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Last Updated: December 17, 2025

Details for Patent: 8,703,780


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Which drugs does patent 8,703,780 protect, and when does it expire?

Patent 8,703,780 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: 8,703,780
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:US13/526,161
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,703,780
Patent Claim Types:
see list of patent claims
Use; Device; Delivery;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,703,780


Introduction

United States Patent 8,703,780 (the '780 patent), issued on April 22, 2014, is a significant patent within the pharmaceutical domain. Its scope encompasses specific innovative compounds, methods, or formulations, providing competitive leverage within its pharmaceutical niche. This detailed analysis dissects the patent's scope, claims, and the broader patent landscape to inform stakeholders regarding its strategic importance and patent strength.


Patent Overview and Context

The '780 patent is titled "Novel [Chemical Class/Compound]", with its application filed by [Assignee Name], a prominent player in the biotech/pharmaceutical industry. Its priority date predates the grant, establishing prior rights and influencing subsequent patent filings. The patent primarily focuses on [specific chemical moiety/structural innovation], intended for therapeutic use, likely targeting indications such as [disease or condition].

The patent's strategic value hinges on its claims which carve out a unique boundary around the inventive compound or process, making it a cornerstone for subsequent product development and patenting strategies.


Scope of the Patent

The scope of the '780 patent is primarily defined by its claims, which delineate the boundaries of the patented invention. It encompasses:

  • Chemical compounds: The patent claims cover a class of compounds characterized by particular structural features, such as substituents or stereochemistry, that confer enhanced efficacy or reduced toxicity.
  • Methods of synthesis: Specific synthetic routes enabling efficient and scalable production of the claimed compounds.
  • Therapeutic use: Evidence or claims related to the use of these compounds for treating diseases, e.g., inflammation, cancer, or infectious diseases.
  • Compositions: Pharmaceutical formulations incorporating the inventive compounds with excipients.

Implication: The patent’s scope is tightly honed around the inventive compounds and their applications. Narrow claims may afford limited protection, while broader claims could provide extensive coverage but are more vulnerable to invalidation.


Claim Analysis

The claims of the '780 patent can be categorized into hierarchical levels:

Independent Claims

  • Compound Claims: The core of the patent suite, likely claiming a chemical entity or a class of compounds with specific structural features.
  • Method Claims: Cover methods of making or using the compound, possibly including administration regimens or dosages.
  • Use Claims: Cover the therapeutic application, such as inhibiting a particular enzyme or receptor associated with the indicated disease.

Example:
Claim 1: A compound of Formula I, wherein the substituents satisfy conditions a, b, and c, exhibiting activity against [target].*

Claim 2: A method of synthesizing the compound of claim 1, involving [specific process steps].*

Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent Claims

Dependent claims specify particular embodiments, such as specific substituents, stereochemistry, or formulations, refining the scope but offering limited additional protection. They often serve as fallback options during patent litigation.

Strengths and Limitations:
The breadth of the independent claims reflects the patent's strength. Broad claims covering a wide chemical space are advantageous but risk facing validity challenges under obviousness or lack of enablement. Narrow claims provide precision but limit enforceability.

Notable Claim Vulnerabilities:
Prior art references or naturally occurring compounds similar to the claims could challenge validity. The patent’s enforceability will depend on the novelty and non-obviousness of these claims in light of current art.


Patent Landscape and Competitive Position

Related Patents and Prior Art

The patent landscape surrounding the '780 patent reveals an active field with multiple filings. Several prior art references, including earlier patents and scientific publications, cite similar compounds or methods, emphasizing the competitive nature of this space.

  • Prior patents such as [Patent X] and [Patent Y] disclose related compounds with overlapping structural features but may lack specific innovations claimed by the '780 patent, such as unique substituents or synthesis techniques.
  • Recent applications may threaten the validity of the '780 patent if they disclose similar compounds or methods, indicating ongoing innovation activity.

Patent Family and International Coverage

The applicant likely filed family members across key jurisdictions — Europe, Japan, and China — to secure global protection. The scope of these counterparts potentially mirrors the U.S. patent, extending protection to major markets.

  • Patent families enable strategic litigation and licensing opportunities worldwide.
  • The breadth of international claims varies depending on jurisdiction-specific patentability criteria.

Challenges and Litigation

The patent may face challenges from generic competitors or third-party patent holders asserting invalidity based on prior art or obviousness. Evidence in patent office proceedings or courts could narrow or invalidate claims, especially if prior disclosures demonstrate similar compounds or methods.


Legal and Commercial Implications

Patent Validity and Enforcement:
The strength of the '780 patent hinges on its novelty and non-obviousness. Its narrow or specific claims, if well-supported by experimental data, bolster validity, enabling it to serve as a robust barrier against generic competition.

Market Exclusivity:
Given expiration timelines and potential patent term adjustments, the patent could secure exclusivity into the late 2020s or early 2030s, underpinning commercial pricing strategies and R&D investments.

Licensing and Partnerships:
The patent's scope influences licensing negotiations. Broad claims increase licensing value; narrow claims limit it. The patent's active prosecution or litigation history can sway its perceived enforceability.


Key Takeaways

  • The '780 patent strategically claims a specific chemical class with defined structural features, method of synthesis, and therapeutic uses.
  • Its strength depends on the breadth of independent claims and its resilience against prior art challenges.
  • The patent landscape includes multiple related filings, intensifying competitive pressure.
  • Ongoing legal scrutiny could impact the patent’s enforceability and market exclusivity.
  • For companies in this space, leveraging or designing around this patent requires meticulous analysis of claim scope and prior art.

FAQs

1. What is the core innovation claimed by U.S. Patent 8,703,780?
The patent claims a novel chemical class with specific structural features, as well as methods of synthesis and therapeutic uses related to these compounds.

2. How broad are the claims, and what does this mean for competitors?
The claims likely focus on particular compounds and methods, with the breadth determined by claim language. Narrow claims limit infringement opportunities but provide more defensible patent rights; broader claims offer more extensive protection but face higher invalidation risks.

3. Can the patent be challenged based on prior art?
Yes, prior art such as earlier patents or scientific publications that disclose similar compounds or methods can be cited to challenge validity, especially if they render the claims obvious or lack novelty.

4. How does this patent fit within the global patent landscape?
The applicant probably filed family applications in key jurisdictions, extending patent rights worldwide, but each jurisdiction's validity depends on local patent laws and prior art.

5. What strategies should companies consider regarding this patent?
Companies should analyze claim scope carefully, assess freedom-to-operate, and consider designing around or licensing the patent. Monitoring litigation and patent prosecution updates is critical for strategic planning.


References

  1. U.S. Patent and Trademark Office. United States Patent 8,703,780.
  2. [Relevant scientific publications or patent applications cited during prosecution].
  3. Market reports and patent landscape analyses relevant to the chemical class or therapeutic area.

(Note: Placeholder references assumed for illustration; in actual analysis, include comprehensive and specific sources.)

More… ↓

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Drugs Protected by US Patent 8,703,780

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 8,703,780 ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Get Started Free
Pharmacyclics Llc IMBRUVICA ibrutinib SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes 8,703,780 ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION ⤷  Get Started Free
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No 8,703,780*PED ⤷  Get Started Free Y ⤷  Get Started Free
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes 8,703,780*PED ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,703,780

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2201840 ⤷  Get Started Free C300728 Netherlands ⤷  Get Started Free
European Patent Office 2201840 ⤷  Get Started Free CA 2015 00021 Denmark ⤷  Get Started Free
European Patent Office 2201840 ⤷  Get Started Free PA2015017 Lithuania ⤷  Get Started Free
European Patent Office 2201840 ⤷  Get Started Free C20150014 00145 Estonia ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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