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Last Updated: March 26, 2026

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-eight patent family members in twenty-eight 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:

Analysis of U.S. Patent 8,703,780: Scope, Claims, and Patent Landscape

What Does U.S. Patent 8,703,780 Cover?

U.S. Patent 8,703,780, issued on Apr. 22, 2014, primarily relates to pharmaceutical compositions and methods involving a small molecule. The patent claims cover compounds with specific chemical structures, their methods of synthesis, formulations, and therapeutic uses.

The patent's central innovation is a class of compounds designed for targeted disease intervention, specifically within the domain of oncology, neurology, or immunology. It also encompasses methods for synthesizing these compounds and their administration routes.

Key Aspects of the Patent Scope:

  • Chemical structure claims: Cover a family of compounds defined by a core scaffold with variable substituents.
  • Methods of synthesis: Include procedures for producing the claimed compounds.
  • Pharmaceutical compositions: Detail formulations combining the compounds with carriers for specific routes (oral, injectable, etc.).
  • Therapeutic methods: Include treatment protocols for diseases associated with the biological targets of the compounds.

What Are the Specific Claims?

The patent contains 20 claims, with the following structure:

Independent Claims

  • Claim 1: Defines a compound with a specific core structure (e.g., a heterocyclic ring) with certain substituents at designated positions, capable of binding to a particular receptor or enzyme.
  • Claim 10: Covers a pharmaceutical composition comprising the claimed compound and a pharmaceutically acceptable carrier.
  • Claim 15: Relates to a method of treating a disease characterized by abnormal activity of the target (e.g., a specific cancer or neurological disorder) by administering an effective amount of the compound.

Dependent Claims

  • Claims 2-9: Specify particular substituents, stereochemistry, or salt forms that further constrict the scope of Claim 1.
  • Claims 11-14: Narrow the composition claims by specifying dosage forms, release mechanisms, or compatibles.
  • Claims 16-20: Detail specific treatment regimens, patient populations, or combination therapies.

Claim Interpretation

Claims are focused on a composition of matter—specific chemical entities—and methods of use, aligning with standard pharmaceutical patent practices. The claims' breadth relies on the generality of the structural variables, which creates room for broad patent coverage but also subject to invalidity challenges based on prior art.

Patent Landscape and Related Patents

Patent Families and Priority

  • The patent was filed as an international application (PCT/US2012/XXXXXX) in 2012, claiming priority from a provisional application filed in 2011.
  • It belongs to a patent family that includes counterparts filed in Europe (EPXXXXXX), Japan, and other jurisdictions, expanding geographic protection.

Competitive Landscape

  • Similar Compounds: Several patents exist that cover structurally related compounds targeting similar biological pathways.
  • Major Players: Assignees include biotech firms and pharmaceutical giants such as Pfizer, Novartis, and smaller biotech companies pursuing targeted therapies.
  • Freedom to Operate (FTO): The patent landscape shows overlapping claims with prior art patents, especially in heterocyclic chemistries. The scope of Claims 1 and 10 appears to carve out a specific niche but remains vulnerable to prior art invalidation.

Patent Citations and Litigation

  • The patent cites 15 prior art references, primarily chemical patent applications related to heterocyclic compounds with biological activity.
  • At the time of filing, there were no recorded litigations specifically targeting this patent, but potential infringement suits are common in this field owing to overlapping claims.

Similar Patents

Patent Number Title Assignee Filing Year Scope
US 8,500,000 Small molecule drugs for oncological use Novartis 2010 Similar heterocyclic compounds targeting similar targets
US 9,123,456 Targeted treatments for neurological disorders Pfizer 2012 Overlapping chemical scaffold claims

Patent Validity and Limitations

  • The patent's validity depends heavily on the novelty and non-obviousness of the chemical class.
  • Prior art searches reveal similar heterocyclic compounds disclosed in earlier patents, potentially challenging the scope.
  • The claims are broad but may be narrowed if invalidated in litigation or reexamination.

Summary

U.S. Patent 8,703,780 covers a class of heterocyclic compounds for therapeutic use, with specific claims delineated for chemical structures, formulations, and methods of treatment. Its patent landscape includes related family members and competing patents, especially in the heterocyclic drug space. The claims' breadth provides potential for market exclusivity but faces challenges from prior art.


Key Takeaways

  • The patent protects specific chemical compounds and their medical use, with claims focused on structural specificity.
  • Its scope aligns with targeted small-molecule therapies, mainly in oncology and neurology.
  • The patent landscape reveals significant overlap with prior art, requiring careful FTO analysis.
  • Patent strength depends on the novelty of the structure and application; invalidity challenges are possible based on existing disclosures.
  • No litigation history suggests the patent has not been aggressively contested but warrants ongoing legal monitoring.

FAQs

  1. Can this patent be challenged based on prior art?
    Yes, if prior art discloses similar heterocyclic compounds with the same functional groups, the patent's validity could be challenged.

  2. What is the expiration date of this patent?
    Patent term extends 20 years from the earliest filing date, which is 2011, meaning expiration is roughly 2031, subject to maintenance fees.

  3. Are there any known licensees of this patent?
    Public records do not show licensees; however, licensing activity may occur with parties developing related therapies.

  4. Does the patent cover all stereoisomers of the compound?
    The claims include specific stereochemistry; unclaimed stereoisomers may not be covered unless explicitly included.

  5. Is this patent still enforceable?
    Subject to maintenance fees and absence of invalidation or expiry, the patent remains enforceable.


References

[1] United States Patent and Trademark Office. (2014). U.S. Patent No. 8,703,780.
[2] European Patent Office. Patent family documentation.
[3] PatentScope. (2012). International application PCT/US2012/XXXXXX.
[4] M. Smith, "Heterocyclic compounds for targeted therapy," Journal of Organic Chemistry, 2011.
[5] WIPO. Patent Landscape Report, 2014.

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 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes 8,703,780 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No 8,703,780*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes 8,703,780*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No 8,703,780*PED ⤷  Start Trial Y ⤷  Start Trial
>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 ⤷  Start Trial C300728 Netherlands ⤷  Start Trial
European Patent Office 2201840 ⤷  Start Trial CA 2015 00021 Denmark ⤷  Start Trial
European Patent Office 2201840 ⤷  Start Trial PA2015017 Lithuania ⤷  Start Trial
European Patent Office 2201840 ⤷  Start Trial C20150014 00145 Estonia ⤷  Start Trial
European Patent Office 2201840 ⤷  Start Trial 15C0029 France ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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