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):	Hartman; Andrew (Belmont, CA), Rubino; Christopher M. (Williamsville, NY), Robinson; Cynthia Y. (Burlingame, CA)
Assignee:	Pernix Ireland Pain Designated Activity Company (Dublin, IE)
Application Number:	15/477,561
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

United States Patent 10,028,946: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 10,028,946, hereafter referred to as the '946 patent, is a significant patent in the pharmaceutical sector, particularly involving methods of administering extended-release hydrocodone bitartrate. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background and Assignees

The '946 patent was originally assigned to Daravita Limited and later transferred to Recro Gainesville LLC. The patent is part of a series of patents listed in the Orange Book, which are crucial for the approval and marketing of generic drugs[5].

Claims and Scope

Claim Structure

The '946 patent includes several claims, with a focus on methods of administering extended-release hydrocodone bitartrate to subjects, particularly those with hepatic impairment. Claim 1, for example, outlines specific pharmacokinetic limitations that the method must satisfy to be considered within the scope of the patent[5].

Pharmacokinetic Limitations

The claims are directed towards ensuring that the extended-release formulation of hydrocodone bitartrate meets certain pharmacokinetic parameters. This includes maintaining specific plasma concentration levels over a defined period, which is critical for the efficacy and safety of the drug in patients with hepatic impairment[5].

Infringement and Validity

In a significant legal battle, Alvogen's proposed generic product was found to infringe the '946 patent's claims due to its satisfaction of the pharmacokinetic limitations. However, the district court also ruled that the patents were invalid, a decision that was appealed by Pernix, the subsequent owner of the patents[5].

Patent Landscape

Orange Book Listings

The '946 patent is listed in the Orange Book, a catalog of approved drugs and their associated patents. This listing is crucial for generic drug manufacturers, as it informs them of the patents they must certify against when seeking FDA approval for their generic versions[5].

Litigation and Settlements

The patent has been at the center of several legal disputes. Daravita Limited initially sued Alvogen for infringement, leading to a settlement that allowed Alvogen to market its generic product. Subsequent litigation between Alvogen and Pernix further highlighted the complexities and challenges associated with patent validity and infringement in the pharmaceutical sector[5].

Patent Scope Metrics

Independent Claim Length and Count

Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and validity. While the '946 patent's claims are not explicitly analyzed in such studies, the general trend indicates that narrower claims, as seen in this patent, are often associated with higher probabilities of grant and shorter examination processes[3].

Examination Process

Narrowing of Claims

The examination process for patents like the '946 patent often results in the narrowing of claims to ensure clarity and validity. This process can significantly impact the scope of the patent, making it more specific and less prone to challenges of obviousness or invalidity[3].

Global Dossier and Prior Art

Access to Related Applications

Tools like the Global Dossier and Common Citation Document (CCD) provide access to the file histories and prior art citations of related patent applications. These resources are essential for understanding the broader patent landscape and ensuring that new patents do not infringe on existing ones. For the '946 patent, such tools would help in identifying any prior art or related applications that could impact its validity or scope[4].

Public Search and Resource Centers

USPTO Resources

The USPTO offers various resources, including the Patent Public Search tool and Patent and Trademark Resource Centers (PTRCs), which can be used to conduct thorough searches for prior art and related patents. These resources are vital for patent attorneys and inventors to ensure that their patents are novel and non-obvious[4].

Legal and Policy Considerations

Small Claims Patent Court

The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could potentially impact the litigation landscape for patents like the '946 patent. Such a court would provide a more streamlined and cost-effective way to resolve patent disputes, which could be beneficial for smaller entities involved in pharmaceutical patent litigation[2].

Obviousness-Type Double Patenting (ODP)

Relevance to Patent Term

The issue of ODP, as seen in cases like In re Cellect, highlights the importance of ensuring that patents do not extend beyond their rightful term. This is particularly relevant in the pharmaceutical sector, where patent term adjustments and terminal disclaimers can significantly impact the market exclusivity period[1].

Key Takeaways

• The '946 patent is crucial for the administration of extended-release hydrocodone bitartrate, particularly in patients with hepatic impairment.
• The patent's claims are specific and directed towards maintaining certain pharmacokinetic parameters.
• The patent has been involved in significant litigation, highlighting the complexities of patent infringement and validity in the pharmaceutical sector.
• Tools like the Global Dossier and CCD are essential for understanding the broader patent landscape.
• The concept of a small claims patent court could streamline patent dispute resolution.

FAQs

What is the main focus of the '946 patent?

The '946 patent focuses on methods of administering extended-release hydrocodone bitartrate, particularly to subjects with hepatic impairment.

Why is the Orange Book listing important for this patent?

The Orange Book listing informs generic drug manufacturers of the patents they must certify against when seeking FDA approval, which is crucial for market entry.

What were the outcomes of the litigation involving the '946 patent?

The litigation resulted in findings of infringement by Alvogen's generic product, but the patents were also ruled invalid by the district court. The decision was appealed by Pernix.

How do tools like the Global Dossier impact patent searches?

Tools like the Global Dossier provide access to file histories and prior art citations of related patent applications, helping to ensure that new patents do not infringe on existing ones.

What is the relevance of ODP to the '946 patent?

ODP is relevant in ensuring that patents do not extend beyond their rightful term, which can impact market exclusivity periods, although it is not directly applicable to the '946 patent's current status.

Cited Sources

1. In re Cellect - United States Court of Appeals for the Federal Circuit, August 28, 2023.
2. U.S. Patent Small Claims Court - Administrative Conference of the United States.
3. Patent Claims and Patent Scope - SSRN, September 29, 2016.
4. Search for patents - USPTO - United States Patent and Trademark Office.
5. Division of Dockets Management (HFA-305), Food and Drug Administration - October 7, 2019.

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

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