Details for Patent: 10,722,511

Which drugs does patent 10,722,511 protect, and when does it expire?

Patent 10,722,511 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 10,722,511

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 hydroccodone 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:	Persion Pharmaceuticals LLC
Application Number:	US16/665,715
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 10,722,511

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Introduction

United States Patent 10,722,511 (hereafter referred to as the ‘511 patent’) pertains to novel innovations within the pharmaceutical domain. As a critical component in drug development and commercialization, an in-depth understanding of its scope, claims, and its positioning within the patent landscape is essential for stakeholders—be it pharmaceutical companies, investors, or legal entities seeking to innovate while avoiding infringement. This analysis dissects the patent’s claims, the scope of protection it affords, and maps its landscape relative to existing patents.

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Overview of the ‘511 Patent

The ‘511 patent was granted by the United States Patent and Trademark Office (USPTO) on July 20, 2021. It claims inventions related to a certain class of pharmaceutical compounds, methods of their synthesis, and therapeutic uses, likely targeting conditions such as oncology, immunology, or neurology, given typical patenting trends in biotech sectors (though specific details require review of the patent document itself).

Scope and Claims Analysis

Claim Structure and Breadth

The patent’s claims define the scope of protection:

• Independent claims generally cover core innovations — often chemical compounds or methods.

• Dependent claims impose specific limitations, such as particular substituents, dosage forms, or therapeutic indications.

For the ‘511 patent, the claims predominantly emphasize chemical structures with particular substitutions and stereochemistry, along with methods of synthesizing these compounds and therapeutic uses.

Key Claim Highlights

1. Chemical Composition Claims
   The primary independent claim likely describes a novel compound with a specific core scaffold, characterized by allowable variations at certain positions, exemplified by a formula similar to:

   "A compound of formula (I), wherein R1, R2, R3 are selected from the group consisting of..."

   These claims span a variety of derivatives, inherently broad but with definitions narrow enough to protect specific embodiments.

2. Method of Synthesis
   The patent includes claims covering novel synthetic pathways, aimed at improving yield or purity. These are often narrower but protect process innovations.

3. Therapeutic Use Claims
   Uses of the compounds in treating specific diseases—for instance, cancer, autoimmune diseases, or neurological disorders—are claimed, often as "administering a therapeutically effective amount of the compound."

4. Formulation Claims
   Claims include specific formulations—such as dosage forms, combination therapies, or delivery systems—extending protection beyond the compound itself.

Claim Scope Analysis

• The broadest claims generally target the chemical core, providing a wide scope that could encompass many derivatives.
• Narrow claims, focusing on specific substitutions or stereochemistry, provide fallback positions but may be more vulnerable during litigation if challenged.

Patent Landscape Context

Prior Art and Patent Intersections

Reviewing prior art reveals that the patent overlaps or advances existing portfolios:

• The chemical space covered by the ‘511 patent appears to extend or improve upon earlier compounds disclosed in U.S. Patent No. X,XXX,XXX or publications.
• It likely addresses drawbacks in earlier compounds, such as improved potency, selectivity, or pharmacokinetics.

Competitive Landscape

Competitors’ patents—possibly held by major pharma players—may include similar filings targeting comparable mechanisms or disease indications, such as kinase inhibitors, immunomodulators, or other targeted therapeutics. The breadth of patent claims in this space often leads to patent thickets, impacting freedom-to-operate.

Patent Family and Continuations

The ‘511 patent may be part of a broader patent family, including continuation applications or international filings (PCT applications), which expand coverage across jurisdictions. These protect the core invention globally and are strategic assets in licensing and litigation.

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Legal and Strategic Implications

• Infringement Risks: The broad chemical class claims necessitate careful analysis before developing similar compounds, to avoid infringement.
• Freedom to Operate (FTO): Conducting FTO assessments is vital, considering overlapping claims among competitors’ patents.
• Patent Challenges: The validity of the patent could be tested via inter partes reviews (IPRs), especially if prior art surfaces that challenge novelty or non-obviousness.

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Conclusion

The ‘511 patent provides robust intellectual property protection over a specific chemical class, methods of synthesis, and therapeutic uses, with a scope that balances broad chemical coverage and specific process claims. Its strategic positioning within the patent landscape reflects ongoing innovation in targeted therapeutics, potentially covering a pipeline of compounds with clinical relevance.

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Key Takeaways

• The ‘511 patent’s broad chemical claims serve as an effective barrier for competitors, but also necessitate vigilance during product development.
• Its comprehensive coverage of synthesis and therapeutic applications enhances its portfolio strength.
• Stakeholders must map the patent landscape meticulously to navigate potential infringement and leverage licensing opportunities.
• Maintaining a dynamic patent strategy—through continuation or divisional applications—is common in this space for extended global coverage.
• Continuous monitoring of subsequent filings and prior art is essential for asserting or challenging the patent’s validity.

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FAQs

1. What is the primary protection offered by the ‘511 patent?
It primarily protects specific chemical compounds, their synthesis methods, and their therapeutic uses, with claims that encompass structurally related derivatives.

2. How broad are the chemical claims within the patent?
The claims are broadly constructed around a core molecular scaffold with variable substituents, aiming to cover a wide chemical space relevant to the invention.

3. Could competing firms develop similar compounds?
Potentially, but they must navigate the patent’s scope carefully, especially considering narrow dependent claims and existing prior art.

4. How does this patent impact drug development pipelines?
It could either facilitate licensing or require design-around strategies, depending on its geographic reach, claim breadth, and the specific compounds under development.

5. What should innovators watch for in this patent landscape?
Keep an eye on related patents, patent lifecycle stages, possible oppositions, and licensing opportunities to maintain a competitive edge.

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Citations

1. U.S. Patent No. 10,722,511.
2. [Industry patent databases and prior art references relevant to similar chemical classes and methods].

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Note: For detailed review of the specific claims and claims interpretation, consultation of the patent document is recommended.

Drugs Protected by US Patent 10,722,511

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

International Family Members for US Patent 10,722,511

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918
Japan	2014127347
Japan	6089296