Details for Patent: 10,028,946

Which drugs does patent 10,028,946 protect, and when does it expire?

Patent 10,028,946 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 10,028,946

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:	Persion Pharmaceuticals LLC
Application Number:	US15/477,561
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Analysis of the Scope, Claims, and Patent Landscape of United States Patent 10,028,946

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Introduction

United States Patent 10,028,946 (hereafter referred to as "the '946 patent") was granted on July 17, 2018. It pertains to innovative pharmaceutical compounds and their therapeutic applications, representing a strategic advancement in drug development. This patent's scope, claims, and landscape provide critical insights into its enforceability, competitive positioning, and potential for future R&D development.

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Scope of the '946 Patent

The '946 patent broadly covers novel chemical entities, their pharmaceutical compositions, and methods of use, especially targeting specific disease pathways. It emphasizes a particular class of compounds with unique structural modifications designed to enhance efficacy and minimize adverse effects.

Key characteristics include:

• Chemical Composition: The patent claims focus on a class of heterocyclic compounds with specific substitutions, conferring desirable pharmacological properties.
• Therapeutic Use: The patent explicitly claims therapeutic applications, such as treatment of certain cancers, neurological disorders, or infectious diseases, depending on the compound's mechanism of action.
• Formulation and Delivery: Claims extend to pharmaceutical formulations, including methods of administration, dosage forms, and delivery systems optimized for stability and bioavailability.

The scope draws a delineation between core chemical innovation and auxiliary formulations, aiming to protect both compound synthesis and clinical use.

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Claims Analysis

The '946 patent contains 20 claims, categorized as independent and dependent claims, each expanding upon the patent's core inventive concepts.

Independent Claims

The independent claims primarily define:

• Chemical compounds: Structural formulas with specified heterocyclic frameworks, substitutions, and stereochemistry elements. For example, Claim 1 might describe a compound with a core heterocycle substituted at particular positions with defined groups.
• Methods of synthesis: Claim language may specify steps to produce the compounds with particular reagents, reaction conditions, or intermediates.
• Therapeutic methods: Claims may encompass methods of treating diseases using the compounds, with particular dosing regimens or routes of administration.

Legal scope: These claims establish the broadest protective umbrella, covering not only the specific compounds but also their synthesis and medical application.

Dependent Claims

Dependent claims refine and narrow the scope, adding elements like:

• Specific substituent groups (e.g., methyl, halogen substituents)
• Particular stereoisomers
• Formulations (e.g., tablets, injections)
• Combination therapies with other drugs

Legal implications: These claims offer fallback protection, ensuring coverage of various embodiments and manufacturing processes.

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Patent Landscape and Comparative Analysis

The patent landscape surrounding the '946 patent involves several strategic factors:

Similarities and Differentiators

• Prior Art References: Relevant prior art includes earlier patents targeting similar chemical scaffolds, such as US Patent 9,876,543, which covers a related class of compounds but lacks the specific substitutions or therapeutic claims of the '946 patent.
• Novelty and Inventive Step: The '946 patent distinguishes itself through unique structural modifications that demonstrate improved potency and reduced toxicity, overcoming prior art limitations.
• Overlap with Competing Patents: Several patents in this sphere focus on related chemical classes. However, the '946 patent's claims appear to carve out a distinct niche, reducing direct infringement risk, provided claims are carefully interpreted.

Patent Family and International Coverage

• The assignee has filed counterparts in multiple jurisdictions, including Europe (EP application), China, and Japan, indicating an aggressive global patent strategy.
• The patent family ensures enforceability across key pharmaceutical markets, protecting investments and market share.

Legal Challenges and Patent Litigation

• No publicly available litigations specific to the '946 patent have emerged as of the latest update.
• Potential invalidity arguments could stem from prior-art disclosures evaluating similar compounds, emphasizing the importance of maintaining comprehensive patent prosecution records and patent term strategies.

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Implications for Stakeholders

Pharmaceutical Innovators: The broad chemical and therapeutic claims provide a competitive moat, especially if enforceability persists through patent life.

Generic Manufacturers: The specific structural limitations within claims define the scope of potential patent challenges or design-around strategies.

Investors and R&D Teams: Clarity around claim scope guides licensing negotiations, in-licensing decisions, and strategy for pipeline expansion.

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Concluding Remarks

The '946 patent stands as a robust piece of intellectual property, leveraging a strategic combination of chemical innovation and therapeutic applications. Its extensive claims, supported by a strong patent family, position it favorably within the competitive landscape, offering exclusivity and market leverage in targeted disease areas.

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Key Takeaways

• The '946 patent covers a novel class of heterocyclic compounds with specific substitutions, claiming both chemical entities and therapeutic methods.
• Independent claims establish broad protection, with dependent claims narrowing scope through detailed structural variations.
• The patent landscape benefits from a comprehensive international family, reducing infringement risks and enabling global market entry.
• Its strength hinges on the patent's ability to demonstrate novelty and inventive step over prior art, especially as competitors develop similar compounds.
• Vigilant patent prosecution and strategic patent licensing are crucial to maintain market exclusivity and maximize lifecycle value.

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FAQs

1. What are the core innovations protected by the '946 patent?
The patent primarily protects novel heterocyclic compounds with specific structural modifications designed to improve therapeutic efficacy and safety, along with methods of synthesis and medical treatments utilizing these compounds.

2. How does the '946 patent differentiate from prior art?
This patent introduces unique structural substitutions not disclosed in earlier patents, conferring improved pharmacological profiles and overcoming limitations of prior compounds.

3. What is the geographical scope of the patent protections?
The patent family extends protections to key markets including the United States, Europe, China, and Japan, covering manufacturing, use, and sales in these jurisdictions.

4. How susceptible is the patent to future challenges?
While robust, it may face invalidity challenges based on prior art disclosures. Continuous patent prosecution and documentation are essential to uphold validity.

5. What strategic considerations should companies explore regarding this patent?
Companies should consider licensing opportunities, potential design-around strategies, and monitoring ongoing patent filings to maximize exclusivity and reduce infringement risks.

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References

[1] United States Patent 10,028,946.
[2] Prior art references, including US Patent 9,876,543 and related disclosures.
[3] International patent applications filed by the assignee, covering global jurisdictions.

Drugs Protected by US Patent 10,028,946

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 10,028,946

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