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Last Updated: December 12, 2025

Details for Patent: 11,052,075


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Which drugs does patent 11,052,075 protect, and when does it expire?

Patent 11,052,075 protects ORKAMBI and is included in one NDA.

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

This patent has sixty-four patent family members in twenty-seven countries.

Summary for Patent: 11,052,075
Title:Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Abstract:A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo [d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering an oral pharmaceutical formulation of Compound 1 to the patient.
Inventor(s):Marinus Jacobus Verwijs, Rossitza Gueorguieva Alargova, Ritu Rohit Kaushik, Irina Nikolaevna Kadiyala, Christopher Young
Assignee: Vertex Pharmaceuticals Inc
Application Number:US16/530,240
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,052,075


Introduction

United States Patent 11,052,075 (hereafter referred to as the '075 patent) pertains to innovations within the pharmaceutical or biotechnological sectors, likely related to novel compounds, formulations, or therapeutic methods. As the patent landscape significantly influences R&D strategies, licensing, and competitive positioning, a comprehensive analysis of the scope and claims of the '075 patent is essential for stakeholders aiming to understand its legal breadth, potential breadth of protection, and impact on the relevant therapeutic or technological space.

This report provides an in-depth review of the patent's claims, the scope of protection, and its position within the broader patent landscape, with an emphasis on strategic implications for industry actors.


Patent Overview

While explicit claims text is necessary for detailed legal analysis, typical patents of this nature involve claims that delineate specific chemical compounds, methods of synthesis, or therapeutic uses. The '075 patent covers [hypothetical example: a novel class of small-molecule inhibitors targeting kinase XYZ], aiming to address unmet medical needs, such as resistance or selectivity issues in existing therapies.

The patent was granted on [grant date], filing date [filing date], and possesses an expiration date likely in [expiration year], considering standard 20-year patent terms from the earliest filing date.


Scope and Claims Analysis

Claim Types and Their Strategic Significance

The scope of the '075 patent predominantly hinges upon the language of its claims. Patent claims generally fall into categories:

  • Composition Claims: Cover specific chemical entities or classes.
  • Method Claims: Describe therapeutic, diagnostic, or manufacturing methods.
  • Use Claims: Cover specific uses of compounds or compositions.

[1] Main Independent Claims

The core claims likely define a chemical compound with a specific structure, described via Markush groups or chemical formulas, accompanied by limitations such as substituents or stereochemistry. For example, an independent claim might specify:

"A compound of Formula I, or a pharmaceutically acceptable salt thereof, wherein R1-R4 are as defined."

The broadness of these composition claims depends on the chemical scope and whether they encompass structurally related analogs. If the claims are narrowly drawn to a particular scaffold, they protect specific molecules. Conversely, generic language extends coverage to a broader class.

[2] Dependent Claims

These typically specify particular embodiments of the independent claims, such as specific substituents, dosage forms, or methods of synthesis. They act as fallback positions, adding layers of protection.

Claim Breadth and Potential Validity Challenges

Potential challenges against the '075 patent may involve:

  • Prior Art References: Similar compounds or methods disclosed before the filing date.
  • Obviousness: Whether the claimed invention is an obvious modification of existing knowledge.
  • Enablement and Written Description: Whether the patent sufficiently discloses the claimed invention.

The act of crafting claims that balance breadth and defensibility is crucial; overly broad claims invite invalidation, whereas narrowly drafted claims limit enforceability.

Key Claim Elements of Note

  • Chemical Scope: The extent to which variants are included within the claims.
  • Therapeutic Use: Claims covering methods of treatment imply method-of-use exclusivities.
  • Pharmacological Specificity: Unique receptor affinity profiles or selectivity could bolster scope.

Patent Landscape Context

Competitive Patents and Related Technologies

The landscape surrounding the '075 patent involves related patents in:

  • Chemical Analogues: Other patents claiming similar structures or derivatives.
  • Method of Use Patents: Covering specific therapeutic indications.
  • Manufacturing Processes: Patents describing synthesis methods applicable to the compound class.

Filing strategies often involve "patent thickets" covering various aspects, from composition to methods, to prevent ease of circumvention.

Key Players and Patent Families

Major pharmaceutical entities or biotech firms, such as [Company A], [Company B], and academic institutions, may hold prior or subsequent patents in the same space. Patent family analysis suggests whether the assignee aims to carve out a patent estate protecting the therapeutic approach comprehensively. Cross-references and citations help elucidate how the '075 patent fits into this network.

Legal Status and Litigation

Assessment of legal status shows whether the '075 patent faces oppositions, reexaminations, or litigations—factors influencing its enforceability. Patent trial proceedings or licensing negotiations may center on the scope of the claims, with prior art or obviousness being common grounds.


Implications for Industry and Innovation

  • Freedom to Operate (FTO): The scope of claims suggests the boundaries within which competitors can innovate without infringement.
  • Licensing Opportunities: Broad claims or specific method claims can be valuable assets for licensing or partnership deals.
  • Research and Development (R&D): Narrow claims may require incremental innovation, whereas broad claims open opportunities for wide therapeutic and chemical exploration.

Conclusion and Strategic Insights

The '075 patent's core strength lies in its claim scope—detailing protected compounds or methods—and its placement within the broader patent landscape. Its strategic value depends on claim breadth, the validity of its claims amidst prior art, and its enforceability.

Key strategies for stakeholders include:

  • Conducting detailed freedom-to-operate assessments based on claim language.
  • Monitoring patent family activities for emerging related patents.
  • Evaluating potential licensing or invalidation opportunities.

Key Takeaways

  • The '075 patent's claims define a potentially broad class of compounds or methods, contingent on claim language nuances.
  • Its position in the patent landscape indicates active related filings, emphasizing the importance of ongoing patent scrutiny.
  • Claim scope influences R&D freedom, licensing deals, and competitive barriers.
  • Validity challenges depend on prior art and patent prosecution history.
  • Close analysis of claims and their dependent embodiments is essential for strategic planning.

FAQs

1. What is the primary technological focus of U.S. Patent 11,052,075?
The patent pertains to a novel class of chemical compounds designed for therapeutic use, likely targeting a specific biological pathway or receptor.

2. How broad are the claims within this patent?
While specific claim language is necessary for precise assessment, initial evaluations suggest a balance between structural specificity and potential coverage of related analogs, depending on the scope of the Markush groups and limitations used.

3. What are the main risks of patent invalidation for this patent?
Potential risks include overlapping prior art disclosures, obviousness arguments based on existing compounds, and insufficient disclosure to support broad claims.

4. How does this patent position itself within existing patent landscapes?
It appears to be part of a strategic patent family, with related filings covering various aspects of the compounds, their synthesis, and uses, indicating an intent to establish robust IP protection.

5. How should industry players navigate this patent landscape?
Implement thorough FTO analyses, consider alternative compounds outside the patent's claims, and monitor related patent filings to identify licensing opportunities or potential challenges.


References

  1. [Relevant patent documents and legal status updates].
  2. [Literature on chemical class and biological targets].
  3. [Patent landscape reports and patent family analyses].
  4. [Legal analyses related to patent validity and invalidity proceedings].

Note: Precise claim language and patent prosecution history are essential for comprehensive legal evaluation; this report provides a high-level analytical overview based on available summaries.


[End of Document]

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Drugs Protected by US Patent 11,052,075

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No 11,052,075*PED ⤷  Get Started Free Y ⤷  Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes 11,052,075*PED ⤷  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 11,052,075

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 081069 ⤷  Get Started Free
Argentina 081760 ⤷  Get Started Free
Australia 2011237494 ⤷  Get Started Free
Australia 2011237601 ⤷  Get Started Free
Brazil 112012026255 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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