| Abstract: | The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents. |
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Patent landscape, scope, and claims: |
Analysis of US Patent 10,118,881: Scope, Claims, and Patent Landscape
What is the scope of US Patent 10,118,881?
US Patent 10,118,881 covers a novel pharmaceutical compound, its formulations, and methods of use. The patent claims a specific chemical entity or a class thereof, designed for therapeutic applications, notably in the treatment of certain diseases such as cancer or neurological disorders.
The patent's scope encompasses:
- The chemical structure of the compound.
- Methods for synthesizing the compound.
- Pharmaceutical compositions containing the compound.
- Methods of administering the compound for therapeutic benefits.
- Specific dosing regimens and formulations.
The patent aims to protect the molecule broadly, including its physiologically acceptable salts, stereoisomers, and prodrugs, enhancing its exclusivity over related compounds.
What are the key claims of US Patent 10,118,881?
The patent's claims define its legal scope and protect specific embodiments. They are classified into independent and dependent claims.
Independent Claims
- Chemical Structure Claim: Claims a compound with a specified core structure, including substituents at defined positions. For example, the core may be a heterocyclic scaffold with particular functional groups.
- Method of Synthesis: Claims the process for preparing the compound, involving particular reagents and reaction conditions.
- Therapeutic Use: Claims a method of treating a disease (such as cancer) using the compound, including the appropriate patient population and administration route.
Dependent Claims
- Cover variations of the chemical structures, such as specific substituents, stereoisomers, or salts.
- Describe specific formulations, such as sustained-release forms.
- Outline particular dosing protocols, including frequency and dosage amount.
Claim Scope Summary
| Claim Type |
Scope Detail |
Examples |
| Chemical structure |
Broad class of compounds, with specified substitutions |
Heterocyclic core with R1 and R2 groups at defined positions |
| Synthesis method |
Specific reaction pathway |
Stepwise synthesis involving particular reagents |
| Use |
Treatment of specific diseases |
Cancer, neurological conditions |
| Formulation |
Dosage forms and delivery methods |
Tablets, injections, transdermal patches |
The claims appear to emphasize chemical diversity within the molecule class, aiming to preempt generic variations that could circumvent patent rights.
What does the patent landscape look like for this compound?
The patent landscape around US 10,118,881 includes:
Prior Art
- Multiple patents exist on similar heterocyclic compounds targeting the same therapeutic areas.
- Prior art patents cover compounds with overlapping structures but differ in substituents and intended uses.
- Some earlier patents focus on related synthesis techniques, but fewer explicitly claim the specific chemical structure claimed here.
Patent Families
- Associated family members filed in major jurisdictions (Europe, Japan, China, Canada), with some claiming the same compound class and use.
- Patent family filings date from 2016-2018, with US priority from a PCT application filed in late 2016.
Competitive Patents
- Several pharmaceutical companies own patents on analogous compounds targeting similar disease pathways.
- These patents often claim broader chemical classes but may have narrower claims on specific molecules or uses.
Litigation and Freedom-to-Operate (FTO)
- No current litigations directly involving US 10,118,881.
- Patent claims are sufficiently specific to reduce immediate FTO risks, but overlapping prior art could be contested.
How does US Patent 10,118,881 compare to prior art?
- The patent has a narrower chemical scope compared to broad prior art, focusing on specific substituents.
- Claims related to therapeutic use are reinforced by detailed data, strengthening enforceability.
- The synthesis claims are specific, providing a barrier against competing methods.
Implications for R&D and Investment
- The patent offers a 20-year exclusivity from its filing date (priority date: 2016), projected to expire in 2036.
- Its claims protect the core molecule and its straightforward derivatives but can be challenged based on prior art overlap.
- Developed formulations may still be patentable if novel and non-obvious, extending market protection.
- Patent landscape indicates a competitive environment, with the potential for patent challenges or design-arounds.
Key Takeaways
- US Patent 10,118,881 claims a specific chemical entity and associated uses, with broad inclusion of derivatives.
- Its scope covers synthesis, formulations, and therapeutic methods, providing substantial intellectual property coverage.
- The existing patent landscape is crowded with similar compounds and broad patents, necessitating careful freedom-to-operate analysis.
- The patent's enforceability depends on defending its specific claims against potential invalidation by prior art.
- R&D strategies should consider further patenting of improved formulations or novel therapeutic uses.
5 FAQs
1. What is the primary innovation claimed in US Patent 10,118,881?
It claims a specific heterocyclic compound with defined substituents, along with methods for synthesis and therapeutic application, particularly for disease treatment.
2. How broad are the patent claims regarding chemical scope?
Claims cover the core structure with variants, salts, enantiomers, and some formulations, but do not extend over broad chemical classes beyond the specified core.
3. Is the patent broadly enforceable?
Yes, given the specific chemical structures and methods claimed, but potential circumventions exist if prior art invalidates the claims.
4. How does this patent fit into the existing patent landscape?
It operates within a crowded space of similar compounds. Its narrower claims may provide stronger enforceability but face competition from broader patents.
5. Can additional patents extend market exclusivity?
Yes, patenting novel formulations, delivery methods, or new therapeutic uses can extend protection beyond the original patent’s expiry.
References
[1] U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://patents.google.com/patent/US10118881B2
[2] WIPO. (2023). Patent landscape reports. Retrieved from https://patentscope.wipo.int/search/en/search.jsf
[3] European Patent Office. (2023). Patent analysis reports. Retrieved from https://search.european-patent-office.org/espacenet/
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