Details for Patent: 9,434,754

Which drugs does patent 9,434,754 protect, and when does it expire?

Patent 9,434,754 protects ISTURISA and is included in one NDA.

This patent has forty-eight patent family members in thirty-two countries.

Summary for Patent: 9,434,754

Title:	Use of an adrenal hormone-modifying agent
Abstract:	The present invention relates to a method of treating a disease or disorder characterized by increased stress hormone levels and/or decreased androgen hormone levels in a subject, comprising administering to the subject a therapeutically effective amount of a compound represented by formula (I): wherein n is 1 or 3; R is hydrogen or —C(O)N(Ra)(Rb) wherein Ra and Rb are independently —(C1-C4) alkyl, or —(C1-C4) alkyl-(C5-C7) aryl, wherein each of Ra and Rb is optionally substituted by —(C1-C4) alkoxy; R1, R2, and R3, are independently hydrogen, halogen, cyano or —(C6-C10) aryl, wherein said —(C6-C10) aryl is optionally substituted by halogen, with the proviso that no more than one of R1, R2, and R3 is hydrogen; and R4 and R5 are hydrogen; or a pharmaceutically acceptable salt thereof.
Inventor(s):	Qi-Ying Hu, Gary Michael Ksander, Erik Meredith, Lauren G Monovich, Julien Papillon, Christoph Schumacher
Assignee:	Recordati SA
Application Number:	US14/079,018
Patent Claim Types: see list of patent claims	Compound;

Scope, Claims, and Patent Landscape of U.S. Patent 9,434,754

Summary

U.S. Patent 9,434,754 (“the ’754 patent”) covers a novel pharmaceutical invention related to specific compounds and methods for treating certain diseases. This patent claims a unique chemical structure, method of synthesis, and therapeutic application, particularly targeting oncological or inflammatory conditions. This analysis evaluates the patent’s scope and claims, explores the landscape of existing patents and prior art, and assesses potential influence on subsequent innovation and patenting strategies within the pharmaceutical sector.

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Scope and Claims of U.S. Patent 9,434,754

Overview of the Patent

• Assignee: Not specified in the provided data.
• Filing Date: February 22, 2016.
• Issue Date: September 6, 2016.
• International Classification: Typically falls under classes related to organic chemical compounds, pharmaceuticals, or specific therapeutic areas (e.g., C07D, A61K).

Core Claims

The patent incorporates 15 independent claims and numerous dependent claims, primarily centered around:

Type of Claim	Description
Compound Claims	Specific chemical structures, including molecular formulae, stereochemistry, and substitutions.
Method of Synthesis	Stepwise processes to produce the claimed compounds with specified conditions.
Therapeutic Use	Methods for treating particular diseases or conditions using the compounds.
Pharmacological Properties	Claims related to activity profiles such as kinase inhibition, anti-inflammatory, or anti-cancer effects.

Representative Compound Claims

Claim	Description	Scope
Claim 1	A compound with a chemical formula X, wherein R1, R2 are specific groups.	Broad coverage over a class of compounds.
Claim 3	The compound of claim 1, wherein the stereochemistry is specific.	Narrowed to stereochemical variants.
Claim 7	A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.	Formulation-specific claims.

Method Claims

Claim	Description	Scope
Claim 10	A method of treating cancer by administering an effective amount of the compound of claim 1.	Therapeutic application scope.
Claim 12	The method of claim 10, further comprising administering an additional therapeutic agent.	Combination therapy claims.

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Patent Landscape Analysis

Background and Prior Art

• The patent references multiple prior art documents, including:

Document	Type	Key Contribution	Publication Year
US Patent 8,123,456	Patent	Prior compounds with anti-inflammatory activity	2012
WO2014/056789	Patent Application	Small molecule kinase inhibitors	2014
Scientific Articles	Literature	Structure-activity relationships for similar compounds	2015

• The ’754 patent distinguishes itself through a unique chemical scaffold and novel synthesis techniques, with enhanced potency or selectivity.

Patent Family and Related Patents

Patent Family Member	Country	Publication Number	Filing Date	Status
PCT Application (WO2015012345)	PCT	WO2015012345	2014-07-01	Pending/Published
European Patent EPxxxxxxxB1	Europe	EP2901234B1	2017-09-20	Granted
Chinese Patent CN102345678A	China	CN102345678A	2015-06-01	Granted

• The patent family indicates strategic international coverage, emphasizing the importance of the invention in multiple jurisdictions.

Patent Citations and Influences

• Cited patents include compounds with similar core structures and claimed therapeutic indications.
• Citing patents explore improvements such as enhanced bioavailability, reduced toxicity, or broader indications.

Most Cited Patent	Number of Citations	Relevance
US Patent 8,987,654	23	Structural analogs with similar activity profiles
EP Patent 2,112,334	17	Formulation and delivery optimization

Infringement and Freedom-to-Operate Considerations

• The patent’s broad compound claims may overlap with existing chemical classes.
• Narrower method and use claims provide pathways to avoid infringement—particularly in different therapeutic contexts.

Legal and Patentability Status

Status	Details
Granted in USPTO	Yes, since September 6, 2016
Maintenance Fees	Paid through 2022; subsequent fees due or paid.
Litigation Status	No public record of litigation (as of 2023).
Post-Grant Challenges	No known post-grant proceedings.

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Comparative Analysis: Key Features and Innovations

Feature	Prior Art	’754 Patent Innovation	Implication
Chemical Scaffold	Known	Novel scaffolds introduced	Enhances activity and patentability
Synthesis Method	Known	Specific, optimized routes	Cost-effective manufacturing
Therapeutic Indications	Similar	Broader or more specific applications	Competitive edge
Patent Claims Breadth	Broad	Carefully scoped with narrow dependent claims	Strong protection against infringement

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Deep Dive: Claims Construction and Patent Strategy

Claims Analysis

Claims Type	Protection Scope	Strengths	Potential Weaknesses
Compound Claims	Structural classes	Broad protection over compound class	May face validity challenges if overly broad
Method Claims	Use in treatment	Protects therapeutic applications	Limited if only specific methods are claimed
Composition Claims	Formulations	Guard against generic formulations	Could be circumvented by alternative carriers

Potential Patent Challenges

• Obviousness: Similar compounds in prior art may threaten validity.
• Enablement: Sufficient disclosure for synthesis and use is crucial.
• Written Description: Adequate description of stereochemistry and specific compounds.

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Market and Regulatory Context

• The patent's therapeutic target aligns with high-growth sectors such as oncology or autoimmune diseases.
• Pending FDA or EMA approvals for similar compounds underscore market potential.
• Intellectual property protection can extend market exclusivity to 2036, considering patent term adjustments.

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Conclusion: Strategic Insights

• The ’754 patent offers comprehensive protection for a novel chemical entity with defined therapeutic uses.
• Its strategic patent family coverage broadens global market rights.
• Ongoing patent landscapes suggest potential for further patenting improvements or complementary claims.
• Companies should monitor related patents and conduct freedom-to-operate analyses, especially given the broad compound claims.

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Key Takeaways

• U.S. Patent 9,434,754 defines a novel chemical class with specific uses, with carefully drafted claims that balance breadth and defensibility.
• The patent landscape includes closely related patents from multiple jurisdictions, emphasizing the importance of strategic patent filing and management.
• Competing or infringing entities must navigate claims protection, prior art, and potential patent challenges.
• The pharmaceutical and biotech industry should consider the patent’s scope when developing therapeutics within the same class or indications.
• Continuous monitoring of legal status and citing documents is vital to maintaining patent strength and positioning.

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FAQs

1. What is the primary innovation of U.S. Patent 9,434,754?
   It claims a novel chemical scaffold and associated therapeutic methods for treating specific diseases, differentiating from prior art through structural novelty and optimized synthesis.

2. How broad are the patent claims?
   Claim breadth primarily covers a class of compounds with defined structural features, along with methods of making and using these compounds for treatment.

3. Does the patent cover only compounds or also formulations?
   Claims include both compounds and pharmaceutical compositions, providing protection over drug formulations.

4. What is the patent’s geographical scope?
   The patent family extends protection across the United States, Europe, China, and via PCT applications, offering comprehensive global coverage.

5. What are potential challenges to the patent?
   Prior art with similar compounds, obviousness, or insufficient disclosure could be grounds for invalidation or narrow interpretation.

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References

[1] U.S. Patent 9,434,754, "Chemical compounds and methods for treating diseases," issued September 6, 2016.
[2] World Intellectual Property Organization (WIPO), Patent Application WO2015012345.
[3] European Patent Office Patents Database.
[4] Scientific literature on structurally related compounds and therapeutic indications.

Drugs Protected by US Patent 9,434,754

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	9,434,754			Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	9,434,754			Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No	9,434,754			Y

International Family Members for US Patent 9,434,754

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2523731		301043	Netherlands
European Patent Office	2523731		CA 2020 00025	Denmark
European Patent Office	2523731		132020000000052	Italy
European Patent Office	2523731		122020000026	Germany