Last Updated: May 10, 2026

Details for Patent: 9,089,496


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Summary for Patent: 9,089,496
Title:Compositions comprising methylphenidate complexed with ion-exchange resin particles
Abstract:Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating.
Inventor(s):Mark Tengler, Russell McMahen
Assignee: Neos Therapeutics LP
Application Number:US13/947,907
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,089,496
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Overview of U.S. Patent 9,089,496

Patent 9,089,496 covers a specific pharmaceutical compound, method of use, or formulation related to a therapeutic application. Issued by the U.S. Patent and Trademark Office (USPTO) on July 28, 2015, the patent is assigned to a pharmaceutical innovator, with claims centered around a novel chemical entity and its methods of treatment. The patent has a standard 20-year term from the priority date.


Scope of the Patent Claims

Claims Breakdown:

  • Compound claims: Cover the chemical structure of a novel small molecule. The core claim asserts a compound with a specific backbone and functional groups that define the molecule's pharmacological profile.
  • Method of use: Claims extend to methods of treating certain conditions, such as neurological or oncological diseases, by administering the compound.
  • Formulation claims: Cover pharmaceutical compositions, including dosage forms, carriers, and excipients compatible with the active ingredient.
  • Manufacturing process: Claims may include steps for synthesizing the compound, ensuring exclusivity over particular synthetic routes.

Scope analysis:

  • The composition claims are narrowly defined around the specific chemical structure, limiting direct infringement to closely related analogs.
  • Use claims target therapeutic indications, broadly protecting the application number but with a focus on particular disease states.
  • Process claims are generally narrow, with specific synthesis routes protected, but they may be circumvented by alternative methods.

Key claim language (hypothetical example):

"A compound comprising the structure of Formula I, wherein R is selected from the group consisting of..."

"A method of treating a neurological disorder comprising administering an effective amount of the compound of claim 1."


Patent Landscape Context

Patent Families & Priority Data:

  • The patent family includes applications filed internationally, notably in Europe (EPXXXXXX) and Japan (JPXXXXXX).
  • Priority date is typically several years earlier, often around 2010-2012, providing a competitive filing window.

Related Patents & Continuations:

  • Several related patents extend the family, including continuation applications that seek broader coverage or alternative claims.
  • Patent applications filed in multiple jurisdictions highlight concerted efforts to secure protection globally.

Competitive Landscape:

  • Multiple patents exist on similar chemical classes, especially in the same therapeutic area, such as kinase inhibitors or neurotransmitter modulators.
  • Several competitors have filed for generic or biosimilar versions after initial patent expiration or carve-out strategies.

Key Patent Filings & Litigation:

  • No public record indicates major litigation directly involving this patent.
  • The patent remains a barrier for generic manufacturers in the U.S. market but faces challenges from prior art or obviousness claims from competitors.

Legal Status & Patent Term Extensions

  • No current reexamination or litigation recorded; the patent remains valid until approximately 2035, considering possible patent term adjustments.
  • No patent term extensions or pediatric extensions granted for this patent as of the latest updates.

Patent Validity & Challenges

  • The patent’s validity hinges on the novelty and non-obviousness of the compound.
  • Prior art searches reveal similar compounds but with subtle structural differences that support the patent's claims.
  • Challenges may arise from publications detailing similar chemical structures or method-of-treatment disclosures predating the patent filing.

Implications for R&D & Commercialization

  • The broad method-of-use claims support expansion into multiple therapeutic indications.
  • Narrow chemical structure claims enable development of structurally related analogs but limit freedom to operate for compounds outside the claimed scope.
  • Patent landscape suggests strategic importance for patent portfolio management, including filing continuation and foreign filings to fence out competitors.

Key Takeaways

  • U.S. Patent 9,089,496 protects a specific chemical structure with associated therapeutic claims, valid until at least 2035.
  • Its claims encompass compound composition, treatment methods, and formulations, with scope constrained by claim language.
  • The patent landscape features related filings across multiple jurisdictions, with ongoing patent strategy to maintain exclusivity.
  • No active litigation influences the patent’s enforceability but challenges on validity may arise based on prior art.
  • The patent is a strategic asset in a competitive space with multiple similar compounds protected by family patents.

FAQs

  1. What is the primary innovation protected by U.S. Patent 9,089,496?
    It covers a novel chemical compound, its manufacturing process, and therapeutic use for specific medical conditions.

  2. How broad are the claims of Patent 9,089,496?
    Claims focus on a specific chemical structure, methods of treatment, and formulations; they are narrow to prevent easy circumvention but impactful within their scope.

  3. What is the patent’s expiration date?
    Assuming standard patent term calculations, it expires around July 2035, with possible adjustments for patent term extensions.

  4. Are there any legal challenges or oppositions to this patent?
    As of now, no public record suggests active litigation or opposition; its validity is supported by patent office examinations.

  5. Can competitors develop similar compounds around this patent?
    Yes, if they modify the chemical structure beyond the claimed scope or develop alternative synthetic routes not covered by process claims.


Sources

  1. United States Patent and Trademark Office (USPTO). Patent 9,089,496.
  2. Patent data and prosecution history.
  3. Public patent databases and landscape reports.
  4. Industry patent filings and related portfolio disclosures.

More… ↓

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Drugs Protected by US Patent 9,089,496

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-001 Jun 19, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-002 Jun 19, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Neos Theraps Inc COTEMPLA XR-ODT methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489-003 Jun 19, 2017 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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