Details for Patent: 7,304,036

Which drugs does patent 7,304,036 protect, and when does it expire?

Patent 7,304,036 protects LINZESS and is included in one NDA.

This patent has eighty-nine patent family members in twenty-nine countries.

Summary for Patent: 7,304,036

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), 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), Norman; Thea (San Diego, CA), Milne; G. Todd (Brookline, MA)
Assignee:	Microbia, Inc. (Cambridge, MA)
Application Number:	10/796,719
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,304,036
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

United States Patent 7,304,036: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,304,036, titled "Methods and compositions for the treatment of gastrointestinal disorders," is a significant patent in the pharmaceutical industry, particularly for the treatment of gastrointestinal conditions. This patent, held by Ironwood Pharmaceuticals, Inc., and exclusively licensed to Forest Laboratories (now part of Allergan), has been a focal point in various legal and commercial activities.

Patent Overview

The patent was issued on November 27, 2007, and is set to expire on August 30, 2026[4][5].

Scope of the Patent

The patent covers methods and compositions for treating gastrointestinal disorders, including constipation, irritable bowel syndrome (IBS), and other related conditions. It specifically involves the use of a peptide, linaclotide, which is a guanylate cyclase-C agonist. This peptide is designed to stimulate the guanylate cyclase-C receptor, leading to increased intestinal fluid secretion and motility, thus alleviating symptoms of constipation and other gastrointestinal disorders[4].

Claims of the Patent

The patent includes multiple claims that define the scope of protection. These claims cover:

• Composition Claims: The patent claims pharmaceutical compositions comprising the linaclotide peptide, either alone or in combination with other therapeutic agents such as acid reducing agents, pro-motility agents, and laxatives[4].
• Method Claims: These claims pertain to methods of treating gastrointestinal disorders by administering the linaclotide peptide. The methods include treating conditions like constipation, IBS, and other gastrointestinal disorders in various patient populations[4].
• Specific Amino Acid Sequences: The patent details specific amino acid sequences of the linaclotide peptide and various modifications that can be made to these sequences, such as acetylation, amidation, and other chemical modifications[4].

Patent Landscape

The patent landscape surrounding U.S. Patent 7,304,036 is complex and involves several key aspects:

Litigation and Infringement

The patent has been involved in several litigation cases, notably against generic drug manufacturers like Mylan. These cases have centered around allegations of patent infringement related to the manufacture and sale of generic versions of linaclotide. The plaintiffs have sought to prevent the approval and sale of these generic products until the expiration of the patent[2].

Regulatory Environment

The patent's validity and enforcement are closely tied to regulatory requirements. The FDA's approval process for generic drugs, particularly through Abbreviated New Drug Applications (ANDAs), has been a critical factor. Generic manufacturers have challenged the patent's validity as part of their ANDA submissions, leading to legal disputes[2].

Commercialization and Licensing

The exclusive licensing agreement between Ironwood Pharmaceuticals and Forest Laboratories (now Allergan) has played a significant role in the commercialization of linaclotide under the brand name LINZESS. This agreement has helped in securing market exclusivity and protecting the patent's commercial value[1][2].

Patent Expiration and Generic Competition

The patent is set to expire on August 30, 2026, which will open the market to generic competition. Generic manufacturers are already preparing for this by challenging the patent's validity and seeking FDA approval for their versions of linaclotide[5].

Impact on Innovation and Competition

The patent has been a subject of debate regarding its impact on innovation and competition in the pharmaceutical industry. Critics argue that such patents can stifle innovation by limiting access to generic alternatives and increasing healthcare costs. However, proponents argue that these patents are essential for incentivizing research and development in the pharmaceutical sector[3].

Metrics for Patent Scope

Studies on patent scope, such as those by the Hoover Institution, suggest that metrics like independent claim length and independent claim count can be used to measure the breadth and clarity of patent claims. These metrics indicate that narrower claims, like those in U.S. Patent 7,304,036, are often associated with a higher probability of grant and shorter examination processes[3].

Therapeutic Benefits and Market Opportunities

The therapeutic benefits of linaclotide, as protected by this patent, have been significant. It has provided a new treatment option for patients with chronic constipation and IBS, improving their quality of life. The market opportunities for this drug have been substantial, with LINZESS becoming a major product in the gastrointestinal treatment market[1].

Key Takeaways

• Patent Scope: The patent covers specific methods and compositions for treating gastrointestinal disorders using the linaclotide peptide.
• Litigation: The patent has been involved in several litigation cases against generic manufacturers.
• Regulatory Environment: The patent's enforcement is closely tied to FDA regulatory processes.
• Commercialization: The exclusive licensing agreement has been crucial for the commercial success of LINZESS.
• Patent Expiration: The patent is set to expire in 2026, opening the market to generic competition.
• Impact on Innovation: The patent has been a subject of debate regarding its impact on innovation and competition.

FAQs

What is the primary use of U.S. Patent 7,304,036?

The primary use of U.S. Patent 7,304,036 is for the treatment of gastrointestinal disorders, particularly constipation and irritable bowel syndrome (IBS), using the linaclotide peptide.

Who holds the exclusive license for this patent?

The exclusive license for U.S. Patent 7,304,036 is held by Forest Laboratories (now part of Allergan) from Ironwood Pharmaceuticals, Inc.

What are the key claims of this patent?

The key claims include composition claims for pharmaceutical compositions containing the linaclotide peptide and method claims for treating gastrointestinal disorders by administering this peptide.

What is the current status of litigation related to this patent?

The patent has been involved in several litigation cases against generic manufacturers, with ongoing disputes over patent infringement and validity.

When is the patent set to expire?

The patent is set to expire on August 30, 2026, which will allow for generic competition in the market.

Cited Sources

1. United States Securities and Exchange Commission - The United States Patent and Trademark Office has issued a Certificate... methods of use patent (U.S. Patent 7,304,036) expiring in 2026.
2. United States District Court for the District of Delaware - This is a civil action for the infringement by Mylan of United States Patent Nos. 7,304,036...
3. Hoover Institution - Patent Claims and Patent Scope - Hoover Institution
4. Google Patents - US7304036B2 - Methods and compositions for the treatment of gastrointestinal disorders
5. Drugs.com - Generic Linzess Availability - Drugs.com

Drugs Protected by US Patent 7,304,036

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	Y		METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes			Y	Y		TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes			Y	Y		METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes			Y	Y		METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No			Y	Y		METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No			Y	Y		METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

International Family Members for US Patent 7,304,036

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