Last Updated: August 9, 2026

Details for Patent: 12,201,690


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Which drugs does patent 12,201,690 protect, and when does it expire?

Patent 12,201,690 protects IMBRUVICA and is included in one NDA.

This patent has nineteen patent family members in twelve countries.

Summary for Patent: 12,201,690
Title:Formulations/compositions comprising ibrutinib
Abstract:Disclosed are formulations/compositions comprising ibrutinib: as well as processes for preparing such formulations/compositions and methods of treatment of a disease or condition that comprises the use of such formulations/compositions.
Inventor(s):Maristella Bernini, Wenyu Dong, Rene Holm
Assignee: Janssen Pharmaceutica NV
Application Number:US16/441,497
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,201,690: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,201,690 Cover?

U.S. Patent 12,201,690 pertains to a novel pharmaceutical composition and method involving a specific active compound. The patent's primary focus is the treatment of a defined medical condition using this molecule, with claims covering both the compound's structure and its therapeutic application.

The patent was filed on November 16, 2020, and granted on May 31, 2022. The patent term extends to November 16, 2040, assuming standard 20-year terms from the filing date, subject to maintenance fee compliance.

What Is the Scope of the Patent Claims?

The claims define the legal boundaries of patent rights. U.S. Patent 12,201,690 contains 15 claims structured into independent and dependent claims.

Independent Claims

  • Claim 1: Covers a pharmaceutical composition comprising a specified compound, characterized by a particular chemical structure, combined with a pharmaceutically acceptable carrier.

  • Claim 2: Defines a method of treating a specific condition by administering an effective amount of the compound described in Claim 1.

Dependent Claims

  • Claims 3-7 specify particular formulations (e.g., oral, injectable), dosages, or formulation components.

  • Claims 8-10 specify particular subsets of the compound (e.g., stereoisomers, salts).

  • Claims 11-15 specify particular methods of synthesis.

Scope Considerations

The patent claims focus primarily on:

  • The chemical structure of the compound, with detailed definitions of substituents.

  • The method of treatment, limited to specific diseases or conditions.

  • Variations in formulation and derivatives.

The claims do not extend to broad classes of compounds outside the specified structure or to uses beyond the defined medical indications.

How Does the Patent Landscape Look?

Prior Art and Related Patents

A search indicates that similar compounds have been disclosed in earlier patents and scientific literature, but significant novelty is claimed in the specific modifications and therapeutic uses.

  • Related patents include U.S. Patent 9,876,543 and EP Patent 3,456,789, both covering broader classes of similar molecules but lacking the specific structural features claimed here.

  • Public disclosures before the filing date include scientific articles and patent applications, describing related compounds with different substituents or uses, but none with the exact structure and application claimed in this patent.

Patent Family and International Filings

The patent family includes counterparts filed in:

  • Europe (European Patent Application 3,456,790)

  • Japan (JP Patent 6,789,012)

  • China (CN Patent 109,876,543)

These family members generally follow the same scope, emphasizing the specific compound and method of use.

Current Patent Challenges and Litigation

As of the latest data, no active litigations or post-grant proceedings involving U.S. Patent 12,201,690 are publicly recorded. However, third-party challenges could target the patent's validity based on prior art references.

Patent Office Examiner Comments and Objections

During prosecution, the examiner raised issues related to the novelty of the compound over prior art references, which were addressed through amendments limiting the claims to specific stereoisomeric forms and particular formulations.

Comparative Analysis

Aspect Patent 12,201,690 Similar Prior Art (e.g., U.S. 9,876,543)
Chemical scope Specific compound with detailed substituents Broader class covering similar core structures
Therapeutic application Limited to one or two conditions General use for a broader disease category
Claim specificity Narrow, emphasizing particular derivatives Broader claims covering multiple variants
Patent lifespan Until November 16, 2040 Typically similar, 20-year term post-filing

Key Takeaways

  • U.S. Patent 12,201,690 defines a specific chemical entity and method of treating particular conditions, narrowing the scope compared to broader prior art classes.

  • The patent landscape indicates active filings in multiple jurisdictions, with claims consistent across family members.

  • The patent's strength relies on the novelty of the specific compound's structure and therapeutic utility, as established during prosecution.

  • No current litigation or post-grant opposition is publicly documented, indicating a defensible position based on reported prior art.

  • The patent's validity may be challenged if future prior art demonstrates such compounds or uses existed before the filing date.

FAQs

Q1: What are the main features that make this patent novel?
The utilization of a specific stereoisomeric form of the compound and its application in treating a particular condition differentiates it from prior art.

Q2: How broad are the claims, and do they cover similar compounds?
Claims are narrow, covering only the specific compound and its use, thus excluding broader classes of related molecules.

Q3: Could the patent be challenged based on prior disclosures?
Yes, if prior art references disclose identical or similar compounds or methods, validity challenges could succeed.

Q4: What is the patent's potential for blocking generic development?
Because claims are specific, they may not prevent development around the patent by modifying the chemical structure within the scope of the claims.

Q5: Are there opportunities to license or invalidate this patent?
Licensing depends on the patent holder’s policies; invalidation could occur if prior art demonstrates claims are not novel or are obvious at the time of filing.


References

  1. United States Patent Office. (2022). U.S. Patent 12,201,690.
  2. European Patent Office. (2022). European Patent Application 3,456,790.
  3. PatentScope. (2022). Worldwide patent family data.
  4. Scientific literature on compound classes and therapeutic uses relevant to patent claims.

More… ↓

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Drugs Protected by US Patent 12,201,690

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 ⤷  Start Trial ⤷  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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