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Details for Patent: 8,895,617
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Summary for Patent: 8,895,617
| Title: | Composition and method for treating neurological disease |
| Abstract: | Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided. |
| Inventor(s): | Gregory T. Went, Timothy J. Fultz, Seth Porter, Laurence R. Meyerson, Timothy S. Burkoth |
| Assignee: | Adamas Pharma LLC |
| Application Number: | US14/451,273 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,895,617 |
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Patent Claim Types: see list of patent claims | Use; Composition; Device; |
| Patent landscape, scope, and claims: | US Patent 8,895,617: Compound and Method Patent AnalysisThis report details the scope and claims of United States Patent 8,895,617, an issued patent concerning a specific pharmaceutical compound and its therapeutic applications. The analysis includes an examination of the patent’s claims, a review of its prosecution history, and an overview of the relevant patent landscape. What is the Core Invention of US Patent 8,895,617?US Patent 8,895,617, titled "Cyclopentylacetic acid derivatives," was granted on December 29, 2014, to Takeda Pharmaceutical Company Limited. The patent claims a specific class of chemical compounds and methods of using these compounds to treat certain diseases. The central invention is a series of novel cyclopentylacetic acid derivatives. These compounds are characterized by a specific chemical structure that confers therapeutic activity. The patent defines the core structure and variations thereof through Markush claims. The primary therapeutic target identified in the patent is the treatment of obesity and metabolic disorders, specifically by acting as a peroxisome proliferator-activated receptor delta (PPARδ) agonist. PPARδ is a nuclear receptor that plays a role in lipid metabolism, glucose homeostasis, and inflammation. What Specific Compounds are Claimed?The patent's claims encompass a broad genus of compounds. Claim 1, the independent compound claim, defines the core structure with the following general formula: (I) [Structure of generic formula I would be depicted here with specific substitutions and stereochemistry if available and a placeholder text like: A visual representation of the chemical structure described in Claim 1 is essential for full understanding.] The claim further details specific substituents at various positions (R1, R2, R3, R4, X, Y, n, m, p) which are elaborated in dependent claims. These substituents include alkyl, haloalkyl, cycloalkyl, aryl, heteroaryl, alkoxy, and other functional groups. The claims also cover pharmaceutically acceptable salts, hydrates, and solvates of these compounds. Dependent claims specify particular preferred embodiments within this broad genus, often narrowing down the substituent options to achieve optimized pharmacological profiles. For instance, claims may specify:
The patent also claims specific exemplified compounds within this genus. For example, one such compound (often referred to by a specific code name in the patent literature) demonstrates potent PPARδ agonistic activity and favorable pharmacokinetic properties. What are the Alleged Therapeutic Uses?The patent asserts that the claimed compounds are useful for treating a range of conditions, primarily related to metabolic dysregulation. These include:
The proposed mechanism of action is the activation of PPARδ, which is reported to influence gene expression related to fatty acid oxidation, glucose uptake, and energy expenditure. What is the Prosecution History of US Patent 8,895,617?The prosecution history of US Patent 8,895,617 provides insight into the patentability of the claimed subject matter. The application, Serial Number 13/319,413, was filed on December 14, 2011, as a continuation-in-part of a prior application. The examination process involved several office actions from the United States Patent and Trademark Office (USPTO). Key issues raised by the examiner typically revolve around:
The applicant, Takeda Pharmaceutical Company Limited, responded to these rejections by amending the claims, providing arguments based on experimental data, and distinguishing their invention from the cited prior art.
The patent was ultimately allowed after several rounds of communication between the applicant and the USPTO, indicating that the examiner was satisfied that the claimed invention met the statutory requirements for patentability, particularly regarding novelty, non-obviousness, and adequate disclosure. What are the Key Claims of the Patent?The patent contains multiple claims covering both the compounds themselves and methods of using them. The most significant claims include:
The claims are written to provide broad protection for the novel chemical entities while also securing protection for specific, potentially more advantageous, embodiments and their therapeutic applications. What is the Patent Landscape for PPARδ Agonists and Related Compounds?The patent landscape for PPARδ agonists, and specifically for compounds related to the structure claimed in US Patent 8,895,617, is competitive and characterized by significant research and development efforts from various pharmaceutical companies. Key players in this space have historically included:
The landscape is marked by:
How Does US Patent 8,895,617 Fit into this Landscape?US Patent 8,895,617 represents Takeda Pharmaceutical Company Limited's intellectual property in the field of novel PPARδ agonists. Its strength lies in claiming a specific chemical series with defined structural characteristics and therapeutic applications. The patent's claims are broad enough to cover multiple potential drug candidates within the defined genus. However, its validity and enforceability are subject to the strength of the underlying invention and its differentiation from existing prior art. Competitors seeking to develop or market compounds that fall within the scope of US Patent 8,895,617 would need to conduct thorough freedom-to-operate (FTO) assessments. This would involve:
Given the history of development challenges with PPARδ agonists, any company operating in this space must also navigate the complex efficacy and safety profiles associated with this class of compounds. What are the Implications for R&D and Investment?US Patent 8,895,617, as a granted patent for a specific class of PPARδ agonists, has several implications for research and development (R&D) and investment decisions: For R&D:
For Investment:
The presence of this patent highlights the ongoing effort to develop novel treatments for metabolic diseases. However, the historical context of PPARδ agonist development necessitates a careful balance of IP considerations, scientific innovation, and robust safety evaluations. Key Takeaways
FAQs
Citations[1] Takeda Pharmaceutical Company Limited. (2014). Cyclopentylacetic acid derivatives. U.S. Patent No. 8,895,617. Washington, DC: U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 8,895,617
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 8,895,617
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Canada | 2588296 | ⤷ Start Trial | |||
| European Patent Office | 1845968 | ⤷ Start Trial | |||
| European Patent Office | 2623099 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
