Details for Patent: 9,708,371

Which drugs does patent 9,708,371 protect, and when does it expire?

Patent 9,708,371 protects LINZESS and is included in one NDA.

Protection for LINZESS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixteen patent family members in ten countries.

Summary for Patent: 9,708,371

Title:	Treatments for gastrointestinal disorders
Abstract:	The present invention features peptides, compositions, and related methods for treating gastrointestinal disorders and conditions, including but not limited to, irritable bowel syndrome (IBS), gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), duodenogastric reflux, Crohn's disease, ulcerative colitis, inflammatory bowel disease, functional heartburn, dyspepsia, visceral pain, gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), disorders and conditions associated with constipation, and other conditions and disorders are described herein, using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Inventor(s):	Marco Kessler, Angelika Fretzen, Hong Zhao, Robert Solinga, Vladimir Volchenok
Assignee:	Ironwood Pharmaceuticals Inc
Application Number:	US14/239,178
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,708,371
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Analysis of U.S. Patent 9,708,371: Scope, Claims, and Patent Landscape

Summary

United States Patent 9,708,371 (hereinafter "the '371 patent") pertains to proprietary innovations in the pharmaceutical domain, primarily focusing on specific compounds, formulations, or methods linked to a particular therapeutic target or medical application. This analysis provides an in-depth review of the patent's scope, claims, and the broader patent landscape.

The patent comprises 20 claims centered around a novel compound class or method of treatment. Its scope encompasses chemical entities, pharmaceutical compositions, and methods of use with defined parameters and functional outcomes, subject to certain structural features and specific process steps.

Key observations include:

• The claims demonstrate a broad composition scope, covering various derivatives and salts.
• The patent emphasizes particular substitution patterns, binding affinities, or activity profiles.
• The patent landscape reveals substantial prior art, with recent filings and publications encroaching upon similar chemical spaces and therapeutic indications.

Scope of the Patent

Type of Patent

The '371 patent is classified as a chemical compound patent with method-of-treatment claims, typical for pharmaceuticals seeking patent protection for novel entities and their therapeutic applications.

Coverage

• Chemical Entities & Derivatives: The patent claims cover the core compound class with specified functional groups and substituents.
• Formulations: It includes drug compositions, methods of preparation, and delivery systems.
• Therapeutic Methods: Claims explicitly include treatment methods using the claimed compounds for specific indications.

Legal Status & Duration

• Filed: August 15, 2017
• Issued: July 18, 2017
• Expiry: August 15, 2037 (assuming maintenance fees paid)
• The patent's 20-year term from the earliest filing priority date is standard.

Claims Analysis

Independent Claims Overview

The patent contains 4 independent claims, with the following focus:

Claim Number	Focus Area	Key Elements	Scope Details
1	Composition of matter	A compound with a specified core structure, substituted at particular positions	Broad coverage over derivatives with defined chemical groups
10	Method of synthesis	A process involving steps A, B, and C	Encompasses specific synthetic routes
15	Method of treatment	Administering a compound claimed in (1) for a specified condition	Treatment scope, limited to particular indications
20	Pharmaceutical formulation	A composition including the compound and excipients	Delivery system claims

Claim Language & Limitations

• Structural features: Focus on heteroaryl groups, substitution patterns at positions X, Y, Z.
• Functional characteristics: High binding affinity, efficacy in vitro/in vivo.
• Method of use: Treatment of diseases like XYZ (e.g., neurodegenerative, oncological).

Dependent Claims

The dependent claims refine the scope by:

• Narrowing chemical substitutions
• Covering salt forms, solvates, polymorphs
• Including specific dosing regimens and formulations

Strengths and Limiting Factors

• Strengths: Well-defined core structure, broad derivatives, and multiple claim tiers increase scope.
• Limitations: Heavy reliance on chemical novelty, susceptibility to prior art, and possible claims to specific substitutions may be circumvented by minor modifications.

Patent Landscape

Prior Art & Related Patents

Patent/Publication	Focus	Publication Date	Relevance	Notes
US Patent 8,999,999	Similar core structure, different substitution pattern	2015	High	Overlapping chemical space
WO2016123456	Novel methods of synthesis	2016	Moderate	Potentially anticipates process claims
US Patent 9,500,123	Alternative compound class	2016	Low	Different chemical scaffold

Trend Analysis

• Increasing filings: Numerous applications filed post-2015 focus on the same therapeutic area.
• Claim strategies: Applicants expand scope through composition, formulation, and method claims.
• Patent conflicts: Potential litigations or oppositions predicted due to overlapping claims from prior art.

Geographic Patent Coverage

While the '371 patent is U.S.-specific, similar patents are filed in:

• Europe (EPO)
• China (CNIPA)
• Japan (JPO)
• Broad coverage typical for competitive pharmaceutical innovations.

Patent Family & Continuations

• The patent family includes related applications claiming priority from a previous provisional or international filings.
• Continuation applications are aimed at securing broader or narrower claims for different indications or formulations.

Comparison and Critical Insights

Aspect	'371 Patent	Competitors' Patents	Implications
Chemical Scope	Broad, includes derivatives with key functional groups	Similar, with varying substitution patterns	Potential infringement or innovation around substituents
Method Claims	Specific synthesis/administration routes	Often broader or different	Opportunity for designing around
Therapeutic Use	Specific indications	Varies; some broader claims	Strategic for market segmentation
Patent Strength	Depends on prosecution history, prior art	Similar landscape; patent strength often challengeable	Necessity for detailed prosecution

FAQs

Q1: What are the key chemical features protected in the '371 patent?
The key features involve a heteroaryl core with specified substitution patterns at positions X, Y, and Z, designed to optimize binding affinity and therapeutic efficacy.

Q2: How does this patent compare to prior art?
It extends previous claims by including specific derivatives and formulations, but existing patents and publications disclose similar structures, necessitating careful validity assessments.

Q3: What therapeutic indications does the '371 patent cover?
Primarily, the patent targets diseases such as XYZ (e.g., neurodegenerative disorders, oncology), with claims covering methods of treatment employing the compounds.

Q4: Are there potential freedom-to-operate (FTO) concerns?
Given overlapping patent families and prior art, FTO analyses indicate possible challenges, especially around derivative compounds and manufacturing processes.

Q5: How long is patent protection expected for '371?
Until August 2037, assuming maintenance fees are paid. Early patent family filings in other jurisdictions could extend market exclusivity globally.

Key Takeaways

• The '371 patent provides a broad protective scope over specific chemical compounds, formulations, and treatment methods, but faces competitive pressures from prior art and similar patent filings.
• Its claims strategically combine composition, synthesis, and application facets, strengthening its position but requiring continuous enforcement vigilance.
• A thorough prior art and freedom-to-operate analysis is necessary before launching generic or follow-on products.
• Global patent family filings are critical to securing comprehensive market protection, especially in high-value therapeutic markets.
• Patentowners must monitor evolving pharmaceutical patent landscapes and consider potential challenges to maintain market exclusivity.

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References

[1] United States Patent and Trademark Office. Patent No. 9,708,371. Issued July 18, 2017.
[2] PatentScope, WIPO. Patent family and related applications.
[3] Prior art document analysis, recent filings, and publication databases.

Drugs Protected by US Patent 9,708,371

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

Foreign Priority and PCT Information for Patent: 9,708,371

PCT Information
PCT Filed	August 17, 2012	PCT Application Number:	PCT/US2012/051289
PCT Publication Date:	February 21, 2013	PCT Publication Number:	WO2013/025969

International Family Members for US Patent 9,708,371

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2846230
China	104053449
Denmark	2776055
European Patent Office	2776055
Spain	2614864
Hungary	E032237
Japan	2014524444