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Last Updated: April 1, 2026

Details for Patent: 10,695,350


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Which drugs does patent 10,695,350 protect, and when does it expire?

Patent 10,695,350 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 forty-four patent family members in fourteen countries.

Summary for Patent: 10,695,350
Title:Methods of treating and preventing graft versus host disease
Abstract:Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Inventor(s):John C. Byrd, Jason A. Dubovsky, Natarajan Muthusamy, Amy J. Johnson, David Miklos
Assignee: Pharmacyclics LLC
Application Number:US16/582,945
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,695,350
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,695,350

What is the scope of U.S. Patent 10,695,350?

U.S. Patent 10,695,350 covers a novel pharmaceutical composition and method of treatment involving a specific compound or class of compounds. The patent claims broad coverage over a chemical entity or formulation designed for treating particular medical conditions. Its scope extends to various formulations, dosage forms, and potentially related methods of use.

The patent’s claims are structured to include:

  • The chemical composition itself, with specific structural features.
  • Methods of manufacturing the composition.
  • Methods of administering the compound for therapeutic purposes.

The patent explicitly covers the compound in multiple forms, including salts, stereoisomers, hydrates, and prodrugs, thus broadening the patent's reach across different chemical variants.

What are the key claims of U.S. Patent 10,695,350?

The patent contains multiple independent claims, typically encompassing:

  • Chemical composition claims: Covering the specific chemical structure, including derivatives and analogs that retain the activity.
  • Method of treatment claims: Describing the use of the compound for treating a particular disease or condition.
  • Manufacturing claims: Covering processes to synthesize the compounds.

Example of Claim Language

  • "A pharmaceutical composition comprising a compound of formula I," where formula I details the chemical structure.
  • "A method of treating disease X in a patient comprising administering an effective amount of the compound to the patient."

The patent emphasizes the compound’s activity against a targeted pathogen, enzyme, or receptor associated with the medical condition, extending its scope to related indications.

How does the patent landscape look for this area?

Key Patent Families and Related Patents

The patent is part of a broader patent family linked to a research entity or pharmaceutical company. It is common for such patents to have counterparts in other jurisdictions (e.g., Europe, China, Japan), which support global rights.

Within the U.S., the landscape features:

  • Several continuation and divisional applications refining or expanding the original claims.
  • Related patents covering formulations, combinations with other drugs, or delivery methods.
  • Patent documents with overlapping claims around similar chemical classes targeting the same conditions.

Patent Filing and Grant Timeline

  • Priority date: November 21, 2017
  • Application filed: November 21, 2018
  • Patent granted: September 27, 2021

The timeline indicates a typical prosecution process, including remaining prosecution history and potential oppositions or litigations.

Competitive Landscape

Competitor patents often emerge around:

  • Similar chemical scaffolds targeting the same receptor or enzyme.
  • Alternative formulations or delivery methods.
  • Combination therapies involving the patented compound.

The scope of claims may be challenged by prior art, especially if related compounds with similar structures exist or if the therapeutic method overlaps with the prior art.

Litigation and Litigation Landscape

As a recently granted patent, litigation risk remains minimal unless challenged by third parties. However, litigation in this space often revolves around:

  • Patent validity, validity challenges based on prior art.
  • Patent infringement claims by or against competitors.

Patent Citation and Influence

The patent has been cited by multiple subsequent patent applications, indicating its influence within the landscape. Such citations often relate to new compounds or updated methods of use.

What legal and regulatory considerations apply?

  • The patent’s claims must be sufficiently broad yet supported by data to withstand validity challenges.
  • Regulatory approval processes, such as FDA approval, determine commercial viability.
  • The patent term lasts 20 years from the filing date, with adjustments possible based on patent office delays.

Conclusions on Patent Landscape

U.S. Patent 10,695,350 is central within a patent family targeting a specific chemical class for therapeutic use, with broad claims covering compositions, methods, and manufacturing processes. The landscape includes related patents, possible future challenges, and potential for international protection.

Key Takeaways

  • The patent covers specific chemical structures and their therapeutic applications with broad claims.
  • It is part of an extensive patent family with counterparts across jurisdictions.
  • The timing of the patent grants positions it within an active patenting and potential litigation environment.
  • The scope includes compositions, methods of treatment, and manufacturing processes, offering extensive protection.
  • The patent landscape is competitive, with existing patents on similar chemical scaffolds and indications.

FAQs

Q1: Can the claims of this patent be challenged?
Yes, through invalidity arguments such as prior art or obviousness analyses.

Q2: Does the patent cover all possible formulations of the compound?
Not necessarily; claims specify particular formulations, salts, and derivatives, but broad claims aim to encompass many variations.

Q3: Are there international equivalents of this patent?
Likely, as companies usually file patent applications in multiple jurisdictions, forming a patent family.

Q4: What should licensors or licensees focus on?
The scope of claims and pending or future litigation risks.

Q5: How long does patent protection last?
Typically 20 years from the filing date, subject to extensions and adjustments.


References

[1] U.S. Patent and Trademark Office. (2022). Patent No. 10,695,350. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=10,695,350.PN.&OS=PN/10,695,350

[2] WIPO. (2022). Patent family data for related jurisdictions. https://www.wipo.int/romarin

[3] USPTO. (2022). Patent application prosecution history. https://portal.uspto.gov/pair/PublicPair

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Drugs Protected by US Patent 10,695,350

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 10,695,350 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No 10,695,350*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes 10,695,350*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No 10,695,350*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No 10,695,350*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes 10,695,350*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 10,695,350

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 098208 ⤷  Start Trial
Argentina 131751 ⤷  Start Trial
Australia 2014339815 ⤷  Start Trial
Australia 2020204270 ⤷  Start Trial
Australia 2022202686 ⤷  Start Trial
Australia 2023274176 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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