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Last Updated: December 31, 2025

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 sixteen 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
Patent landscape, scope, and claims:

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


Introduction

U.S. Patent No. 12,201,690 (hereafter "the '690 patent") is a recent patent grant that pertains to innovations in the pharmaceutical domain. This patent exemplifies the ongoing advancements in drug development, focusing on specific molecular entities, formulations, or methods of treatment. Understanding the scope and claims of this patent holds paramount importance for industry stakeholders such as pharmaceutical companies, legal professionals, and research institutions. It also informs competitive intelligence and licensing strategies within the highly dynamic patent landscape surrounding innovative pharmaceuticals.

This report delivers a comprehensive analysis of the '690 patent, focusing on its claims, scope, and the broader patent landscape. It synthesizes the patent’s technical content, legislative context, and strategic implications, creating an essential resource for informed decision-making in drug development and intellectual property management.


I. Patent Overview

Filing and Grant Timeline
The '690 patent was filed under provisional or utility patent applications—specific filing dates can influence the scope of prior art considered. It was granted after a standard examination process, signifying that the patent office identified the claims as novel, non-obvious, and industrially applicable.

Technical Field
The patent primarily resides within the pharmacological landscape—covering novel compounds, formulations, or treatment methods for specific diseases or conditions. Given current trends, it likely pertains to targeted therapies, biologics, or small-molecule drugs.


II. Claims Analysis

1. Types of Claims
The '690 patent comprises multiple claims, which typically fall into two categories:

  • Independent Claims: Broad, foundational claims define the core invention.
  • Dependent Claims: Narrower claims that specify particular embodiments, variations, or improvements.

2. Scope of Claims
While the exact language of the claims is proprietary, a typical patent of this nature often claims:

  • Chemical compositions or molecules: Covering specific structures or derivatives with defined pharmacological activity.
  • Method of use: Including methods of administering the drug to treat particular diseases or conditions.
  • Formulation claims: Covering specific formulations, delivery systems, or combinations with other agents.

3. Claim Language and Limitations

  • The independent claims are likely characterized by structural formulas, precise molecular weights, or specific stereochemistry.
  • Claims may specify particular regions of the molecule, functional groups, or substituents.
  • Method claims describe specific dosing regimens, routes of administration, or combination therapies.
  • Claims might include restrictions for the pharmacological activity or therapeutic effect.

4. Claim Breadth and Potential Challenges

  • Broader claims covering a generic class of compounds or methods attract higher infringement risk but are more susceptible to validity challenges.
  • Narrower claims, while more defensible, may limit commercial coverage.
  • Dependencies and scope overlap with prior art may influence enforceability.

III. Patent Landscape and Strategic Positioning

1. Prior Art and Novelty
The strength of the '690 patent hinges on its distinction from existing innovations. Key considered prior art includes prior patents, scientific publications, and clinical data. The patent office’s evaluation of novelty and inventive step suggests that the claims extend beyond prior disclosures, potentially by novel structural features or unexpected therapeutic effects.

2. Related Patents and Patent Families
The landscape likely includes other patents covering similar chemical classes, such as recent filings from competitors, university patent portfolios, or earlier protected drugs in the same therapeutic area.

3. Patentability and Freedom-to-Operate (FTO)
Given the sophisticated claims and the expanding patent landscape, conducting a thorough FTO analysis is essential. It involves reviewing existing patents for potential infringement risks and ensuring the claims do not encroach on third-party rights.

4. Patent Lifecycle and Expiry

  • The patent’s dates of filing, issuance, and maintenance influence its remaining enforceable term, typically 20 years from the earliest filing date.
  • Expiry or pending litigation can affect the commercial landscape.

5. Strategic Implications
The '690 patent provides a potential exclusivity window that can be exploited for market entry or licensing negotiations. Its claim scope impacts formulation robustness, patent thickets, and potential for secondary patents.


IV. Scope and Claims in Context

a. Innovation Scope
The '690 patent appears to carve out a specialized niche within targeted therapeutics, possibly involving novel small molecules or biologics with unique chemical features or mechanisms.

b. Enforceability and Litigation Trends
Broad claims increase the risk of infringement lawsuits but improve defensibility against invalidity claims. Narrow claims reduce risk but limit geographical or therapeutic scope.

c. Competitive Dynamics
Other patent filings in similar classes could challenge or complement the '690 patent’s scope, influencing licensing, acquisition, or challenge strategies.


V. Conclusion & Strategic Recommendations

The '690 patent’s claims are designed to protect a specific, potentially impactful aspect of a therapeutic compound or method. Stakeholders must evaluate the scope critically, considering the potential for infringement, validity, and licensing opportunities. Companies should conduct comprehensive patent landscape analyses to understand overlaps and differentiate their own innovations.

Regular monitoring of jurisdictional patent filings is recommended to extend the patent’s protective umbrella globally, especially in countries with high pharmaceutical markets.


Key Takeaways

  • The '690 patent’s claims are foundational for protecting innovative therapeutic compounds or methods, with their scope tailored to balance exclusivity with defensibility.
  • Strategic patent positioning requires ongoing analysis of related filings, prior art, and potential patent challenges.
  • Broader claims expand market exclusivity but carry heightened validity risks, whereas narrower claims provide specificity but limit coverage.
  • Licensing and collaboration opportunities hinge on understanding the patent landscape and the patent’s enforcement scope.
  • Regular patent landscape reviews ensure alignment with technological progress and competitive positioning in the pharmaceutical domain.

FAQs

1. How does the scope of claims in the '690 patent impact its enforceability?
Broader claims can offer wider protection but are more vulnerable to invalidity challenges, whereas narrower claims are easier to defend but limit market coverage.

2. What are the key considerations when evaluating the patent landscape around the '690 patent?
Analyzing related patents for overlap, potential infringement risks, patent expiry timelines, and jurisdictional coverage provides a comprehensive landscape view.

3. Can the '690 patent be challenged through patent invalidity procedures?
Yes. Competitors or third parties can seek to invalidate broad or overlapping claims via inter partes review (IPR) or opposition processes, especially if prior art is identified.

4. How does this patent influence R&D and commercial strategy?
It protects specific innovations, enabling exclusivity in targeted markets, fostering investment, and incentivizing further development within the protected scope.

5. What role does international patent protection play regarding the '690 patent?
Securing patent rights in key markets through PCT applications or national filings extends protection, preventing generic entry and supporting global commercialization.


References

[1] U.S. Patent and Trademark Office. "Patent Grant: U.S. Patent No. 12,201,690." 2023.
[2] M. Smith, “Pharmaceutical Patent Strategies,” J. Intellectual Property Law, vol. 15, no. 4, 2022.
[3] World Intellectual Property Organization. "Patent Landscapes for Targeted Therapeutics," 2023.

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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 ⤷  Get Started Free ⤷  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 12,201,690

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019287282 ⤷  Get Started Free
Australia 2024287122 ⤷  Get Started Free
Brazil 112020024481 ⤷  Get Started Free
Canada 3100146 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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