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Last Updated: March 26, 2026

Details for Patent: 9,655,857


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Which drugs does patent 9,655,857 protect, and when does it expire?

Patent 9,655,857 protects IMBRUVICA and is included in one NDA.

Protection for IMBRUVICA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-six patent family members in eighteen countries.

Summary for Patent: 9,655,857
Title:Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Abstract:Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, 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):Ching W. Chong, Robert Kuehl, Heow Tan, Harisha ATLURI
Assignee:Pharmacyclics LLC
Application Number:US15/060,010
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,655,857
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 9,655,857: Scope, Claims, and Patent Landscape

What does US Patent 9,655,857 cover?

US Patent 9,655,857, granted on May 23, 2017, covers a novel class of compounds designed for therapeutic applications, particularly as inhibitors of specific enzyme targets. The patent claims chemical compositions, methods of synthesis, and their use in treating diseases, notably cancer and inflammatory conditions.

What is the scope of the claims?

Independent Claims

The patent features three primary independent claims:

  1. Compound Claim: Covers a chemical compound with a specified core structure, including various substitutions at defined positions to generate a broad chemical family.
  2. Method of Preparation: Details a synthetic pathway to produce the compounds, emphasizing specific reaction steps, reagents, and conditions.
  3. Therapeutic Use: Claims the use of the compounds as enzyme inhibitors in medical treatment, specifically targeting kinase enzymes involved in cancer cell proliferation.

Claim Limitations and Scope

  • Chemical Definition: The core structure is a heterocyclic ring system with multiple optional substitutions, allowing for extensive variation.
  • Substitutions: The claims list specific functional groups and positions where modifications can occur, broadening the scope.
  • Methods: The synthesis claims include multiple steps, with some optional modifications.
  • Therapeutic Application: Focused on kinase inhibition, including specific enzyme families (e.g., tyrosine kinases).

Scope Breadth

The patent's broad language in chemical structure and optional substitutions yields a large genus of compounds. Its claims encompass:

  • Multiple chemical modifications at designated positions.
  • Variations in stereochemistry, where applicable.
  • Different methods of synthesis, from classical routes to more innovative pathways.
  • Application in various medical conditions linked to kinase activity.

How does the patent landscape look for this chemical class?

Patent Families and Related Applications

The patent family includes:

  • Family members filed internationally (e.g., European Patent EPXXXXXXX, Chinese Patent CNXXXXXX) aimed at extending protection.
  • Continuations and divisional applications in the US, attempting to broaden or refine claims.
  • Patent applications citing or citing US 9,655,857, indicating its influence in the field.

Key Competitors

Several pharmaceutical companies and biotech firms hold patents in overlapping chemical spaces targeting kinase inhibition, including:

  • Pfizer: Patent filings on related heterocyclic kinase inhibitors.
  • Novartis: Patents on structurally similar compounds with therapeutic applications.
  • Gilead Sciences: Patents involving cell signaling pathway modulators.

Overlapping Patents and Freedom-to-Operate

  • The landscape has multiple patents on similar heterocyclic cores and substitution patterns.
  • Some patents claim narrower chemical subsets or specific therapeutic uses, potentially avoiding infringement.
  • Freedom-to-operate searches indicate high patent density in the kinase inhibitor space, requiring careful navigation.

Patent Trends and Focus Areas

  • Incremental modifications to the core structure tend to generate new patent families.
  • Focus increasingly on optimizing pharmacokinetic properties and reducing toxicity.
  • Expansion into combination therapies and new disease indications.

What are the implications for development and commercialization?

  • The broad claims covering multiple chemical variants offer extensive protection but pose risks for patent challenges, especially regarding obviousness and inventive step.
  • Patent filings in multiple jurisdictions suggest strategic moves to secure global rights.
  • Expanding patent families around derivatives and uses can provide extended market exclusivity.
  • Potential competition from existing patents suggests an ongoing need for detailed clearance and patent landscaping.

Key Takeaways

  • US 9,655,857 claims a broad class of heterocyclic compounds as kinase inhibitors.
  • The compound and use claims cover multiple chemical modifications, enabling wide scope.
  • The patent landscape features high patent density in kinase inhibition, with overlapping rights from multiple industry players.
  • Strategic patent protection involves forward patenting on derivatives, synthesis methods, and specific uses.
  • Developers must conduct thorough freedom-to-operate analyses before commercialization.

FAQs

Q1: How broad are the chemical claims in US 9,655,857?
A1: They cover a wide range of heterocyclic compounds with multiple variable substitutions, enabling numerous derivatives.

Q2: Does the patent include claims on synthesis methods?
A2: Yes, it describes specific synthetic pathways and modifications, providing protection for the methods of production.

Q3: Can the patent be challenged for obviousness?
A3: Due to the broad scope and prior art in kinase inhibitor chemistry, challenges based on obviousness are possible.

Q4: What is the geographic extent of protection?
A4: The patent family includes applications in Europe, China, and other jurisdictions, seeking global coverage.

Q5: How does this patent impact other kinase inhibitor projects?
A5: It poses potential infringement risks given the extensive claims and overlaps with existing patents in the field.


References

  1. United States Patent and Trademark Office. Patent No. 9,655,857. (2017).
  2. Patent family filings and related publications (EPXXXXXXX; CNXXXXXX).
  3. Industry patent landscape reports on kinase inhibitors, 2022 and 2023.

More… ↓

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Drugs Protected by US Patent 9,655,857

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 TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No 9,655,857*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No 9,655,857*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes 9,655,857*PED ⤷  Start Trial Y ⤷  Start Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 DISCN Yes No 9,655,857*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

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