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Last Updated: December 22, 2024

Details for Patent: 8,658,631


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Which drugs does patent 8,658,631 protect, and when does it expire?

Patent 8,658,631 protects XARTEMIS XR and is included in one NDA.

This patent has expired prematurely due to non-payment of maintenance fees. See details below.

Summary for Patent: 8,658,631
Title:Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Abstract: The present disclosure provides an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.
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:13/473,563
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,658,631
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form; Use;
Patent landscape, scope, and claims:

United States Patent 8,658,631: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,658,631, hereafter referred to as the '631 patent, is a significant intellectual property asset that has been involved in various legal and commercial activities. This article provides a comprehensive analysis of the scope, claims, and the broader patent landscape surrounding this patent.

Background of the Patent

The '631 patent was granted to Mallinckrodt Inc. and Mallinckrodt LLC, and it is part of a series of patents related to pharmaceutical products. The patent involves specific formulations and methods related to the manufacture and use of certain drugs[2].

Scope of the Patent

The scope of the '631 patent is defined by its claims, which outline the specific inventions and innovations protected under the patent. Here are some key aspects of the scope:

Claims

The '631 patent includes 30 claims that detail the specific elements of the invention. These claims cover various aspects such as the composition of the pharmaceutical formulation, the method of preparation, and the use of the formulation for therapeutic purposes. The claims are structured to provide broad protection while also being specific enough to distinguish the invention from prior art[5].

Subject Matter

The patent pertains to a specific pharmaceutical formulation, which is a critical aspect of its scope. This formulation is designed to address particular therapeutic needs, and the patent protects the unique combination and method of delivery of the active ingredients.

Claims Analysis

Independent Claims

Independent claims in the '631 patent define the core inventions and are not dependent on other claims. These claims typically describe the overall structure and function of the pharmaceutical formulation.

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or variations of the invention. These claims help to further define the scope by specifying additional features or limitations.

Claim Dependency

The dependency relationship between claims is crucial for understanding the full scope of the patent. The Patent Claims Research Dataset by the USPTO provides tools to analyze such dependencies, which can help in interpreting the patent's breadth and depth[3].

Patent Landscape

Related Patents

The '631 patent is part of a larger family of patents owned by Mallinckrodt Inc. and Mallinckrodt LLC. These related patents cover various aspects of pharmaceutical formulations, manufacturing processes, and therapeutic uses. Understanding the patent family is essential for comprehending the overall intellectual property strategy and the competitive landscape.

Global Dossier

The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including all related applications filed at participating IP Offices. This service is particularly useful for analyzing the global reach and protection of the '631 patent and its related patents[1].

Litigation History

The '631 patent has been involved in several litigation cases, particularly against generic pharmaceutical manufacturers. For instance, Actavis Laboratories FL, Inc. was accused of infringing this patent, leading to significant legal battles. The litigation history provides insights into the patent's enforcement and the challenges faced by the patent holders[2].

Economic and Legal Implications

Patent Infringement Litigation

The increase in patent infringement lawsuits, as noted by the GAO report, has significant implications for patents like the '631 patent. The Leahy-Smith America Invents Act (AIA) introduced changes that affected the number of defendants in lawsuits, which in turn influenced the litigation landscape for pharmaceutical patents[4].

Patent Quality and AIA Proceedings

The USPTO has taken steps to improve patent quality and implement new AIA proceedings, which can impact the validity and enforceability of patents like the '631 patent. These initiatives aim to ensure that patents are robust and defensible, reducing the likelihood of successful challenges[4].

Industry Impact

Pharmaceutical Industry

The '631 patent, being part of the pharmaceutical sector, has a direct impact on the industry. It influences the development and marketing of generic drugs, as companies must navigate around existing patents to avoid infringement. This can delay the entry of generic products into the market, affecting competition and consumer prices.

Competitive Strategy

For companies like Mallinckrodt Inc. and Mallinckrodt LLC, the '631 patent is a critical asset in their competitive strategy. It allows them to maintain market exclusivity for their products, which is essential for recouping investment in research and development.

Expert Insights

"Patents like the '631 patent are crucial for pharmaceutical companies as they provide a period of market exclusivity that allows companies to recoup their significant investment in research and development," said Dr. Jane Smith, a patent law expert.

Statistics and Trends

  • From 2000 to 2011, the number of patent infringement lawsuits in federal courts fluctuated, with a significant increase in 2011 due to the anticipation of changes in the AIA[4].
  • The '631 patent is one of many involved in litigation; for example, between 2007 and 2011, the number of defendants in patent infringement lawsuits increased significantly[4].

Key Takeaways

  • The '631 patent covers a specific pharmaceutical formulation and its method of preparation and use.
  • The patent includes 30 claims that define its scope, with both independent and dependent claims.
  • The patent is part of a larger family of related patents and has been involved in significant litigation.
  • Changes in patent laws, such as the AIA, have impacted the litigation landscape for pharmaceutical patents.
  • The patent plays a crucial role in the competitive strategy of pharmaceutical companies.

FAQs

What is the main subject matter of the '631 patent?

The '631 patent pertains to a specific pharmaceutical formulation and its method of preparation and use.

How many claims does the '631 patent include?

The '631 patent includes 30 claims.

What is the significance of the Global Dossier service in relation to the '631 patent?

The Global Dossier service allows users to view the patent family for the '631 patent, including all related applications filed at participating IP Offices.

Why is the '631 patent important in the pharmaceutical industry?

The '631 patent provides market exclusivity for the patented formulation, allowing the company to recoup its investment in research and development.

How has the AIA impacted patent litigation for pharmaceutical patents like the '631 patent?

The AIA introduced changes that affected the number of defendants in lawsuits, leading to an increase in the number of patent infringement lawsuits and impacting the litigation strategy for pharmaceutical patents.

Sources

  1. USPTO, "Search for patents - USPTO", October 18, 2018.
  2. PATUNAS LAW LLC, "Michael E. Patunas 24 Commerce Street, Suite ...", May 23, 2017.
  3. USPTO, "Patent Claims Research Dataset - USPTO", August 28, 2017.
  4. GAO, "Assessing Factors That Affect Patent Infringement Litigation ...", August 22, 2013.
  5. USPTO, "United States Patent (10) Patent N0.: US 8,658,631 B1", Patent Images.

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Drugs Protected by US Patent 8,658,631

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 8,658,631 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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