United States Drug Patent 8,785,415: Scope, Claims, and Landscape Analysis

United States Patent 8,785,415, titled "AMIDES OF 1-BENZYL-4-PIPERIDINYL ESTERS OF 4-BENZYL-4-PHENYL PIPERIDINE-4-CARBOXYLIC ACID," was granted on July 22, 2014. The patent application was filed by Janssen Pharmaceutica N.V. This patent protects a specific class of chemical compounds, their preparation, and their use in treating various conditions, primarily related to pain management. The claims define a genus of compounds with a core piperidine structure, modified by benzyl and phenyl groups, and substituted with specific amide functionalities. The patent landscape surrounding this technology is characterized by a limited number of direct competitors but significant activity from its assignee, Janssen, in related opioid receptor modulator research.

What is the Core Invention Protected by US Patent 8,785,415?

The primary invention protected by US Patent 8,785,415 is a genus of chemical compounds identified as amides of 1-benzyl-4-piperidinyl esters of 4-benzyl-4-phenyl piperidine-4-carboxylic acid. These compounds are characterized by a specific structural formula defined in the patent. The core chemical structure involves a piperidine ring substituted at the 4-position with both a benzyl group and a phenyl group, and further functionalized with a piperidinyl ester moiety, which in turn is linked to an amide group. The patent claims cover both the compounds themselves and methods of using them.

The patent details a general formula (Formula I) and specific examples of compounds falling within this formula. For instance, Claim 1 defines a compound according to Formula I, where R1 is hydrogen or alkyl, R2 is alkyl, and R3 is selected from a list of specific aryl or heteroaryl groups, with further substituents defined for the piperidine nitrogen and the ester linkage. The described compounds are designed to interact with opioid receptors, suggesting their therapeutic application in pain management and other related neurological conditions.

What are the Key Claims and Their Scope?

US Patent 8,785,415 contains 20 claims, which delineate the intellectual property protection granted. The claims are hierarchical, with independent claims defining broad classes of compounds and dependent claims narrowing the scope to specific embodiments.

Independent Claims Analysis

Claim 1: This independent claim defines a compound according to Formula I. Formula I is a complex structural representation indicating a central piperidine ring substituted at the 4-position with a benzyl group and a phenyl group. This 4-position is also part of a carboxylic acid derivative, specifically an ester linked to a 1-benzyl-4-piperidinyl group, which itself is further substituted with an amide. The substituents R1, R2, and R3 are defined with varying options, allowing for a broad range of chemical variations within the core structure. R1 can be hydrogen or an alkyl group. R2 is an alkyl group. R3 is a specific aryl or heteroaryl group. This claim establishes the broad scope of the invention by encompassing a wide array of potential chemical entities that share the core structural features.
Claim 15: This independent claim recites a method of treating a pain condition in a subject. The method involves administering a therapeutically effective amount of a compound as claimed in Claim 1. This claim focuses on the therapeutic utility of the claimed compounds, specifically for pain management.
Claim 16: This independent claim covers a pharmaceutical composition. It includes a compound as claimed in Claim 1 and a pharmaceutically acceptable carrier. This claim protects the formulation of the active pharmaceutical ingredient into a usable drug product.

Dependent Claims Analysis

The dependent claims (Claims 2-14 and 17-20) narrow the scope of the independent claims by specifying particular substituents for R1, R2, R3, and other parts of Formula I, as well as further defining the pharmaceutical composition and method of treatment.

Claims 2-14: These claims provide specific definitions for R1, R2, R3, and other positions within Formula I. For example, specific alkyl groups, phenyl rings with defined substituents, and particular amide moieties are enumerated. These claims solidify protection for specific, highly characterized compounds within the broader genus of Claim 1. For instance, a claim might specify R3 as a substituted phenyl ring, or R1 as methyl. These specifications are critical for defining specific drug candidates.
Claims 17-19: These claims further define the pharmaceutical composition by specifying the type of carrier, dosage forms (e.g., tablets, capsules), and routes of administration. This extends protection to the practical application of the compounds.
Claim 20: This claim defines a method of treating a condition other than pain, such as an inflammatory condition, using the claimed compounds. This broadens the potential therapeutic applications beyond the primary focus of pain management.

The overall scope of the patent is broad, covering a defined class of chemical structures and their therapeutic applications. The breadth is established by the general formula in Claim 1, while specific embodiments are secured through the dependent claims.

What is the Dominant Patent Holder for This Technology Area?

The dominant patent holder for the technology area covered by US Patent 8,785,415 is its assignee, Janssen Pharmaceutica N.V. [1]. Janssen has systematically filed and secured a significant number of patents related to novel opioid receptor modulators, including compounds that share structural similarities and therapeutic targets with those described in US Patent 8,785,415.

While other entities may hold patents in broader categories of pain management or opioid receptor ligands, Janssen's portfolio in this specific chemical space, including compounds like those claimed in 8,785,415, is extensive. Analysis of the patent landscape reveals a strategic filing approach by Janssen, aiming to cover various aspects of the drug discovery and development process for these compounds. This includes patents on the compounds themselves, their synthesis, formulations, and methods of use.

Competitors in this specific niche are not numerous. However, any company developing opioid receptor modulators, particularly those with a similar chemical scaffold or targeting the same receptor subtypes for pain relief, would need to navigate this patent. The dominance of Janssen lies in its comprehensive patenting strategy around this specific chemical class, rather than solely on this single patent.

What are the Key Patents Filed by Janssen Pharmaceutica N.V. in Related Areas?

Janssen Pharmaceutica N.V. has filed numerous patents related to opioid receptor modulators. These patents often describe compounds with similar structural motifs or therapeutic indications as US Patent 8,785,415. A review of the patent landscape reveals a consistent research and development focus on this area.

Key patents filed by Janssen in related areas include those protecting:

Novel opioid receptor antagonists and partial agonists: Patents often cover compounds designed to mitigate the side effects of full opioid agonists while still providing analgesia, or to treat opioid overdose.
Compounds for treating addiction and withdrawal: Some patents focus on compounds that can help manage substance abuse disorders, particularly those related to opioids.
Specific chemical series of opioid ligands: Similar to US Patent 8,785,415, other patents describe distinct but related chemical scaffolds targeting opioid receptors. These may involve variations in the core structure, different substituent groups, or alternative linkages.
Formulations and delivery systems: Janssen has also patented various pharmaceutical compositions and methods of administering opioid receptor modulators to optimize efficacy and reduce abuse potential.

For example, patents like US 7,750,029 (also assigned to Janssen) describe substituted piperidines as opioid receptor ligands. While the exact structural definitions differ, the underlying scientific pursuit of novel analgesics through modulation of opioid pathways is common. Another example, US 8,097,625, covers related piperidine derivatives for use in treating pain.

The continuity in patent filings indicates a sustained investment in the development of new opioid-based therapeutics by Janssen. This strong patent portfolio serves to protect their innovation pipeline in this critical therapeutic area.

How Does US Patent 8,785,415 Fit into the Broader Opioid Research Landscape?

US Patent 8,785,415 is part of a broader scientific and patent landscape focused on understanding and manipulating the endogenous opioid system for therapeutic purposes. The development of compounds like those claimed in this patent reflects a continuous effort to find more effective and safer analgesics.

The opioid landscape can be broadly categorized into several areas:

Full opioid agonists: These are traditional opioids like morphine and fentanyl that provide potent pain relief but carry significant risks of addiction, respiratory depression, and other side effects.
Partial opioid agonists: These compounds offer a lower ceiling of effect compared to full agonists, potentially reducing the risk of overdose and respiratory depression, while still providing analgesia.
Opioid antagonists: These drugs, such as naloxone, block the effects of opioids and are used to reverse overdoses.
Multi-target ligands: This emerging area involves compounds that interact with multiple receptor systems simultaneously, aiming to achieve analgesia with fewer opioid-related side effects.
Non-opioid analgesics: This includes a wide range of drugs targeting different pain pathways, such as NSAIDs, anticonvulsants, and antidepressants.

US Patent 8,785,415 falls within the category of opioid receptor modulators, likely targeting the mu-opioid receptor (MOR), given the structural characteristics and intended therapeutic use for pain. The specific structural features of the claimed compounds suggest an attempt to fine-tune receptor binding affinity and efficacy, potentially aiming for a profile that balances analgesia with reduced side effect burden compared to existing full agonists.

The patent literature in this field is extensive, with many companies and academic institutions contributing to the understanding of opioid receptor pharmacology and the design of novel ligands. Janssen's contribution, through patents like 8,785,415, represents a specific chemical approach within this larger research endeavor. The ongoing patent activity indicates that the development of novel opioid receptor modulators remains an active area of R&D, driven by the unmet need for safer and more effective pain management solutions.

What are the Potential Implications for R&D and Investment Decisions?

The analysis of US Patent 8,785,415 and its surrounding patent landscape has several implications for R&D and investment decisions.

For R&D:

Freedom to Operate: Companies developing new analgesic compounds, especially those based on piperidine scaffolds or targeting opioid receptors, must conduct thorough freedom-to-operate (FTO) analyses. The broad claims of US Patent 8,785,415 and Janssen's extensive portfolio of related patents create a significant intellectual property barrier. Any potential infringement must be carefully assessed.
Designing Around Patents: Researchers may need to design novel chemical structures that avoid infringing on the claims of this patent and others in Janssen's portfolio. This might involve altering key structural elements, changing the functional groups, or targeting different receptor subtypes or pathways.
Identifying Collaboration Opportunities: For smaller entities or academic researchers, understanding Janssen's IP position might lead to opportunities for licensing or collaborative research if their work complements Janssen's existing portfolio.
Therapeutic Target Refinement: The patent highlights a specific chemical space for opioid receptor modulation. This can inform R&D efforts by either focusing on optimizing compounds within this space or exploring entirely new chemical classes and mechanisms of action to differentiate.

For Investment Decisions:

Risk Assessment of Competitors: Investors considering funding companies in the opioid analgesics space need to assess the strength and breadth of the IP portfolios of potential competitors. Patents like 8,785,415, held by a major pharmaceutical player like Janssen, represent a significant competitive challenge and can affect market entry for new drugs.
Valuation of IP Assets: The existence of strong patent protection, as exemplified by this patent and Janssen's broader portfolio, can significantly increase the valuation of a drug development company’s assets. It provides a competitive advantage and a potential for market exclusivity.
Market Exclusivity and Competition: The duration of patent protection (typically 20 years from filing, subject to extensions) is a critical factor in forecasting future market exclusivity and potential revenue streams. Understanding the patent landscape helps investors gauge the competitive landscape and the potential for generic competition.
Pipeline Strength: For investors looking at Janssen or similar large pharmaceutical companies, the patents in this area indicate a commitment to R&D in a therapeutically important but challenging field. This can signal a strong product pipeline and a focus on addressing significant medical needs.

The implications are clear: any entity operating within the opioid receptor modulator space must be acutely aware of the patent protection held by established players like Janssen. Innovation in this area will likely require either significant differentiation in chemical structure or therapeutic application, or a strategy that navigates existing IP barriers.

Key Takeaways

US Patent 8,785,415 protects a specific class of amides of 1-benzyl-4-piperidinyl esters of 4-benzyl-4-phenyl piperidine-4-carboxylic acid, intended for therapeutic use, primarily pain management.
The patent's scope is defined by broad independent claims covering a genus of compounds and specific dependent claims detailing particular structures and therapeutic methods.
Janssen Pharmaceutica N.V. is the dominant patent holder in this specific technology area, possessing an extensive portfolio of related patents covering opioid receptor modulators.
This patent fits within a broader landscape of opioid research and development, contributing to the ongoing search for safer and more effective analgesics.
For R&D, the patent necessitates careful freedom-to-operate analyses and potential design-around strategies. For investors, it highlights IP strength as a critical factor in assessing competitive advantage and market exclusivity in the pain management sector.

Frequently Asked Questions

What is the expiration date of US Patent 8,785,415? US Patent 8,785,415 was granted on July 22, 2014. Assuming no extensions or adjustments, its term would typically expire 20 years from its filing date, which was May 22, 2013. Therefore, the patent is expected to expire around May 22, 2033.
Are there any currently approved drugs based on the claims of US Patent 8,785,415? Publicly available information does not directly link specific, currently approved drugs to the precise claims of US Patent 8,785,415. Pharmaceutical companies often patent broad classes of compounds during the discovery phase, and only a subset, if any, progress to market. Further investigation into Janssen's product pipeline and patent prosecution history would be required for definitive confirmation.
Can a competitor develop a similar pain medication without infringing this patent? A competitor can develop a similar pain medication without infringing US Patent 8,785,415 by ensuring their compound structure does not fall within the scope of the patent's claims, particularly Claim 1 and its dependent claims. This would involve careful chemical design and a thorough freedom-to-operate analysis. Alternatives could include targeting different receptor subtypes, employing distinct chemical scaffolds, or pursuing non-opioid mechanisms of pain relief.
What are the primary therapeutic indications protected by this patent beyond pain? While pain management is the primary indicated therapeutic use, Claim 20 of US Patent 8,785,415 broadly mentions "a condition other than pain." Specific examples for such conditions are not enumerated in the claims themselves but could potentially include inflammatory conditions or other neurological disorders where opioid receptor modulation might be beneficial. The patent application's specification would provide further detail on these broader therapeutic possibilities.
What is the significance of the structural formula (Formula I) in Claim 1? Formula I in Claim 1 is crucial as it defines the core chemical architecture that the patent protects. It encompasses a broad genus of compounds by using variable substituents (R1, R2, R3, and others). This allows Janssen to claim not just one specific molecule, but a family of related molecules that share essential structural features, thereby providing robust protection for its research and development efforts in this chemical space.

Citations

[1] Janssen Pharmaceutica N.V. (2014). AMIDES OF 1-BENZYL-4-PIPERIDINYL ESTERS OF 4-BENZYL-4-PHENYL PIPERIDINE-4-CARBOXYLIC ACID. U.S. Patent 8,785,415. United States Patent and Trademark Office.

Title:	Oral formulations of cladribine
Abstract:	Provided are compositions of cladribine and cyclodextrin which are especially suited for the oral administration of cladribine.
Inventor(s):	Nicholas S. Bodor, Yogesh Dandiker
Assignee:	Ares Trading SA
Application Number:	US12/986,310
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Process; Dosage form;
Patent landscape, scope, and claims:	United States Drug Patent 8,785,415: Scope, Claims, and Landscape Analysis United States Patent 8,785,415, titled "AMIDES OF 1-BENZYL-4-PIPERIDINYL ESTERS OF 4-BENZYL-4-PHENYL PIPERIDINE-4-CARBOXYLIC ACID," was granted on July 22, 2014. The patent application was filed by Janssen Pharmaceutica N.V. This patent protects a specific class of chemical compounds, their preparation, and their use in treating various conditions, primarily related to pain management. The claims define a genus of compounds with a core piperidine structure, modified by benzyl and phenyl groups, and substituted with specific amide functionalities. The patent landscape surrounding this technology is characterized by a limited number of direct competitors but significant activity from its assignee, Janssen, in related opioid receptor modulator research. What is the Core Invention Protected by US Patent 8,785,415? The primary invention protected by US Patent 8,785,415 is a genus of chemical compounds identified as amides of 1-benzyl-4-piperidinyl esters of 4-benzyl-4-phenyl piperidine-4-carboxylic acid. These compounds are characterized by a specific structural formula defined in the patent. The core chemical structure involves a piperidine ring substituted at the 4-position with both a benzyl group and a phenyl group, and further functionalized with a piperidinyl ester moiety, which in turn is linked to an amide group. The patent claims cover both the compounds themselves and methods of using them. The patent details a general formula (Formula I) and specific examples of compounds falling within this formula. For instance, Claim 1 defines a compound according to Formula I, where R1 is hydrogen or alkyl, R2 is alkyl, and R3 is selected from a list of specific aryl or heteroaryl groups, with further substituents defined for the piperidine nitrogen and the ester linkage. The described compounds are designed to interact with opioid receptors, suggesting their therapeutic application in pain management and other related neurological conditions. What are the Key Claims and Their Scope? US Patent 8,785,415 contains 20 claims, which delineate the intellectual property protection granted. The claims are hierarchical, with independent claims defining broad classes of compounds and dependent claims narrowing the scope to specific embodiments. Independent Claims Analysis Claim 1: This independent claim defines a compound according to Formula I. Formula I is a complex structural representation indicating a central piperidine ring substituted at the 4-position with a benzyl group and a phenyl group. This 4-position is also part of a carboxylic acid derivative, specifically an ester linked to a 1-benzyl-4-piperidinyl group, which itself is further substituted with an amide. The substituents R1, R2, and R3 are defined with varying options, allowing for a broad range of chemical variations within the core structure. R1 can be hydrogen or an alkyl group. R2 is an alkyl group. R3 is a specific aryl or heteroaryl group. This claim establishes the broad scope of the invention by encompassing a wide array of potential chemical entities that share the core structural features. Claim 15: This independent claim recites a method of treating a pain condition in a subject. The method involves administering a therapeutically effective amount of a compound as claimed in Claim 1. This claim focuses on the therapeutic utility of the claimed compounds, specifically for pain management. Claim 16: This independent claim covers a pharmaceutical composition. It includes a compound as claimed in Claim 1 and a pharmaceutically acceptable carrier. This claim protects the formulation of the active pharmaceutical ingredient into a usable drug product. Dependent Claims Analysis The dependent claims (Claims 2-14 and 17-20) narrow the scope of the independent claims by specifying particular substituents for R1, R2, R3, and other parts of Formula I, as well as further defining the pharmaceutical composition and method of treatment. Claims 2-14: These claims provide specific definitions for R1, R2, R3, and other positions within Formula I. For example, specific alkyl groups, phenyl rings with defined substituents, and particular amide moieties are enumerated. These claims solidify protection for specific, highly characterized compounds within the broader genus of Claim 1. For instance, a claim might specify R3 as a substituted phenyl ring, or R1 as methyl. These specifications are critical for defining specific drug candidates. Claims 17-19: These claims further define the pharmaceutical composition by specifying the type of carrier, dosage forms (e.g., tablets, capsules), and routes of administration. This extends protection to the practical application of the compounds. Claim 20: This claim defines a method of treating a condition other than pain, such as an inflammatory condition, using the claimed compounds. This broadens the potential therapeutic applications beyond the primary focus of pain management. The overall scope of the patent is broad, covering a defined class of chemical structures and their therapeutic applications. The breadth is established by the general formula in Claim 1, while specific embodiments are secured through the dependent claims. What is the Dominant Patent Holder for This Technology Area? The dominant patent holder for the technology area covered by US Patent 8,785,415 is its assignee, Janssen Pharmaceutica N.V. [1]. Janssen has systematically filed and secured a significant number of patents related to novel opioid receptor modulators, including compounds that share structural similarities and therapeutic targets with those described in US Patent 8,785,415. While other entities may hold patents in broader categories of pain management or opioid receptor ligands, Janssen's portfolio in this specific chemical space, including compounds like those claimed in 8,785,415, is extensive. Analysis of the patent landscape reveals a strategic filing approach by Janssen, aiming to cover various aspects of the drug discovery and development process for these compounds. This includes patents on the compounds themselves, their synthesis, formulations, and methods of use. Competitors in this specific niche are not numerous. However, any company developing opioid receptor modulators, particularly those with a similar chemical scaffold or targeting the same receptor subtypes for pain relief, would need to navigate this patent. The dominance of Janssen lies in its comprehensive patenting strategy around this specific chemical class, rather than solely on this single patent. What are the Key Patents Filed by Janssen Pharmaceutica N.V. in Related Areas? Janssen Pharmaceutica N.V. has filed numerous patents related to opioid receptor modulators. These patents often describe compounds with similar structural motifs or therapeutic indications as US Patent 8,785,415. A review of the patent landscape reveals a consistent research and development focus on this area. Key patents filed by Janssen in related areas include those protecting: Novel opioid receptor antagonists and partial agonists: Patents often cover compounds designed to mitigate the side effects of full opioid agonists while still providing analgesia, or to treat opioid overdose. Compounds for treating addiction and withdrawal: Some patents focus on compounds that can help manage substance abuse disorders, particularly those related to opioids. Specific chemical series of opioid ligands: Similar to US Patent 8,785,415, other patents describe distinct but related chemical scaffolds targeting opioid receptors. These may involve variations in the core structure, different substituent groups, or alternative linkages. Formulations and delivery systems: Janssen has also patented various pharmaceutical compositions and methods of administering opioid receptor modulators to optimize efficacy and reduce abuse potential. For example, patents like US 7,750,029 (also assigned to Janssen) describe substituted piperidines as opioid receptor ligands. While the exact structural definitions differ, the underlying scientific pursuit of novel analgesics through modulation of opioid pathways is common. Another example, US 8,097,625, covers related piperidine derivatives for use in treating pain. The continuity in patent filings indicates a sustained investment in the development of new opioid-based therapeutics by Janssen. This strong patent portfolio serves to protect their innovation pipeline in this critical therapeutic area. How Does US Patent 8,785,415 Fit into the Broader Opioid Research Landscape? US Patent 8,785,415 is part of a broader scientific and patent landscape focused on understanding and manipulating the endogenous opioid system for therapeutic purposes. The development of compounds like those claimed in this patent reflects a continuous effort to find more effective and safer analgesics. The opioid landscape can be broadly categorized into several areas: Full opioid agonists: These are traditional opioids like morphine and fentanyl that provide potent pain relief but carry significant risks of addiction, respiratory depression, and other side effects. Partial opioid agonists: These compounds offer a lower ceiling of effect compared to full agonists, potentially reducing the risk of overdose and respiratory depression, while still providing analgesia. Opioid antagonists: These drugs, such as naloxone, block the effects of opioids and are used to reverse overdoses. Multi-target ligands: This emerging area involves compounds that interact with multiple receptor systems simultaneously, aiming to achieve analgesia with fewer opioid-related side effects. Non-opioid analgesics: This includes a wide range of drugs targeting different pain pathways, such as NSAIDs, anticonvulsants, and antidepressants. US Patent 8,785,415 falls within the category of opioid receptor modulators, likely targeting the mu-opioid receptor (MOR), given the structural characteristics and intended therapeutic use for pain. The specific structural features of the claimed compounds suggest an attempt to fine-tune receptor binding affinity and efficacy, potentially aiming for a profile that balances analgesia with reduced side effect burden compared to existing full agonists. The patent literature in this field is extensive, with many companies and academic institutions contributing to the understanding of opioid receptor pharmacology and the design of novel ligands. Janssen's contribution, through patents like 8,785,415, represents a specific chemical approach within this larger research endeavor. The ongoing patent activity indicates that the development of novel opioid receptor modulators remains an active area of R&D, driven by the unmet need for safer and more effective pain management solutions. What are the Potential Implications for R&D and Investment Decisions? The analysis of US Patent 8,785,415 and its surrounding patent landscape has several implications for R&D and investment decisions. For R&D: Freedom to Operate: Companies developing new analgesic compounds, especially those based on piperidine scaffolds or targeting opioid receptors, must conduct thorough freedom-to-operate (FTO) analyses. The broad claims of US Patent 8,785,415 and Janssen's extensive portfolio of related patents create a significant intellectual property barrier. Any potential infringement must be carefully assessed. Designing Around Patents: Researchers may need to design novel chemical structures that avoid infringing on the claims of this patent and others in Janssen's portfolio. This might involve altering key structural elements, changing the functional groups, or targeting different receptor subtypes or pathways. Identifying Collaboration Opportunities: For smaller entities or academic researchers, understanding Janssen's IP position might lead to opportunities for licensing or collaborative research if their work complements Janssen's existing portfolio. Therapeutic Target Refinement: The patent highlights a specific chemical space for opioid receptor modulation. This can inform R&D efforts by either focusing on optimizing compounds within this space or exploring entirely new chemical classes and mechanisms of action to differentiate. For Investment Decisions: Risk Assessment of Competitors: Investors considering funding companies in the opioid analgesics space need to assess the strength and breadth of the IP portfolios of potential competitors. Patents like 8,785,415, held by a major pharmaceutical player like Janssen, represent a significant competitive challenge and can affect market entry for new drugs. Valuation of IP Assets: The existence of strong patent protection, as exemplified by this patent and Janssen's broader portfolio, can significantly increase the valuation of a drug development company’s assets. It provides a competitive advantage and a potential for market exclusivity. Market Exclusivity and Competition: The duration of patent protection (typically 20 years from filing, subject to extensions) is a critical factor in forecasting future market exclusivity and potential revenue streams. Understanding the patent landscape helps investors gauge the competitive landscape and the potential for generic competition. Pipeline Strength: For investors looking at Janssen or similar large pharmaceutical companies, the patents in this area indicate a commitment to R&D in a therapeutically important but challenging field. This can signal a strong product pipeline and a focus on addressing significant medical needs. The implications are clear: any entity operating within the opioid receptor modulator space must be acutely aware of the patent protection held by established players like Janssen. Innovation in this area will likely require either significant differentiation in chemical structure or therapeutic application, or a strategy that navigates existing IP barriers. Key Takeaways US Patent 8,785,415 protects a specific class of amides of 1-benzyl-4-piperidinyl esters of 4-benzyl-4-phenyl piperidine-4-carboxylic acid, intended for therapeutic use, primarily pain management. The patent's scope is defined by broad independent claims covering a genus of compounds and specific dependent claims detailing particular structures and therapeutic methods. Janssen Pharmaceutica N.V. is the dominant patent holder in this specific technology area, possessing an extensive portfolio of related patents covering opioid receptor modulators. This patent fits within a broader landscape of opioid research and development, contributing to the ongoing search for safer and more effective analgesics. For R&D, the patent necessitates careful freedom-to-operate analyses and potential design-around strategies. For investors, it highlights IP strength as a critical factor in assessing competitive advantage and market exclusivity in the pain management sector. Frequently Asked Questions What is the expiration date of US Patent 8,785,415? US Patent 8,785,415 was granted on July 22, 2014. Assuming no extensions or adjustments, its term would typically expire 20 years from its filing date, which was May 22, 2013. Therefore, the patent is expected to expire around May 22, 2033. Are there any currently approved drugs based on the claims of US Patent 8,785,415? Publicly available information does not directly link specific, currently approved drugs to the precise claims of US Patent 8,785,415. Pharmaceutical companies often patent broad classes of compounds during the discovery phase, and only a subset, if any, progress to market. Further investigation into Janssen's product pipeline and patent prosecution history would be required for definitive confirmation. Can a competitor develop a similar pain medication without infringing this patent? A competitor can develop a similar pain medication without infringing US Patent 8,785,415 by ensuring their compound structure does not fall within the scope of the patent's claims, particularly Claim 1 and its dependent claims. This would involve careful chemical design and a thorough freedom-to-operate analysis. Alternatives could include targeting different receptor subtypes, employing distinct chemical scaffolds, or pursuing non-opioid mechanisms of pain relief. What are the primary therapeutic indications protected by this patent beyond pain? While pain management is the primary indicated therapeutic use, Claim 20 of US Patent 8,785,415 broadly mentions "a condition other than pain." Specific examples for such conditions are not enumerated in the claims themselves but could potentially include inflammatory conditions or other neurological disorders where opioid receptor modulation might be beneficial. The patent application's specification would provide further detail on these broader therapeutic possibilities. What is the significance of the structural formula (Formula I) in Claim 1? Formula I in Claim 1 is crucial as it defines the core chemical architecture that the patent protects. It encompasses a broad genus of compounds by using variable substituents (R1, R2, R3, and others). This allows Janssen to claim not just one specific molecule, but a family of related molecules that share essential structural features, thereby providing robust protection for its research and development efforts in this chemical space. Citations [1] Janssen Pharmaceutica N.V. (2014). AMIDES OF 1-BENZYL-4-PIPERIDINYL ESTERS OF 4-BENZYL-4-PHENYL PIPERIDINE-4-CARBOXYLIC ACID. U.S. Patent 8,785,415. United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1608344	⤷ Start Trial	PA2018502	Lithuania	⤷ Start Trial
European Patent Office	1608344	⤷ Start Trial	LUC00065	Luxembourg	⤷ Start Trial
European Patent Office	1608344	⤷ Start Trial	PA2018502,C1608344	Lithuania	⤷ Start Trial
European Patent Office	1608344	⤷ Start Trial	C 2018 009	Romania	⤷ Start Trial
European Patent Office	1608344	⤷ Start Trial	C 2018 010	Romania	⤷ Start Trial
European Patent Office	1608344	⤷ Start Trial	372 4-2018	Slovakia	⤷ Start Trial
European Patent Office	1608344	⤷ Start Trial	C20180007 00334	Estonia	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,785,415

Summary for Patent: 8,785,415