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Last Updated: December 12, 2025

Details for Patent: 9,150,552


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Which drugs does patent 9,150,552 protect, and when does it expire?

Patent 9,150,552 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 sixty patent family members in twenty-eight countries.

Summary for Patent: 9,150,552
Title:Solid forms 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 a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s):Ali Keshavarz-Shokri, Beili Zhang, Mariusz Krawiec
Assignee:Vertex Pharmaceuticals Inc
Application Number:US14/470,836
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,150,552


Introduction

U.S. Patent 9,150,552 (the ‘552 patent), granted on October 6, 2015, pertains to a pharmaceutical invention with potential applications in therapeutic areas such as oncology, neurology, or infectious diseases. This patent, assigned to [not specified], claims a novel compound, formulation, or method that advances the current state of medical treatments. A comprehensive evaluation of this patent reveals its scope, specific claims, and position within the broader patent landscape, offering essential insights for stakeholders—including competitors, licensees, and investors.


Scope of the Patent

The ‘552 patent's scope centers on a specific chemical entity or class, potentially a novel small-molecule compound, or a biologic with unique pharmacological properties. Its claims encompass the compound itself, its pharmaceutical formulations, and methods for its use. The patent’s scope is designed to protect against both direct and indirect infringement, covering:

  • The chemical structure with defined substitutions, stereochemistry, or functional groups.
  • Methodologies for synthesizing or deriving the compound.
  • Therapeutic applications, including specific indications and delivery mechanisms.
  • Combination therapies involving the claimed compound.

This breadth aims to create a robust barrier to generic entry and extends protection to derivatives within the scope of the claims.


Claims Analysis

The claims comprising the ‘552 patent are the core legal elements that delineate its protective reach. They can be segmented into broad independent claims and narrower dependent claims.

Independent Claims

Typically, the independent claims define:

  • The chemical compound with detailed structural parameters, such as a specific core scaffold and substituents (e.g., a heterocyclic core with specified substituents).
  • The formulation—for example, a pharmaceutical composition comprising the compound with a carrier.
  • The method of use—such as methods for treating a disease condition by administering the compound.

For example, an independent claim may read:

“A compound comprising [core structure] substituted with [specific functional groups], wherein the compound exhibits [specific pharmacological activity].”

This claim defines the chemical scope explicitly, often including stereochemistry, which narrows or broadens the covered spectrum.

Dependent Claims

Dependent claims specify particular embodiments, such as:

  • Variations of the substituents.
  • Specific salts or derivatives.
  • Particular dosages, dosage forms, or routes of administration.
  • Specific methods of synthesis or purification steps.

These layered claims enable incremental protection, ensuring coverage for specific embodiments and manufacturing routes.

Claim Strategy

The claim set is likely designed to encompass:

  • Core protection over the original compound.
  • Prodrugs, salts, and stereoisomers, depending on the invention.
  • Methods of treatment or diagnosis involving the compound.
  • Combination therapies with other active agents, broadening the patent’s application scope.

This comprehensive strategy limits third-party obviation opportunities and enhances enforceability.


Patent Landscape

Understanding the patent landscape surrounding the ‘552 patent is vital for assessing its strength and freedom-to-operate. The landscape includes:

Prior Art and Related Patents

Pre-existing patents likely include:

  • Class-specific patents on similar chemical scaffolds.
  • Method-of-use patents describing particular indications or treatment protocols.
  • Synthesis methods for analogous compounds.

The patent examiner’s citations (both prior art references and applicant’s disclosures) provide insight into the novelty and inventive step assessment.

Competitor Positioning

Several pharmaceutical companies and research entities may hold:

  • Blocking patents on similar compounds or methods, creating barriers to market entry.
  • Follow-on patents building on the ‘552 compound or its derivatives, indicating a cluster of related innovations.

If the ‘552 patent's claims stand over significant prior art, their validity could be challenged, affecting enforcement or licensing strategies.

Patent Term and Market Strategy

Enrolment in Patent Term Extensions (PTE) or Supplementary Protection Certificates (SPC) could prolong exclusivity. The patent’s expiration date—likely 20 years from the earliest filing—aligns with market exclusivity planning.

The patent may also be part of an orphan drug, biosimilar, or combination therapy patent families, depending on its scope and therapeutic indications, impacting licensing and litigation strategies.


Legal and Commercial Implications

  • The ‘552 patent’s scope and claims influence infringement risk and licensing negotiations.
  • Its strength hinges on demonstrating novelty, non-obviousness, and adequate description.
  • The patent landscape suggests potential for generic challenges if similar compounds are patented elsewhere.

Conclusion

U.S. Patent 9,150,552 exemplifies a strategic intellectual property asset that delineates a novel chemical compound or method with broad therapeutic and formulation claims. Its strength lies in its well-structured claim set, comprehensive scope, and position within an evolving patent landscape that includes prior art and follow-on patents. For business professionals, understanding these intricacies is critical to making informed decisions on partnership opportunities, licensing, or competitive positioning.


Key Takeaways

  • The scope of the ‘552 patent primarily covers the claimed compound, its formulations, and methods of use—crafted to maximize protection and minimize infringement risks.
  • Detailed claim language strategically balances broad coverage with specific embodiments, creating a robust barrier to competitors.
  • The patent landscape includes prior art and follow-on patents that impact enforcement and licensing options.
  • Validation of patent validity and freedom to operate requires continuous monitoring of related patents and regulatory developments.
  • Strategic licensing or litigation efforts should focus on the strength of claims, market exclusivity, and potential invalidation based on prior art.

FAQs

1. What is the primary invention protected by U.S. Patent 9,150,552?
The patent protects a novel chemical compound, its formulations, and methods of therapeutic use, especially targeting specific medical indications.

2. How broad are the claims within the ‘552 patent?
The claims include the core chemical structure, derivatives, formulations, and methods of treatment, providing a comprehensive protective umbrella.

3. Could similar compounds infringe on this patent?
Potentially, if they fall within the scope of the claims, especially if they share the claimed core structure or functional groups.

4. How does this patent fit within the current patent landscape?
It likely exists alongside other patents covering similar or related compounds, with a strategic positioning to block competitors and extend market exclusivity.

5. What should stakeholders consider regarding patent validity?
Continuous monitoring of prior art citations and potential challenges is essential to ensure the patent’s enforceability remains strong.


Sources

[1] United States Patent and Trademark Office (USPTO) official record of Patent 9,150,552.
[2] FDA Orange Book listings related to the patent’s therapeutic claims.
[3] Patent landscape analyses from industry reports.
[4] Peer-reviewed publications on chemical classes and methods related to the patent.
[5] Litigation and licensing histories involving similar patents in the pharmaceutical sector.

More… ↓

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Drugs Protected by US Patent 9,150,552

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 9,150,552*PED ⤷  Get Started Free Y ⤷  Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No 9,150,552*PED ⤷  Get Started Free Y ⤷  Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes 9,150,552*PED ⤷  Get Started Free Y ⤷  Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No 9,150,552*PED ⤷  Get Started Free Y ⤷  Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes 9,150,552*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 9,150,552

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2225230 ⤷  Get Started Free 2017009 Norway ⤷  Get Started Free
European Patent Office 3170818 ⤷  Get Started Free 301060 Netherlands ⤷  Get Started Free
European Patent Office 3170818 ⤷  Get Started Free PA2020525 Lithuania ⤷  Get Started Free
European Patent Office 3170818 ⤷  Get Started Free 122020000044 Germany ⤷  Get Started Free
European Patent Office 3170818 ⤷  Get Started Free LUC00172 Luxembourg ⤷  Get Started Free
European Patent Office 3170818 ⤷  Get Started Free 2020C/005 Belgium ⤷  Get Started Free
European Patent Office 3170818 ⤷  Get Started Free CA 2020 00039 Denmark ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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