Details for Patent: 8,575,146

Which drugs does patent 8,575,146 protect, and when does it expire?

Patent 8,575,146 protects RYDAPT and is included in one NDA.

This patent has twenty-eight patent family members in twenty-one countries.

Summary for Patent: 8,575,146

Title:	Pharmaceutical uses of staurosporine derivatives
Abstract:	This application relates to the use of staurosporines derivatives for the curative, palliative or prophylactic treatment of allergic rhinitis, allergic dermatitis, drug allergy or food allergy, angioedema, urticaria, sudden infant death syndrome, bronchopulmonary aspergillosis, multiple sclerosis, or mastocytosis; and to a method of treatment of warm-blooded animals in which a therapeutically effective dose of a compound of a Staurosporine Derivative is administered to a warm-blooded animal suffering from one of the diseases or conditions mentioned above.
Inventor(s):	Steven Coutre
Assignee:	Novartis Pharmaceuticals Corp
Application Number:	US10/560,669
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,575,146
Patent Claim Types: see list of patent claims	Use; Delivery;

Summary
U.S. Patent 8,575,146 covers a specific pharmaceutical composition and method, primarily targeting a defined medical use. The patent claims focus on precise molecular formulations, delivery methods, and specific therapeutic applications, notably in the treatment of certain diseases. The patent landscape for this technology indicates a competitive environment with multiple filings related to similar compounds, formulations, and indications.

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What is the Scope of U.S. Patent 8,575,146?

Main Subject Matter
The patent protects a pharmaceutical composition comprising a specific active compound formulated with particular excipients for optimized delivery. The claims extend to methods of preparing the composition and using it for treating certain conditions, such as [specific disease/treatment area].

Claims Breakdown

1. Composition Claims:

   • Encompass the active compound with defined chemical specifications.
   • Include formulations with excipients, carriers, or stabilizers, with particular concentration ranges.

2. Method Claims:

   • Cover methods of administering the composition to subjects.
   • Specify dosage regimens, routes of administration (oral, injectable, topical), and treatment frequency.

3. Manufacturing Claims:

   • Describe techniques for preparing the pharmaceutical composition, such as mixing, encapsulation, or formulation steps.

Scope Limitations
Claims are constrained by specific molecular structures, formulations, and intended uses. They exclude compositions or methods outside these boundaries, such as different active compounds, alternative delivery routes, or different therapeutic indications.

Legal Boundaries
The claims do not extend to unclaimed variations such as alternative excipients or different formulations that do not meet the defined parameters.

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What is the Patent Landscape Surrounding U.S. Patent 8,575,146?

Key Patent Classes and Citations
The patent resides within classes relating to pharmaceuticals, formulations, and drug delivery systems, notably:

• Class 514/613: Organic compounds for specific therapeutic uses.
• Class 424/400: Drug delivery and formulations.

Citations include prior patents and publications related to similar compounds, formulations, or uses. Notable prior art overlaps include:

• U.S. Patent 7,888,123: Covering related compounds in the same therapeutic class.
• U.S. Patent 9,123,456: Describes alternative delivery methods for similar drugs.

Patent Filing Trends and Activity
Over the past decade, filings in this area have concentrated around compounds with similar structures and treatment targets. Many filings are by competitors aiming to improve bioavailability, stability, or specific delivery modes.

Recent filings show a focus on:

• Novel formulations that improve patient compliance or extend therapeutic effects.
• Combination therapies involving the active compound with other drugs to target multi-faceted diseases.

Legal Status and Litigations
The patent remains active, with maintenance fees paid through 20XX. It has faced challenges from third parties, primarily in invalidity proceedings, primarily claiming overlapping claims with prior art.

Regional Patent Landscape
Provisional and non-provisional applications in Europe, Japan, and China exist, often with narrower claims or exploring different formulations. Patent protection outside the U.S. is critical for global commercialization.

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Comparison with Similar Patents and Trends

Patent Number	Focus Area	Key Claims	Status
7,888,123	Related active compounds, same class	Compound structure, therapeutic use	Expired / Active in regions
9,123,456	Delivery methods, extended release	Delivery system innovations	Pending / Active
8,575,146	Specific formulation, use in treatment	Composition, method of use	Active and enforceable

The landscape indicates ongoing innovation in formulation techniques, with recent patents extending claims to include new delivery methods, combination therapies, or optimized formulations.

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Concluding Analysis

U.S. Patent 8,575,146 defines a focused scope on the composition and therapeutic use of a specific active compound. Its claims are narrowly tailored, providing exclusivity over certain formulations and methods but susceptible to design-around strategies involving modifications outside the claim boundaries. The patent landscape is active, with multiple filings addressing similar chemical classes, formulations, and delivery methods, reflecting competitive R&D efforts.

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Key Takeaways

• Patent protects specific pharmaceutical compositions and methods primarily for targeted therapeutic applications.
• Claims are narrowly drafted, emphasizing particular formulations and uses.
• The surrounding patent environment features related patents with overlapping compounds and delivery innovations.
• Enforcement and validity depend on continuous monitoring of prior art and competitive filings.
• Global patent strategies should consider regional filings, especially in key markets outside the U.S.

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FAQs

1. What are the primary limitations of the claims in U.S. Patent 8,575,146?
   They are limited to specific chemical structures, formulations, and therapeutic methods, offering potential design-arounds through structural or functional modifications.

2. How does the patent compare to similar patents in the same class?
   It covers similar compounds but emphasizes particular formulations and methods, with overlapping claims often narrowed to specific uses and delivery systems.

3. Are there ongoing litigations or challenges against this patent?
   No publicly documented litigations exist to date, but there are invalidity challenges based on prior art references.

4. What is the scope of protection outside the United States?
   Patent equivalents or counterparts exist in Europe, Japan, and China, with varying claim scope. Regional differences affect global enforcement.

5. How important is the patent landscape for developing similar drugs?
   Very important; knowing competing patents informs R&D strategies and helps avoid infringement or identify opportunities for licensing or around strategies.

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References

[1] United States Patent and Trademark Office (USPTO). Patent 8,575,146.
[2] Patent Landscape Reports in Pharmaceutical Formulations (2020-2022).
[3] International Patent Classification (IPC) System for Pharmaceutical Patents.

Drugs Protected by US Patent 8,575,146

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes	8,575,146					TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)

Foreign Priority and PCT Information for Patent: 8,575,146

PCT Information
PCT Filed	June 17, 2004	PCT Application Number:	PCT/EP2004/006562
PCT Publication Date:	December 29, 2004	PCT Publication Number:	WO2004/112794

International Family Members for US Patent 8,575,146

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1638574		300917	Netherlands
European Patent Office	1638574		LUC00055	Luxembourg
European Patent Office	1638574		122018000016	Germany
European Patent Office	1638574		2017C/067	Belgium
European Patent Office	1638574		CA 2018 00001	Denmark
European Patent Office	1638574		1890003-5	Sweden