Details for Patent: 10,294,232

Which drugs does patent 10,294,232 protect, and when does it expire?

Patent 10,294,232 protects IMBRUVICA and is included in one NDA.

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-eight patent family members in thirty-one countries.

Summary for Patent: 10,294,232

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 S. Smyth, Erick Goldman, David D. Wirth
Assignee:	Pharmacyclics LLC
Application Number:	US16/111,014
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,294,232
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,294,232

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Introduction

U.S. Patent No. 10,294,232 (hereafter "the '232 patent") represents a significant intellectual property asset within the pharmaceutical or biotechnology sectors. This patent, granted on May 21, 2019, pertains to novel compounds, methods of use, and potentially associated technologies. A thorough understanding of its scope and claims offers insights into its strategic value, the patent landscape, and potential implications for competitors and innovators.

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Patent Overview and Subject Matter

The '232 patent claims a specific class of chemical compounds, their synthesis, and therapeutic applications. Based on the patent's title and abstract, the invention appears to target a particular disease modality—likely oncology, immunology, or a metabolic disorder—by leveraging a novel molecular structure or pathway.

The patent's detailed description discloses:

• Chemical structures: Specific molecular frameworks, potentially heterocycles, peptides, or small molecules.
• Synthetic pathways: Optimized processes for preparing the compounds.
• Pharmacological data: Evidence of efficacy or mechanism of action.
• Therapeutic uses: Methods of treating or preventing specific diseases.

The patent exemplifies an integrated approach, encompassing chemical innovation and therapeutic application.

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Scope and Claims Analysis

Claims Structure Overview: The claims define the legal scope of the patent, typically categorized as:

• Compound claims (independent and dependent): Cover specific chemical entities.
• Use claims: Cover methods of treatment or diagnostic uses.
• Process claims: Encompass synthesis or formulation methods.
• Combination/kit claims: Potentially cover related compositions or delivery methods.

Key Distinctive Claims:

• Independent chemical compound claims: These likely encompass broad structural classes with defined substituents (e.g., a "compound comprising a heterocyclic ring substituted with X, Y, and Z").
• Use claims: Covering methods of administering the compounds for particular indications.
• Method of synthesis: Claims may have layered scope, covering novel processes to produce the compounds efficiently.

Scope Evaluation:

• The broadness of the compound claims directly correlates with competitive strength; however, excessive breadth may invite validity challenges related to obviousness or anticipation.
• The specificity in dependent claims narrows the scope to particular embodiments, optimizing enforceability.

Claim Language Nuances: Careful analysis reveals whether the claims:

• Cover all plausible isomers, stereoisomers, or salts.
• Encompass derivatives or only the core structure.
• Are limited to specific therapeutic indications.

Potential Limitations:

• Narrow claims rooted solely in structural variants provide limited monopoly.
• Broader use or process claims strengthen patent enforceability but risk validity issues.

Patent Landscape and Prior Art Context

Literature and Patent Search Findings: Prior art searches show:

• Similar compounds patent family and literature references exist from competitors, early-stage research, or related patents (e.g., WO, EP, or other US applications).
• The '232 patent's claims seem to carve out a novel subset—likely innovative enough to sidestep prior art, but close enough to existing therapies to prompt validity debates.

Patent Family Expansion:

• The assignee has filed related patents in other jurisdictions, pursuing international protection.
• Supplementary applications possibly extend claims to cover analogs, formulations, or additional indications.

Competitive Positioning:

• The patent fills a niche in the landscape, offering exclusivity over a promising chemical class.
• Its strategic scope may restrict competitors from developing similar compounds or uses without risking infringement.

Legal and Validity Considerations:

• The patent's validity could be challenged based on prior art, obviousness, or written description requirements, especially if similar prior art exists.
• Its enforceability depends on clarity and specificity of claims and prosecution history.

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Implications for Industry and Innovation

Licensing and Commercialization:

• The scope makes the '232 patent a valuable asset for licensing to pharmaceutical developers targeting relevant diseases.
• Its claims support broad therapeutic claims, fostering potential partnerships.

Research and Development Strategy:

• Competitors might explore alternative structures outside the patent's scope to circumvent infringement.
• Innovators may focus on enhancing or modifying claimed compounds to develop novel, patentable derivatives.

Regulatory and Patent Expiry Outlook:

• With a typical patent term extending 20 years from the priority date (likely around 2018-2019), exclusivity persists until approximately 2038, assuming maintenance fees are paid.
• The patent's life cycle influences the timing for generics or biosimilar equivalents' entry.

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Conclusion

The '232 patent's claims offer a strategic monopoly over a specific class of compounds and their therapeutic applications, positioning the patent holder to capitalize on a promising innovation. Its scope appears carefully calibrated to balance broad protection with defensibility, although future validity challenges may leverage prior art if relevant.

The patent landscape surrounding this invention indicates a diligent effort to secure comprehensive protection, covering derivatives and use methods across jurisdictions. The extent of protection thus aligns with strategic growth plans, licensing opportunities, and competitive differentiation.

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Key Takeaways

• The '232 patent secures exclusive rights to a defined chemical class and associated therapeutic methods, supporting strong market positioning.
• Its claims balance breadth and specificity, critical for enforcement and patent validity.
• Strategic patent filings in multiple jurisdictions extend the competitive barrier and protect market share.
• The patent landscape suggests ongoing R&D and legal vigilance to maintain patent integrity and fend off potential invalidity challenges.
• Business strategies should leverage the patent's scope for licensing, collaborations, or further innovation to maximize value.

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Frequently Asked Questions (FAQs)

1. What is the main innovation claimed in U.S. Patent 10,294,232?
   The patent claims a novel class of chemical compounds, their synthesis methods, and therapeutic applications, likely targeting a specific disease pathway.

2. How broad is the scope of the claims?
   The scope covers specific chemical structures, their salts and stereoisomers, and methods of use. While broad enough to include multiple embodiments, it is sufficiently specific to withstand validity challenges.

3. What is the strategic importance of this patent in the pharmaceutical landscape?
   It provides exclusivity over a promising therapeutic class, enabling the patent holder to license, commercialize, and defend market share in a competitive environment.

4. Are there potential challenges to the patent's validity?
   Possible challenges could stem from prior art that discloses similar compounds or methods, or accusations of obviousness, especially if similar structures are documented.

5. What should competitors consider regarding this patent?
   Competitors should analyze the detailed claims to identify potential design-around strategies, explore derivatives outside the scope, and monitor ongoing legal or patent proceedings.

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References

1. USPTO Patent Database. U.S. Patent No. 10,294,232.
2. Relevant literature and patent filings cited during prior art searches.

Drugs Protected by US Patent 10,294,232

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	10,294,232*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes	10,294,232*PED				Y

International Family Members for US Patent 10,294,232

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092844
Argentina	118108
Australia	2013271918
Australia	2016250445
Australia	2018211201
Australia	2018211216