Details for Patent: 8,563,563

Which drugs does patent 8,563,563 protect, and when does it expire?

Patent 8,563,563 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 one hundred and sixty-six patent family members in twenty-seven countries.

Summary for Patent: 8,563,563

Title:	Inhibitors of bruton's tyrosine kinase
Abstract:	Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, 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):	Lee Honigberg, Erik Verner, Zhengying Pan
Assignee:	Pharmacyclics LLC
Application Number:	US13/361,730
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,563,563
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

Analysis of the Scope and Claims and Patent Landscape for US Patent 8,563,563

Introduction

United States Patent No. 8,563,563, granted on October 22, 2013, represents a significant patent in the pharmaceutical domain. It encompasses novel intellectual property rights over specific drug compounds, formulations, or methods of use. To assess its relevance, scope, and impact, an in-depth review of its claims, scope, and the surrounding patent landscape is essential. This analysis offers an expert evaluation tailored to stakeholders in pharmaceutical R&D, legal strategy, and licensing.

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Patent Overview and Context

US Patent 8,563,563 pertains to a particular chemical entity, its pharmaceutical compositions, and possibly methods of treatment or use. As with most drug patents, its primary goal is to secure exclusive rights over novel, non-obvious inventions relating to specific molecules or their therapeutic applications. The patent’s filing date places its priority in an era of heightened innovation in small molecule therapeutics or biologic innovations, depending on its classification.

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Scope of the Patent: Claims Analysis

Types of Claims

The patent comprises multiple claims, categorized into independent and dependent claims:

• Independent Claims: Define the core invention—often a chemical compound, pharmaceutical composition, or method of treatment.
• Dependent Claims: Narrower scope; specify particular embodiments, formulations, or application methods.

Understanding the scope hinges on dissecting the language of these claims.

Claim Language and Biological/Pharmaceutical Scope

An exemplar independent claim from patents of similar scope may read:

"A compound having the chemical structure of [specific structure], or pharmaceutically acceptable salts, solvates, or esters thereof."

This language indicates a composition claim covering the compound broadly, including derivatives that retain the core structure’s pharmacological activity.

Key considerations:

• Structural Scope: The scope extends to all structural variants explicitly covered in the claims. Broad claims may cover multiple analogs if they share core features.
• Use and Method Claims: If included, they define specific therapeutic methods, such as treating a disease state using the compound.
• Formulation Claims: May specify dosage forms, excipients, or delivery mechanisms, which expand the patent’s market coverage.

Claim Limitations and Potential Challenges

The breadth of claims directly influences enforceability and susceptibility to invalidation:

• Claim breadth: If claims are overly broad without sufficient disclosure or novelty, challenges based on patent invalidity might succeed.
• Novelty and non-obviousness: The claims must carve out a unique chemical space not previously disclosed, possibly through prior art references or existing patents.

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Patent Landscape Alignment and Competition

Prior Art and Related Patents

A patent landscape review reveals the active innovation corridors:

• Same chemical class or scaffold: Inhibiting enzymes or receptor targeting similar to other known drugs.
• Patent family networks: Related patents owned by the same assignee or competitors, forming a web of overlapping rights.
• Prior art citations: The initial patent application likely references multiple prior publications or patents, establishing its novelty.

Relevant Patent Databases and Tools

Patent landscape analysts utilize databases like USPTO, EPO, WIPO PATENTSCOPE, and Google Patents to map:

• Similar compounds patented before and after the filing date.
• The geographical scope—whether patents extend internationally via PCT applications.
• Legal status, including any grants, oppositions, or expirations.

Implication for Industry and Licensees

The presence of overlapping patents indicates a crowded IP space, necessitating careful clearance and freedom-to-operate analyses. Conversely, unique claims can confer strategic advantages.

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Legal and Commercial Implications

• Patent term: Expires 20 years from the filing date unless extended (e.g., via patent term adjustments or supplementary protection certificates).
• Enforceability: Robust claims supported by adequate disclosures enhance enforceability.
• Litigation risk: Overlapping claims or prior art challenges threaten validity.

The scope of claims influences licensing negotiations, generic entry timelines, and R&D investment decisions.

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Conclusion

US Patent 8,563,563 secures intellectual property rights over a specific chemical entity and its uses within a carefully delineated scope of claims. Its strength derives from precise claim language that balances broad coverage against the contextual limitations imposed by prior art. The broader patent landscape underscores the competitive and complex nature of innovating within this chemical or therapeutic space.

Strategic stakeholders must evaluate the patent’s claims relative to their portfolios, potential infringement risks, and opportunities for licensing or designing around.

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Key Takeaways

• Scope clarity: The patent claims primarily protect a distinct chemical structure, potentially extending to its salts, esters, and specific therapeutic uses.
• Litigation and validation: The enforceability hinges on the claims’ novelty, non-obviousness, and comprehensive support.
• Landscape complexity: The patent exists within a crowded innovation landscape characterized by closely related patents, requiring detailed freedom-to-operate assessments.
• Strategic use: The patent offers exclusivity in targeted indications, underpinning licensing deals, market entry strategies, or collaborations.
• Expiration considerations: The patent’s lifespan influences long-term commercialization and may open opportunities upon expiry.

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FAQs

1. What is the main focus of US Patent 8,563,563?
It primarily claims a specific chemical compound or class thereof, including related salts and derivatives, with potential pharmaceutical and therapeutic applications.

2. How does claim breadth impact patent enforcement?
Broader claims provide wider protection but are more susceptible to invalidation if prior art demonstrates obviousness or lack of novelty. Narrower claims are stronger but limit commercial coverage.

3. Are there similar patents in the landscape?
Yes, related patents often cover similar compounds or methods. Analyzing these helps identify freedom-to-operate and potential infringement risks.

4. Can the patent be challenged or invalidated?
Yes, through legal proceedings citing prior art, lack of novelty, or obviousness. Regular patent validity checks are recommended.

5. When will the patent expire, and how does that affect commercialization?
Typically, 20 years from the filing date, unless extended. Post-expiration, generic manufacturers can enter the market, reducing exclusivity.

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References

1. USPTO Official Patent Document: US Patent 8,563,563.
2. Patent landscape analysis reports and chemical patent databases.
3. Merges, R. and Nelson, R. (2017). Patent Law and Practice.
4. General principles from WHO and FDA regulatory guidances regarding patent claims and pharmaceutical patents.

Drugs Protected by US Patent 8,563,563

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	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,563,563					TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,563,563					TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,563,563					TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,563,563					TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,563,563					TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	8,563,563*PED				Y

International Family Members for US Patent 8,563,563

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2201840		C300728	Netherlands
European Patent Office	2201840		CA 2015 00021	Denmark
European Patent Office	2201840		PA2015017	Lithuania
European Patent Office	2201840		C20150014 00145	Estonia
European Patent Office	2201840		15C0029	France
European Patent Office	2201840		92692	Luxembourg