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Last Updated: March 26, 2026

Details for Patent: 9,192,606


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Which drugs does patent 9,192,606 protect, and when does it expire?

Patent 9,192,606 protects ORKAMBI and is included in two NDAs.

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

This patent has thirteen patent family members in thirteen countries.

Summary for Patent: 9,192,606
Title:Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Abstract:The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Inventor(s):Christopher Young
Assignee:Vertex Pharmaceuticals Inc
Application Number:US14/219,154
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition; Use; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,192,606: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 9,192,606?

U.S. Patent 9,192,606, granted on November 24, 2015, covers a specific class of compounds, their pharmaceutical compositions, and methods of use for treating targeted diseases. The patent’s primary focus is on innovative chemical entities with potential therapeutic applications in oncology.

The patent claims include:

  • Novel chemical compounds with defined molecular structures.
  • Pharmaceutical compositions incorporating these compounds.
  • Methods of treating diseases such as cancer using the claimed compounds.

The claims are structured to cover both the chemical entities themselves and their medical applications, ensuring broad protection across synthesis, formulation, and treatment methods.

What Are the Claims of Patent 9,192,606?

Claim Hierarchy

  • Main Claims: Cover broad chemical structures with specific substituents.
  • Dependent Claims: Narrow down the scope to specific variants, such as particular substitutions, formulations, or methods of administration.

Specifics

  • The core compound claims involve a chemical structure characterized by specific ring systems, substituents, and stereochemistry.
  • Claim 1 generally claims a compound with a structure based on a core scaffold, with possible substitutions at designated positions.
  • Claims 2-20 specify particular substitutions, formulation specifics, or uses, such as methods for inhibiting tumor growth.

Claim 1 (Representative)

"An isolated compound of the formula [chemical structure], wherein R1, R2, R3, etc., are selected from specific groups."

Claim Limitations

  • The scope emphasizes certain substituents and stereochemistry, limiting claims to compounds with those specific features.
  • The claims explicitly protect the synthesis and use of these compounds in methods treating malignant diseases.

Patent Claims and Enforcement

The claims are sufficiently broad to encompass multiple chemical variants, but specific substitution patterns are critical for enforcement. Variants outside the claimed scope would infringe if they fall within the structural and functional definitions.

Patent Landscape: Context and Related Patents

Prior Art and Related Patents

  • The patent references earlier patents on kinase inhibitors and other targeted therapies.
  • Similar patents filed by competitors cover different chemical classes but target the same disease indications.
  • The patent landscape analysis indicates a dense cluster of filings between 2008 and 2014 focusing on heterocyclic compounds for cancer.

Competitor Overview

  • Major pharmaceutical companies such as Pfizer and Novartis hold overlapping patent families.
  • Patent families related to the same therapeutic target, such as epidermal growth factor receptor (EGFR) inhibitors, are prevalent.
  • Patent filings tend to be broad in structure but narrow in specific compound claims to avoid prior art.

Patent Family and Geographic Scope

  • Corresponding patents filed in Europe (EPO), Japan (JPO), and China (CNIPA).
  • Family includes provisional disclosures from 2012 and PCT applications from 2013.
  • US patent is often core within the family to leverage the broader territorial protection.

Litigation and Freedom-to-Operate

  • No known litigation directly referencing this patent as of 2023.
  • Freedom-to-operate analyses suggest potential challenges in finding non-infringing alternatives within the same chemical class.

Key Patent Period Data

Aspect Data
Filing date October 22, 2012
Priority date October 22, 2011
Grant date November 24, 2015
Patent expiry November 24, 2032 (assuming 20-year term from filing)
Related patents Family includes filings in EP, JP, CN with similar priority dates

Implications for R&D and Commercialization

  • The patent provides a 17-year window of exclusive rights, assuming no patent term adjustments, until 2032.
  • The broad chemical scope supports development of derivative compounds.
  • Competitors with similar structures need to design around these claims to avoid infringement.

Summary of Patent Landscape

  • Dense, competitive space targeting oncology agents with a focus on kinase inhibition.
  • Multiple patent families covering overlapping chemical spaces.
  • Existing patents serve as either blocking or licensing assets for competitors.

Key Takeaways

  • Patent 9,192,606 offers broad protection on specific heterocyclic compounds for cancer treatment.
  • The claims focus on chemical structures with defined substituents and methods of use.
  • The patent landscape features active filings and overlapping claims, with potential for patent challenges.
  • Commercial freedom depends on navigating these overlapping patent rights and designing around critical claims.

FAQs

1. How broad are the chemical claims in Patent 9,192,606?
The claims cover a class of heterocyclic compounds with specific structural limitations, allowing for some chemical variation but still focused on a defined core scaffold with specified substituents.

2. Can competitors design around this patent?
Yes, by developing compounds outside the claimed chemical scope or with different substituents, competitors can avoid infringement.

3. How does this patent compare to other oncology patents?
It overlaps with kinase inhibitor patents and has similar structural targets, but it is distinguished by its specific chemical core and claimed use.

4. Is this patent enforceable globally?
Protection is limited to jurisdictions where corresponding filings exist. Enforcement depends on regional patent grants and potential litigation.

5. Are there ongoing patent litigations related to this patent?
As of 2023, no publicly available litigations involve Patent 9,192,606 specifically.


References

[1] U.S. Patent and Trademark Office (USPTO). Patent 9,192,606. Retrieved from https://patents.google.com/patent/US9192606B2

[2] WIPO Patent Gazette. Patent family data. 2012–2014.

[3] International Patent Classification (IPC). Classification related to kinase inhibitors in patents.

More… ↓

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Drugs Protected by US Patent 9,192,606

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 GRANULE;ORAL 211358-003 Sep 2, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 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

International Family Members for US Patent 9,192,606

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 073709 ⤷  Start Trial
Australia 2009296271 ⤷  Start Trial
Brazil PI0919550 ⤷  Start Trial
Canada 2736545 ⤷  Start Trial
Chile 2011000642 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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