Details for Patent: 9,610,286

Which drugs does patent 9,610,286 protect, and when does it expire?

Patent 9,610,286 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,610,286

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):	Hartman; Andrew (Belmont, CA), Rubino; Christopher M. (Williamsville, NY), Robinson; Cynthia Y. (Burlingame, CA)
Assignee:	Pernix Ireland Pain Limited (Dublin, IE)
Application Number:	15/340,502
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

United States Patent 9,610,286: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 9,610,286, assigned to Persion Pharmaceuticals LLC, is a significant patent in the pharmaceutical industry, particularly in the realm of pain management and drug delivery systems. This patent is part of a series of continuations and is crucial for understanding the intellectual property landscape surrounding extended-release pharmaceutical formulations.

Patent Background

The patent in question is a continuation of several earlier applications, highlighting its evolution and the comprehensive nature of the invention. Here is a brief overview of its lineage:

• Continuation History: The patent is a continuation of application No. 15/243,432, filed on August 22, 2016, which itself is a continuation of earlier applications dating back to 2013[2].

Inventors and Assignees

• Inventors: The patent lists Andrew Hartman, Christopher M. Rubino, and Cynthia Y. Robinson as the inventors.
• Assignees: The assignee is Persion Pharmaceuticals LLC, indicating the company's significant investment in this technology[2].

Claims and Scope

Claim Structure

The patent contains multiple claims, each detailing specific aspects of the invention. Here are some key points:

• Independent Claims: These claims define the broadest scope of the invention, often focusing on the overall composition and method of use.
• Dependent Claims: These claims narrow down the scope by adding specific limitations or additional features to the independent claims[2].

Scope Concepts

The claims can be categorized into several scope concepts:

• Extended Release Formulations: The patent primarily deals with extended-release formulations, particularly those designed to manage pain in patients.
• Active Ingredients: The claims specify the use of certain active ingredients, such as hydrocodone, and their combinations with other compounds to achieve extended release profiles.
• Delivery Mechanisms: The invention includes various delivery mechanisms to ensure the controlled release of the active ingredients over a prolonged period[2].

Technical Details

Composition

The patent describes a specific composition for an extended-release capsule, such as Tussicaps® or Hi-Tech Pharma’s oral suspension, designed to treat conditions like cold, flu, allergies, and other breathing illnesses[2].

Dosage and Administration

• Dosing Regimens: The claims outline the dosing regimens, ensuring that the active ingredients are released in a controlled manner to maintain therapeutic levels over an extended period.
• Formulation Variants: The patent includes various formulation variants to accommodate different patient needs and conditions, such as hepatic impairment[5].

Patent Family and Related Patents

Patent Family

The patent is part of a larger patent family, which includes other related patents filed at various stages:

• Related Patents: Patents like 9,421,200, 9,486,451, and 10,322,120 are part of this family, each contributing to the overall intellectual property protection for extended-release pharmaceutical compositions[5].

International Patent Landscape

The invention is also protected internationally through corresponding patents filed in other jurisdictions, which can be accessed through databases like the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO)[1].

Expiration Dates and Maintenance

Patent Expiration

The patent is set to expire on September 12, 2034, which is a critical date for both the assignee and potential competitors[5].

Maintenance and Extensions

The patent may be subject to extensions or adjustments under 35 U.S.C. 154(b), and it includes a terminal disclaimer, which affects its term and enforceability[2].

Impact on the Pharmaceutical Industry

Market Protection

This patent provides significant market protection for Persion Pharmaceuticals LLC, preventing others from manufacturing or selling similar extended-release formulations without permission.

Innovation and Development

The patent encourages innovation by protecting the intellectual property of the inventors, allowing them to invest in further research and development without fear of immediate competition.

Regulatory Compliance

The patent ensures compliance with regulatory requirements, such as those set by the FDA, by detailing specific formulations and dosing regimens that have been approved or are under review[4].

Patent Analytics and Claim Coverage

Claim Coverage Matrix

To fully understand the scope and claims of this patent, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify gaps or opportunities in the intellectual property landscape[3].

Interactive Claim Charts

Using tools like ClaimScape® software, interactive claim charts can be generated to review patent coverage with engineers, scientists, and management. These charts help in determining whether a particular scope concept is applicable to a target product or method[3].

Conclusion

United States Patent 9,610,286 is a pivotal patent in the pharmaceutical industry, particularly in the area of extended-release pain management formulations. Its comprehensive claims and scope protect a significant portion of Persion Pharmaceuticals LLC's intellectual property. Understanding this patent's background, claims, and scope is essential for navigating the complex landscape of pharmaceutical patents.

Key Takeaways

• Patent Lineage: The patent is part of a series of continuations, indicating its evolutionary nature.
• Claims and Scope: The patent includes detailed claims on extended-release formulations and delivery mechanisms.
• Expiration Dates: The patent is set to expire on September 12, 2034.
• Market Impact: The patent provides significant market protection and encourages innovation.
• Regulatory Compliance: The patent ensures compliance with FDA regulations.

FAQs

Q: What is the primary focus of United States Patent 9,610,286? A: The primary focus is on extended-release pharmaceutical formulations, particularly for pain management.

Q: Who are the inventors of this patent? A: The inventors are Andrew Hartman, Christopher M. Rubino, and Cynthia Y. Robinson.

Q: What is the expiration date of this patent? A: The patent is set to expire on September 12, 2034.

Q: How does this patent protect Persion Pharmaceuticals LLC? A: It provides market protection by preventing others from manufacturing or selling similar extended-release formulations without permission.

Q: What tools can be used to analyze the claims and scope of this patent? A: Tools like Claim Coverage Matrix and ClaimScape® software can be used to analyze and visualize the claims and scope.

Sources

1. USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
2. United States Patent - googleapis.com. Retrieved from https://patentimages.storage.googleapis.com/88/57/87/bd60a56e86ab8c/US10456393.pdf
3. Patent Analytics | Intellectual Property Law. Retrieved from https://www.slwip.com/services/patent-analytics/
4. FORM 10-K Pernix Therapeutics Holdings, Inc.. Retrieved from https://www.bsx.com/CompanyDocuments/1099938865/PernixTherapeuticsHoldingsInc_10K_20180308.pdf
5. Generic Zohydro ER Availability - Drugs.com. Retrieved from https://www.drugs.com/availability/generic-zohydro-er.html

Drugs Protected by US Patent 9,610,286

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	9,610,286					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	9,610,286					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	9,610,286					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	9,610,286					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	9,610,286					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 9,610,286

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