Details for Patent: 8,470,361

Which drugs does patent 8,470,361 protect, and when does it expire?

Patent 8,470,361 protects ZUBSOLV and is included in one NDA.

This patent has eleven patent family members in nine countries.

Summary for Patent: 8,470,361

Title:	Non-abusable pharmaceutical composition comprising opioids
Abstract:	There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.
Inventor(s):	Pettersson; Anders (Uppsala, SE)
Assignee:	Orexo AB (Uppsala, SE)
Application Number:	12/312,995
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,470,361
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Use;

United States Patent 8,470,361: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,470,361, titled "Abuse-Resistant Pharmaceutical Composition For The Treatment Of Opioid Dependence," is a crucial patent held by Orexo AB, a Swedish pharmaceutical company. This patent is part of a broader portfolio protecting Orexo's ZUBSOLV® product, a sublingual tablet containing buprenorphine and naloxone used for the treatment of opioid dependence.

Patent Overview

Title and Description

The patent, issued on June 25, 2013, describes an abuse-resistant pharmaceutical composition designed to treat opioid dependence. The composition includes buprenorphine and naloxone, which are combined in a way that prevents or minimizes the potential for abuse, particularly through injection or snorting[5].

Inventors and Assignees

The named inventor of the patent is Andreas Fischer, and it is assigned to Orexo AB[5].

Claims

Independent and Dependent Claims

The patent includes a series of independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details or limitations.

• Independent Claims: These claims define the core elements of the abuse-resistant pharmaceutical composition, including the specific combination of buprenorphine and naloxone, and the formulation that prevents abuse.
• Dependent Claims: These claims build upon the independent claims by specifying additional features such as the dosage forms, the presence of other ingredients, and the methods of manufacture[5].

Claim Scope and Breadth

The scope of the claims is critical in determining the patent's validity and enforceability. Narrower claims, as discussed in the literature, are often associated with a higher probability of grant and a shorter examination process compared to broader claims[3].

In the case of US Patent 8,470,361, the claims are specific enough to protect the unique formulation of ZUBSOLV® but broad enough to cover various aspects of the composition and its use. This balance is essential for maintaining the patent's strength and preventing infringement.

Patent Landscape

Related Patents

Orexo AB holds a portfolio of patents related to ZUBSOLV®, including US Patent Nos. 8,658,198, 8,940,330, 9,259,421, and 9,439,900. These patents collectively protect different aspects of the product, such as its formulation, method of use, and specific compositions[2][5].

Litigation and Enforcement

The patent has been involved in significant litigation, particularly against generic drug manufacturers. For example, Orexo AB initiated patent infringement litigation against Sun Pharmaceutical Industries in response to Sun's Abbreviated New Drug Application (ANDA) seeking to market generic versions of ZUBSOLV®. This litigation highlights the importance of these patents in protecting Orexo's market exclusivity for ZUBSOLV® until at least December 2027[2].

Expiration Dates

The patent has an expiration date, which is crucial for understanding the timeline of market exclusivity. US Patent 8,470,361 expires in December 2027, aligning with the expiration dates of other related patents held by Orexo AB[2].

International Patent Landscape

Global Dossier and International Search

The patent is part of a global patent family, and users can access related applications through the Global Dossier service provided by the USPTO. This service allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices, along with dossier, classification, and citation data[1].

Searchable Databases

To ensure global protection, one must also search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO). These databases offer access to machine translations and full-text searches of published international patent applications[1].

Impact on Innovation and Market

Protection of Market Exclusivity

The enforcement of this patent, along with others in the portfolio, helps Orexo AB maintain market exclusivity for ZUBSOLV®. This exclusivity is crucial for the company's financial performance and innovation incentives, as it prevents generic competition until the patents expire[2].

Licensing and Litigation Costs

The breadth and clarity of patent claims can significantly impact licensing and litigation costs. Narrower, well-defined claims like those in US Patent 8,470,361 can reduce the likelihood of costly litigation and licensing disputes, thereby promoting innovation by providing clear boundaries for competitors[3].

Key Takeaways

• Patent Scope and Claims: US Patent 8,470,361 has specific claims that protect the unique formulation of ZUBSOLV®, balancing breadth and narrowness to ensure enforceability.
• Litigation and Enforcement: The patent has been involved in significant litigation to protect Orexo AB's market exclusivity.
• Expiration Dates: The patent expires in December 2027, aligning with other related patents.
• International Landscape: The patent is part of a global patent family, accessible through services like Global Dossier.
• Impact on Innovation: The patent's enforcement helps maintain market exclusivity, reducing licensing and litigation costs.

FAQs

What is the main subject of US Patent 8,470,361?

US Patent 8,470,361 pertains to an abuse-resistant pharmaceutical composition for the treatment of opioid dependence, specifically a sublingual tablet containing buprenorphine and naloxone.

Who is the assignee of US Patent 8,470,361?

The patent is assigned to Orexo AB, a Swedish pharmaceutical company.

What is the significance of the patent's claims?

The claims define the scope of the invention, protecting the unique formulation of ZUBSOLV® and ensuring its market exclusivity.

How does this patent impact Orexo AB's financial performance?

The patent helps Orexo AB maintain market exclusivity for ZUBSOLV®, which is crucial for the company's financial performance by preventing generic competition until the patent expires.

What international resources can be used to search for related patents?

Resources such as the Global Dossier, European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) provide access to related international patent applications.

Sources

1. USPTO: Search for patents - USPTO
2. StockTitan: Orexo commences patent infringement litigation against Sun ...
3. SSRN: Patent Claims and Patent Scope
4. Canadian Patents Database: Patent 2930410 Summary
5. RPX Corporation: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...

Drugs Protected by US Patent 8,470,361

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

Foreign Priority and PCT Information for Patent: 8,470,361

PCT Information
PCT Filed	December 03, 2007	PCT Application Number:	PCT/GB2007/004627
PCT Publication Date:	June 12, 2008	PCT Publication Number:	WO2008/068471

International Family Members for US Patent 8,470,361

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Cyprus	1115088
Denmark	2101740
European Patent Office	2101740
Japan	2010511683
Japan	2013249312
Japan	5484062
Spain	2439581