Details for Patent: 8,741,885

Which drugs does patent 8,741,885 protect, and when does it expire?

Patent 8,741,885 protects XARTEMIS XR and is included in one NDA.

Summary for Patent: 8,741,885

Title:	Gastric retentive extended release pharmaceutical compositions
Abstract:	The present disclosure provides extended release pharmaceutical compositions comprising an opioid and an additional active pharmaceutical ingredient, wherein the composition exhibits gastric retentive properties which are achieved by a combination of a physical property of the composition and release of the opioid, wherein upon administration to a subject, the composition has at least one pharmacokinetic parameter that differs by less than about 30% when the subject is in a fasted state as compared to a fed state.
Inventor(s):	Devarakonda; Krishna (St. Louis, MO), Guiliani; Michael J (Creve Coeur, MO), Gupta; Vishal K (Hillsborough, NJ), Heasley; Ralph A (Webster Groves, MO), Shelby; Susan (Creve Coeur, MO)
Assignee:	Mallinckrodt LLC (Hazelwood, MO)
Application Number:	13/473,571
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,741,885
Patent Claim Types: see list of patent claims	Composition; Compound; Formulation; Process; Dosage form; Use;

Analyzing the Scope and Claims of United States Patent 8,741,885

Introduction

United States Patent 8,741,885, titled "Gastric Retentive Extended Release Pharmaceutical Compositions," is a patent that has been at the center of significant legal and pharmaceutical discussions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Patent Number and Issue Date

• The patent number is 8,741,885, and it was issued on June 3, 2014[5].

Application Number and Filing Date

• The application number is 13/473,571, and it was filed on May 16, 2012[5].

Scope of the Patent

Invention Description

• The patent pertains to gastric retentive extended release pharmaceutical compositions. These compositions are designed to remain in the stomach for an extended period, ensuring a controlled release of the active pharmaceutical ingredient. This technology is crucial for improving the bioavailability and efficacy of certain drugs.

Technical Details

• The patent describes specific formulations and methods for preparing these compositions. It includes details on the types of polymers, excipients, and other components used to achieve the desired gastric retention and release profile.

Claims of the Patent

Independent and Dependent Claims

• The patent includes a set 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 additional limitations[3].

Claim Examples

• For instance, Claim 1 might describe a general formulation of a gastric retentive composition, while Claim 2 might specify a particular type of polymer used in the composition. Understanding these claims is essential for determining what is protected under the patent.

Patent Claims Research Dataset

• The USPTO's Patent Claims Research Dataset can provide detailed insights into the claims of this patent. This dataset includes parsed claims text and claim-level statistics, which can help in analyzing the scope and dependency relationships between claims[3].

Legal and Litigation Context

Patent Infringement Litigation

• The patent has been involved in significant litigation, particularly in the case of Mallinckrodt LLC vs. Actavis Laboratories FL, Inc. Actavis had filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of the pharmaceutical product covered by this patent, leading to allegations of patent infringement[2].

Court Rulings and Jurisdiction

• The litigation highlighted the importance of jurisdiction and venue in patent cases. The court had subject matter jurisdiction over the action under 28 U.S.C. §§ 1331 and 1338(a), and personal jurisdiction over Actavis due to its corporate presence and business activities in New Jersey[2].

Patent Landscape and Global Context

International Patent Offices

• To understand the global patent landscape, it is crucial to search databases from other international intellectual property offices. Resources like the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) provide access to international patent databases and machine translations, which can help in identifying similar or related patents worldwide[1].

Global Dossier and Common Citation Document

• Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search for related applications and prior art across multiple patent offices. These tools are essential for ensuring that the patent does not infringe on existing patents globally[1].

Maintenance Fees and Patent Life

Maintenance Fees

• To keep the patent in force, the patent holder must pay maintenance fees at specified intervals. For U.S. Patent 8,741,885, these fees are due at 3.5, 7.5, and 11.5 years after the issue date[5].

Patent Life and Expiration

• The patent will expire 20 years from the filing date of the application, which is May 16, 2032, assuming all maintenance fees are paid[5].

Key Takeaways

• Patent Scope and Claims: Understanding the specific claims and scope of U.S. Patent 8,741,885 is crucial for determining what is protected and what might infringe on the patent.
• Legal Context: The patent has been involved in significant litigation, highlighting the importance of jurisdiction and the need to defend against infringement.
• Global Patent Landscape: Searching international patent databases and using tools like the Global Dossier and CCD are essential for ensuring global compliance.
• Maintenance Fees: Regular payment of maintenance fees is necessary to keep the patent in force.

FAQs

1. What is the title of U.S. Patent 8,741,885?

   • The title is "Gastric Retentive Extended Release Pharmaceutical Compositions."

2. When was U.S. Patent 8,741,885 issued?

   • It was issued on June 3, 2014.

3. What is the application number for U.S. Patent 8,741,885?

   • The application number is 13/473,571.

4. Why is the Global Dossier important in patent searching?

   • The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping users identify related applications and prior art globally.

5. How can one ensure that a new pharmaceutical composition does not infringe on U.S. Patent 8,741,885?

   • Conduct a thorough search using resources like the Patent Public Search tool, Global Dossier, and international patent databases to identify any overlapping claims or prior art.

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. PATUNAS LAW LLC - Litigation Document
   • https://insight.rpxcorp.com/litigation_documents/12463585
3. USPTO - Patent Claims Research Dataset
   • https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. U.S. Department of Commerce - U.S. Patent and Trademark Office
   • https://www.commerce.gov/bureaus-and-offices/uspto
5. USPTO Fee Processing - Maintenance Fee Details
   • https://fees.uspto.gov/MaintenanceFees/fees/details?patentNumber=8741885&applicationNumber=13473571

Drugs Protected by US Patent 8,741,885

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,741,885		Y			MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA