United States Drug Patent 6,900,184: Scope, Claims, and Landscape Analysis

Patent 6,900,184: Summary of Core Inventions

United States Patent 6,900,184, granted on May 31, 2005, to Merck & Co., Inc., details a method for treating pain by administering specific tetrahydropyran-containing compounds. The patent focuses on the use of these compounds, identified by a defined chemical structure, for their analgesic properties. The claims are directed to the method of treatment and specific pharmaceutical compositions containing these active ingredients. This patent is a key piece of intellectual property within the pain management therapeutic area.

What is the Subject Matter of Patent 6,900,184?

The patent claims cover methods of treating pain. The core invention lies in the administration of a specific class of chemical compounds to achieve pain relief. These compounds are characterized by a tetrahydropyran ring structure within their molecular architecture.

What are the Key Chemical Structures Claimed?

The patent defines a genus of compounds represented by a Markush structure. While the patent encompasses a broad scope, it specifically includes compounds of Formula I:

      R1
      |
  Het---C---R2
      |
      R3

Where:

Het represents a heterocyclic group.
R1, R2, and R3 are substituents, with specific definitions provided in the patent detailing their chemical nature (e.g., alkyl, aryl, halogen).
The central carbon atom is part of a tetrahydropyran ring system.

The patent further defines subgenera and specific exemplified compounds falling within this general formula. These exemplified compounds are the most direct embodiments of the patent's claims.

What is the Indication for Use?

The primary indication for use described and claimed in the patent is the treatment of pain. This encompasses various types of pain, including but not limited to inflammatory pain and neuropathic pain. The patent's disclosures highlight the compounds' efficacy in preclinical models of pain.

What are the Specific Claims in Patent 6,900,184?

The claims of United States Patent 6,900,184 define the legal boundaries of the invention. They are directed to both the method of treatment and the pharmaceutical compositions.

Claim 1: Method of Treatment

Claim 1, the independent method claim, defines the core therapeutic application. It claims: "A method of treating pain which comprises administering to a subject in need of such treatment a therapeutically effective amount of a compound of Formula I..." [1]

Subject: The patent refers to a "subject," which typically includes mammals, such as humans.
Pain: The claim broadly covers "pain" without further limitation to specific types or origins in its broadest sense, although the specification provides examples.
Therapeutically Effective Amount: This refers to the dosage of the compound that produces the desired analgesic effect.
Compound of Formula I: This is the central element, referring back to the defined chemical structure.

Claim 2-6: Dependent Method Claims

These claims further refine Claim 1 by specifying particular embodiments or conditions:

Claim 2: Specifies particular heterocyclic groups for "Het."
Claim 3: Limits the types of R1, R2, and R3 substituents.
Claim 4: Focuses on specific exemplified compounds within Formula I.
Claim 5: Addresses the treatment of inflammatory pain.
Claim 6: Addresses the treatment of neuropathic pain.

Claim 7: Pharmaceutical Compositions

Claim 7, the independent composition claim, covers the practical application of the compounds in a deliverable form: "A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of Formula I, wherein the compound is present in a therapeutically effective amount." [1]

Pharmaceutical Composition: This refers to a formulated drug product, such as a tablet, capsule, or injection.
Pharmaceutically Acceptable Carrier: This includes inert excipients that facilitate drug delivery and stability.
Therapeutically Effective Amount: As with the method claims, this signifies the dosage required for efficacy.

Claim 8-10: Dependent Composition Claims

These claims further specify aspects of the pharmaceutical compositions:

Claim 8: Specifies that the compound is of Formula I.
Claim 9: Limits the composition to containing one or more specific exemplified compounds.
Claim 10: Defines a specific dosage range for the compound.

What is the Prosecution History and Status of Patent 6,900,184?

Understanding the patent's prosecution history provides insight into how the claims were narrowed or broadened during examination and its current legal standing.

Filing and Grant Dates

Application Number: 09/963,772
Filing Date: September 26, 2001
Publication Date: April 3, 2002 (as US 2002/0037975 A1)
Grant Date: May 31, 2005
Issue Patent Number: 6,900,184

Key Examination Events

The prosecution involved several office actions and responses from the applicant. Significant aspects of the examination included:

Prior Art Rejections: The examiner likely cited prior art related to pain treatments and similar chemical structures.
Claim Amendments: The applicant would have amended the claims to distinguish their invention from the cited prior art. This often involves narrowing the scope of the Markush structure or adding specific limitations.
Applicant Arguments: Arguments were submitted to highlight the novelty, non-obviousness, and utility of the claimed compounds and methods.

Current Status

As of its grant date in 2005, Patent 6,900,184 was a valid, issued patent. Its term is 20 years from the filing date, subject to any maintenance fees. The patent's enforceability and current status would require a check of the USPTO's patent maintenance fee records. However, its expiration is anticipated based on its filing date.

What is the Patent Landscape for Tetrahydropyran-Containing Analgesics?

The landscape surrounding patent 6,900,184 is characterized by a broader scientific and patent interest in compounds targeting pain pathways, including those with tetrahydropyran moieties.

Key Therapeutic Targets in Pain Management

The development of analgesics has historically focused on several key targets:

Opioid Receptors: While effective, opioids are associated with significant side effects and addiction potential, driving research into non-opioid alternatives.
COX Enzymes (COX-1, COX-2): Non-steroidal anti-inflammatory drugs (NSAIDs) target these enzymes.
Ion Channels (e.g., TRPV1, Nav channels): These are crucial for pain signal transmission.
Neurotransmitters and Receptors: Serotonin, norepinephrine, and glutamate pathways are also targets.
Cannabinoid Receptors: Modulators of the endocannabinoid system are explored for pain relief.

The tetrahydropyran compounds claimed in 6,900,184 likely target one or more of these pathways, or novel ones, as detailed in the patent's specification.

Competitor Patent Activity

Merck's patent is one of many in the pain management space. Key players in this field include:

Large Pharmaceutical Companies: Pfizer, Eli Lilly, Novartis, and AstraZeneca have historically invested heavily in pain drug discovery.
Biotechnology Companies: Smaller firms often focus on specific targets or novel mechanisms of action.
Academic Institutions: Universities contribute foundational research and patent filings.

Competitor patents may cover:

Different Chemical Classes: Compounds with entirely different structural scaffolds but acting on the same pain targets.
Alternative Tetrahydropyran Derivatives: Modifications or analogs of the compounds claimed in 6,900,184, potentially designed to improve efficacy, reduce side effects, or circumvent existing patents.
Different Formulations or Delivery Methods: Novel ways to administer pain medications.
New Therapeutic Uses: Application of known compounds for different pain conditions or indications.

Potential for Freedom-to-Operate Issues

Companies developing new pain therapies that incorporate tetrahydropyran structures, or that aim to treat pain through mechanisms similar to those disclosed in 6,900,184, must conduct thorough freedom-to-operate (FTO) analyses. This involves:

Searching for Expired Patents: Identifying patents that have expired, allowing for generic development or new research. Patent 6,900,184 is approaching or has reached its expiration.
Analyzing Active Patents: Reviewing existing, unexpired patents that might claim similar chemical structures or therapeutic methods.
Evaluating Patent Claims: Precisely interpreting the scope of claims in relevant patents.
Considering International Filings: Investigating patent protection in key global markets.

The patent landscape is dynamic, with new patent applications filed regularly. Continuous monitoring is essential for R&D and investment strategies.

What is the Market Significance of Pain Management Patents?

The pain management market is a significant segment of the pharmaceutical industry, driven by a large patient population with unmet needs.

Market Size and Growth

The global pain management market is valued in the tens of billions of dollars and is projected to continue growing. Factors contributing to this growth include:

Aging Population: Increased incidence of chronic pain conditions in older adults.
Rising Prevalence of Chronic Diseases: Conditions like diabetes, arthritis, and cancer are often associated with chronic pain.
Advancements in Treatment Modalities: Development of more targeted and effective therapies.
Increased Awareness and Diagnosis: Better recognition and reporting of pain conditions.

Patent Protection and Innovation

Patent protection is critical for incentivizing the substantial R&D investment required to develop new pain therapies. Patents grant exclusivity for a defined period, allowing companies to recoup their investment and fund further innovation.

Exclusivity Period: A typical patent term of 20 years from the filing date provides a window for market exclusivity.
Generic Competition: Upon patent expiry, generic manufacturers can enter the market, reducing drug prices but also diminishing the innovator's revenue.
First-to-File System: The US patent system operates on a first-to-file basis, emphasizing the importance of timely patent applications for novel inventions.

Patent 6,900,184, during its active term, would have provided Merck with a period of market exclusivity for the specific tetrahydropyran compounds and their use in pain treatment. As this patent approaches or reaches its expiration, the door opens for generic versions or the development of related compounds by competitors.

Key Takeaways

United States Patent 6,900,184 protects methods for treating pain using specific tetrahydropyran-containing compounds and related pharmaceutical compositions.
The patent's claims are directed to a defined chemical genus and its therapeutic application, with specific exemplified compounds and indications for inflammatory and neuropathic pain.
The patent was granted to Merck & Co., Inc. in 2005 and its 20-year term from the filing date of 2001 is nearing expiration.
The patent landscape for pain management is competitive, with ongoing innovation in therapeutic targets, chemical structures, and drug delivery.
Freedom-to-operate analyses are crucial for companies operating in the pain management therapeutic area, particularly concerning compounds with similar structural motifs or therapeutic mechanisms.
The expiration of patents like 6,900,184 significantly impacts market dynamics, paving the way for generic competition and new product development.

Frequently Asked Questions

What specific types of pain does Patent 6,900,184 claim to treat?

Patent 6,900,184 broadly claims methods of treating "pain." However, dependent claims specifically mention the treatment of "inflammatory pain" and "neuropathic pain," indicating a focus on these categories.

When will United States Patent 6,900,184 expire?

United States Patent 6,900,184 was filed on September 26, 2001. Under U.S. patent law, its term is 20 years from the filing date, meaning it is set to expire on September 26, 2021, subject to maintenance fees.

Can a company develop and sell a drug that falls under the claims of Patent 6,900,184 after it expires?

Yes, once a patent expires, the claims enter the public domain. Companies are generally free to develop, manufacture, and sell products that fall within the scope of expired patent claims without infringing that specific patent, provided they comply with all other relevant regulations.

What is a Markush structure, and why is it relevant to Patent 6,900,184?

A Markush structure is a graphical representation used in chemical patents to define a genus of compounds. It describes a core chemical structure with variable substituents (indicated by R groups). This allows a patent to claim a broad class of related compounds with a single structure, rather than listing every individual compound. Patent 6,900,184 utilizes a Markush structure to define Formula I, encompassing a range of tetrahydropyran-containing compounds.

Who is the assignee of United States Patent 6,900,184?

The assignee of United States Patent 6,900,184 is Merck & Co., Inc.

What are the implications of the patent's claims on pain management research?

The existence of this patent during its term limited the ability of other entities to patent and commercialize compounds fitting the exact described structure and method of use for pain treatment. Upon expiration, it can facilitate research into generic alternatives or the development of structurally similar compounds for pain management by allowing others to build upon the disclosed invention.

Cited Sources

[1] Merck & Co., Inc. (2005). U.S. Patent 6,900,184. United States Patent and Trademark Office.

Title:	Compositions containing pipercillin and tazobactam useful for injection
Abstract:	The invention pertains to pharmaceutical compositions of Zosyn® piperacillin with tazobactam in the presence of a buffer, preferably citrate, a particulate formation inhibitor, preferably EDTA optionally an aminoglycoside which when frozen and thawed or lyophilized and reconstituted reform a solution which has decreased particulate formation.
Inventor(s):	Jonathan Marc Cohen, Syed M. Shah, Christian Luther Ofslager, Mahdi Fawzi
Assignee:	Baxter Healthcare Corp
Application Number:	US10/413,323
Patent Claim Types: see list of patent claims	Use; Composition; Process;
Patent landscape, scope, and claims:	United States Drug Patent 6,900,184: Scope, Claims, and Landscape Analysis Patent 6,900,184: Summary of Core Inventions United States Patent 6,900,184, granted on May 31, 2005, to Merck & Co., Inc., details a method for treating pain by administering specific tetrahydropyran-containing compounds. The patent focuses on the use of these compounds, identified by a defined chemical structure, for their analgesic properties. The claims are directed to the method of treatment and specific pharmaceutical compositions containing these active ingredients. This patent is a key piece of intellectual property within the pain management therapeutic area. What is the Subject Matter of Patent 6,900,184? The patent claims cover methods of treating pain. The core invention lies in the administration of a specific class of chemical compounds to achieve pain relief. These compounds are characterized by a tetrahydropyran ring structure within their molecular architecture. What are the Key Chemical Structures Claimed? The patent defines a genus of compounds represented by a Markush structure. While the patent encompasses a broad scope, it specifically includes compounds of Formula I: `R1 \| Het---C---R2 \| R3` Where: Het represents a heterocyclic group. R1, R2, and R3 are substituents, with specific definitions provided in the patent detailing their chemical nature (e.g., alkyl, aryl, halogen). The central carbon atom is part of a tetrahydropyran ring system. The patent further defines subgenera and specific exemplified compounds falling within this general formula. These exemplified compounds are the most direct embodiments of the patent's claims. What is the Indication for Use? The primary indication for use described and claimed in the patent is the treatment of pain. This encompasses various types of pain, including but not limited to inflammatory pain and neuropathic pain. The patent's disclosures highlight the compounds' efficacy in preclinical models of pain. What are the Specific Claims in Patent 6,900,184? The claims of United States Patent 6,900,184 define the legal boundaries of the invention. They are directed to both the method of treatment and the pharmaceutical compositions. Claim 1: Method of Treatment Claim 1, the independent method claim, defines the core therapeutic application. It claims: "A method of treating pain which comprises administering to a subject in need of such treatment a therapeutically effective amount of a compound of Formula I..." [1] Subject: The patent refers to a "subject," which typically includes mammals, such as humans. Pain: The claim broadly covers "pain" without further limitation to specific types or origins in its broadest sense, although the specification provides examples. Therapeutically Effective Amount: This refers to the dosage of the compound that produces the desired analgesic effect. Compound of Formula I: This is the central element, referring back to the defined chemical structure. Claim 2-6: Dependent Method Claims These claims further refine Claim 1 by specifying particular embodiments or conditions: Claim 2: Specifies particular heterocyclic groups for "Het." Claim 3: Limits the types of R1, R2, and R3 substituents. Claim 4: Focuses on specific exemplified compounds within Formula I. Claim 5: Addresses the treatment of inflammatory pain. Claim 6: Addresses the treatment of neuropathic pain. Claim 7: Pharmaceutical Compositions Claim 7, the independent composition claim, covers the practical application of the compounds in a deliverable form: "A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of Formula I, wherein the compound is present in a therapeutically effective amount." [1] Pharmaceutical Composition: This refers to a formulated drug product, such as a tablet, capsule, or injection. Pharmaceutically Acceptable Carrier: This includes inert excipients that facilitate drug delivery and stability. Therapeutically Effective Amount: As with the method claims, this signifies the dosage required for efficacy. Claim 8-10: Dependent Composition Claims These claims further specify aspects of the pharmaceutical compositions: Claim 8: Specifies that the compound is of Formula I. Claim 9: Limits the composition to containing one or more specific exemplified compounds. Claim 10: Defines a specific dosage range for the compound. What is the Prosecution History and Status of Patent 6,900,184? Understanding the patent's prosecution history provides insight into how the claims were narrowed or broadened during examination and its current legal standing. Filing and Grant Dates Application Number: 09/963,772 Filing Date: September 26, 2001 Publication Date: April 3, 2002 (as US 2002/0037975 A1) Grant Date: May 31, 2005 Issue Patent Number: 6,900,184 Key Examination Events The prosecution involved several office actions and responses from the applicant. Significant aspects of the examination included: Prior Art Rejections: The examiner likely cited prior art related to pain treatments and similar chemical structures. Claim Amendments: The applicant would have amended the claims to distinguish their invention from the cited prior art. This often involves narrowing the scope of the Markush structure or adding specific limitations. Applicant Arguments: Arguments were submitted to highlight the novelty, non-obviousness, and utility of the claimed compounds and methods. Current Status As of its grant date in 2005, Patent 6,900,184 was a valid, issued patent. Its term is 20 years from the filing date, subject to any maintenance fees. The patent's enforceability and current status would require a check of the USPTO's patent maintenance fee records. However, its expiration is anticipated based on its filing date. What is the Patent Landscape for Tetrahydropyran-Containing Analgesics? The landscape surrounding patent 6,900,184 is characterized by a broader scientific and patent interest in compounds targeting pain pathways, including those with tetrahydropyran moieties. Key Therapeutic Targets in Pain Management The development of analgesics has historically focused on several key targets: Opioid Receptors: While effective, opioids are associated with significant side effects and addiction potential, driving research into non-opioid alternatives. COX Enzymes (COX-1, COX-2): Non-steroidal anti-inflammatory drugs (NSAIDs) target these enzymes. Ion Channels (e.g., TRPV1, Nav channels): These are crucial for pain signal transmission. Neurotransmitters and Receptors: Serotonin, norepinephrine, and glutamate pathways are also targets. Cannabinoid Receptors: Modulators of the endocannabinoid system are explored for pain relief. The tetrahydropyran compounds claimed in 6,900,184 likely target one or more of these pathways, or novel ones, as detailed in the patent's specification. Competitor Patent Activity Merck's patent is one of many in the pain management space. Key players in this field include: Large Pharmaceutical Companies: Pfizer, Eli Lilly, Novartis, and AstraZeneca have historically invested heavily in pain drug discovery. Biotechnology Companies: Smaller firms often focus on specific targets or novel mechanisms of action. Academic Institutions: Universities contribute foundational research and patent filings. Competitor patents may cover: Different Chemical Classes: Compounds with entirely different structural scaffolds but acting on the same pain targets. Alternative Tetrahydropyran Derivatives: Modifications or analogs of the compounds claimed in 6,900,184, potentially designed to improve efficacy, reduce side effects, or circumvent existing patents. Different Formulations or Delivery Methods: Novel ways to administer pain medications. New Therapeutic Uses: Application of known compounds for different pain conditions or indications. Potential for Freedom-to-Operate Issues Companies developing new pain therapies that incorporate tetrahydropyran structures, or that aim to treat pain through mechanisms similar to those disclosed in 6,900,184, must conduct thorough freedom-to-operate (FTO) analyses. This involves: Searching for Expired Patents: Identifying patents that have expired, allowing for generic development or new research. Patent 6,900,184 is approaching or has reached its expiration. Analyzing Active Patents: Reviewing existing, unexpired patents that might claim similar chemical structures or therapeutic methods. Evaluating Patent Claims: Precisely interpreting the scope of claims in relevant patents. Considering International Filings: Investigating patent protection in key global markets. The patent landscape is dynamic, with new patent applications filed regularly. Continuous monitoring is essential for R&D and investment strategies. What is the Market Significance of Pain Management Patents? The pain management market is a significant segment of the pharmaceutical industry, driven by a large patient population with unmet needs. Market Size and Growth The global pain management market is valued in the tens of billions of dollars and is projected to continue growing. Factors contributing to this growth include: Aging Population: Increased incidence of chronic pain conditions in older adults. Rising Prevalence of Chronic Diseases: Conditions like diabetes, arthritis, and cancer are often associated with chronic pain. Advancements in Treatment Modalities: Development of more targeted and effective therapies. Increased Awareness and Diagnosis: Better recognition and reporting of pain conditions. Patent Protection and Innovation Patent protection is critical for incentivizing the substantial R&D investment required to develop new pain therapies. Patents grant exclusivity for a defined period, allowing companies to recoup their investment and fund further innovation. Exclusivity Period: A typical patent term of 20 years from the filing date provides a window for market exclusivity. Generic Competition: Upon patent expiry, generic manufacturers can enter the market, reducing drug prices but also diminishing the innovator's revenue. First-to-File System: The US patent system operates on a first-to-file basis, emphasizing the importance of timely patent applications for novel inventions. Patent 6,900,184, during its active term, would have provided Merck with a period of market exclusivity for the specific tetrahydropyran compounds and their use in pain treatment. As this patent approaches or reaches its expiration, the door opens for generic versions or the development of related compounds by competitors. Key Takeaways United States Patent 6,900,184 protects methods for treating pain using specific tetrahydropyran-containing compounds and related pharmaceutical compositions. The patent's claims are directed to a defined chemical genus and its therapeutic application, with specific exemplified compounds and indications for inflammatory and neuropathic pain. The patent was granted to Merck & Co., Inc. in 2005 and its 20-year term from the filing date of 2001 is nearing expiration. The patent landscape for pain management is competitive, with ongoing innovation in therapeutic targets, chemical structures, and drug delivery. Freedom-to-operate analyses are crucial for companies operating in the pain management therapeutic area, particularly concerning compounds with similar structural motifs or therapeutic mechanisms. The expiration of patents like 6,900,184 significantly impacts market dynamics, paving the way for generic competition and new product development. Frequently Asked Questions What specific types of pain does Patent 6,900,184 claim to treat? Patent 6,900,184 broadly claims methods of treating "pain." However, dependent claims specifically mention the treatment of "inflammatory pain" and "neuropathic pain," indicating a focus on these categories. When will United States Patent 6,900,184 expire? United States Patent 6,900,184 was filed on September 26, 2001. Under U.S. patent law, its term is 20 years from the filing date, meaning it is set to expire on September 26, 2021, subject to maintenance fees. Can a company develop and sell a drug that falls under the claims of Patent 6,900,184 after it expires? Yes, once a patent expires, the claims enter the public domain. Companies are generally free to develop, manufacture, and sell products that fall within the scope of expired patent claims without infringing that specific patent, provided they comply with all other relevant regulations. What is a Markush structure, and why is it relevant to Patent 6,900,184? A Markush structure is a graphical representation used in chemical patents to define a genus of compounds. It describes a core chemical structure with variable substituents (indicated by R groups). This allows a patent to claim a broad class of related compounds with a single structure, rather than listing every individual compound. Patent 6,900,184 utilizes a Markush structure to define Formula I, encompassing a range of tetrahydropyran-containing compounds. Who is the assignee of United States Patent 6,900,184? The assignee of United States Patent 6,900,184 is Merck & Co., Inc. What are the implications of the patent's claims on pain management research? The existence of this patent during its term limited the ability of other entities to patent and commercialize compounds fitting the exact described structure and method of use for pain treatment. Upon expiration, it can facilitate research into generic alternatives or the development of structurally similar compounds for pain management by allowing others to build upon the disclosed invention. Cited Sources [1] Merck & Co., Inc. (2005). U.S. Patent 6,900,184. United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

Details for Patent: 6,900,184

Summary for Patent: 6,900,184