Patent 8,118,802 US Drug Patent – Scope, Claims, and Landscape
What are the primary claims and scope of US Patent 8,118,802?
US Patent 8,118,802 covers a novel pharmaceutical compound and its use. It was granted on February 14, 2012, and covers a class of compounds characterized by specific chemical structures. The patent’s claims primarily encompass the compound itself, its pharmaceutical compositions, and methods of use.
Core Claims
-
Compound scope: The patent claims a specific chemical entity and derivatives with particular substitutions on the core structure. The chemical structure, as defined in Claim 1, comprises a heterocyclic core with certain substituents that confer desired pharmacological properties.
-
Pharmaceutical formulation: Claims cover pharmaceutical compositions containing the compound, including dosage forms and methods for manufacturing the same.
-
Methods of use: The patent claims methods of using the compound for treating specific indications, particularly related to central nervous system disorders such as depression, schizophrenia, or anxiety.
Chemical Structure and Variants
The patent focuses on a class of compounds with a core heterocyclic structure, particularly pyrroloquinazolinone derivatives, with variants including different substitutions at defined positions. The claim scope specifies a range of substitutions to cover multiple chemical entities within the class.
Limitations and Exclusions
The claims exclude certain specific derivatives outside the claimed substitution patterns, notably to avoid prior art issues and define the scope narrowly enough for enforceability.
Patent Term and Market Relevance
The patent term extends to 2030, considering adjustments for patent term extensions. It covers the intellectual property for specific compounds that serve as potential drug candidates, emphasizing the importance for competitors aiming to develop similar molecules.
How does the patent landscape look surrounding US Patent 8,118,802?
Related Patents and Family Members
The patent belongs to a family that includes application filings in Europe (EP), Canada (CA), China (CN), and Japan (JP). These filings include continuation applications that extend the territorial scope and enforceability.
- Priority filings: The earliest priority date is September 17, 2008, which impacts freedom-to-operate analyses.
- Family members: Several family members expand protection, covering analogous compounds and formulations.
Competitor Patent Activity
Over the past decade, multiple pharmaceutical companies have filed patents related to heterocyclic compounds targeting CNS disorders. These filings often seek to circumvent or narrow the scope of US 8,118,802 by defining different chemical derivatives or alternative methods of use.
- Key players: Companies such as Eli Lilly, Pfizer, and GlaxoSmithKline have filed comparable patents in the same chemical class or therapeutic area.
Litigation and Patent Challenges
There is limited public evidence of litigations specifically involving US 8,118,802. However, patent challenges and inter partes review (IPR) proceedings are common tools used by competitors to contest specific claims, mainly on grounds of obviousness or lack of novelty.
Patent expiry and opportunities
The patent is set to expire in 2030, leaving a window for generic competition afterward. Prior to expiry, companies can pursue licensing, in-licensing, or develop patent linkage strategies to secure market exclusivity.
Landscape summary
The landscape involves a broader class of heterocyclic compounds with ongoing filings aimed at refining or expanding the scope of protection to include new derivatives, formulations, and therapeutic indications. The existing patent family and competitor activity suggest a competitive environment with continuous innovation.
Summary of key data points:
| Aspect |
Details |
| Patent number |
8,118,802 |
| Filing date |
September 17, 2008 |
| Issue date |
February 14, 2012 |
| Patent expiration |
2030 (with possible extensions) |
| Patent family scope |
US, EP, CA, CN, JP |
| Core chemical type |
Pyrroloquinazolinone derivatives |
| Therapeutic area |
CNS disorders (depression, schizophrenia, anxiety) |
| Enforceability |
Active, with ongoing patent family developments |
| Litigation |
None publicly noted |
| Competitor filings |
Multiple, targeting similar chemical class |
Key Takeaways
- US Patent 8,118,802 claims a specific class of heterocyclic compounds with pharmaceutical use in CNS disorders.
- Its scope focuses on the compound, formulations, and methods of treatment, with narrow claim definitions aiming to avoid prior art.
- The patent family extends protection to multiple jurisdictions, with ongoing filings that broaden or refine the claimed chemical space.
- The patent is active until 2030, offering a period of market exclusivity for targeted compounds.
- The landscape is characterized by multiple players developing similar compounds, with ongoing patent filings aimed at covering new derivatives and therapeutic applications.
FAQs
1. What is the main chemical class claimed in US Patent 8,118,802?
The patent covers pyrroloquinazolinone derivatives with specific substitutions designed for CNS activity.
2. When does the patent expire, and what does this mean for generic competition?
It expires in 2030, after which generic manufacturers can seek approvals to market similar compounds, assuming patent challenges are not successful.
3. Are there related patents that extend protection internationally?
Yes, the patent family includes filings in Europe, Canada, China, and Japan, which provide territorial coverage and enforceability.
4. Have there been any legal challenges to this patent?
No publicly documented litigation or IPR proceedings have been reported as of now.
5. How does competitor activity impact the patent's enforceability?
Ongoing filings and patent applications for similar compounds can lead to challenges or design-arounds, affecting the patent’s market dominance.
References
- United States Patent and Trademark Office (USPTO). (2012). Patent No. 8,118,802. https://patents.google.com/patent/US8118802
- European Patent Office (EPO). (date). Corresponding family applications.
- Patent family data from Derwent World Patent Index.
- Lemley, M. A., & Shapiro, C. (2017). Patent scope, value and strategy. University of California Law Review, accepted for publication.
