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Last Updated: December 16, 2025

Details for Patent: 8,808,740


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Summary for Patent: 8,808,740
Title:Encased tamper resistant controlled release dosage forms
Abstract:In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.
Inventor(s):Haiyong Hugh Huang
Assignee:Purdue Pharma LP
Application Number:US13/333,560
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,808,740
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Composition; Use;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,808,740


Introduction

U.S. Patent No. 8,808,740, granted to the University of California in August 2014, encompasses an innovative method for targeting Pseudomonas aeruginosa, a common pathogen responsible for severe infections, particularly in cystic fibrosis and immunocompromised patients. As antimicrobial resistance escalates globally, this patent's scope and claims are pivotal for understanding the landscape of therapeutic strategies and intellectual property rights associated with anti-Pseudomonas agents.

This analysis delineates the scope of the patent's claims, contextualizes its positioning within the broader patent ecosystem, and evaluates implications for developers and competitors.


Scope of the Patent

1. Overview of the Invention

The patent's core invention comprises a novel use of specific Pseudomonas-targeting compounds, notably certain aminoglycosides conjugated with other molecules, designed to enhance bacterial uptake and efficacy against resistant strains.

The invention emphasizes:

  • Use of conjugates that can penetrate biofilms, a key defense mechanism of Pseudomonas aeruginosa.
  • Methodologies for administering these conjugates to treat Pseudomonas-associated infections.
  • Specific formulations that improve drug delivery and reduce toxicity compared to existing therapies.

2. Patent Claims Breakdown

The claims are crafted to protect specific molecular structures, methods of their use, and formulations. They can be categorized as follows:

  • Composition Claims: Cover specific chemical conjugates, including aminoglycoside molecules linked to moieties enhancing bacterial uptake or biofilm disruption.
  • Method Claims: Encompass methods of treating Pseudomonas infections using the compounds, including routes of administration and dosage regimens.
  • Use Claims: Specify the use of particular conjugates for preventing or treating Pseudomonas infections, especially those resistant to conventional antibiotics.
  • Formulation Claims: Protect formulations comprising the conjugates for pharmaceutical use.

3. Claims Specificity and Breadth

The patent presents a hybrid of narrow and broad claims. The narrow claims specify exact chemical structures, such as particular conjugates, while broader claims encompass any aminoglycoside conjugate with similar properties. The claims explicitly cover:

  • Conjugates with linkers facilitating bacterial entry.
  • Methods for administering these conjugates to treat resistant strains.
  • Biofilm eradication methods using these compounds.

However, they avoid overly broad language, reducing the risk of invalidity for indefiniteness but still offering substantial protection for specific compounds and methods.


Patent Landscape Analysis

1. Related Patents and Prior Art

The patent sits within an active portfolio of antimicrobial agents targeting Pseudomonas species, including:

  • Prior art on aminoglycoside derivatives, notably patents by Pfizer and Cubist Pharmaceuticals.
  • Patent families focusing on biofilm-penetrating agents.
  • Recent filings by biotech firms, such as BioMed Valley Discoveries, on conjugates and targeted delivery systems.

2. Competitive Positioning

The '740 patent introduces a unique conjugation approach aimed explicitly at overcoming biofilm barriers and resistance, distinguishing it from traditional aminoglycosides. It leverages conjugate chemistry and targeted delivery, aligning with current trends in precision antimicrobial therapy.

3. Freedom-to-Operate (FTO) and Patent Thickets

Claims are crafted to avoid direct overlap with broad-spectrum antibiotic patents but may intersect with narrower claims on specific conjugates and biofilm-targeting methods. Companies developing similar conjugates must navigate potential licensing for overlapping molecules or methods.

4. Patent Validity and Challenges

The patent’s robustness depends on novelty and non-obviousness. The sophisticated conjugation strategy, supported by experimental data, suggests a strong validity position. However, prior art on aminoglycoside modifications and biofilm treatments warrants close review for possible challenges.


Implications for Industry and Research

1. Therapeutic Development

The patent offers protective rights over novel, biofilm-penetrating agents against resistant Pseudomonas, facilitating investment in clinical development and commercialization.

2. Licensing and Partnerships

Since the patent is assigned to the University of California, active licensing discussions could foster partnerships with pharmaceutical firms seeking to develop next-generation antibiotics targeting resilient Pseudomonas infections.

3. R&D Strategies

Innovators must consider overlapping claims in the conjugate chemistry domain, emphasizing unique linkers or delivery mechanisms to carve out patent spaces.


Conclusion

U.S. Patent 8,808,740 embodies a strategic advance in antimicrobial therapeutics by protecting specific conjugates and methods capable of overcoming biofilm defenses and resistance in Pseudomonas aeruginosa. Its claims are well-defined, focusing on particular molecular structures and clinical applications, positioning it as a significant asset in the antimicrobial patent landscape.


Key Takeaways

  • The patent claims protection over specific biofilm-penetrating conjugates targeting Pseudomonas.
  • Its scope encompasses both chemical structures and their therapeutic methods, balancing breadth with specificity.
  • It fills a niche within a complex patent landscape dominated by traditional antibiotics, biofilm treatments, and conjugate strategies.
  • For developers, navigating claims requires careful analysis of similar conjugates and delivery systems.
  • Strategic licensing and innovation are essential to leverage and build upon this patent effectively.

FAQs

Q1: What specific chemical structures are protected by U.S. Patent 8,808,740?
The patent protects conjugates consisting of aminoglycosides linked to moieties designed for enhanced bacterial and biofilm penetration, including particular linker chemistries specified within the claims.

Q2: How does this patent differ from prior aminoglycoside patents?
It emphasizes conjugation strategies targeting biofilm disruption and resistance, focusing on delivery enhancements rather than just the antibiotic molecules themselves.

Q3: Can this patent block development of similar conjugates targeting Pseudomonas?
Yes, broad claims covering certain conjugate classes could pose freedom-to-operate challenges; developers should evaluate the exact scope and consider designing around specific claims.

Q4: What is the potential for licensing this patent?
Given its assignment to the University of California, licensing opportunities are available, especially for pharmaceutical companies seeking innovative anti-Pseudomonas therapies.

Q5: Are there any known legal challenges to this patent?
No publicly reported challenges exist; however, validity will depend on ongoing patent examinations and potential future oppositions related to prior art.


Sources

  1. United States Patent and Trademark Office. U.S. Patent No. 8,808,740.
  2. Relevant scientific literature on aminoglycoside conjugates and biofilm treatment strategies.
  3. Industry patent filings related to anti-Pseudomonas agents.

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Drugs Protected by US Patent 8,808,740

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  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 8,808,740

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 3815 ⤷  Get Started Free
Argentina 084575 ⤷  Get Started Free
Australia 2011346757 ⤷  Get Started Free
Australia 2015246094 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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