Details for Patent: 9,492,391

Which drugs does patent 9,492,391 protect, and when does it expire?

Patent 9,492,391 protects HYSINGLA ER and OXYCONTIN and is included in two NDAs.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,492,391

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	McKenna; William H. (Yonkers, NY), Mannion; Richard O. (Furlong, PA), O'Donnell; Edward P. (Basking Ridge, NJ), Huang; Haiyong H. (Princeton, NJ)
Assignee:	PURDUE PHARMA L.P. (Stamford, CT) PURDUE PHARMACEUTICALS L.P. (Wilson, NC)
Application Number:	14/729,626
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,492,391
Patent Claim Types: see list of patent claims	Use; Dosage form; Device;

Analyzing the Scope and Claims of United States Patent 9,492,391

Introduction

United States Patent 9,492,391, hereafter referred to as the '391 patent, is part of a complex patent landscape, particularly in the pharmaceutical industry. This patent, along with others, has been involved in several high-profile litigation cases. Here, we will delve into the details of the patent's scope, claims, and its position within the broader patent landscape.

Patent Overview

The '391 patent is one of the patents asserted by Purdue Pharma and its affiliates in various litigation cases, particularly those related to their product Hysingla® ER (hydrocodone bitartrate)[2][5].

Patent Claims

Patent claims are the heart of any patent, defining the scope of the invention and what is protected by the patent. The '391 patent, like other patents in this series, includes multiple claims that cover various aspects of the invention.

• Independent Claims: These are the broadest claims in a patent and define the overall scope of the invention. For the '391 patent, independent claims typically relate to the composition, method of manufacture, and method of use of hydrocodone bitartrate formulations.
• Dependent Claims: These claims are narrower and build upon the independent claims. They often specify particular embodiments or variations of the invention.

Scope of the Patent

The scope of the '391 patent is determined by its claims and the description provided in the patent specification.

• Composition Claims: These claims cover the specific formulation of hydrocodone bitartrate, including the active ingredient, excipients, and other components.
• Method of Manufacture Claims: These claims describe the processes used to produce the formulation, which can include steps like mixing, granulating, and tablet formation.
• Method of Use Claims: These claims outline the intended use of the formulation, such as the treatment of pain and the dosage regimen.

Patent Landscape

The '391 patent is part of a larger patent family and landscape, particularly in the context of pharmaceuticals.

Related Patents

The '391 patent is often asserted alongside other patents, such as the '412, '413, '389, '390, '380, '236, '779, and '804 patents, in litigation against generic drug manufacturers. These patents collectively cover various aspects of the Hysingla® ER product, including its formulation, manufacturing process, and use[2][5].

Litigation History

The '391 patent has been involved in several legal battles, particularly against companies like Alvogen and Actavis, which have filed Abbreviated New Drug Applications (ANDAs) and Paragraph IV notices challenging the validity and infringement of these patents. These cases highlight the strategic importance of these patents in protecting Purdue Pharma's intellectual property[2][5].

Measuring Patent Scope

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims[3].

• Independent Claim Length: This metric can indicate the complexity and specificity of the claims. Shorter independent claims might suggest a more focused and narrower scope.
• Independent Claim Count: A higher number of independent claims can indicate a broader scope, as it covers more aspects of the invention.

International Patent Landscape

While the '391 patent is a U.S. patent, its relevance extends globally due to the international nature of pharmaceutical patents.

• Global Dossier: This service provided by the USPTO allows users to see the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the global reach and protection of similar inventions[4].
• PATENTSCOPE: This database by WIPO provides access to international Patent Cooperation Treaty (PCT) applications and patent documents from participating national and regional patent offices, facilitating global patent searches[1].

Search and Analysis Tools

Several tools are available for searching and analyzing patents, which can be crucial for understanding the scope and claims of the '391 patent.

• Patent Public Search: This tool by the USPTO provides enhanced access to prior art and is useful for conducting comprehensive patent searches[4].
• Cooperative Patent Classification (CPC): This database helps in finding relevant classification schemes, which can aid in identifying similar patents and understanding the broader patent landscape[1].

Key Takeaways

• Patent Claims: The '391 patent includes independent and dependent claims that define its scope, covering composition, method of manufacture, and method of use.
• Litigation: The patent is part of several high-profile litigation cases, particularly against generic drug manufacturers.
• Patent Scope Metrics: Metrics like independent claim length and count can help in understanding the patent's scope and its implications.
• Global Landscape: The patent's relevance extends globally, with tools like Global Dossier and PATENTSCOPE facilitating international patent searches.

FAQs

1. What is the '391 patent related to? The '391 patent is related to the formulation, manufacture, and use of hydrocodone bitartrate, specifically Purdue Pharma's product Hysingla® ER.

2. How is the scope of a patent measured? The scope of a patent can be measured using metrics such as independent claim length and independent claim count.

3. What tools are available for searching patents globally? Tools like PATENTSCOPE by WIPO and Global Dossier by the USPTO are available for global patent searches.

4. Why is the '391 patent involved in litigation? The '391 patent is involved in litigation as part of Purdue Pharma's efforts to protect its intellectual property against generic drug manufacturers.

5. How can one access the full text of international patent applications? The PATENTSCOPE database by WIPO provides full-text access to international Patent Cooperation Treaty (PCT) applications and other patent documents from participating national and regional patent offices[1].

Sources

1. Clemson University Libraries - Advanced Patent Searching
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Complaint
3. SSRN - Patent Claims and Patent Scope
4. USPTO - Search for Patents
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Declaratory Judgment

Drugs Protected by US Patent 9,492,391

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,492,391

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796
Argentina	109797