonin receptor modulators.
- The patent offers broad protection within its claims for treating multiple neurological disorders.
- The patent landscape shows active development of serotonin receptor drugs, with competitors patenting related compounds.
- The patent's validity has not been challenged; its expiration in 2030 opens market opportunities.
- European equivalents provide jurisdictional strategic options for patent enforcement and licensing.
FAQs
Q1: How broad are the claims in US Patent 8,067,472?
Claims cover compounds with specific structural features as well as methods for treating neurological disorders using these compounds. This creates a broad coverage across different formulations and dosages, effectively blocking competitors from using similar compounds for the claimed indications without licensing.
Q2: Are there similar patents in other jurisdictions?
Yes. European Patent EP 2,128,863 shares similar claims and priority dates, creating an international patent family. Japan and China also hold patent filings with comparable scope.
Q3: Has the patent faced any legal challenges?
As of 2023, no legal litigations or invalidity challenges against US 8,067,472 have been documented publicly.
Q4: What are potential patent expiration considerations?
The patent is set to expire in October 2030. Patent term adjustments could extend this slightly; however, the standard expiration aligns with the 20-year term from the filing date.
Q5: Will market entry be affected post-2030?
Yes. Once the patent expires, generic manufacturers can produce equivalent compounds, increasing competition in the market for serotonin receptor modulators used in neurological disorder treatments.
Sources
[1] USPTO. (2011). Patent No. 8,067,472.
[2] European Patent Office. (2014). EP 2,128,863.
[3] PatentScope. (2023). Patent filings related to serotonin receptor modulators.
[4] World Intellectual Property Organization (WIPO). Patent Landscape Reports 2022.
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