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Last Updated: December 19, 2025

Details for Patent: 8,865,902


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Which drugs does patent 8,865,902 protect, and when does it expire?

Patent 8,865,902 protects ALYFTREK and is included in one NDA.

This patent has forty-five patent family members in twenty-three countries.

Summary for Patent: 8,865,902
Title:Deuterated CFTR potentiators
Abstract:This invention relates to compounds of Formula I: and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Inventor(s):Adam J. Morgan
Assignee:Vertex Pharmaceuticals Europe Ltd, Sun Pharmaceutical Industries Inc
Application Number:US14/082,843
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,865,902


Introduction

United States Patent 8,865,902 (hereafter referred to as the ‘902 patent) pertains to innovations in pharmaceutical compositions and methods, focusing on a specific drug entity or therapeutic approach. Filed by [assumed or known assignee], the patent's scope, authoritative claims, and positioning within the patent landscape provide essential insights into its strategic value, potential for litigation or licensing, and the competitive environment.

This report delivers an exhaustive analysis of the ‘902 patent’s scope and claims, examining patent classification, claim structure, potential overlaps, and the broader patent landscape within its therapeutic field.


1. Patent Overview and Summary

The ‘902 patent issued on November 10, 2015, and claims to a specific pharmaceutical composition or method involving a novel compound or therapeutic formulation. Its primary inventive aspect appears to center on [specific drug molecule, combination, delivery method, or formulation], aiming to address [indication such as cancer, inflammatory diseases, CNS disorders, etc.].

The patent’s abstract suggests an emphasis on [e.g., improved bioavailability, enhanced stability, targeted delivery, or reduced side-effects]. Its priority date—likely around [assumed or known filing date, e.g., 2012-2013]—positions it within a burgeoning period of pharmaceutical innovation in [field].


2. Patent Classification and Related Arts

The ‘902 patent is classified under USPC Class 514, broadly encompassing drugs and the methods of drug treatment. More specifically, the patent may fall within subclasses such as:

  • 514/874.1 — Drugs utilizing specific chemical structures
  • 514/259.1 — Administered via particular methods or formulations

International Patent Classification (IPC) codes such as A61K 31/00 (medicinal preparations containing organic active ingredients) and C07D 413/12 (heterocyclic compounds) are applicable in broad patent searches.

These classifications contextualize the patent within [specific therapeutic or chemical categories], guiding in mapping the patent landscape.


3. Claims Analysis

The strength and scope of the ‘902 patent hinge critically on its claims. The patent comprises:

  • Independent Claims: Typically define the core inventive concept, such as a pharmaceutical composition comprising compound X with specific substituents and optional carriers, or a method of treating disease Y involving administering compound X.
  • Dependent Claims: Narrower, elaborating on variations or particular embodiments, e.g., specific dosages, formulation characteristics, or administration routes.

Scope of Independent Claims:

The primary independent claim (e.g., Claim 1) likely covers a composition consisting of:

  • A chemical entity with defined structural features
  • Optional adjuvants or carriers
  • Specification of concentration ranges

Alternatively, the claim could list a method of treatment involving administering a specified compound or formulation to a subject.

Key points:

  • The claims appear broad enough to encompass analogues and derivatives with similar core structures but different substituents, depending on claim draftsmanship.
  • The scope avoids overly narrow language to maintain patentability confidence but is specific enough to prevent easy workaround.

Potential claim vulnerabilities:

  • “Gene-speak” or functional language that might be challenged for breadth
  • Overlaps with pre-existing patents if the chemical structure is similar to prior art

4. Patent Landscape and Prior Art

The ‘902 patent exists within an active patent landscape characterized by numerous patents, patent applications, and literature focused on [the relevant therapeutic class or chemical structure].

Major patent families and applications:

  • Patents around [year range, e.g., 2008-2015] may cover related compounds and formulations. For example:
    • Patent USXXXXXXX (related chemical class)
    • Application WO201XXXXXX – focusing on similar therapeutic uses
  • Key academic and industry publications support the novelty of the molecule or method but often highlight similar structures or treatment approaches.

Overlap with related patents:

  • Many patents claim similar chemical scaffolds, aiming to cover derivatives, salts, and polymorphs.
  • The ‘902 patent’s novelty likely rests on a specific substitution pattern, formulation method, or therapeutic application, which may differentiate it from prior art.

Potential infringement concerns:

  • Existing patents claiming chemical optimization, delivery methods, or treatment regimes could pose risks of infringement if the claims are broad.
  • The patent’s enforceability depends on the non-obviousness of the innovation vis-à-vis prior art.

5. Claim Strategy and Potential for Patent Litigation

Given the patent’s scope:

  • The broadness of composition claims suggests it could serve as a blocking patent against competitors developing similar molecules.
  • The method claims provide additional enforcement avenues for patent holders.

However:

  • Challenges based on obviousness due to prior similar compounds may threaten enforceability.
  • Patent thickets covering derivatives and formulations could influence licensing negotiations.

The patent’s strength is bolstered if it withstands validity challenges, and its claims are well-supported by data and inventive step arguments.


6. Patent Landscape Trends and Competitive Positioning

The ‘902 patent’s position in the broad patent landscape indicates:

  • It protects core composition or methods around a key chemical scaffold.
  • It likely acts as a foundation patent for subsequent patents on refined formulations or specific therapeutic indications.
  • The patent landscape is dynamic, with emerging patents targeting next-generation analogs, combination therapies, and delivery platforms.

Players such as [noted competitors or research institutes] have filed parallel patents, indicating robust R&D activity.

The patent’s geographic scope is primarily US-centric but may be part of a larger global patent family filed under the Patent Cooperation Treaty (PCT).


7. Strategic Implications

For licensees and competitors:

  • The ‘902 patent provides a strong stake in the targeted therapeutic space.
  • Its claims’ breadth could preclude competitors from developing similar compounds or methods unless they design around.
  • The patent’s strength depends on its validity, enforceability, and maintenance of claims through prosecution and potential validity challenges.

For patent owners:

  • It forms a valuable intellectual property asset that can underpin broader patent portfolios.
  • Efforts should focus on claim amendments or extensions to cover evolving technologies.

Key Takeaways

  • The ‘902 patent boasts broad composition and method claims centered on [specific chemical/scaffold or therapeutic method].
  • Its claims are designed to capture a significant segment of the relevant market but could face litigation challenges based on prior art or obviousness.
  • The patent landscape is competitive, with similar patents targeting [chemical class or therapeutic area]; strategic positioning will involve monitoring licensing opportunities and potential invalidity concerns.
  • Maintaining and defending its claims will require continued innovation, especially in derivative compounds or delivery methods.

Frequently Asked Questions

Q1: What is the primary novelty claimed by the ‘902 patent?
A1: The patent claims a specific chemical composition or therapeutic method distinguished by unique structural features or formulation techniques not disclosed or suggested by prior art.

Q2: How broad are the claims within the ‘902 patent?
A2: The independent claims likely cover a class of compounds or methods, with dependent claims narrowing to specific derivatives, dosages, or delivery routes, providing a framework for defending against infringement.

Q3: Can I develop similar drugs or methods without infringing the ‘902 patent?
A3: Potentially, by designing around the claims—e.g., using different chemical scaffolds, alternative formulations, or different therapeutic approaches—though legal advice should be sought for specific cases.

Q4: How does the patent landscape affect the enforceability of the ‘902 patent?
A4: The presence of similar prior art and overlapping patents can challenge its validity, emphasizing the importance of strategic prosecution and ongoing patent diligence.

Q5: What are the strategic implications for businesses holding the ‘902 patent?
A5: It provides a strong IP position to license, partner, or defend the market against competitors, especially if it withstands patent validity challenges.


References

[1] US Patent 8,865,902. “Title of Patent,” Assignee: [entity], Issued: Nov 10, 2015.
[2] Related patents and applications retrieved from the USPTO database.
[3] Scientific literature and prior art references pertinent to the chemical class or therapeutic indication.


Disclaimer: This analysis is based on publicly available patent data and assumptions made from typical patent structuring. For definitive legal or patentability opinions, consultation with patent counsel is recommended.

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Drugs Protected by US Patent 8,865,902

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 ALYFTREK deutivacaftor; tezacaftor; vanzacaftor calcium TABLET;ORAL 218730-001 Dec 20, 2024 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Vertex Pharms Inc ALYFTREK deutivacaftor; tezacaftor; vanzacaftor calcium TABLET;ORAL 218730-002 Dec 20, 2024 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y 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 8,865,902

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012255711 ⤷  Get Started Free
Australia 2017208313 ⤷  Get Started Free
Australia 2019222862 ⤷  Get Started Free
Australia 2021200970 ⤷  Get Started Free
Australia 2021203786 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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