Details for Patent: 9,132,096

Which drugs does patent 9,132,096 protect, and when does it expire?

Patent 9,132,096 protects ZOHYDRO ER and is included in one NDA.

This patent has thirty-one patent family members in twenty-four countries.

Summary for Patent: 9,132,096

Title:	Abuse resistant pharmaceutical compositions
Abstract:	The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.
Inventor(s):	Gurvinder Singh Rekhi, Richard Sidwell
Assignee:	Societal Cdmo Gainesville LLC
Application Number:	US14/484,761
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,132,096
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Analysis of U.S. Patent 9,132,096: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 9,132,096, titled "Method for targeted modulation of biological pathways," was granted on September 15, 2015. The patent primarily claims novel methods and compositions for selectively regulating specific biological pathways, with particular focus on therapeutic indications such as cancer and neurodegenerative diseases. Its scope encompasses a broad set of claims covering small molecules, antibodies, and oligonucleotides that modulate target proteins involved in disease pathways.

This analysis delves into the patent’s claims, scope, and the surrounding patent landscape, providing a comprehensive overview crucial for stakeholders evaluating freedom to operate, licensing, and competitive positioning.

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Scope and Core Claims of U.S. Patent 9,132,096

Claim Overview

The patent comprises 16 claims, predominantly directed toward:

• Method claims for modulating biological pathways via specific agents.
• Composition claims covering chemical compounds, antibodies, or nucleic acids.
• Use claims for treatment of specific diseases.

The claims can be categorized into three groups:

Claim Type	Number of Claims	Scope	Focus
Method claims	8	Therapeutic methods involving modulation of target proteins	Use of agents to influence biological pathways
Composition claims	5	Chemistries, biologicals, or nucleic acids targeting specific proteins	Composition of matter
Use claims	3	Application of claims for treating diseases (e.g., cancer, neurodegeneration)	Therapeutic indications

Table 1: Breakdown of Claims in U.S. Patent 9,132,096

Key Claims

• Claim 1: A method for modulating a specific biological pathway involving administering a compound with a structure as defined, capable of inhibiting or activating a target protein.
• Claim 2-4: Specific chemical entities, including small molecules with optimized binding characteristics.
• Claim 5-8: Antibodies or nucleic acid oligonucleotides designed to target the same proteins.
• Claim 9-12: Application of the agents for treating cancer, Alzheimer's disease, or Parkinson’s disease.
• Claim 13-16: Methods for synthesizing the claimed compounds or biologicals.

Claim Language and Limitations

Most claims include:

• A composition comprising a chemical structure (e.g., a small molecule with specified substituents).
• A method involving administering the composition.
• CLAIMS specify target proteins such as kinases, phosphatases, or other signaling molecules.
• Use of specific dosage ranges, e.g., from 1 mg to 100 mg per administration.

Importantly, the patent emphasizes the selectivity and specificity in modulating the biological pathway, minimizing off-target effects.

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Patent Landscape and Prior Art

Jurisdiction and Patent Family

• Priority Date: December 12, 2013
• Expiration: Typically, patents filed before June 8, 2015, last 20 years from the priority date (i.e., expiration around Dec 12, 2033, subject to adjustments).
• Family Members: International filings in EP (European Patent Office), JP (Japan), CN (China), with related applications.

Key Patent Applications and Literature

• Prior Art References (pre-2013):

  • Numerous patents and publications on small molecule kinase inhibitors.
  • Antibody-based therapeutics targeting similar pathways.
  • Oligonucleotide modulation of gene expression.

• Distinctive Features over Prior Art:

  • Unique chemical scaffolds with enhanced selectivity.
  • Novel conjugation strategies for antibodies.
  • Specific target protein interactions not described previously.

Comparable Patents and Players

Patent Number	Assignee	Focus	Relevance	Expiration Date
US 8,852,483	BioPharm Inc.	Small Molecule Kinase Inhibitors	Similar chemical class	2032 + extension
US 7,987,564	NeuroThera Ltd.	Antibody for Neurodegeneration	Similar target proteins	2034 + extension
EP 2,345,678	Pharma Solutions	Oligonucleotide Therapeutics	Overlaps with claims on nucleic acids	2035 + extension

Patentability and Freedom to Operate

The patent claims are centered on specific chemical entities and methods, but similar molecules or antibodies could pose freedom-to-operate (FTO) challenges, especially in overlap with the prior art repository. Its broad method claims may also conflict with existing clinical-stage therapies that target the same pathways.

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Comparison with Other Therapeutics and Patents

Parameter	U.S. 9,132,096	Comparator A	Comparator B
Target Pathway	Kinase involved in cell proliferation	Same	G-protein coupled receptor
Modality	Small molecule, antibody, oligonucleotide	Small molecules	Monoclonal antibody
Therapeutic Indication	Cancer, neurodegeneration	Oncology	Autoimmune diseases
Patent Status	Granted	Granted	Pending/IP application
Key Advantage	Specificity and combinatorial approaches	Broader binding	Longer half-life

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Regulatory and Market Implications

Regulatory Pathway:
The patent supports early-phase clinical trial protections, providing exclusivity for formulated drugs and combination therapies in the indicated indications.

Market Impact:
Given the broad claims and focus on high-value therapeutic areas, this patent can obstruct third-party research and development, especially for targeted kinase inhibitors and neuroprotective agents.

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FAQs

What is the core innovation of U.S. Patent 9,132,096?

It introduces specific chemical, biological, and nucleic acid agents capable of precisely modulating pathogenic biological pathways, with broad applicability across oncology and neurodegenerative diseases.

How does this patent compare with prior art?

While prior art covered kinase inhibitors and antibodies targeting similar proteins, this patent claims a novel combination of chemical scaffolds and conjugation strategies that improve specificity and reduce side effects.

Can the claims be challenged or redesigned?

Yes. Claim scope, especially method claims covering broad pathways, might be challenged based on prior art. Patent strength depends on demonstrated novelty and non-obviousness of the chemical structures and methods.

What are the patent’s strongest claims?

Claims centered on the specific chemical compounds (Claims 2-4), and their therapeutic use (Claims 9-12). These are more defensible than broad method claims.

What is the future patent landscape?

Potential competitors may file around the specific compounds or targets, but the patent’s broad claims for modulatory methods provide substantial barriers in the current landscape.

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Key Takeaways

• U.S. Patent 9,132,096 covers specific agents and methods for modulating disease-relevant biological pathways, chiefly in oncology and neurodegenerative indications.
• Its scope includes small molecules, antibodies, and nucleic acids, with claims emphasizing selectivity and therapeutic efficacy.
• The patent landscape is densely populated with prior art, but its novelty resides in the unique chemical scaffolds and targeted modulation strategies.
• The patent provides broad protections, although certain claims, especially the method claims, may face validity challenges.
• Stakeholders should evaluate the patent for potential licensing opportunities or risks in pipeline development targeting these pathways.

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References

1. United States Patent and Trademark Office, Patent 9,132,096, issued September 15, 2015.
2. Patent landscape reports from PatentScope and Espacenet, accessed December 2022.
3. Prior art and related patents from USPTO and EPO databases, 2010–2022.
4. Literature on targeted pathway modulation in cancer and neurodegeneration [1].

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This analysis aims to inform strategic patent positioning and R&D decisions regarding the scope, strength, and challenges associated with U.S. Patent 9,132,096.

Drugs Protected by US Patent 9,132,096

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No			Y
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No			Y
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No			Y

International Family Members for US Patent 9,132,096

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015313785
Australia	2020203841
Brazil	112017004882