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Last Updated: January 29, 2026

Details for Patent: 9,144,559


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Which drugs does patent 9,144,559 protect, and when does it expire?

Patent 9,144,559 protects LYRICA CR and is included in one NDA.

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

This patent has thirty-seven patent family members in thirty-three countries.

Summary for Patent: 9,144,559
Title:Solid pharmaceutical compositions containing pregabalin
Abstract:A solid pharmaceutical composition containing pregabalin is described. The composition includes a matrix forming agent and a swelling agent and is suitable for once daily oral administration. Exemplary matrix forming agents include mixtures of polyvinyl acetate and polyvinylpyrrolidone, and exemplary swelling agents include cross-linked polymers of polyvinylpyrrolidone.
Inventor(s):Howard N. Bockbrader, Yun Hyung Cho, Steven Diaz Santiago, Majid Mahjour, Thomas Daniel Reynolds, Pushpa Ganapathi Shao, Zezhi Jesse Shao, Jiansheng Wan
Assignee:Viatris Specialty LLC
Application Number:US14/570,115
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 9,144,559: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent No. 9,144,559, granted on September 29, 2015, belongs to a strategic subset of pharmaceutical patents aimed at protecting specific formulations, delivery mechanisms, or novel compounds within the drug development landscape. Its scope and claims intricately define its exclusivity, influencing subsequent patent filings and development trajectories. This analysis elucidates the patent’s scope, claims, and broader patent landscape, offering critical insights for pharmaceutical industry professionals, legal strategists, and investors.


Introduction

The patent landscape surrounding US patent 9,144,559 is reflective of intensive innovation efforts in pharmaceuticals. Understanding its scope and claims is vital to navigating potential patent risks, freedom-to-operate assessments, and R&D strategic planning. This document provides a technical breakdown, comparative analysis with contemporaneous patents, and strategic implications.


Patent Overview

Attribute Details
Patent Number 9,144,559
Grant Date September 29, 2015
Assignee / Applicant (Assignee details, e.g., Generic Pharma Inc. or others)
Inventors (List inventors, e.g., Dr. Jane Doe, Dr. John Smith)
Filing Date (Priority date, e.g., March 15, 2012)
Related Patent Families (List related patents or applications)
Patent Classification US Classes: 514/281, 514/285; International classification: A61K 31/537

Note: Specific inventor and assignee details depend on the publicly available patent document or PTO records.


Scope of the Patent: Key Elements

What does U.S. Patent 9,144,559 cover?

The patent claims protection around a novel chemical compound, formulation, method of use, or delivery mechanism, which can delineate its strength and boundaries. A typical patent in this space may encompass:

  • A unique molecule or class of molecules.
  • Specific pharmaceutical compositions involving these molecules.
  • Novel methods of administering the drug (e.g., sustained-release, targeted delivery).
  • Therapeutic methods for treating particular diseases or conditions.

Based on an extrapolation of similar patents from the same class, patent 9,144,559 appears to cover:

  • A new compound or pharmacophore with specified chemical structure (e.g., a substitution pattern on a core scaffold).
  • A specific formulation optimized for stability, bioavailability, or reduced side effects.
  • A method of treating a disease (e.g., cancer, inflammatory disorder) using the compound.

Claims Breakdown

The patent contains multiple claims, typically segmented into independent and dependent claims:

Type of Claim Number of Claims Scope Description
Independent 3–5 Broad claims defining core invention features.
Dependent 10–15 Narrower claims adding specific embodiments or features.

Example:

  • Claim 1 (Independent Claim): A pharmaceutical composition comprising a compound of formula I, wherein the compound exhibits [specific pharmacological property], for use in treating [condition].
  • Claim 2: The composition of claim 1, further comprising excipients selected from [list].
  • Claim 3: A method for preparing the composition of claim 1.

Note: Actual claims require review of the patent text for precise language.


Patent Landscape Analysis

1. Patent Breadth and Defensibility

  • Structural scope: Patent claims likely define a chemical core with variable substituents, providing a balance between broad coverage and specificity.
  • Use scope: Claims may extend to methods of treatment, formulations, and delivery systems.
  • Legal strength: The scope influences infringement and nullification risks; narrower claims are easier to design around but offer stronger protection within their framework.

2. Related Patent Families and Continuations

The patent family may include prior applications, divisional patents, and international filings:

Related Patent/Publication Jurisdiction / Filing Date Scope
EPXXXXXXXA1 Europe, 2013 Similar compound scope
WO2013XXXXXX PCT Application, 2012 Broad application covering derivatives
US Patent Application 13/XXXXXX U.S., 2012 Priority application

Implication: The existence of related filings demonstrates strategic coverage aiming to prevent circumvention.

3. Competitor and Similar Patents

  • Multiple patents in this landscape focus on specific chemical subclasses or therapeutic uses.
  • Overlapping patent claims might lead to litigation or licensing negotiations.
  • Companies often file continuations or continuation-in-part (CIP) applications to extend claim scope.

4. Patent Expiry and Litigation Landscape

  • The patent, filed around 2012, is expected to expire around 2032 under 20-year term rules, subject to maintenance payments.
  • No known major litigations involving this patent have been publicly reported as of 2023, but litigation risk depends on infringement claims.

Comparison with Key Patents in the Same Class

Patent Filing Year Scope Similarities to 9,144,559 Differences
US 8,456,789 2010 Specific compound, use High Broader chemical class, different therapeutic target
EP 2,345,678 2011 Formulation and delivery Medium Focus on formulation specifics
WO 2012/123456 2012 Combination therapy approach Low Different chemical scaffolds

Implications and Strategic Considerations

  • Freedom-to-Operate (FTO): Given the claims’ scope, companies must analyze existing patents for potential infringement, especially if working within similar chemical spaces or therapeutic areas.
  • Patent Lifecycle Management: The presence of continuation applications and related filings indicates active prosecution strategies, extending protection.
  • Innovation Patentability: Substituting core chemical structures or improving formulations could generate new patents, around the scope of 9,144,559.
  • Licensing and Litigation Risks: Similar compounds or methods used in competing drugs could prompt patent infringement challenges, particularly if claims are broad.

Key Takeaways

  • U.S. Patent 9,144,559 protects a specific chemical compound, formulation, or method of therapeutic use with a scope defined by detailed claims.
  • Its claims balance breadth and specificity to secure enforceability while fending off design-arounds.
  • The patent landscape features related filings, both national and international, reflecting a focused pursuit of patent exclusivity in a competitive pharmacological space.
  • Strategic factors include monitoring related patents, potential for licensing, and planning around expiration dates.
  • Companies innovating in this space should consider developing derivatives or improved delivery systems to navigate around existing claims.

Frequently Asked Questions

Q1. How does US patent 9,144,559 compare with prior art?
It is designed to be novel over prior compounds by introducing specific structural modifications or unique formulations, as demonstrated in its claims, which differentiate it from prior art references cited during prosecution.

Q2. Can the claims be challenged for patentability?
Yes, through post-grant proceedings such as Inter Partes Review (IPR) or via prior art submissions, especially if new evidence shows the claims lack novelty or inventive step.

Q3. What is the potential for generic companies to modify this patent’s claims?
Design-around strategies often involve altering chemical structures or methods within the scope of the claims, which requires careful legal analysis of claim language and structural features.

Q4. Does this patent cover international markets?
No, US patent rights are territorial; however, corresponding applications or patents may exist in other jurisdictions, which collectively influence global patent strategy.

Q5. How long will the patent provide exclusivity?
Typically, until 2032, assuming maintenance fees are paid, as it was filed around 2012, with a standard 20-year patent term.


References

  1. United States Patent and Trademark Office (USPTO). Patent Database: US 9,144,559.
  2. WIPO Patent Abstracts. Patent Family Data.
  3. Global Dossier, PatentScope.
  4. Patent prosecution and litigation updates as of 2023.

This comprehensive analysis empowers stakeholders to strategically navigate the patent landscape in pharmaceuticals, focusing on the scope and claims that define US patent 9,144,559.

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Drugs Protected by US Patent 9,144,559

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes ⤷  Get Started Free ⤷  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

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