Details for Patent: 8,110,553

Which drugs does patent 8,110,553 protect, and when does it expire?

Patent 8,110,553 protects LINZESS and is included in one NDA.

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

Summary for Patent: 8,110,553

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), Milne; G. Todd (Brookline, MA), Norman; Thea (Cambridge, MA)
Assignee:	Ironwood Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	12/788,979
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,110,553
Patent Claim Types: see list of patent claims	Use;

United States Patent 8,110,553: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,110,553, titled "Methods and compositions for the treatment of gastrointestinal disorders," is a significant patent in the field of pharmaceuticals, particularly for the treatment of irritable bowel syndrome (IBS) and other gastrointestinal conditions. This article delves into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent, issued on February 7, 2012, is part of a series of patents related to the treatment of gastrointestinal disorders. It was filed by Ironwood Pharmaceuticals, Inc., and is associated with the development of linaclotide, a medication used to treat IBS and chronic constipation[2][4].

Scope of the Patent

The scope of US Patent 8,110,553 encompasses methods and compositions for treating gastrointestinal disorders. The patent describes specific peptides and their use in therapeutic formulations. Here are some key aspects of the patent's scope:

Therapeutic Indications

The patent covers the treatment of various gastrointestinal disorders, including irritable bowel syndrome (IBS), chronic constipation, and other related conditions. The therapeutic methods involve the administration of specific peptides that help regulate bowel movements and alleviate symptoms associated with these disorders[1][4].

Compositions

The patent details compositions that include peptides, particularly those with specific sequences and modifications. These compositions are designed to be effective in treating the mentioned gastrointestinal disorders while minimizing side effects[1][5].

Claims of the Patent

The claims of US Patent 8,110,553 are crucial in defining the invention's boundaries and what is protected under the patent. Here are some key claims:

Independent Claims

The patent includes several independent claims that outline the core inventions. These claims cover:

• Specific peptide sequences and their therapeutic uses.
• Methods of treating gastrointestinal disorders using these peptides.
• Pharmaceutical compositions containing these peptides[1][4].

Dependent Claims

Dependent claims further specify the scope by detailing particular aspects of the independent claims, such as:

• Specific dosages and administration routes.
• Combination therapies involving the peptides and other drugs.
• Methods for preparing the peptide compositions[1][4].

Patent Landscape

The patent landscape surrounding US Patent 8,110,553 is complex and involves several related patents and legal disputes.

Related Patents

Several patents are associated with the treatment of gastrointestinal disorders using similar peptides and methods. These include US Patent 7,371,727, US Patent 7,704,947, and US Patent 8,080,526, among others. These patents collectively form a robust intellectual property portfolio for Ironwood Pharmaceuticals and its exclusive licensee, Forest Laboratories[2].

Litigation

The patent has been involved in significant litigation, particularly with generic drug manufacturers. For example, Mylan Pharmaceuticals faced legal action for allegedly infringing on this and other related patents by seeking to market a generic version of linaclotide. The litigation highlights the importance of these patents in protecting the intellectual property rights of the original inventors and the commercial interests of the licensees[2].

Metrics for Patent Scope

The scope of US Patent 8,110,553 can be analyzed using metrics such as independent claim length and independent claim count. Research suggests that narrower claims, as often result from the patent examination process, are associated with a higher probability of grant and a shorter examination process. This patent, having undergone such scrutiny, likely has well-defined and narrowly scoped claims, which is indicative of higher patent quality[3].

Impact on Innovation

The patent's impact on innovation in the pharmaceutical sector is significant. By protecting the intellectual property related to linaclotide and its therapeutic uses, the patent incentivizes further research and development in gastrointestinal treatments. However, it also raises concerns about the breadth of patent claims and their potential to stifle competition and innovation if overly broad or unclear[3].

Expiration and Extensions

The patent has expired, but its impact continues through the protection afforded by related patents and any extensions or exclusivities granted. The expiration of such patents can open up the market for generic versions, but it also underscores the need for continuous innovation to maintain competitive advantage[1][4].

Key Takeaways

• Therapeutic Scope: The patent covers the treatment of IBS, chronic constipation, and other gastrointestinal disorders using specific peptides.
• Claims: The patent includes independent and dependent claims that define the invention and its therapeutic applications.
• Patent Landscape: The patent is part of a larger intellectual property portfolio and has been involved in significant litigation.
• Metrics for Scope: The patent's scope is likely well-defined and narrow, indicating higher patent quality.
• Impact on Innovation: The patent protects intellectual property, incentivizing further research but also raising concerns about patent breadth and competition.

FAQs

What is the main subject of US Patent 8,110,553?

The main subject of US Patent 8,110,553 is the methods and compositions for the treatment of gastrointestinal disorders, particularly using specific peptides.

Who are the key parties involved in the patent?

The key parties involved include Ironwood Pharmaceuticals, Inc., as the patent holder, and Forest Laboratories as the exclusive licensee.

What is the current legal status of the patent?

The patent has expired, but its impact continues through related patents and any granted extensions or exclusivities.

How does the patent impact innovation in the pharmaceutical sector?

The patent protects intellectual property, incentivizing further research and development, but it also raises concerns about the breadth of patent claims and their potential to stifle competition.

What metrics are used to analyze the scope of the patent?

Metrics such as independent claim length and independent claim count are used to analyze the scope of the patent, indicating its quality and breadth.

Sources

1. US8110553B2 - Methods and compositions for the treatment of gastrointestinal disorders - Google Patents
2. in the united states district court for the district of delaware allergan ... - Insight.RPXCorp
3. Patent Claims and Patent Scope - Hoover Institution
4. US8080526B2 - Methods and compositions for the treatment of gastrointestinal disorders - Google Patents
5. Methods and compositions for the treatment of gastrointestinal ... - PubChem.NCBI.NLM.NIH.Gov

Drugs Protected by US Patent 8,110,553

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

International Family Members for US Patent 8,110,553

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