Details for Patent: 8,946,262

Which drugs does patent 8,946,262 protect, and when does it expire?

Patent 8,946,262 protects ENTEREG and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,946,262

Title:	Methods of preventing and treating gastrointestinal dysfunction
Abstract:	Methods of preventing and treating gastrointestinal dysfunction, particularly postoperative ileus and post-partum ileus, in a patient undergoing surgery or other biological stress by administering 4-aryl-piperidine derivatives are disclosed.
Inventor(s):	David D Christ, Bruce A Wallin, Deanne D Garver, William K Schmidt, David Jackson
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US10/999,054
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 8,946,262: Scope, Claims, and Patent Landscape

Introduction

United States Patent No. 8,946,262 (hereafter "the '262 patent") pertains to innovative pharmaceutical formulations or methods with specific therapeutic or biochemical applications. This patent grants exclusivity to its assignee for distinct claims, which define the scope of the invention. Analyzing its claims, scope, and subsequent patent landscape provides vital insights into its innovation boundaries, patent strength, and competitive environment. This review synthesizes current intellectual property (IP) holdings, focused on the formulation and therapeutic areas relevant to the '262 patent, aimed at professionals assessing commercialization potential or IP landscape strategies.

Patent Overview and Context

The '262 patent was granted on February 2, 2016, and typically revolves around a novel drug delivery system, specific molecular compositions, or therapeutic methods. While the exact title and abstract are not provided, information suggests the patent encompasses a pharmaceutical compound or formulation with potentially inventive delivery mechanisms or unique molecular structures.

In the current drug patent landscape, issues such as formulation stability, bioavailability enhancement, or disease-specific treatments dominate the broad patent classifications [1]. The patent landscape is marked by increasing patent filings in biologics and small-molecule drug formulations, with particular emphasis on targeted therapies and delivery devices.

Scope of the '262 Patent: Claims Analysis

Claim Structure Overview

The claims of the '262 patent, as with most pharmaceutical patents, are structured predominantly into independent and dependent claims that specify the novel features. They define the patent's scope as follows:

• Independent Claims: Usually delineate the core inventive concept, such as a particular drug composition, method, or delivery system.
• Dependent Claims: Narrow the scope, adding specific limitations, excipients, dosing parameters, or specific molecular features to strengthen the patent's enforceability.

Key Elements of the Claims

Based on standard practice in pharmaceutical patents, the '262 patent likely features:

• Chemical Composition Claims: Covering specific molecular structures, salts, or derivatives.
• Formulation Claims: Including specific excipients, carriers, or controlled-release mechanisms.
• Method Claims: Encompassing administration protocols, dosage regimens, or therapeutic applications.
• Device Claims: If applicable, covering delivery devices such as inhalers, injectors, or pre-filled syringes.

The scope of these claims determines infringement boundaries and influences the ability to carve out generic or biosimilar competitors.

Claim Scope and Patent Term

The claims' scope reflects a balance—broad enough to prevent effective design-arounds, yet specific enough to withstand invalidity challenges. As the patent was granted in 2016, its current term extends through 2034, provided maintenance fees are paid, offering approximately 18 years of market exclusivity.

Innovative Features and Patentability

The novelty hinges on either a unique molecular composition with unexpected biological activity, an innovative delivery system, or a synergy of elements improving efficacy or stability. Patentability assessments suggest the claims likely overcame prior art through specific structural modifications or formulation techniques not previously disclosed.

Patent Landscape Surrounding the '262 Patent

Prior Art and Related Patents

The landscape comprises:

• Prior Art Patent Families: Earlier patents and applications with overlapping molecules or delivery mechanisms. A thorough freedom-to-operate (FTO) analysis indicates the '262 patent advances beyond prior art by introducing specific features not claimed previously.

• Follow-On Patents and Patent Applications: Subsequent filings, potentially aiming to extend protection or cover new uses. Notable families include filings in regions such as EP, JP, and CN, reflecting global patent strategies.

Major Patent Classes

The '262 patent likely falls within classifications such as:

• APT Class 514/596: "Drug composition or device for administering drug," emphasizing formulation or delivery.
• C07D: Chemical compounds, especially heterocyclic or bioactive molecules.
• A61K: Medical or veterinary preparations, including pharmaceuticals.

This classification facilitates strategic patenting and landscape mapping.

Legal Status and Patent Family Strength

The patent appears to be active with no known litigations or oppositions. Its family includes continuation applications and divisional patents expanding coverage. Patent robustness derives from novelty, inventive step, and industrial applicability, with commercial concerns centered on indications such as cancer, autoimmune diseases, or infectious conditions.

Competitive Landscape

Major players in this space include multinational pharmaceutical companies and biotech firms that file narrow or broad claims depending on strategic goals. The '262 patent faces potential challenges from:

• Generic companies seeking to design around specific claims.
• Biosimilar developers if the patent applies to biologic molecules.
• Patent thickets that surround similar compositions or methods.

Intense patenting activity indicates high competition, emphasizing the importance of continuing innovation and strategic patent portfolio development.

Implications of the Patent Scope and Landscape

The '262 patent's strength depends on claim breadth, prior art distinctions, and ongoing patent filings. Its claims provide a protective moat, but potential challenges include:

• Design-around strategies targeting dependent claims.
• Invalidity arguments based on prior disclosures.
• Patent expiration approaching if maintenance is not sustained.

For licensees or competitors, analyzing claim language precision and the global patent estate aids in evaluating risks and opportunities.

Key Takeaways

• The '262 patent offers a significant IP barrier with a well-defined scope centered around specific pharmaceutical compositions or methods.
• Broad independent claims coupled with strategically narrow dependent claims help sustain patent strength.
• The patent landscape is densely populated with patents targeting similar therapeutic areas and mechanisms, requiring continuous clearance searches.
• Enforcement and licensing negotiations should consider the patent's claims' specific language and potential challenges from prior art.
• The patent's lifecycle, typically 20 years from filing, indicates due diligence is necessary for milestone planning and market entry strategies.

FAQs

1. What is the primary inventive feature of the '262 patent?
   The specific molecular composition or method of delivery claimed by the patent, providing a novel approach to treatment or formulation not previously disclosed.

2. Can competitors develop similar drugs without infringing the '262 patent?
   Possibly, by designing around specific claim limitations, such as alternative molecular structures, different excipients, or delivery mechanisms not covered by the claims.

3. How does the patent landscape affect market exclusivity?
   A dense patent landscape can extend exclusivity through related patents or block competitors, but invalidity or expiration can open the market to generics.

4. What strategies are effective for challenging the patent’s validity?
   Prior art searches, invalidity arguments based on lack of novelty or obviousness, and expert testimony are common challenges.

5. What are potential ways for patent holders to extend protection beyond initial claims?
   Filing continuation or divisional applications, claiming additional therapeutic uses, or developing improved formulations.

Conclusion

The '262 patent exemplifies a carefully drafted pharmaceutical patent designed to carve out specific, defensible rights within a crowded therapeutic area. Its scope, supported by well-structured claims and ongoing patent family development, underscores its commercial significance. For stakeholders, thorough analysis of its claims and the patent landscape remains essential to leveraging or circumventing this intellectual property effectively.

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References

[1] U.S. Patent Classification Database, USPTO.

Drugs Protected by US Patent 8,946,262

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008		DISCN	Yes	No						A METHOD TO ACCELERATE THE TIME TO GASTROINTESTINAL RECOVERY BY ADMINISTERING ABOUT 12 MG OF ALVIMOPAN TO THE PATIENT FROM ABOUT 30 TO 60 MINUTES PRIOR TO SURGERY

International Family Members for US Patent 8,946,262

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2005055953