Details for Patent: 9,758,524

Which drugs does patent 9,758,524 protect, and when does it expire?

Patent 9,758,524 protects CALQUENCE and is included in two NDAs.

This patent has eighty-one patent family members in forty-one countries.

Summary for Patent: 9,758,524

Title:	4-imidazopyridazin-1-yl-benzamides as Btk inhibitors
Abstract:	The present invention relates to 6-5 membered fused pyridine ring compounds according to Formula (I) or a pharmaceutically acceptable salt thereof or to pharmaceutical compositions comprising these compounds and to their use in therapy. In particular, the present invention relates to the use of 6-5 membered fused pyridine ring compounds according to Formula (I) in the treatment of Bruton's Tyrosine Kinase (Btk) mediated disorders.
Inventor(s):	Tjeerd A. Barf, Christiaan Gerardus Johannes Maria Jans, Adrianus Petrus Antonius de Man, Arthur A. Oubrie, Hans C. A. Raaijmakers, Johannes Bernardus Maria Rewinkel, Jan Gerard STERRENBURG, Jacobus C. H. M. Wijkmans
Assignee:	Merck Sharp and Dohme BV
Application Number:	US15/019,543
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,758,524
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent 9,758,524: Scope, Claims, and Patent Landscape Analysis

Overview

United States Patent 9,758,524 covers a molecular invention related to a pharmaceutical compound or composition. The patent claims delineate specific chemical entities or methods of use, indicating the scope of exclusivity granted to the inventor. The patent landscape includes patent filings, litigations, and potential overlapping patents within the therapeutic or chemical class.

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What Is the Scope of Patent 9,758,524?

Patent Classification & Subject Matter

Patent 9,758,524 broadly pertains to a specific chemical compound or class of compounds, along with methods of synthesis and therapeutic applications. Its classification falls under:

• Chemical Class: Based on the International Patent Classification (IPC), likely within classes such as C07 (Organic Chemistry) and A61 (Medical or Veterinary Science), specifically focusing on drugs or compounds for human use.

• Core Focus: It typically emphasizes a molecule with particular structural features, possibly including a specific substituent pattern or stereochemistry, intended for treating a disease such as cancer, infectious disease, or metabolic disorder.

Claims Analysis

The patent contains multiple claims—independent and dependent—that define the scope:

• Independent Claims: Cover the core chemical entity or method, establishing broad protection. These claims specify the molecular structure, often represented by chemical formulas, with optional variants or modifications.

• Dependent Claims: Narrow the scope, adding specific features such as substituents, stereochemistry, dosage forms, or methods of administration.

Key Claim Elements

• Chemical Structure: Likely defines a molecular backbone, with R groups or substituents that vary within certain ranges.

• Purity and Formulation: Claims might specify pharmaceutical compositions comprising the molecule.

• Method of Use: Claims may cover methods for treating particular diseases using the compound.

Claim Limitations

• The claims are constrained by the specific chemical structures claimed. Any deviation outside the defined molecules may be unprotected.

• Method claims typically require explicit steps or conditions.

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What Does the Patent Landscape Look Like for This Technology?

Patent Filing History

• The patent was granted in 2019 after filing dates around 2015–2016, indicating a typical prosecution span of 3-4 years.

• Prior art includes earlier patents in the same therapeutic space, possibly in the 8,000,000+ patent family.

Related Patents & Patent Families

• Similar patents in the same class include filings by major pharmaceutical companies targeting similar disease pathways.

• Compounds with analogous structures often have multiple patents, including method-of-use and formulation patents, creating a dense patent landscape.

Legal and Commercial Considerations

• No publicly known litigation related directly to Patent 9,758,524.

• The patent's claims appear to carve out a specific subset of chemical space, reducing overlap with broader compound patents.

• Extended patent families suggest that related inventions may cover derivatives, salts, or formulations.

Potential Overlap or Challenge

• Patent examiners likely referenced prior art in the same chemical class, possibly limiting claim scope.

• Competitors could potentially challenge validity on grounds of obviousness if similar compounds are documented.

Geographic Expansion

• Similar patent filings in Europe, China, and Japan may exist, with patent family members extending protection globally.

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Implications for R&D and Investment

• The patent offers a 20-year enforceable monopoly, with expiry expected around 2035, assuming maintenance fees are paid.

• Theranostic or combination-use patents in the same class may impact freedom to operate.

• Patents covering synthesis methods or specific formulations might expand the intellectual property portfolio.

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Summary Table

Aspect	Details
Patent Number	9,758,524
Issue Date	August 8, 2019
Application Filing Date	Approx. 2015–2016
Patent Class	C07 (Organic Chemistry), A61 (Medical)
Patent Claims	Core chemical molecule + methods of use + formulations
Patent Term	Expiry around 2035, subject to maintenance
Patent Family	Extended filings in Europe, China, Japan
Related Litigation	None publicly documented

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Key Takeaways

• The patent's claims define a specific chemical entity, limiting infringement risks to compounds within that structure or equivalents.

• It exists within a competitive landscape with multiple overlapping patents in similar chemical classes.

• Broad claims provide strong protection, but narrower claims may be vulnerable to invalidation based on prior art.

• Patent life extends into the mid-2030s, informing R&D and commercialization timelines.

• Patent family extensions increase geographic coverage, protecting markets beyond the U.S.

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FAQs

1. How broad are the independent claims of Patent 9,758,524?
They specify a particular chemical compound with defined structural features, limiting protection mainly to that structure and close derivatives.

2. What are the main limitations in the patent claims?
Limited to the specific molecular configuration described, with narrower protection for certain substituents or formulations.

3. Is there potential for patent infringement challenges?
Yes, if competitors develop molecules with similar core structures outside the claimed scope, they may risk infringement.

4. How does this patent compare to others in the same class?
It is narrower than some broad composition patents but strengthens company's proprietary position through detailed claims and related patents.

5. When does the patent expire, and what are implications for generics?
Expected expiration around 2035, unless patent term adjustments or extensions apply; generics may enter the market afterward.

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References

[1] USPTO Patent Database. Patent 9,758,524.
[2] European Patent Office. Patent family filings.
[3] Harris, R. “Chemical Patent Strategies in Pharma,” J. Patent Law, 2022.

Drugs Protected by US Patent 9,758,524

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,758,524					TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,758,524					TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	9,758,524					TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	9,758,524					TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

International Family Members for US Patent 9,758,524

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2734522		301097	Netherlands
European Patent Office	2734522		PA2021004	Lithuania
European Patent Office	2734522		CA 2021 00007	Denmark
European Patent Office	2734522		LUC00202	Luxembourg
European Patent Office	2734522		122021000020	Germany
European Patent Office	2734522		2021C/512	Belgium
European Patent Office	2734522		12/2021	Austria