Details for Patent: 7,976,870

Which drugs does patent 7,976,870 protect, and when does it expire?

Patent 7,976,870 protects XARTEMIS XR and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 7,976,870

Title:	Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Abstract:	Controlled release oral dosage forms are provided for the continuous, sustained administration of a pharmacologically active agent to the upper gastrointestinal tract of a patient in whom the fed mode as been induced. The majority of the agent is delivered, on an extended release basis, to the stomach, duodenum and upper regions of the small intestine, with drug delivery in the lower gastrointestinal tract and colon substantially restricted. The dosage form comprises a matrix of a biocompatible, hydrophilic, erodible polymer with an active agent incorporated therein, wherein the polymer is one that both swells in the presence of water and gradually erodes over a time period of hours, with swelling and erosion commencing upon contact with gastric fluid, and drug release rate primarily controlled by erosion rate.
Inventor(s):	Berner; Bret (Half Moon Bay, CA), Louie-Helm; Jenny (Fremont, CA), Shell; John W. (Hillsborough, CA)
Assignee:	Depomed, Inc. (Menlo Park, CA)
Application Number:	10/769,574
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,976,870
Patent Claim Types: see list of patent claims	Use; Dosage form; Delivery; Formulation;

United States Patent 7,976,870: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 7,976,870, titled "Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract," is a significant patent in the pharmaceutical industry. This patent, granted to innovators in the field of drug delivery systems, outlines a novel approach to oral drug administration. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication and Status

The patent was published on July 12, 2011, and has since expired due to fee-related issues[1][5].

Inventors and Assignees

The patent was filed by inventors who have contributed to the development of advanced drug delivery systems. The assignees of this patent are typically pharmaceutical companies or research institutions involved in the development and commercialization of these systems.

Scope of the Patent

Purpose and Design

The patent describes a gastric retentive oral dosage form designed to release the active agent primarily in the lower gastrointestinal tract. This is achieved through a formulation that ensures the drug remains in the stomach for an extended period, allowing for controlled release as it moves through the digestive system[1][5].

Key Components

• Active Agent: The patent specifies the use of various active agents, such as ciprofloxacin, which are released in a controlled manner.
• Dosage Form: The dosage form is engineered to float or remain buoyant in the stomach, ensuring prolonged gastric retention.
• Release Mechanism: The mechanism involves a combination of materials that restrict the release of the drug until it reaches the lower gastrointestinal tract.

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically cover the dosage form, the method of preparation, and the specific characteristics of the formulation that enable gastric retention and controlled release[1].

Dependent Claims

Dependent claims further detail the specifics of the invention, including the types of active agents that can be used, the materials and their proportions, and the methods for manufacturing the dosage form.

Patent Landscape

Related Patents

The patent landscape in the field of drug delivery systems is complex and includes numerous patents related to gastric retentive dosage forms. Other patents, such as those listed in litigation documents (e.g., U.S. Patent Nos. 8,597,681, 8,980,319, 8,668,929), also address various aspects of drug delivery and formulation[2].

Litigation and Enforcement

Patent litigation is a significant aspect of the patent landscape. The enforcement of patents like U.S. Patent 7,976,870 often involves legal battles, as seen in cases where generic manufacturers challenge the validity or infringement of such patents. For instance, the increase in patent infringement lawsuits, particularly around the time of the Leahy-Smith America Invents Act (AIA) in 2011, highlights the contentious nature of patent enforcement[4].

Industry Impact

The development and patenting of gastric retentive oral dosage forms have a substantial impact on the pharmaceutical industry. These innovations can improve drug efficacy, reduce side effects, and enhance patient compliance. The patent landscape reflects the ongoing research and development in this area, with numerous companies and research institutions actively involved in creating and protecting their intellectual property.

Trends in Patent Litigation

Recent Increases

The number of patent infringement lawsuits has seen significant fluctuations, with a notable increase around 2011 due to changes in patent law, such as the AIA. This increase is partly attributed to the breaking down of lawsuits into multiple cases and the involvement of nonpracticing entities (NPEs)[4].

Software and Other Technologies

While the patent in question is specific to pharmaceuticals, the broader trend in patent litigation includes a significant focus on software-related patents. However, the principles of patent litigation and the importance of linking litigation trends to patent examination processes are relevant across various technological fields[4].

Improving Patent Quality

USPTO Initiatives

The U.S. Patent and Trademark Office (USPTO) has taken steps to improve patent quality, including initiatives to develop more uniform terminology and to analyze trends in patent litigation. This analysis can help in identifying patterns in the examination of patents that end up in court, thereby enhancing the quality of issued patents[4].

Data and Analytics

The use of datasets, such as the Patent Claims Research Dataset provided by the USPTO, can offer detailed insights into patent claims and their relationship to litigation. These datasets help in understanding the scope and complexity of patents, which can be crucial for improving patent quality and reducing litigation[3].

Key Takeaways

• Innovative Drug Delivery: U.S. Patent 7,976,870 represents a significant innovation in drug delivery systems, focusing on gastric retentive oral dosage forms.
• Complex Patent Landscape: The patent landscape is complex, with numerous related patents and ongoing litigation.
• Industry Impact: These patents have a substantial impact on the pharmaceutical industry, influencing drug efficacy and patient compliance.
• Litigation Trends: The number of patent infringement lawsuits has increased, influenced by changes in patent law and the involvement of NPEs.
• Improving Patent Quality: Initiatives by the USPTO and the use of detailed datasets aim to enhance patent quality and reduce litigation.

FAQs

What is the main purpose of U.S. Patent 7,976,870?

The main purpose of U.S. Patent 7,976,870 is to describe a gastric retentive oral dosage form that releases the active agent primarily in the lower gastrointestinal tract.

How does the dosage form ensure prolonged gastric retention?

The dosage form is designed to float or remain buoyant in the stomach, ensuring prolonged gastric retention through a combination of materials.

What are some of the key components of the patent?

Key components include the active agent (e.g., ciprofloxacin), the dosage form, and the release mechanism that restricts drug release until it reaches the lower gastrointestinal tract.

Why is patent litigation important in this context?

Patent litigation is crucial as it involves the enforcement of intellectual property rights, which can impact the commercialization and development of new drug delivery systems.

How does the USPTO contribute to improving patent quality?

The USPTO contributes through initiatives such as developing uniform terminology, analyzing trends in patent litigation, and using detailed datasets to improve the patent examination process.

Sources

1. US7976870B2 - Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract - Google Patents.
2. PATUNAS LAW LLC Michael E. Patunas - Insight.RPXCorp.
3. Patent Claims Research Dataset - USPTO.
4. Assessing Factors That Affect Patent Infringement Litigation - GAO.
5. Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract - PubChem.

Drugs Protected by US Patent 7,976,870

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						METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM

International Family Members for US Patent 7,976,870

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2409552
European Patent Office	1439826
Japan	2005507000