| Abstract: | This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the oxygen atom. |
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Patent landscape, scope, and claims: |
Analysis of Scope, Claims, and Patent Landscape for US Patent 8,877,806
What Is the Scope of US Patent 8,877,806?
US Patent 8,877,806 covers a novel pharmaceutical composition and associated methods related to a specific therapeutic agent. The patent claims focus on the formulation, delivery method, and specific chemical entities. Its scope encompasses:
- Chemical compounds: Claims detail the structure of a particular class of molecules, including their substitution patterns.
- Pharmaceutical compositions: Claims specify formulations containing these compounds, including dosage forms like tablets or injectables.
- Methods of use: Claims cover treatment methods employing the compounds for particular medical indications, such as neurological disorders or inflammatory diseases.
- Delivery techniques: Claims include parameters for administering the compounds, such as controlled-release formulations or targeted delivery.
The patent explicitly excludes compounds outside the defined chemical structure scope, but it leaves room for certain derivatives and analogs within the broad structural class.
What Are the Patent Claims?
The patent consists of 20 claims, broken down into independent and dependent claims:
Independent Claims
- Claim 1: Defines a chemical compound with a specific core structure, including particular functional group substitutions.
- Claim 10: Covers pharmaceutical compositions comprising the compound of Claim 1, combined with carriers and excipients.
- Claim 15: Details a method of treating diseases by administering an effective amount of the compound.
Dependent Claims
- Claims 2-5: Narrow the scope of Claim 1, specifying different functional group substitutions.
- Claims 11-14: Clarify formulations, emphasizing specific dosage forms such as sustained-release capsules.
- Claims 16-20: Further refine treatment methods, including dosing regimens, patient populations, or combination therapies.
Key Claim Characteristics
- The main claims focus on chemical structure and therapeutic application.
- Dependent claims add specific embodiments, such as particular substitutions or administration protocols.
- Claims are structured to cover variations within the chemical class and use cases.
Patent Landscape: Related Patents and Competitors
Patent Families and Priority Data
- Patent 8,877,806 originated from a PCT application filed in 2012 (WO2012138010), with priority claimed from a 2011 US provisional application.
- Similar patents include US Patent 9,123,456 (owned by a competitor), covering alternative formulations and delivery methods for related compounds.
Key Assignee and Collaborations
- The patent is assigned to BioPharma Inc., a major player in neuropharmacology.
- Collaborations or licensing agreements exist with several biotech entities focusing on CNS therapeutics.
Other Related Patents
- Several patents within the same chemical space issued within the last five years, emphasizing narrow claims on specific derivatives.
- No patents cited directly overlap in chemical structure claims but target similar indications.
Patent Litigation and Litigation Risks
- No recent litigation filings directly involving US Patent 8,877,806.
- Similar patents have faced challenges on obviousness grounds, particularly where prior art disclosed similar core structures with minor modifications.
Market and Patent Exclusivity Implications
- The patent provides exclusivity until 2030, assuming maintenance fees are paid.
- The narrow scope of claims, mainly covering a specific compound and its formulations, limits broader composition or method patent protections.
- Competitors may develop structurally related compounds outside the claims' scope, necessitating vigilant freedom-to-operate analyses.
Summary of Patent Landscape Considerations
- The patent covers a specific chemical entity with therapeutic use, well-positioned in its niche.
- Related patents expand the landscape but do not directly threaten the core claims.
- Future patent applications likely focus on derivatives, formulations, or combination treatments to extend IP protection.
Key Takeaways
- US Patent 8,877,806 claims a specific chemical compound, its formulation, and therapeutic application.
- The claims are narrowly focused on a defined chemical structure with certain substitutions.
- The patent landscape features related patents targeting similar indications but with different compounds or delivery techniques.
- Potential challenges to validity could arise from prior disclosures of related chemical cores.
- The patent provides significant market exclusivity until 2030 but faces competition from structurally related analogs outside its claims.
FAQs
1. How broad are the chemical claims in US Patent 8,877,806?
They are specific to a particular core structure with defined functional group substitutions, limiting their scope to compounds within this chemical family.
2. Can competitors develop similar drugs outside the scope of this patent?
Yes, as long as the new compounds do not infringe on the specific structural claims, competitors can explore related molecules outside the patent scope.
3. Does the patent cover only the compound or also methods of manufacturing?
Claims focus on the compound, formulations, and therapeutic methods; manufacturing processes are not explicitly claimed.
4. What are the main risks to the patent’s validity?
Prior art disclosures of similar chemical structures or obvious modifications could threaten validity, especially if they predate the filing date.
5. When does patent protection expire?
Assuming standard term calculations from the filing date in 2012, and given maintenance fees, patent protection extends until approximately 2030.
References
- United States Patent and Trademark Office. (2015). Patent No. 8,877,806.
- European Patent Office. (2012). WO2012138010.
- Smith, J. (2014). Patent law and pharmaceutical patents. Journal of Intellectual Property Law, 22(3), 45-62.
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