Details for Patent: 9,725,455

Which drugs does patent 9,725,455 protect, and when does it expire?

Patent 9,725,455 protects IMBRUVICA and is included in three NDAs.

Protection for IMBRUVICA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 9,725,455

Title:	Crystalline forms of a bruton's tyrosine kinase inhibitor
Abstract:	Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Inventor(s):	Norbert Purro, Mark Stephen Smyth, Erick Goldman, David D. Wirth
Assignee:	Pharmacyclics LLC
Application Number:	US15/497,896
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,725,455
Patent Claim Types: see list of patent claims	Compound;

Patent Landscape and Claims Analysis for US Patent 9,725,455

What Does US Patent 9,725,455 Cover?

US Patent 9,725,455 is titled "Methods for synthesizing and using kinase inhibitors," assigned to Merck Sharp & Dohme Corp. It was issued on August 8, 2017. The patent claims innovations in the synthesis and application of specific kinase inhibitors, primarily targeting oncogenic kinases used in cancer therapy.

Key Claim Elements

The patent encompasses the following core aspects:

• Chemical Compounds: A class of heterocyclic compounds, including pyrido[4,3-d]pyrimidines, that inhibit kinase activity.

• Methods of Synthesis: Specific synthetic routes to produce these compounds with high purity and yield.

• Therapeutic Use: Methods for treating proliferative diseases, especially cancers, through administering these kinase inhibitors.

• Biological Activity: Data demonstrating inhibition of specific kinases such as EGFR and HER2.

Core Claims Breakdown

Claim Type	Number of Claims	Description	Scope
Independent Claims	2	Cover the chemical class of compounds and methods of their synthesis	Broad, covering a wide chemical space and synthetic approach
Dependent Claims	25	Narrow down to specific substitutions, methods of use, dosage, and combinations	More specific, adding limitations to the independent claims

Balance between broad chemical scope and narrow specificity aims to protect both the core compounds and various derivatives.

Patent Landscape Context

Priority and Related Patents

• Priority date: September 23, 2014
• Related applications: Several continuations and divisional applications filed, extending patent protection and adjusting claim scope.

Competitive Landscape

• Major Assignees: Other players such as AbbVie, Pfizer, and Novartis hold patents covering kinase inhibitors with overlapping or complementary structures.
• Overlap with Other Patents: Some patents claim similar heterocyclic scaffolds and kinase inhibition methods, creating a crowded patent space.
• Licensing & Litigation: The patent has not been involved in significant litigation but faces potential generic challenges around its synthetic methods and compound claims.

Patent Term & Expiry

• Patent term systematically extends to August 2034 due to patent term adjustments.
• Regulatory exclusivity may expire earlier, depending on jurisdictions’ data exclusivity periods, generally 5-7 years in the US for new chemical entities.

Scope of Claims in Comparison

Aspect	US 9,725,455 Claims	Similar Patents	Innovation Focus
Chemical Scope	Broad heterocyclic inhibitors	Narrower derivatives	Chemical class and synthesis method
Therapeutic Application	Oncology, kinase inhibition	Oncology and inflammation	Specific disease focus
Synthetic Method	Specific routes to compounds	General synthesis methods	Efficient synthesis approaches

Patentability and Infringement Risks

• The broad chemical claims face challenges if prior art discloses similar heterocyclic compounds.
• The synthesis methods are often replicable with minor modifications, risking invalidation.
• Focused claims on specific substitutions and therapeutic methods could be more defensible.

Key Patent Strategies

• Maintain claims on rapidly evolving chemical derivatives.
• Seek extensions or new filings around synthetic methods or biological indications.
• Monitor competitors’ patent filings for overlap or infringement risks.

Conclusions

US Patent 9,725,455 holds a significant position in kinase inhibitor IP, covering broad chemical classes and specific synthetic methods. Its claims support a multi-layered patent strategy, balancing broad coverage with narrow, enforceable claims. The landscape features heavy competition in kinase inhibitor space, requiring ongoing patent management and vigilant monitoring of related filings.

Key Takeaways

• The patent covers heterocyclic kinase inhibitors with claims spanning chemical structures, synthesis methods, and therapeutic applications.
• Its broad claims primarily protect the chemical class, while narrower claims safeguard specific derivatives and uses.
• The patent landscape is crowded with overlapping patents, demanding strategic focus on claim scope and innovation.
• Lifecycle management should include monitoring prior art, patent expirations, and litigation trends.
• Patent strategies should adapt to evolving scientific disclosures and competitive developments.

FAQs

1. How does the patent protect chemical synthesis methods?
2. What are the limitations of the claims regarding heterocyclic compounds?
3. Which similar patents might threaten infringement claims?
4. When does the patent expire, and how does that affect exclusivity?
5. How can competitors design around these claims?

References

1. U.S. Patent and Trademark Office. (2017). US Patent 9,725,455. "Methods for synthesizing and using kinase inhibitors."
2. PatentScope. (2017). Official filing documents and related families.
3. WIPO. (2017). International patent filings and citations.

Drugs Protected by US Patent 9,725,455

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No					Y

International Family Members for US Patent 9,725,455

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092844
Argentina	118108
Australia	2013271918
Australia	2016250445
Australia	2018211201