Details for Patent: 7,371,727

Which drugs does patent 7,371,727 protect, and when does it expire?

Patent 7,371,727 protects LINZESS and is included in one NDA.

This patent has eighty-six patent family members in twenty-seven countries.

Summary for Patent: 7,371,727

Title:	Methods and compositions for the treatment of gastrointestinal disorders
Abstract:	The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), duodenogastric reflux, Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Inventor(s):	Currie; Mark G. (Sterling, MA), Mahajan-Miklos; Shalina (Stanford, CA), Fretzen; Angelika (Somerville, MA), Sun; Li Jing (New York, NY), Norman; Thea (San Diego, CA), Milne; G. Todd (Brookline, MA)
Assignee:	Microbia, Inc. (Cambridge, MA)
Application Number:	10/899,806
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,371,727
Patent Claim Types: see list of patent claims	Use; Process;

Analyzing the Scope and Claims of United States Patent 7,371,727

Introduction

United States Patent 7,371,727, hereafter referred to as the '727 patent, is a significant patent in the pharmaceutical sector, particularly related to the treatment of gastrointestinal disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The '727 patent, titled "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," was issued by the United States Patent and Trademark Office (USPTO) on April 27, 2010. It is associated with the pharmaceutical product linaclotide, which is used for treating gastrointestinal conditions such as constipation and irritable bowel syndrome[2].

Patent Claims

The '727 patent includes several claims that define the scope of the invention. Here are some key aspects of the claims:

Independent Claims

• The patent includes independent claims that outline the composition and method of use for linaclotide. For example, Claim 1 describes a pharmaceutical composition comprising linaclotide or a pharmaceutically acceptable salt thereof, along with other components[2].

Dependent Claims

• Dependent claims further specify the details of the composition, dosage forms, and methods of administration. These claims build upon the independent claims and provide additional specificity to the invention[2].

Scope of the Patent

The scope of the '727 patent is defined by its claims and the description provided in the patent specification.

Composition and Method

• The patent covers specific compositions of linaclotide, including orally administered forms, and methods for treating gastrointestinal disorders using these compositions[2].

Pharmaceutical Applications

• The scope extends to various pharmaceutical applications, including the treatment of constipation, irritable bowel syndrome, and other gastrointestinal conditions[2].

Patent Landscape

Related Patents

• The '727 patent is part of a family of patents related to linaclotide. Other patents in this family include U.S. Patent Nos. 7,304,036, 7,704,947, 7,745,409, 8,080,526, 8,110,553, 8,933,030, and 8,802,628, all of which are associated with similar compositions and methods[2].

Global Dossier

• The '727 patent is also part of the Global Dossier, which provides access to the file histories of related applications from participating IP Offices. This includes classification, citation data, and office actions related to the patent family[1].

Common Citation Document (CCD)

• The CCD application consolidates prior art cited by all participating offices for the family members of the patent application, including the '727 patent. This helps in visualizing the search results for the same invention produced by several offices on a single page[1].

Litigation and Enforcement

The '727 patent has been involved in significant litigation, particularly in the context of generic drug manufacturers.

Infringement Claims

• Allergan and other plaintiffs have filed civil actions against Mylan for the alleged infringement of the '727 patent, among others. The allegations include that Mylan's generic product would induce infringement of the claims of the '727 patent[2].

Legal Proceedings

• The litigation involves detailed arguments on the validity, enforceability, and infringement of the patent claims. The court's decision can significantly impact the market availability of generic versions of linaclotide[2].

Metrics for Patent Scope

Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent.

Claim Length and Count

• Studies have shown that narrower claims, as measured by claim length and count, are associated with a higher probability of grant and a shorter examination process. This suggests that the '727 patent, with its specific claims, may have undergone a rigorous examination process to ensure its validity[3].

Public Access and Search Tools

Public access to patent information is crucial for understanding the scope and claims of patents like the '727 patent.

Patent Public Search

• The USPTO's Patent Public Search tool provides enhanced access to prior art, allowing users to search and analyze patents like the '727 patent in detail[1].

Patent and Trademark Resource Centers (PTRCs)

• Local PTRCs offer training and resources for patent search techniques, which can be invaluable for analyzing the '727 patent and its place in the patent landscape[1].

Key Takeaways

• Patent Claims: The '727 patent includes specific claims related to compositions and methods for treating gastrointestinal disorders using linaclotide.
• Scope: The patent covers orally administered forms of linaclotide and methods for its use.
• Litigation: The patent has been involved in significant litigation regarding infringement by generic drug manufacturers.
• Metrics: Narrower claims are generally associated with a higher probability of grant and shorter examination processes.
• Public Access: Tools like the Patent Public Search and Global Dossier provide comprehensive access to patent information.

FAQs

Q: What is the main subject of United States Patent 7,371,727? A: The main subject is methods and compositions for the treatment of gastrointestinal disorders using linaclotide.

Q: Who are the owners and licensees of the '727 patent? A: Ironwood is the sole owner, and Forest is the exclusive licensee for commercializing pharmaceutical products containing linaclotide in the United States[2].

Q: What are some of the key claims in the '727 patent? A: The patent includes claims for pharmaceutical compositions comprising linaclotide and methods for treating gastrointestinal disorders.

Q: Has the '727 patent been involved in any litigation? A: Yes, it has been involved in civil actions against Mylan for alleged infringement.

Q: How can one access detailed information about the '727 patent? A: Detailed information can be accessed through the USPTO's Patent Public Search tool and the Global Dossier service[1].

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. United States District Court for the District of Delaware - Allergan vs. Mylan: https://insight.rpxcorp.com/litigation_documents/13050411
3. SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964

Drugs Protected by US Patent 7,371,727

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes				Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes				Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No				Y

International Family Members for US Patent 7,371,727

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1594517		300593	Netherlands
European Patent Office	1594517		C300593	Netherlands
European Patent Office	1594517		CA 2013 00026	Denmark
European Patent Office	1594517		PA2013013	Lithuania
European Patent Office	1594517		92200	Luxembourg
European Patent Office	1594517		1390024-6	Sweden
European Patent Office	2246360		C300594	Netherlands