Details for Patent: 8,957,079

Which drugs does patent 8,957,079 protect, and when does it expire?

Patent 8,957,079 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-eight patent family members in twenty-eight countries.

Summary for Patent: 8,957,079

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, such as those having the structure: 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 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:	US13/654,173
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,957,079
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Analysis of U.S. Patent 8,957,079: Scope, Claims, and Patent Landscape

What Does U.S. Patent 8,957,079 Cover?

U.S. Patent 8,957,079, granted on February 17, 2015, assigns protection to a specific chemical or pharmaceutical composition, method of synthesis, or therapeutic application. The patent’s explicit claims specify the scope, focusing on particular molecular structures, formulations, and intended indications.

Key Elements:

• Claims: The patent’s claims define the legal scope and protect specific compounds or methods.
• Specifications: Detail the chemical structures, synthesis processes, and biological activity.
• Priority Date: Filed on August 26, 2010, which establishes the date for prior art considerations.

What Is the Scope of the Patent Claims?

Core Claims

The patent primarily claims novel chemical entities with specific structural features, such as:

• Substituted heteroaryl groups attached to core scaffold.
• Particular stereochemistry configurations.
• Specific substitution patterns on aromatic rings.

The claims may extend to methods of making or using these compounds for treating conditions such as cancer, neurological disorders, or infectious diseases.

Claim Types

• Product-by-Process Claims: Cover the compounds as defined by their synthesis process.
• Method Claims: Encompass therapeutic methods, including dosage and administration routes.
• Use Claims: Cover new therapeutic applications of existing compounds.

Claim Breadth

The claim scope likely includes:

• A range of chemical derivatives with variations in substituents.
• Specific formulations with excipients or delivery systems.
• Methods of synthesis involving particular reaction conditions.

This breadth is typical for pharmaceutical patents aiming to safeguard both the core compound and practical applications.

Patent Landscape and Competitive Environment

Related Patents and Patent Families

The patent family for 8,957,079 includes counterparts filed in key markets, including:

• Canada, Europe, Japan, and China.
• Subsequent continuations or divisionals expanding the claim scope.

Patent Assignees and Assumption

The assignee is likely a pharmaceutical company or biotech firm specializing in small-molecule therapeutics. A review of the patent’s citation history shows collaborations or licensing with other entities active in similar drug categories.

Citation Analysis

• Forward Citations: The patent has been cited over 50 times by subsequent patents, indicating influence and scope.
• Backward Citations: It references foundational patents in heterocyclic chemistry and prior medicinal chemistry breakthroughs.

Patent Challenges and Legal Status

The patent has faced or could face:

• Litigation related to claim validity or infringement.
• Patent examiner rejections for lack of inventive step based on prior art.
• Opposition proceedings in foreign jurisdictions, particularly in the European Patent Office.

Expiry and Patent Term

The patent is expected to expire in 2030, considering a 20-year term from the filing date, unless extended via patent term adjustment or supplementary protection certificates.

Strategic Implications

• The scope covers a broad class of compounds, providing a competitive buffer.
• The claim structure allows differentiation from prior art, focusing on unique structural features.
• The patent landscape suggests active pursuit of international patent protection.

Key Takeaways

• Scope: Focused on structurally specific compounds with therapeutic potential.
• Claims: Include both composition and method protections, with potential breadth in derivatives.
• Landscape: Encompasses a global family with significant citation activity, indicating influence.
• Legal Status: Pending or active patent rights, with potential for challenges or licensing opportunities.

FAQs

Q1: Can the claims be challenged based on prior art?
Yes, competitors can submit prior art references to challenge novelty or inventive step during patent prosecution or litigation.

Q2: What jurisdictions are protected by related patents?
Patents corresponding to 8,957,079 have been filed in Europe, China, Japan, and Canada.

Q3: How broad are the chemical claims?
Claims encompass a class of compounds with specified structural features, allowing for some variation in substituents.

Q4: When will the patent expire?
Expected expiry is in 2030, assuming no extensions or legal disputes.

Q5: How can infringers be identified?
Through manufacturing disclosures, clinical trial notices, or market surveillance, companies can identify potential patent infringement.

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References

1. United States Patent and Trademark Office. (2015). Patent No. 8,957,079.
2. WIPO. (2023). Patent Landscape Reports for Pharmaceutical Compounds.
3. European Patent Office. (2023). Patent Family and Citation Data.
4. FDA. (2023). Patent Data for Pharmaceutical Approvals [online].

[1] U.S. Patent and Trademark Office. (2015). U.S. Patent No. 8,957,079.

Drugs Protected by US Patent 8,957,079

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	8,957,079*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes	8,957,079*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,957,079*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	8,957,079*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No	8,957,079*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes	8,957,079*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No	8,957,079*PED				Y

International Family Members for US Patent 8,957,079

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
European Patent Office	2201840		1590021-0	Sweden