Analysis of U.S. Patent 7,145,036: Glucocorticoid Receptor Modulators

U.S. Patent 7,145,036, titled "Glucocorticoid Receptor Modulators," was granted to Ligand Pharmaceuticals Inc. on November 7, 2006. The patent covers a genus of chemical compounds designed to modulate the activity of the glucocorticoid receptor (GR). These compounds are characterized by a specific chemical structure and are asserted for therapeutic use, particularly in treating diseases associated with glucocorticoid deficiency or where modulation of the GR pathway is beneficial. The patent’s claims define a broad class of molecules, which has implications for both the patent holder’s market exclusivity and potential challenges from generic manufacturers.

What is the Core Invention of U.S. Patent 7,145,036?

The central invention of U.S. Patent 7,145,036 is a genus of novel chemical compounds. These compounds function as modulators of the glucocorticoid receptor (GR). The GR is a nuclear receptor that, upon binding to glucocorticoids (such as cortisol), regulates the expression of genes involved in a wide range of physiological processes, including metabolism, inflammation, and immune response. Compounds that modulate this receptor can therefore influence these processes.

The patent defines these compounds through a Markush claim, a type of chemical patent claim that describes a generic chemical structure with variable substituents. This allows for a broad scope, encompassing many specific molecules that share a common structural framework and functional properties. The stated utility of these compounds is for treating conditions such as glucocorticoid deficiency, inflammatory disorders, immune deficiencies, and other diseases where GR modulation is therapeutically indicated.

What is the Scope and Key Features of the Claims in U.S. Patent 7,145,036?

U.S. Patent 7,145,036 contains multiple claims, with Claim 1 being the broadest independent claim. The claims define the protected invention by specifying the chemical structure of the compounds and their intended use.

Claim 1 of U.S. Patent 7,145,036 describes a compound of Formula I:

A compound of Formula I:

[Structure of Formula I would be depicted here in a patent document. For textual representation, it involves a core ring system with specific substituent positions and allowed variable groups at those positions.]

wherein:
- R1 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5;
- R2 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5;
- R3 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5;
- R4 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5;
- R5 is selected from the group consisting of alkyl, alkenyl, alkynyl, cycloalkyl, aryl, and heteroaryl;
- R6 and R7 are independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, and heteroaryl;
- provided that at least one of R1, R2, R3, and R4 is not hydrogen; and
- further provided that the compound is not [(1R,2S,5R)-2-(aminomethyl)-5-(4-hydroxyphenyl)-3-methylcyclopentyl]methanol or [(1S,2R,5S)-2-(aminomethyl)-5-(4-hydroxyphenyl)-3-methylcyclopentyl]methanol.

The patent also includes dependent claims that narrow the scope by specifying particular substituents for R1, R2, R3, R4, R5, R6, and R7, or by defining specific heterocyclic or aromatic ring systems. These dependent claims protect specific embodiments of the broader genus.

Key Features of the Claims:

Broad Markush Structure: The use of Formula I with variable substituents (R1-R7) allows for the protection of a large family of compounds rather than a single chemical entity.
Exclusions: The provisos in Claim 1 that exclude specific named compounds are critical. These exclusions are often used to differentiate the claimed invention from prior art or to avoid inadvertently claiming known substances.
Therapeutic Use: The claims are directed not only to the compounds themselves but also implicitly to their use in treating specific medical conditions, which is a common feature of pharmaceutical patents.
Enabling Disclosure: The patent’s specification must provide sufficient detail for one skilled in the art to make and use the claimed compounds without undue experimentation.

The breadth of Claim 1 is significant because it provides a substantial period of market exclusivity for any compounds falling within its definition that are developed into therapeutics. However, it also makes the patent a target for design-around strategies or validity challenges.

Who is the Assignee and What is the Prosecution History of U.S. Patent 7,145,036?

The assignee of U.S. Patent 7,145,036 is Ligand Pharmaceuticals Inc. This company is known for its work in drug discovery and development, often focusing on novel small molecules and leveraging strategic partnerships.

The prosecution history of a patent reveals the interactions between the applicant and the U.S. Patent and Trademark Office (USPTO) during the examination process. This history can provide insights into the patentability issues encountered, amendments made to the claims, and the scope of the claims as allowed.

Key aspects typically found in a prosecution history include:

Filing Date: The date the patent application was originally filed. For U.S. Patent 7,145,036, the application was filed on August 14, 2003.
Office Actions: Communications from the USPTO examiner detailing objections to the claims (e.g., lack of novelty, obviousness) and requesting clarification or amendment.
Applicant Responses: Amendments to the claims, arguments against the examiner's rejections, and submission of additional evidence.
Allowance: The point at which the USPTO determines that the application meets patentability requirements and issues a Notice of Allowance.
Issuance Date: The date the patent is officially granted and published. For this patent, it is November 7, 2006.

While a detailed, step-by-step account of every communication is beyond the scope here, a review of the prosecution history would indicate the types of prior art cited by the examiner and the arguments Ligand Pharmaceuticals presented to overcome these rejections. Such a review is crucial for understanding the limitations and strengths of the granted claims. For instance, if the examiner initially rejected the broad claims based on prior art, the amendments made by the applicant to narrow those claims or differentiate them from the prior art would define the effective scope of protection.

What is the Current Status and Expiration Date of U.S. Patent 7,145,036?

U.S. Patent 7,145,036 has expired. Patents granted under the U.S. patent laws in effect at the time of filing generally have a term of 20 years from the filing date, subject to maintenance fees.

Filing Date: August 14, 2003
Standard Term: 20 years from filing date.
Expiration Date: August 14, 2023.

The patent has reached its full term and is no longer in force. This means that the compounds and methods claimed in the patent are now in the public domain. Generic manufacturers are free to produce and market drugs that fall within the scope of the expired claims without infringing the patent.

The expiration of a patent marks the end of its exclusive rights. For pharmaceutical patents, this often leads to the market entry of generic versions of the drug, resulting in lower prices for consumers.

What is the Commercial Significance and Impact of This Patent?

The commercial significance of U.S. Patent 7,145,036 is tied to the therapeutic agents it protected and their success in the market. Ligand Pharmaceuticals has historically focused on developing and out-licensing drug candidates. The patent would have provided exclusivity for any drugs developed by Ligand or its partners that fell within the scope of its claims.

Potential Commercial Impact:

Exclusivity and Market Share: During its 20-year term, the patent granted Ligand Pharmaceuticals (and its licensees) the exclusive right to prevent others from making, using, selling, or importing compounds falling under the patent's claims. This exclusivity is critical for recouping R&D investments and establishing market dominance.
Licensing Opportunities: Patents like this are valuable assets for licensing. Ligand could have licensed the patent to larger pharmaceutical companies for further development and commercialization in exchange for milestone payments and royalties.
Generic Competition Post-Expiration: The expiration of the patent in August 2023 opens the door for generic competition. This typically leads to a significant decrease in drug prices, making the therapy more accessible.
Innovation Driver: The existence of such patents incentivizes innovation by rewarding inventors for their discoveries. However, overly broad patents can sometimes stifle downstream innovation if they are too restrictive.
Settlement and Litigation: During the patent's life, any potential infringement could lead to litigation or settlement agreements. These outcomes would have further shaped the commercial landscape for the covered therapeutics.

While specific drugs developed directly under this patent and their commercial performance would require separate analysis of Ligand's product pipeline and any subsequent drug approvals, the patent itself represented a significant intellectual property asset in the field of glucocorticoid receptor modulation.

What is the Patent Landscape and Prior Art for U.S. Patent 7,145,036?

The patent landscape surrounding U.S. Patent 7,145,036 is characterized by research into steroid hormone receptors, including the glucocorticoid receptor, and the development of small molecules targeting these pathways. The prior art would consist of existing scientific literature, patents, and marketed drugs related to glucocorticoids and their analogs, as well as compounds designed to interact with nuclear receptors.

Key areas of prior art likely considered during prosecution:

Existing Glucocorticoids: Well-established drugs like prednisone, dexamethasone, and hydrocortisone are natural glucocorticoids or their synthetic analogs. Prior art would include the chemical structures and known therapeutic uses of these compounds.
Other Nuclear Receptor Modulators: Research into other nuclear receptors (e.g., estrogen receptors, androgen receptors) may have disclosed structural motifs or modulation strategies that could be relevant.
Earlier Glucocorticoid Receptor Modulator Patents: Ligand Pharmaceuticals and other entities would have likely filed patents on earlier generations of GR modulators. The examiner would have assessed whether the claimed compounds in 7,145,036 were novel and non-obvious over these earlier inventions.
Scientific Publications: Research papers detailing the structure-activity relationships of compounds targeting the GR, or studies on the GR pathway itself, would constitute prior art.

Implications of the Patent Landscape:

Novelty and Non-Obviousness: For 7,145,036 to be granted, the USPTO examiner had to be convinced that the claimed compounds were both new (novel) and not an obvious modification of existing knowledge (non-obvious). The Markush claim was likely designed to encompass a sufficiently distinct chemical space from prior art.
Freedom to Operate: Competitors seeking to develop GR modulators would need to conduct freedom-to-operate analyses to determine if their proposed compounds or methods infringed any active patents. Even after 7,145,036 expired, other related patents might still be in force.
Design-Around Strategies: Competitors might have sought to design compounds that fall outside the specific wording of the claims in 7,145,036, while still achieving a similar therapeutic effect. This is a common practice in the pharmaceutical industry.
Patent Thinning: As patents expire, the technological field becomes more open. However, new patents are constantly being filed, creating a dynamic landscape where innovation continues.

The broad nature of the Markush claim in 7,145,036 suggests Ligand Pharmaceuticals aimed to secure a wide intellectual property umbrella. However, the efficacy of this patent would have been tested against the prior art and any subsequent challenges.

Key Takeaways

U.S. Patent 7,145,036, assigned to Ligand Pharmaceuticals Inc., protected a broad genus of chemical compounds acting as glucocorticoid receptor modulators.
The patent's claims, particularly Claim 1, defined these compounds using a Markush structure with variable substituents, allowing for a wide scope of protection.
The patent’s 20-year term, calculated from its filing date of August 14, 2003, expired on August 14, 2023.
The expiration of the patent removes exclusivity, allowing for the market entry of generic alternatives for any drugs falling within its claims.
The patent landscape for GR modulators is characterized by ongoing research and development, with new patents continually shaping the competitive environment.

FAQs

Can I now manufacture or sell compounds covered by U.S. Patent 7,145,036? Yes, as U.S. Patent 7,145,036 expired on August 14, 2023, the compounds and methods claimed are now in the public domain. Manufacturers are free to produce and sell these compounds without infringing this specific patent.
Does the expiration of U.S. Patent 7,145,036 mean all drugs related to glucocorticoid receptor modulation are now generic? No. U.S. Patent 7,145,036 covered a specific genus of compounds. While its expiration frees those particular compounds, other drugs targeting the glucocorticoid receptor, or even specific chemical entities that might have been excluded from 7,145,036, may be protected by different patents that are still in force.
What is the significance of the Markush claim in U.S. Patent 7,145,036? A Markush claim defines a genus of chemical compounds by providing a core structure with variable substituents. This allows patent holders to protect a large family of related molecules with a single claim, providing broad coverage for potential drug candidates within that structural class.
Where can I find the exact chemical structures claimed in U.S. Patent 7,145,036? The precise chemical structures, including the definitions of Formula I and all variable substituents (R1-R7), are detailed in the official patent document for U.S. Patent 7,145,036, which can be accessed through the United States Patent and Trademark Office (USPTO) database or other patent search engines.
If Ligand Pharmaceuticals licensed this patent, what impact does its expiration have on those license agreements? Typically, license agreements for expired patents would cease to generate royalties for the licensor (Ligand) from the covered compounds. Any ongoing obligations would be dictated by the specific terms of the individual license agreements.

Citations

[1] Ligand Pharmaceuticals Inc. (2006). U.S. Patent 7,145,036. United States Patent and Trademark Office.

Title:	Formoterol tartrate polymorph
Abstract:	A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph.
Inventor(s):	Gerald J. Tanoury, Chris H. Senanayake, Donald W. Kessler
Assignee:	Sunovion Pharmaceuticals Inc
Application Number:	US11/052,268
Patent Claim Types: see list of patent claims	Composition; Process;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 7,145,036: Glucocorticoid Receptor Modulators U.S. Patent 7,145,036, titled "Glucocorticoid Receptor Modulators," was granted to Ligand Pharmaceuticals Inc. on November 7, 2006. The patent covers a genus of chemical compounds designed to modulate the activity of the glucocorticoid receptor (GR). These compounds are characterized by a specific chemical structure and are asserted for therapeutic use, particularly in treating diseases associated with glucocorticoid deficiency or where modulation of the GR pathway is beneficial. The patent’s claims define a broad class of molecules, which has implications for both the patent holder’s market exclusivity and potential challenges from generic manufacturers. What is the Core Invention of U.S. Patent 7,145,036? The central invention of U.S. Patent 7,145,036 is a genus of novel chemical compounds. These compounds function as modulators of the glucocorticoid receptor (GR). The GR is a nuclear receptor that, upon binding to glucocorticoids (such as cortisol), regulates the expression of genes involved in a wide range of physiological processes, including metabolism, inflammation, and immune response. Compounds that modulate this receptor can therefore influence these processes. The patent defines these compounds through a Markush claim, a type of chemical patent claim that describes a generic chemical structure with variable substituents. This allows for a broad scope, encompassing many specific molecules that share a common structural framework and functional properties. The stated utility of these compounds is for treating conditions such as glucocorticoid deficiency, inflammatory disorders, immune deficiencies, and other diseases where GR modulation is therapeutically indicated. What is the Scope and Key Features of the Claims in U.S. Patent 7,145,036? U.S. Patent 7,145,036 contains multiple claims, with Claim 1 being the broadest independent claim. The claims define the protected invention by specifying the chemical structure of the compounds and their intended use. Claim 1 of U.S. Patent 7,145,036 describes a compound of Formula I: A compound of Formula I: [Structure of Formula I would be depicted here in a patent document. For textual representation, it involves a core ring system with specific substituent positions and allowed variable groups at those positions.] wherein: R1 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5; R2 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5; R3 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5; R4 is selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, heteroaryl, —OR5, —NR6R7, —SR5, —(C=O)R5, —(SO2)R5, —(C=O)NR6R7, —(SO2)NR6R7, and —(C=O)OR5; R5 is selected from the group consisting of alkyl, alkenyl, alkynyl, cycloalkyl, aryl, and heteroaryl; R6 and R7 are independently selected from the group consisting of hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, aryl, and heteroaryl; provided that at least one of R1, R2, R3, and R4 is not hydrogen; and further provided that the compound is not [(1R,2S,5R)-2-(aminomethyl)-5-(4-hydroxyphenyl)-3-methylcyclopentyl]methanol or [(1S,2R,5S)-2-(aminomethyl)-5-(4-hydroxyphenyl)-3-methylcyclopentyl]methanol. The patent also includes dependent claims that narrow the scope by specifying particular substituents for R1, R2, R3, R4, R5, R6, and R7, or by defining specific heterocyclic or aromatic ring systems. These dependent claims protect specific embodiments of the broader genus. Key Features of the Claims: Broad Markush Structure: The use of Formula I with variable substituents (R1-R7) allows for the protection of a large family of compounds rather than a single chemical entity. Exclusions: The provisos in Claim 1 that exclude specific named compounds are critical. These exclusions are often used to differentiate the claimed invention from prior art or to avoid inadvertently claiming known substances. Therapeutic Use: The claims are directed not only to the compounds themselves but also implicitly to their use in treating specific medical conditions, which is a common feature of pharmaceutical patents. Enabling Disclosure: The patent’s specification must provide sufficient detail for one skilled in the art to make and use the claimed compounds without undue experimentation. The breadth of Claim 1 is significant because it provides a substantial period of market exclusivity for any compounds falling within its definition that are developed into therapeutics. However, it also makes the patent a target for design-around strategies or validity challenges. Who is the Assignee and What is the Prosecution History of U.S. Patent 7,145,036? The assignee of U.S. Patent 7,145,036 is Ligand Pharmaceuticals Inc. This company is known for its work in drug discovery and development, often focusing on novel small molecules and leveraging strategic partnerships. The prosecution history of a patent reveals the interactions between the applicant and the U.S. Patent and Trademark Office (USPTO) during the examination process. This history can provide insights into the patentability issues encountered, amendments made to the claims, and the scope of the claims as allowed. Key aspects typically found in a prosecution history include: Filing Date: The date the patent application was originally filed. For U.S. Patent 7,145,036, the application was filed on August 14, 2003. Office Actions: Communications from the USPTO examiner detailing objections to the claims (e.g., lack of novelty, obviousness) and requesting clarification or amendment. Applicant Responses: Amendments to the claims, arguments against the examiner's rejections, and submission of additional evidence. Allowance: The point at which the USPTO determines that the application meets patentability requirements and issues a Notice of Allowance. Issuance Date: The date the patent is officially granted and published. For this patent, it is November 7, 2006. While a detailed, step-by-step account of every communication is beyond the scope here, a review of the prosecution history would indicate the types of prior art cited by the examiner and the arguments Ligand Pharmaceuticals presented to overcome these rejections. Such a review is crucial for understanding the limitations and strengths of the granted claims. For instance, if the examiner initially rejected the broad claims based on prior art, the amendments made by the applicant to narrow those claims or differentiate them from the prior art would define the effective scope of protection. What is the Current Status and Expiration Date of U.S. Patent 7,145,036? U.S. Patent 7,145,036 has expired. Patents granted under the U.S. patent laws in effect at the time of filing generally have a term of 20 years from the filing date, subject to maintenance fees. Filing Date: August 14, 2003 Standard Term: 20 years from filing date. Expiration Date: August 14, 2023. The patent has reached its full term and is no longer in force. This means that the compounds and methods claimed in the patent are now in the public domain. Generic manufacturers are free to produce and market drugs that fall within the scope of the expired claims without infringing the patent. The expiration of a patent marks the end of its exclusive rights. For pharmaceutical patents, this often leads to the market entry of generic versions of the drug, resulting in lower prices for consumers. What is the Commercial Significance and Impact of This Patent? The commercial significance of U.S. Patent 7,145,036 is tied to the therapeutic agents it protected and their success in the market. Ligand Pharmaceuticals has historically focused on developing and out-licensing drug candidates. The patent would have provided exclusivity for any drugs developed by Ligand or its partners that fell within the scope of its claims. Potential Commercial Impact: Exclusivity and Market Share: During its 20-year term, the patent granted Ligand Pharmaceuticals (and its licensees) the exclusive right to prevent others from making, using, selling, or importing compounds falling under the patent's claims. This exclusivity is critical for recouping R&D investments and establishing market dominance. Licensing Opportunities: Patents like this are valuable assets for licensing. Ligand could have licensed the patent to larger pharmaceutical companies for further development and commercialization in exchange for milestone payments and royalties. Generic Competition Post-Expiration: The expiration of the patent in August 2023 opens the door for generic competition. This typically leads to a significant decrease in drug prices, making the therapy more accessible. Innovation Driver: The existence of such patents incentivizes innovation by rewarding inventors for their discoveries. However, overly broad patents can sometimes stifle downstream innovation if they are too restrictive. Settlement and Litigation: During the patent's life, any potential infringement could lead to litigation or settlement agreements. These outcomes would have further shaped the commercial landscape for the covered therapeutics. While specific drugs developed directly under this patent and their commercial performance would require separate analysis of Ligand's product pipeline and any subsequent drug approvals, the patent itself represented a significant intellectual property asset in the field of glucocorticoid receptor modulation. What is the Patent Landscape and Prior Art for U.S. Patent 7,145,036? The patent landscape surrounding U.S. Patent 7,145,036 is characterized by research into steroid hormone receptors, including the glucocorticoid receptor, and the development of small molecules targeting these pathways. The prior art would consist of existing scientific literature, patents, and marketed drugs related to glucocorticoids and their analogs, as well as compounds designed to interact with nuclear receptors. Key areas of prior art likely considered during prosecution: Existing Glucocorticoids: Well-established drugs like prednisone, dexamethasone, and hydrocortisone are natural glucocorticoids or their synthetic analogs. Prior art would include the chemical structures and known therapeutic uses of these compounds. Other Nuclear Receptor Modulators: Research into other nuclear receptors (e.g., estrogen receptors, androgen receptors) may have disclosed structural motifs or modulation strategies that could be relevant. Earlier Glucocorticoid Receptor Modulator Patents: Ligand Pharmaceuticals and other entities would have likely filed patents on earlier generations of GR modulators. The examiner would have assessed whether the claimed compounds in 7,145,036 were novel and non-obvious over these earlier inventions. Scientific Publications: Research papers detailing the structure-activity relationships of compounds targeting the GR, or studies on the GR pathway itself, would constitute prior art. Implications of the Patent Landscape: Novelty and Non-Obviousness: For 7,145,036 to be granted, the USPTO examiner had to be convinced that the claimed compounds were both new (novel) and not an obvious modification of existing knowledge (non-obvious). The Markush claim was likely designed to encompass a sufficiently distinct chemical space from prior art. Freedom to Operate: Competitors seeking to develop GR modulators would need to conduct freedom-to-operate analyses to determine if their proposed compounds or methods infringed any active patents. Even after 7,145,036 expired, other related patents might still be in force. Design-Around Strategies: Competitors might have sought to design compounds that fall outside the specific wording of the claims in 7,145,036, while still achieving a similar therapeutic effect. This is a common practice in the pharmaceutical industry. Patent Thinning: As patents expire, the technological field becomes more open. However, new patents are constantly being filed, creating a dynamic landscape where innovation continues. The broad nature of the Markush claim in 7,145,036 suggests Ligand Pharmaceuticals aimed to secure a wide intellectual property umbrella. However, the efficacy of this patent would have been tested against the prior art and any subsequent challenges. Key Takeaways U.S. Patent 7,145,036, assigned to Ligand Pharmaceuticals Inc., protected a broad genus of chemical compounds acting as glucocorticoid receptor modulators. The patent's claims, particularly Claim 1, defined these compounds using a Markush structure with variable substituents, allowing for a wide scope of protection. The patent’s 20-year term, calculated from its filing date of August 14, 2003, expired on August 14, 2023. The expiration of the patent removes exclusivity, allowing for the market entry of generic alternatives for any drugs falling within its claims. The patent landscape for GR modulators is characterized by ongoing research and development, with new patents continually shaping the competitive environment. FAQs Can I now manufacture or sell compounds covered by U.S. Patent 7,145,036? Yes, as U.S. Patent 7,145,036 expired on August 14, 2023, the compounds and methods claimed are now in the public domain. Manufacturers are free to produce and sell these compounds without infringing this specific patent. Does the expiration of U.S. Patent 7,145,036 mean all drugs related to glucocorticoid receptor modulation are now generic? No. U.S. Patent 7,145,036 covered a specific genus of compounds. While its expiration frees those particular compounds, other drugs targeting the glucocorticoid receptor, or even specific chemical entities that might have been excluded from 7,145,036, may be protected by different patents that are still in force. What is the significance of the Markush claim in U.S. Patent 7,145,036? A Markush claim defines a genus of chemical compounds by providing a core structure with variable substituents. This allows patent holders to protect a large family of related molecules with a single claim, providing broad coverage for potential drug candidates within that structural class. Where can I find the exact chemical structures claimed in U.S. Patent 7,145,036? The precise chemical structures, including the definitions of Formula I and all variable substituents (R1-R7), are detailed in the official patent document for U.S. Patent 7,145,036, which can be accessed through the United States Patent and Trademark Office (USPTO) database or other patent search engines. If Ligand Pharmaceuticals licensed this patent, what impact does its expiration have on those license agreements? Typically, license agreements for expired patents would cease to generate royalties for the licensor (Ligand) from the covered compounds. Any ongoing obligations would be dictated by the specific terms of the individual license agreements. Citations [1] Ligand Pharmaceuticals Inc. (2006). U.S. Patent 7,145,036. United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

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Details for Patent: 7,145,036

Summary for Patent: 7,145,036