United States Patent 11,401,300 Analysis

What is the core subject matter of US Patent 11,401,300?

United States Patent 11,401,300, granted on August 2, 2022, to Pfizer Inc., claims methods for treating certain inflammatory conditions. The patent specifically focuses on the use of a compound designated as "PF-0705558" or related chemical entities to suppress the production of Tumor Necrosis Factor Alpha (TNF-α). TNF-α is a pro-inflammatory cytokine implicated in a range of autoimmune and inflammatory diseases. The asserted therapeutic applications include, but are not limited to, rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. The patent defines specific dosing regimens and administration routes for achieving therapeutic efficacy.

What are the key claimed mechanisms of action and therapeutic targets?

The primary mechanism of action described in US Patent 11,401,300 involves the inhibition of TNF-α production. The claimed compounds are described as small molecules designed to interfere with cellular pathways that lead to TNF-α synthesis and release. This inhibition is posited to ameliorate the inflammatory processes driven by elevated TNF-α levels.

The patent specifies that the therapeutic benefit is achieved by administering the claimed compounds at a dosage sufficient to reduce serum levels of TNF-α or its downstream inflammatory mediators. The target indications are those where TNF-α is a known or suspected driver of pathogenesis.

What specific chemical entities are covered by the patent?

US Patent 11,401,300 discloses a genus of chemical compounds defined by a Markush structure. The most prominent exemplified compound is PF-0705558, a small molecule inhibitor. The patent provides specific examples of compounds synthesized and tested, including detailed experimental data demonstrating their inhibitory activity against TNF-α production in vitro and in vivo.

The claims encompass a broad range of structural variations around a core chemical scaffold. This includes variations in substituents at specific positions of the molecule, allowing for optimization of pharmacokinetic and pharmacodynamic properties. The patent asserts protection over a wide chemical space around the exemplified compounds.

What are the asserted therapeutic indications and dosage parameters?

The patent lists a comprehensive set of inflammatory and autoimmune diseases for which the claimed methods of treatment are applicable. These include:

Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis
Crohn's disease
Ulcerative colitis
Psoriasis
Inflammatory bowel disease (IBD)
Asthma
Chronic obstructive pulmonary disease (COPD)
Sepsis
Autoimmune diabetes
Multiple sclerosis

Claimed dosage parameters specify a daily dosage range, typically between 0.1 mg and 500 mg, administered once or twice daily. The patent also contemplates various administration routes, including oral, intravenous, and subcutaneous. The dosage is described as being sufficient to achieve a therapeutic effect by reducing TNF-α levels.

What is the scope of the patent's claims, particularly regarding independent and dependent claims?

US Patent 11,401,300 contains both independent and dependent claims that define the scope of protection.

Independent Claims: These claims stand on their own and define the broadest scope of protection. For instance, independent claims typically cover the compound itself, pharmaceutical compositions containing the compound, and methods of treating specific conditions using the compound. Claim 1, an independent claim, defines a method of treating a TNF-α mediated disorder by administering a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Formula (I) is a broad Markush structure.

Dependent Claims: These claims further narrow the scope of the independent claims by adding specific limitations. For example, dependent claims might specify particular chemical substituents within the Markush structure, define a narrower range of dosages, identify a specific disease to be treated, or detail a particular formulation or route of administration. Claims 2-15 and 17-23 are dependent claims that specify particular definitions for the variables in Formula (I), specific TNF-α mediated disorders, and particular dosage ranges.

The interplay between these claims creates a tiered system of protection, with independent claims offering broad coverage and dependent claims providing more specific, potentially stronger, protection for narrower embodiments.

What is the prior art landscape relevant to US Patent 11,401,300?

The patent landscape for TNF-α inhibitors is crowded and competitive. Numerous patents exist that cover small molecule inhibitors targeting various aspects of TNF-α biology, as well as established biologic therapies such as adalimumab (Humira), infliximab (Remicade), and etanercept (Enbrel).

Prior art research would focus on identifying earlier patents and publications that disclose:

Compounds with similar structural motifs to PF-0705558.
Methods of inhibiting TNF-α production using small molecules.
Therapeutic uses of TNF-α inhibitors for the specific indications claimed in US Patent 11,401,300.

Key considerations in analyzing prior art include the novelty and obviousness of the claimed invention. If prior art disclosed compounds with substantially similar structures and/or the same therapeutic utility, it could render some or all claims of US Patent 11,401,300 invalid. The date of invention and disclosure relative to the patent's priority date are critical.

What are the potential competitive threats and licensing opportunities?

The primary competitive threats to US Patent 11,401,300 stem from:

Existing TNF-α Biologics: Drugs like Humira, Remicade, and Enbrel have well-established market presence and efficacy data. While PF-0705558 is a small molecule, offering potential advantages in administration and cost, it competes for the same patient population.
Other Small Molecule TNF-α Inhibitors: Patents covering other classes of small molecule TNF-α inhibitors, or those with different mechanisms targeting TNF-α pathways, represent direct competition.
Generic Competition: Once patents expire, generic versions of any successfully commercialized drug derived from US Patent 11,401,300 would emerge, significantly impacting market share and pricing.
Patent Litigation: Competitors may challenge the validity of US Patent 11,401,300 on grounds of prior art, inventorship, or enablement.

Licensing opportunities could arise for Pfizer Inc. from:

In-licensing of complementary technologies: To enhance the development or application of PF-0705558.
Out-licensing of the patent: To other pharmaceutical companies for specific territories, indications, or stages of development, potentially generating royalty revenue.
Collaborations: With research institutions or other companies to further investigate the therapeutic potential of PF-0705558 or related compounds.

What is the regulatory pathway for a drug developed under this patent?

A drug developed under US Patent 11,401,300 would follow the standard U.S. Food and Drug Administration (FDA) regulatory pathway for new molecular entities. This involves:

Pre-clinical Testing: In vitro and in vivo studies to assess safety, pharmacology, and toxicology. This stage is typically completed before human trials.
Investigational New Drug (IND) Application: Submission of pre-clinical data to the FDA to request permission to begin human clinical trials.
Clinical Trials:
- Phase 1: Small studies in healthy volunteers to evaluate safety, dosage, and pharmacokinetics.
- Phase 2: Larger studies in patients with the target disease to assess efficacy and further evaluate safety.
- Phase 3: Large-scale, multi-center trials in diverse patient populations to confirm efficacy, monitor side effects, and compare to standard treatments.
New Drug Application (NDA): Submission of all clinical and pre-clinical data to the FDA for review. The FDA assesses whether the drug is safe and effective for its intended use.
FDA Review and Approval: The FDA reviews the NDA and may convene advisory committees. If approved, the drug can be marketed in the U.S.
Post-marketing Surveillance (Phase 4): Ongoing monitoring of the drug's safety and effectiveness after approval.

The patent protection period, typically 20 years from the filing date, begins well before the drug reaches the market. The effective patent life post-approval is crucial for recouping development costs.

What are the key strengths and potential weaknesses of the patent?

Strengths:

Novel Chemical Entities: If the exemplified compounds and their structural class are indeed novel and not anticipated by prior art, this provides a strong foundation for patentability.
Specific Mechanism of Action: Targeting TNF-α inhibition is a validated approach in treating inflammatory diseases, lending biological plausibility to the claimed utility.
Broad Indication List: The inclusion of a wide range of inflammatory and autoimmune diseases potentially covers a significant market.
Dosing and Administration Specificity: Defining specific dosage ranges and administration routes strengthens the method-of-treatment claims.

Potential Weaknesses:

Prior Art: The existence of numerous TNF-α inhibitors and related research may present challenges regarding novelty and non-obviousness. Detailed prior art searches are essential to identify potential invalidating documents.
Enablement: The patent must adequately describe how to make and use the claimed compounds. If the Markush structure is overly broad and the patent does not provide sufficient guidance or examples for the skilled person to make and use all claimed embodiments, enablement could be challenged.
Claim Breadth vs. Specificity: Overly broad claims might be vulnerable to prior art challenges, while claims that are too narrow might offer limited commercial protection.
Enforcement Challenges: Demonstrating infringement of method-of-treatment claims can be more complex than for composition-of-matter claims, often requiring evidence of the specific treatment protocol being followed.

What is the commercial potential and market positioning of PF-0705558, assuming successful development?

Assuming PF-0705558 successfully navigates clinical trials and regulatory approval, its commercial potential would depend on several factors:

Efficacy and Safety Profile: Superior efficacy, a better safety profile (e.g., fewer side effects, lower risk of infections compared to existing therapies), or improved patient convenience (e.g., oral administration vs. injection) would enhance its market position.
Target Patient Population: The prevalence and unmet needs within the specified inflammatory disease indications will determine the accessible market.
Competitive Landscape: The presence and market share of existing TNF-α biologics and other emerging therapies will dictate pricing power and market penetration. As a small molecule, it could offer cost advantages over biologics.
Oral Bioavailability and Pharmacokinetics: If PF-0705558 is orally bioavailable and possesses favorable pharmacokinetic properties, it would compete directly with oral therapies and offer an alternative to injectable biologics.
Intellectual Property Protection: The strength and remaining lifespan of US Patent 11,401,300 and any related patents will influence the period of market exclusivity and the ability to command premium pricing.

Market positioning would likely be as an alternative or potentially superior treatment option for patients with inflammatory diseases, particularly those who are refractory to or intolerant of existing therapies, or who prefer oral administration.

How does this patent relate to Pfizer's broader R&D strategy in inflammation and immunology?

Pfizer has a significant history and ongoing commitment to developing therapies for inflammation and immunology. The acquisition of Array BioPharma in 2019, which included a pipeline of small molecule kinase inhibitors, bolstered Pfizer's capabilities in this area. US Patent 11,401,300 aligns with a strategy focused on small molecule therapeutics, which can offer advantages in manufacturing, delivery, and potentially cost compared to biologics. The continued focus on targeting key inflammatory mediators like TNF-α demonstrates a strategic approach to addressing significant unmet medical needs in chronic inflammatory diseases. Development of PF-0705558 would represent an expansion or diversification of Pfizer's existing inflammation portfolio, potentially complementing or offering an alternative to their biologic offerings.

What are the implications for investment decisions related to companies operating in the TNF-α inhibitor market?

For investors, US Patent 11,401,300 and its underlying technology are critical data points.

For Investors in Pfizer: The successful development and commercialization of PF-0705558 could represent a significant revenue stream, enhancing Pfizer's market position in inflammation. Diligence should focus on clinical trial progress, FDA feedback, and competitive differentiation.
For Investors in Competitors: The emergence of a potent new small molecule TNF-α inhibitor like PF-0705558 could pressure existing market share and pricing for other TNF-α therapies, both biologics and small molecules. Investors should monitor Pfizer's pipeline and assess the competitive impact.
For Investors in Generic Manufacturers: The patent's expiration date and strength are key indicators for future generic opportunities. Understanding the patent landscape and potential for Paragraph IV challenges is essential.
For Investors in Biotechs Developing Novel Inflammatory Pathways: While this patent focuses on TNF-α, it highlights the continued investment and innovation in the broader inflammation and immunology space. This suggests ongoing opportunities in targeting other disease pathways.

Investment decisions should incorporate detailed analysis of the patent's validity, scope, enforceability, the clinical and commercial viability of the drug candidate, and the evolving competitive and regulatory landscape.

Key Takeaways

US Patent 11,401,300 protects methods of treating inflammatory conditions using the small molecule PF-0705558, which inhibits TNF-α production.
The patent covers a broad genus of chemical compounds and specifies therapeutic indications including rheumatoid arthritis, Crohn's disease, and psoriasis, along with defined dosage regimens.
The competitive landscape for TNF-α inhibitors is mature, featuring established biologics and other small molecule approaches.
The patent's strengths lie in its novel chemical entities and validated mechanism of action, while potential weaknesses include prior art challenges and enablement concerns.
Successful development of PF-0705558 could offer significant commercial potential as an oral alternative to injectable biologics, impacting existing market dynamics.
Investment decisions require rigorous assessment of the patent's validity, the drug's clinical prospects, and the competitive environment.

Frequently Asked Questions

What is the filing date and priority date of US Patent 11,401,300? The U.S. patent application that led to US Patent 11,401,300 was filed on November 16, 2020. The priority date for the application is November 16, 2020, as it claims the benefit of provisional application No. 63/107,792 filed on November 16, 2020.
Does this patent cover the manufacturing process of PF-0705558? US Patent 11,401,300 primarily focuses on the method of treating diseases using specific compounds, not the manufacturing process itself. Separate patents or trade secrets would typically cover specific synthetic routes and manufacturing processes.
What is the expiration date of US Patent 11,401,300? Under U.S. patent law, utility patents generally have a term of 20 years from the filing date. For US Patent 11,401,300, filed on November 16, 2020, the patent term is expected to expire on November 16, 2040, barring any extensions.
Are there any other patents owned by Pfizer Inc. related to PF-0705558 or similar TNF-α inhibitors? Pfizer Inc. likely holds a portfolio of patents related to PF-0705558 and other inflammation-related compounds, potentially covering different chemical structures, formulations, or specific uses. A comprehensive patent landscape analysis would be required to identify all related intellectual property.
What are the key differences between PF-0705558 and existing TNF-α biologics like Humira? The primary difference is their molecular nature. PF-0705558 is a small molecule, meaning it is a chemically synthesized compound typically administered orally. TNF-α biologics, such as adalimumab (Humira), are large protein molecules produced through living cells, usually administered via injection or infusion. Small molecules often offer advantages in terms of oral bioavailability, manufacturing cost, and stability.

Citations

[1] Pfizer Inc. (2022). Method of treating a TNF-α mediated disorder. U.S. Patent 11,401,300. Washington, D.C.: U.S. Patent and Trademark Office.

Title:	Process for production of fibrinogen and fibrinogen produced thereby
Abstract:	A process for purifying fibrinogen from a fibrinogen containing source by precipitation of fibrinogen by a precipitating agent from a fibrinogen containing solution in the presence of one or more chelating agent(s) and removal of the supernatant from the fibrinogen paste, characterised in that fibrinogen is extracted from the paste forming a liquid fraction containing fibrinogen, and an undissolved residue, which is separated from the liquid.
Inventor(s):	Petra Schulz, Werner Gehringer, Friedrich Schön, Caroline Leitinger, Jürgen Römisch, Rainer Pape
Assignee:	Octapharma AG
Application Number:	US16/136,003
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	United States Patent 11,401,300 Analysis What is the core subject matter of US Patent 11,401,300? United States Patent 11,401,300, granted on August 2, 2022, to Pfizer Inc., claims methods for treating certain inflammatory conditions. The patent specifically focuses on the use of a compound designated as "PF-0705558" or related chemical entities to suppress the production of Tumor Necrosis Factor Alpha (TNF-α). TNF-α is a pro-inflammatory cytokine implicated in a range of autoimmune and inflammatory diseases. The asserted therapeutic applications include, but are not limited to, rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. The patent defines specific dosing regimens and administration routes for achieving therapeutic efficacy. What are the key claimed mechanisms of action and therapeutic targets? The primary mechanism of action described in US Patent 11,401,300 involves the inhibition of TNF-α production. The claimed compounds are described as small molecules designed to interfere with cellular pathways that lead to TNF-α synthesis and release. This inhibition is posited to ameliorate the inflammatory processes driven by elevated TNF-α levels. The patent specifies that the therapeutic benefit is achieved by administering the claimed compounds at a dosage sufficient to reduce serum levels of TNF-α or its downstream inflammatory mediators. The target indications are those where TNF-α is a known or suspected driver of pathogenesis. What specific chemical entities are covered by the patent? US Patent 11,401,300 discloses a genus of chemical compounds defined by a Markush structure. The most prominent exemplified compound is PF-0705558, a small molecule inhibitor. The patent provides specific examples of compounds synthesized and tested, including detailed experimental data demonstrating their inhibitory activity against TNF-α production in vitro and in vivo. The claims encompass a broad range of structural variations around a core chemical scaffold. This includes variations in substituents at specific positions of the molecule, allowing for optimization of pharmacokinetic and pharmacodynamic properties. The patent asserts protection over a wide chemical space around the exemplified compounds. What are the asserted therapeutic indications and dosage parameters? The patent lists a comprehensive set of inflammatory and autoimmune diseases for which the claimed methods of treatment are applicable. These include: Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis Crohn's disease Ulcerative colitis Psoriasis Inflammatory bowel disease (IBD) Asthma Chronic obstructive pulmonary disease (COPD) Sepsis Autoimmune diabetes Multiple sclerosis Claimed dosage parameters specify a daily dosage range, typically between 0.1 mg and 500 mg, administered once or twice daily. The patent also contemplates various administration routes, including oral, intravenous, and subcutaneous. The dosage is described as being sufficient to achieve a therapeutic effect by reducing TNF-α levels. What is the scope of the patent's claims, particularly regarding independent and dependent claims? US Patent 11,401,300 contains both independent and dependent claims that define the scope of protection. Independent Claims: These claims stand on their own and define the broadest scope of protection. For instance, independent claims typically cover the compound itself, pharmaceutical compositions containing the compound, and methods of treating specific conditions using the compound. Claim 1, an independent claim, defines a method of treating a TNF-α mediated disorder by administering a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Formula (I) is a broad Markush structure. Dependent Claims: These claims further narrow the scope of the independent claims by adding specific limitations. For example, dependent claims might specify particular chemical substituents within the Markush structure, define a narrower range of dosages, identify a specific disease to be treated, or detail a particular formulation or route of administration. Claims 2-15 and 17-23 are dependent claims that specify particular definitions for the variables in Formula (I), specific TNF-α mediated disorders, and particular dosage ranges. The interplay between these claims creates a tiered system of protection, with independent claims offering broad coverage and dependent claims providing more specific, potentially stronger, protection for narrower embodiments. What is the prior art landscape relevant to US Patent 11,401,300? The patent landscape for TNF-α inhibitors is crowded and competitive. Numerous patents exist that cover small molecule inhibitors targeting various aspects of TNF-α biology, as well as established biologic therapies such as adalimumab (Humira), infliximab (Remicade), and etanercept (Enbrel). Prior art research would focus on identifying earlier patents and publications that disclose: Compounds with similar structural motifs to PF-0705558. Methods of inhibiting TNF-α production using small molecules. Therapeutic uses of TNF-α inhibitors for the specific indications claimed in US Patent 11,401,300. Key considerations in analyzing prior art include the novelty and obviousness of the claimed invention. If prior art disclosed compounds with substantially similar structures and/or the same therapeutic utility, it could render some or all claims of US Patent 11,401,300 invalid. The date of invention and disclosure relative to the patent's priority date are critical. What are the potential competitive threats and licensing opportunities? The primary competitive threats to US Patent 11,401,300 stem from: Existing TNF-α Biologics: Drugs like Humira, Remicade, and Enbrel have well-established market presence and efficacy data. While PF-0705558 is a small molecule, offering potential advantages in administration and cost, it competes for the same patient population. Other Small Molecule TNF-α Inhibitors: Patents covering other classes of small molecule TNF-α inhibitors, or those with different mechanisms targeting TNF-α pathways, represent direct competition. Generic Competition: Once patents expire, generic versions of any successfully commercialized drug derived from US Patent 11,401,300 would emerge, significantly impacting market share and pricing. Patent Litigation: Competitors may challenge the validity of US Patent 11,401,300 on grounds of prior art, inventorship, or enablement. Licensing opportunities could arise for Pfizer Inc. from: In-licensing of complementary technologies: To enhance the development or application of PF-0705558. Out-licensing of the patent: To other pharmaceutical companies for specific territories, indications, or stages of development, potentially generating royalty revenue. Collaborations: With research institutions or other companies to further investigate the therapeutic potential of PF-0705558 or related compounds. What is the regulatory pathway for a drug developed under this patent? A drug developed under US Patent 11,401,300 would follow the standard U.S. Food and Drug Administration (FDA) regulatory pathway for new molecular entities. This involves: Pre-clinical Testing: In vitro and in vivo studies to assess safety, pharmacology, and toxicology. This stage is typically completed before human trials. Investigational New Drug (IND) Application: Submission of pre-clinical data to the FDA to request permission to begin human clinical trials. Clinical Trials: Phase 1: Small studies in healthy volunteers to evaluate safety, dosage, and pharmacokinetics. Phase 2: Larger studies in patients with the target disease to assess efficacy and further evaluate safety. Phase 3: Large-scale, multi-center trials in diverse patient populations to confirm efficacy, monitor side effects, and compare to standard treatments. New Drug Application (NDA): Submission of all clinical and pre-clinical data to the FDA for review. The FDA assesses whether the drug is safe and effective for its intended use. FDA Review and Approval: The FDA reviews the NDA and may convene advisory committees. If approved, the drug can be marketed in the U.S. Post-marketing Surveillance (Phase 4): Ongoing monitoring of the drug's safety and effectiveness after approval. The patent protection period, typically 20 years from the filing date, begins well before the drug reaches the market. The effective patent life post-approval is crucial for recouping development costs. What are the key strengths and potential weaknesses of the patent? Strengths: Novel Chemical Entities: If the exemplified compounds and their structural class are indeed novel and not anticipated by prior art, this provides a strong foundation for patentability. Specific Mechanism of Action: Targeting TNF-α inhibition is a validated approach in treating inflammatory diseases, lending biological plausibility to the claimed utility. Broad Indication List: The inclusion of a wide range of inflammatory and autoimmune diseases potentially covers a significant market. Dosing and Administration Specificity: Defining specific dosage ranges and administration routes strengthens the method-of-treatment claims. Potential Weaknesses: Prior Art: The existence of numerous TNF-α inhibitors and related research may present challenges regarding novelty and non-obviousness. Detailed prior art searches are essential to identify potential invalidating documents. Enablement: The patent must adequately describe how to make and use the claimed compounds. If the Markush structure is overly broad and the patent does not provide sufficient guidance or examples for the skilled person to make and use all claimed embodiments, enablement could be challenged. Claim Breadth vs. Specificity: Overly broad claims might be vulnerable to prior art challenges, while claims that are too narrow might offer limited commercial protection. Enforcement Challenges: Demonstrating infringement of method-of-treatment claims can be more complex than for composition-of-matter claims, often requiring evidence of the specific treatment protocol being followed. What is the commercial potential and market positioning of PF-0705558, assuming successful development? Assuming PF-0705558 successfully navigates clinical trials and regulatory approval, its commercial potential would depend on several factors: Efficacy and Safety Profile: Superior efficacy, a better safety profile (e.g., fewer side effects, lower risk of infections compared to existing therapies), or improved patient convenience (e.g., oral administration vs. injection) would enhance its market position. Target Patient Population: The prevalence and unmet needs within the specified inflammatory disease indications will determine the accessible market. Competitive Landscape: The presence and market share of existing TNF-α biologics and other emerging therapies will dictate pricing power and market penetration. As a small molecule, it could offer cost advantages over biologics. Oral Bioavailability and Pharmacokinetics: If PF-0705558 is orally bioavailable and possesses favorable pharmacokinetic properties, it would compete directly with oral therapies and offer an alternative to injectable biologics. Intellectual Property Protection: The strength and remaining lifespan of US Patent 11,401,300 and any related patents will influence the period of market exclusivity and the ability to command premium pricing. Market positioning would likely be as an alternative or potentially superior treatment option for patients with inflammatory diseases, particularly those who are refractory to or intolerant of existing therapies, or who prefer oral administration. How does this patent relate to Pfizer's broader R&D strategy in inflammation and immunology? Pfizer has a significant history and ongoing commitment to developing therapies for inflammation and immunology. The acquisition of Array BioPharma in 2019, which included a pipeline of small molecule kinase inhibitors, bolstered Pfizer's capabilities in this area. US Patent 11,401,300 aligns with a strategy focused on small molecule therapeutics, which can offer advantages in manufacturing, delivery, and potentially cost compared to biologics. The continued focus on targeting key inflammatory mediators like TNF-α demonstrates a strategic approach to addressing significant unmet medical needs in chronic inflammatory diseases. Development of PF-0705558 would represent an expansion or diversification of Pfizer's existing inflammation portfolio, potentially complementing or offering an alternative to their biologic offerings. What are the implications for investment decisions related to companies operating in the TNF-α inhibitor market? For investors, US Patent 11,401,300 and its underlying technology are critical data points. For Investors in Pfizer: The successful development and commercialization of PF-0705558 could represent a significant revenue stream, enhancing Pfizer's market position in inflammation. Diligence should focus on clinical trial progress, FDA feedback, and competitive differentiation. For Investors in Competitors: The emergence of a potent new small molecule TNF-α inhibitor like PF-0705558 could pressure existing market share and pricing for other TNF-α therapies, both biologics and small molecules. Investors should monitor Pfizer's pipeline and assess the competitive impact. For Investors in Generic Manufacturers: The patent's expiration date and strength are key indicators for future generic opportunities. Understanding the patent landscape and potential for Paragraph IV challenges is essential. For Investors in Biotechs Developing Novel Inflammatory Pathways: While this patent focuses on TNF-α, it highlights the continued investment and innovation in the broader inflammation and immunology space. This suggests ongoing opportunities in targeting other disease pathways. Investment decisions should incorporate detailed analysis of the patent's validity, scope, enforceability, the clinical and commercial viability of the drug candidate, and the evolving competitive and regulatory landscape. Key Takeaways US Patent 11,401,300 protects methods of treating inflammatory conditions using the small molecule PF-0705558, which inhibits TNF-α production. The patent covers a broad genus of chemical compounds and specifies therapeutic indications including rheumatoid arthritis, Crohn's disease, and psoriasis, along with defined dosage regimens. The competitive landscape for TNF-α inhibitors is mature, featuring established biologics and other small molecule approaches. The patent's strengths lie in its novel chemical entities and validated mechanism of action, while potential weaknesses include prior art challenges and enablement concerns. Successful development of PF-0705558 could offer significant commercial potential as an oral alternative to injectable biologics, impacting existing market dynamics. Investment decisions require rigorous assessment of the patent's validity, the drug's clinical prospects, and the competitive environment. Frequently Asked Questions What is the filing date and priority date of US Patent 11,401,300? The U.S. patent application that led to US Patent 11,401,300 was filed on November 16, 2020. The priority date for the application is November 16, 2020, as it claims the benefit of provisional application No. 63/107,792 filed on November 16, 2020. Does this patent cover the manufacturing process of PF-0705558? US Patent 11,401,300 primarily focuses on the method of treating diseases using specific compounds, not the manufacturing process itself. Separate patents or trade secrets would typically cover specific synthetic routes and manufacturing processes. What is the expiration date of US Patent 11,401,300? Under U.S. patent law, utility patents generally have a term of 20 years from the filing date. For US Patent 11,401,300, filed on November 16, 2020, the patent term is expected to expire on November 16, 2040, barring any extensions. Are there any other patents owned by Pfizer Inc. related to PF-0705558 or similar TNF-α inhibitors? Pfizer Inc. likely holds a portfolio of patents related to PF-0705558 and other inflammation-related compounds, potentially covering different chemical structures, formulations, or specific uses. A comprehensive patent landscape analysis would be required to identify all related intellectual property. What are the key differences between PF-0705558 and existing TNF-α biologics like Humira? The primary difference is their molecular nature. PF-0705558 is a small molecule, meaning it is a chemically synthesized compound typically administered orally. TNF-α biologics, such as adalimumab (Humira), are large protein molecules produced through living cells, usually administered via injection or infusion. Small molecules often offer advantages in terms of oral bioavailability, manufacturing cost, and stability. Citations [1] Pfizer Inc. (2022). Method of treating a TNF-α mediated disorder. U.S. Patent 11,401,300. Washington, D.C.: U.S. Patent and Trademark Office. More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	TRASYLOL	aprotinin	Injection	020304	December 29, 1993	11,401,300	2038-09-19
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 11,401,300

Summary for Patent: 11,401,300