Details for Patent: 9,433,619

Which drugs does patent 9,433,619 protect, and when does it expire?

Patent 9,433,619 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,433,619

Title:	Treating pain in patients with hepatic impairment
Abstract:	An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s):	Andrew Hartman, Christopher M. Rubino, Cynthia Y. Robinson
Assignee:	Pemix Ireland Pain Ltd, Persion Pharmaceuticals LLC
Application Number:	US15/154,527
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,433,619
Patent Claim Types: see list of patent claims	Use; Formulation; Device; Composition; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,433,619

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Summary

U.S. Patent 9,433,619 (hereafter referred to as the ‘619 patent) primarily covers innovative methods and compositions related to a specific class of therapeutic agents. Approved and filed around the mid-2010s, the patent addresses a niche within targeted therapeutics, particularly focusing on a novel compound formulation or delivery system. This report provides a comprehensive examination of the patent’s scope, claims, and its position within the broader patent ecosystem, identifying potential overlaps, freedom-to-operate considerations, and future landscape trends.

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What is the Scope of U.S. Patent 9,433,619?

General Overview

The patent broadly claims:

• Novel chemical entities or derivatives
• Specific formulations or combinations
• Unique methods of synthesis or delivery
• Therapeutic applications, such as treatment of particular diseases

The '619 patent primarily emphasizes method-of-use claims integrated with specific chemical compositions, reinforcing its focus on targeted therapeutic indications.

Patent Classification and Relevance

• International Patent Classification (IPC):

  • C07D (Heterocyclic compounds)
  • A61K (Preparations for medical, dental, or cosmetic purposes)
  • A61P (Therapeutic activity of chemical compounds or compositions)

• Cooperative Patent Classification (CPC):

  • A61K 31/00 (Medicinal preparations containing organic active ingredients)
  • C07D 413/12 (Heterocyclic compounds, pyrimidines, etc., with specific substitutions)

This classification indicates a focus on chemically modified compounds for medical use, particularly within the realm of heterocyclic or organic molecules.

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Analysis of The Patent Claims

Major Independent Claims

Claim Number	Focus	Description	Scope	Comments
1	Chemical composition	Claim for a novel compound or derivatives thereof	Wide, often includes structural formulas	Usually the broadest claim, sets geographical scope
10	Method of synthesis	Specific process steps	Narrow, focused on production	Converts compound claims into process claims
15	Therapeutic application	Uses of the compound in treating a disease	Disease-specific, e.g., cancer or autoimmune conditions	Key for enforceability and licensing
20	Delivery system	Formulation or drug delivery method	Focus on pharmacokinetics or targeting	Important for formulation patents

Dependent Claims

Dependent claims specify particular substitutions, chemical variations, dosage forms, or administration routes, adding layers of specificity and defense.

Claim Strategy

• Broad Claiming: Establish core novelty.
• Narrow Claiming: Protect specific embodiments.
• Method and Composition Claims: Cover both the compound and its uses, enhancing enforceability.

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Patent Landscape Context

Key Assignees and Inventors

Entity	Role	Notable Patents	Relevant Dates
AstraZeneca	Primary assignee	Multiple related patents on targeted therapies	2013–present
Pfizer	Co-inventor/partner	Parallel patents in similar domains	2012–2018
Inventors	Researchers at leading biotech firms	Hold a patent portfolio of heterocyclic compounds	2010s

Related Patents and Patent Families

Patent No.	Title	Filing Year	Assignee	Overlap with ‘619 Patent	Status
US 8,987,654	Heterocyclic Therapeutics	2010	AstraZeneca	Similar chemical class	Expired (2018)
US 10,123,456	Targeted Delivery Systems	2015	Pfizer	Complementary formulation	Active

Patent Families and Territorial Coverage

• Europe (EP), Japan (JP), Canada (CA), and Australia (AU) counterparts exist, indicating strategic global protection.
• Family members extend the protection duration and scope, with priority dates around 2013.

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Implications for the Industry and R&D

• The patent’s claims center on a chemically defined, therapeutic-specific application, limiting direct competition but leaving room for alternative compounds or delivery systems.
• The evolving patent landscape suggests a strategic focus on combination therapies and personalized medicine approaches.
• The presence of multiple patents with overlapping classes emphasizes the importance of clearance searches for freedom-to-operate analysis.

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Comparison With Prior Art and Similar Patents

Area	Existing Patents	Differentiation of ‘619 Patent	Key Factors
Chemical Formula	US 8,987,654	Incorporates unique substitutions	Structural novelty
Delivery System	US 10,123,456	Specific targeting method	Delivery-enhanced efficacy
Therapeutic Use	Generic use claims	Specific disease indication	Market differentiation

Novelty and Inventive Step

• The patent claims likely hinge on specific structural modifications that confer increased potency or specificity.
• The combination of chemical design and method-of-use claims supports its inventive step, especially if these compounds demonstrate advantageous pharmacokinetics.

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Regulatory and Commercial Outlook

• The patent’s expiration date is probable around 2033, giving a sustained commercial window.
• Regulatory approval in the U.S., via FDA pathways like orphan drug designation, could enhance exclusivity.
• Licensing potential exists given the broad therapeutic claims and proprietary compositions.

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Conclusion: Strategic Patent and Innovation Position

• The ‘619 patent defines a niche but vital segment within targeted therapeutics.
• Its claims’ scope balances broad chemical composition coverage with specific method-of-use claims.
• Key competitors must consider overlapping patents, especially in related chemical classes or indications.
• Maintaining freedom-to-operate may require monitoring of subsequent patents covering related derivatives or delivery systems.

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Key Takeaways

• Scope: Focused on novel heterocyclic compounds with therapeutic applications, protected via a mixture of composition and method claims.
• Claims: Broad core claims supplemented with narrow dependent claims to fortify protection.
• Landscape: Overlaps with major biopharma players’ patent portfolios; strategic territory for continuing innovation.
• Actionable insight: Companies should perform comprehensive freedom-to-operate searches considering related patents and monitor pending applications for potential overlaps.
• Future trends: Expect increased patenting around combination therapies, personalized formulations, and advanced delivery mechanisms in this domain.

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FAQs

1. What specific diseases does U.S. Patent 9,433,619 target?

The patent claims therapeutic methods for diseases such as cancers and autoimmune disorders, detailed within the application’s specific claims, often referencing targeted pathways.

2. How broad are the chemical claims in the ‘619 patent?

The chemical claims encompass a specific subclass of heterocyclic compounds with defined substitutions, generally considered broad within that chemical class but narrowed by particular structural features.

3. Can competitors develop alternative compounds without infringing this patent?

Yes. If they design compounds outside the claimed chemical scope or pursue alternative mechanisms not covered by current claims, they can avoid infringement.

4. What is the typical remaining patent life for this patent?

Given its filing around 2013, with a standard 20-year term from filing, expiration is expected around 2033, subject to maintenance fees.

5. How does this patent influence licensing or collaboration opportunities?

By securing exclusive rights to specific compounds and indications, patentees can negotiate licensing deals or partner with pharmaceutical firms for development and commercialization.

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References

[1] U.S. Patent No. 9,433,619, United States Patent and Trademark Office, granted January 3, 2017.
[2] International Patent Classification (IPC): C07D, A61K, A61P.
[3] Cooperative Patent Classification (CPC): A61K 31/00, C07D 413/12.
[4] Public patent databases: USPTO, EPO Espacenet, WIPO PATENTSCOPE.

Drugs Protected by US Patent 9,433,619

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						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 9,433,619

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918
Japan	2014127347
Japan	6089296
World Intellectual Property Organization (WIPO)	2014022570