Details for Patent: 10,188,632

Which drugs does patent 10,188,632 protect, and when does it expire?

Patent 10,188,632 protects VIBERZI and is included in one NDA.

This patent has thirty patent family members in twenty countries.

Summary for Patent: 10,188,632

Title:	Opioid receptor modulator dosage formulations
Abstract:	Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.
Inventor(s):	Tim Costello, Jens Jozef Ceulemans, Eugeen Maria Jozef Jans, Philip Erna H. Heyns
Assignee:	Allergan Holdings ULC
Application Number:	US15/588,304
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,188,632
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 10,188,632: An In-Depth Analysis

Introduction

United States Patent 10,188,632, titled "Opioid receptor modulator dosage formulations," is a patent that delves into the realm of pharmaceutical formulations, specifically those related to opioid receptor modulators. This analysis will explore the key aspects of this patent, including its claims, the patent landscape, and the implications of its scope.

Background on Opioid Receptor Modulators

Opioid receptor modulators are compounds designed to interact with opioid receptors in the body, which can be used to treat various conditions such as pain and gastrointestinal disorders. These modulators can offer a more targeted approach to therapy, potentially reducing the side effects associated with traditional opioid treatments[4].

Patent Overview

Publication Details

• Publication Number: US10188632B2
• Authority: United States
• Prior Art Date: This patent builds upon earlier research and patents related to opioid receptor modulators, indicating a continuous evolution in the field[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention.

Independent Claims

• Claim 1 typically defines the broadest scope of the invention, often describing the composition or method in general terms.
• For example, Claim 1 might describe a dosage formulation comprising an opioid receptor modulator, along with specific excipients and their proportions[4].

Dependent Claims

• These claims narrow down the scope by adding specific limitations to the independent claims.
• Examples include claims that specify particular types of opioid receptor modulators, dosage forms (e.g., tablets, capsules), or specific therapeutic uses (e.g., treating irritable bowel syndrome)[4].

Key Components of the Patent

Opioid Receptor Modulator

• The patent focuses on specific chemical structures, such as those containing amino, phenyl, imidazol, propionyl, and carbamoyl groups. These structures are crucial for the modulator's efficacy and safety profile[4].

Dosage Formulations

• The patent details various formulations, including solid dosage forms like tablets and capsules, and liquid formulations. Each formulation is designed to optimize the delivery and bioavailability of the opioid receptor modulator[4].

Therapeutic Applications

• The patent mentions several therapeutic applications, including pain management and gastrointestinal disorders. This indicates the versatility of the opioid receptor modulators in treating different conditions[4].

Patent Landscape

Related Patents

• The patent landscape for opioid receptor modulators is complex, with multiple patents covering various aspects of these compounds.
• For instance, other patents might cover different chemical structures, synthesis methods, or specific therapeutic uses, which could impact the scope and validity of US10188632B2[1][4].

Expiration Dates and Patent Term Adjustments

• The expiration date of a patent is crucial for understanding its market impact. Patents typically expire 20 years from the filing date, but adjustments can be made for delays in prosecution (Patent Term Adjustments - PTA) or extensions (Patent Term Extensions - PTE)[1].

Legal and Regulatory Considerations

Obviousness-Type Double Patenting (ODP)

• This doctrine prevents the unjustified extension of patent exclusivity beyond the life of a patent. It ensures that modifications or variants of an invention, which would have been obvious at the time of the invention, are not patented separately[1].

Small Claims Patent Court

• There have been discussions and studies on the feasibility of a small claims patent court, which could simplify and reduce the costs associated with patent litigation. This could impact how disputes related to patents like US10188632B2 are resolved[5].

Economic and Research Implications

Patent Scope and Claims Research Dataset

• The USPTO provides datasets that analyze patent claims and scope, which can help in understanding the breadth and depth of patent coverage. These datasets can be useful for researchers and practitioners to assess the patent landscape and potential overlaps or conflicts[3].

Industry Expert Insights

• Experts in the field of pharmaceuticals and intellectual property law often emphasize the importance of clear and distinct claims to avoid legal challenges.
• For example, Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO, has highlighted the need for robust patent systems that balance innovation with public access[5].

Case Studies and Analogies

• The case of Allergan USA, Inc. v. MSN Laboratories Private Ltd. illustrates the complexities of patent validity and the doctrine of obviousness-type double patenting. This case can serve as a precedent for understanding how similar issues might be resolved for US10188632B2[1].

Key Takeaways

• Patent Scope: The patent covers specific opioid receptor modulator dosage formulations, including their chemical structures and therapeutic applications.
• Claims: The patent includes independent and dependent claims that define the invention's scope.
• Patent Landscape: The landscape is complex, with multiple related patents and potential legal considerations such as ODP.
• Regulatory Considerations: The patent's validity and enforcement could be influenced by legal doctrines and potential changes in patent litigation processes.
• Economic Implications: The patent's scope and claims can impact research and development in the pharmaceutical industry.

FAQs

What is the primary focus of United States Patent 10,188,632?

The primary focus is on opioid receptor modulator dosage formulations, including their chemical structures and therapeutic applications.

What are the key components of the patent claims?

The claims include descriptions of the opioid receptor modulator, dosage formulations, and specific therapeutic uses.

How does the doctrine of obviousness-type double patenting impact this patent?

It prevents the extension of patent exclusivity beyond the life of a patent by ensuring that obvious modifications or variants are not patented separately.

What is the significance of the USPTO's Patent Claims Research Dataset?

It provides detailed information on patent claims and scope, helping researchers and practitioners understand the patent landscape.

Could a small claims patent court affect disputes related to this patent?

Yes, it could simplify and reduce the costs associated with patent litigation, potentially impacting how disputes are resolved.

Sources

1. ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - U.S. Court of Appeals for the Federal Circuit.
2. U.S. Patent and Trademark Office (USPTO) - USA.gov.
3. Patent Claims Research Dataset - USPTO.
4. US10188632B2 - Opioid receptor modulator dosage formulations - Google Patents.
5. U.S. Patent Small Claims Court - Administrative Conference of the United States.

Drugs Protected by US Patent 10,188,632

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	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No	10,188,632		Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	AB	RX	Yes	Yes	10,188,632		Y

International Family Members for US Patent 10,188,632

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014241076
Brazil	112015022753
Canada	2906472
China	105228629
China	110917159