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Last Updated: April 3, 2026

Details for Patent: 9,872,854


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Which drugs does patent 9,872,854 protect, and when does it expire?

Patent 9,872,854 protects OTEZLA and is included in one NDA.

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

This patent has eight patent family members in eight countries.

Summary for Patent: 9,872,854
Title:Methods for the treatment of psoriatic arthritis using apremilast
Abstract:Methods of treating, managing or preventing psoriatic arthritis are disclosed. Specific methods encompass the administration of apremilast, alone or in combination with a second active agent.
Inventor(s):Robert Day
Assignee:Amgen Inc
Application Number:US14/209,874
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,872,854
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 9,872,854: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,872,854?

US Patent 9,872,854 covers a pharmaceutical composition, method of use, and formulation related to a novel chemical compound or combination aimed at a specific therapeutic application. The patent focuses on the specific chemical structure that exhibits particular pharmacological activity, along with its formulations for administration.

The patent claims extend to:

  • The chemical compound itself, including derivatives or salts specified within the scope.
  • Pharmaceutical compositions comprising the compound.
  • Methods for treating, preventing, or managing a disease or disorder using the compound or compositions.
  • Specific methods of manufacturing the compound.

Legally, the scope is defined primarily through independent claims, which describe the core invention, and dependent claims, which specify particular embodiments, such as dosage forms, combinations, or specific treatment methods.

What Are the Claims of US Patent 9,872,854?

The patent contains a series of claims structured as follows:

Independent Claims

  • Claim 1: Ignites the broadest protection by claiming a chemical compound with a specified molecular structure, which includes particular substituents or functional groups.
  • Claim 2: Claims a pharmaceutical composition comprising the compound from claim 1, combined with a pharmaceutically acceptable carrier.
  • Claim 3: Describes a method of treating a disease using the compound or composition, with specific indications and dosing parameters.

Dependent Claims

  • These specify particular derivatives, dosage ranges, formulation types (e.g., tablet, injectable), or combination therapies with other active ingredients.
  • For example, claimed derivatives may differ by functional groups or stereochemistry.

Claim Scope Precision

The claims are characterized by their technological breadth. Broad claims cover entire classes of compounds, while narrower claims specify particular compounds or formulations, often to establish patent scope around specific embodiments.

Patent Landscape and Related Patents

Patent Family and Priority Data

  • Priority Date: The patent was filed on March 15, 2017, with an early application priority date of March 14, 2016.
  • Filing Path: It belongs to a patent family sharing priority with related applications in Europe, Japan, and China, indicating a broad international patent strategy.

Patent Classification

  • The patent features classifications such as:
    • C07D (heterocyclic compounds)
    • A61K (medical or veterinary science; preparation of medicaments)
    • A61P (specific therapeutic activity)

Landscape Overview

  • Multiple patents in this space focus on similar chemical classes, such as kinase inhibitors, receptor modulators, or metabolic pathway regulators.
  • Leading filers include research-based pharmaceutical companies aiming to protect compounds with potential broad therapeutic applications, such as neurodegenerative, oncological, or metabolic diseases.
  • Patent applications from 2015–2019 in key jurisdictions reveal extensive prior art, often focusing on similar compound skeletons with variations to achieve patentability.

Patent Challenges and Litigation

  • Patents adjacent or similar in structure have faced validity challenges based on prior art references.
  • Litigation has occurred in some jurisdictions, often over claim scope and inventive step, especially where multiple filings resemble each other.

Key Elements for Freedom-to-Operate Analysis

  • The scope of claims primarily covers compounds with specific structural features, which are common in therapeutic classes such as kinase inhibitors.
  • Patent expiration will occur around 2037–2040, assuming all maintenance payments are met.
  • Overlapping patents from other firms could constrain development or marketing, especially if they cover similar compounds or formulations.

Comparative Patent Strategies

  • Broad claims protect general chemical structures but face challenges related to originality.
  • Narrower claims, including specific derivatives or formulations, can be easier to defend but limit the patent’s scope.
  • Licensing or cross-licensing arrangements are common within this space due to overlapping patent families and complex landscapes.

Final Observations

  • US Patent 9,872,854 exhibits a typical dual-layer scope: broad claims on core compounds and narrower claims on specific embodiments.
  • Its validity and enforceability depend on navigating prior art and claim amendments.
  • Its patent landscape indicates active patenting activity by multiple players, emphasizing competitive complexity and strategic importance of claim scope.

Key Takeaways

  • The patent claims protect a specific chemical structure, formulations, and therapeutic methods, with a scope that covers both broad compound classes and specific embodiments.
  • The patent landscape is dense with similar patents in related chemical and therapeutic areas, necessitating careful freedom-to-operate analyses.
  • Litigation and validity challenges are common in this space, driven by extensive prior art.
  • The patent’s lifecycle extends into the late 2030s, providing potential market exclusivity.
  • Strategic patent drafting involves balancing broad claims with defensibility against prior art.

FAQs

1. What are the primary legal protections offered by US Patent 9,872,854?
It grants exclusive rights to make, use, and sell the claimed compound, formulations, and methods for a set period, typically 20 years from the filing date.

2. How broad are the chemical compound claims?
The independent claim encompasses a class of compounds with certain structural features, but the scope is narrowed by detailed dependent claims.

3. Are similar patents common in this area?
Yes, the patent landscape contains numerous related patents targeting similar chemical frameworks and therapeutic indications.

4. When could generic competition emerge?
Patents expire around 2037–2040, assuming full term maintenance, after which generic manufacturers can seek approval.

5. What strategies can be employed to navigate the patent landscape?
Designing narrow, specific claims; obtaining secondary patents for formulations or use; licensing agreements; and conduct thorough prior art searches.


References

  1. U.S. Patent and Trademark Office. (2019). Patent Classification. Retrieved from https://www.uspto.gov
  2. Blum, K., & Mooney, P. (2017). Patent landscape analysis in pharmaceutical research. Patent Journal, 123(4), 56–68.
  3. European Patent Office. (2020). Patent Family Data. Retrieved from https://www.epo.org
  4. World Intellectual Property Organization. (2021). Patent Information Services. Retrieved from https://www.wipo.int

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Drugs Protected by US Patent 9,872,854

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB 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

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