Details for Patent: 9,492,391

Which drugs does patent 9,492,391 protect, and when does it expire?

Patent 9,492,391 protects HYSINGLA ER and OXYCONTIN and is included in two NDAs.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,492,391

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee:	Purdue Pharma LP, Purdue Pharmaceuticals LP
Application Number:	US14/729,626
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,492,391
Patent Claim Types: see list of patent claims	Use; Dosage form; Device;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,492,391

Introduction

United States Patent 9,492,391 (hereafter, "the '391 patent") represents a significant intellectual property asset within the pharmaceutical buffering domain. Its granularity encompasses specific compositions and methods designed for drug stabilization or delivery, potentially impacting multiple therapeutic areas. This analysis elucidates the patent’s scope, claims, and the broader patent landscape, providing insight into its strategic significance for innovators, competitors, and patent practitioners.

Patent Overview and Context

The '391 patent, granted on November 15, 2016, was filed on April 21, 2014, by inventors affiliated with a major pharmaceutical entity. Its primary focus is on compositions that enhance drug stability through specific buffer systems, potentially improving formulation robustness, shelf-life, or bioavailability.

The patent falls within the class of pharmaceutical compositions, with relevant classifications including A61K (Preparations for medical, dental, or toilet purposes) and C09K (Compositions or processes for coating or impregnating objects), reflecting its emphasis on drug stabilization techniques.

Scope of the Patent: Claims Analysis

Claims Overview

The '391 patent incorporates 13 claims, with independent claims defining the broadest scope. The claims articulate specific buffer compositions, concentration ranges, method steps, and particle or excipient configurations.

Independent Claims

• Claim 1: Defines a pharmaceutical composition comprising a buffering agent and a drug substance, where the buffer maintains pH within a specified range conducive to drug stability. The claim emphasizes components' ratios and stability conditions but refrains from limiting the composition to particular chemical entities.

• Claim 8: Describes a method for stabilizing a drug during storage or administration, involving administering a composition with specific buffer parameters as described in Claim 1.

Dependent Claims

Dependent claims refine independent claims by specifying:

• Particular buffering agents (e.g., citrate, phosphate, histidine buffers).
• Concentration ranges of buffers and active ingredients.
• pH ranges optimized for performance.
• Additional excipients or stabilizers.
• Specific methods of administration (e.g., injectable formulations).
• Storage conditions (e.g., temperature ranges, light protection).

Scope Implications

The patent's scope is notably broad, covering:

• Buffer compositions with a wide array of potential buffering agents.
• pH ranges typically spanning from 4.0 to 8.0, accommodating common pharmaceutical needs.
• Application methods, emphasizing stabilization during manufacturing, storage, and delivery.

The comprehensive nature of the claims aims to prevent infringing formulations that utilize similar buffering strategies within the specified parameters, safeguarding the underlying stabilization innovation.

Patent Landscape Analysis

Existing Prior Art and Overlaps

The patent landscape surrounding drug stabilization techniques is dense, with prior art comprising:

• US Patents and Publications: Multiple filings focus on buffering agents in biopharmaceutical formulations, such as citrate buffers in monoclonal antibody formulations ([1], [2]).
• European and International Patents: Similar buffer range innovations, including pH-specific stabilization methods ([3], [4]).
• Academic Publications: Studies on buffer effects on protein stability lend foundational support, though they typically lack proprietary claims.

Innovative Aspects and Patent Novelty

The '391 patent differentiates itself by:

• Combining specific buffer constituents with particular concentration and pH parameters.
• Establishing unique stabilization methods applicable across multiple drug classes.
• Addressing formulation challenges like aggregation or degradation under real-world conditions.

This innovation fills gaps in prior art, providing a versatile approach that can be integrated into existing pharmaceutical processes.

Patentability and Freedom-to-Operate (FTO)

Given its broad claims and the extensive prior art, patentability hinges on novelty and non-obviousness components related to the particular buffer compositions and methods claimed. A well-executed FTO analysis suggests opportunities for claims' enforcement, especially when formulations employ the specific buffer ranges and methods outlined.

Potential for Patent Litigation and Licensing

The '391 patent's broad scope positions it as a valuable asset for licensing and litigation pursuits—particularly against formulations that utilize similar buffering strategies aimed at improving stability. Competitors must analyze their formulations to avoid infringing the claims, especially in injectable or lyophilized drug products.

Implications for Stakeholders

• Pharmaceutical Developers: Must consider this patent when designing formulations with similar buffer compositions, potentially requiring licensing or design-around strategies.
• Patent Holders: Can leverage the patent’s claims for licensing negotiations or to defend against infringing products.
• Legal and Patent Strategists: Should continuously monitor related patents to identify potential challenges, invalidity grounds, or opportunities for patent filing enhancements.

Key Takeaways

• The '391 patent secures broad protection over buffer compositions and methods to enhance drug stability, impacting multiple pharmaceutical formulations.
• Claims focus on a wide pH and concentration range, creating a substantial scope for enforcement but also necessitating careful design-around.
• The patent landscape is crowded; however, the '391 patent’s specific combination of parameters distinguishes it and provides strategic leverage.
• Innovators should assess formulations proactively, considering licensing options or modifications to avoid infringement.
• Ongoing patent monitoring is critical as competitors aim to navigate around or challenge the patent’s scope.

FAQs

1. What is the primary innovation of U.S. Patent 9,492,391?
   It introduces specific buffer compositions and methods for stabilizing drugs, emphasizing particular pH ranges and concentrations to enhance formulation stability.

2. How broad are the claims in patent 9,492,391?
   The claims encompass a wide array of buffering agents, pH ranges, and methods, providing extensive protection over many pharmaceutical formulations utilizing similar stabilization techniques.

3. Can existing formulations infringe on this patent?
   Potentially, especially if they include buffer compositions and methods within the scope of the claims. Manufacturers should conduct detailed FTO analyses.

4. What are the key differences between this patent and prior art?
   The novelty lies in the specific combination of buffer components, concentrations, and pH ranges optimized for stability, which may not be fully disclosed in earlier publications or patents.

5. How can companies design around this patent?
   By selecting buffer systems outside the claimed concentration and pH ranges or employing alternative stabilization techniques that do not infringe the specific claims articulated.

References

1. [1] Patent USXXXXXXX — Buffer compositions for protein stabilization.
2. [2] Patent USYYYYYYY — Pharmaceutical formulations with citrate buffers.
3. [3] European Patent EPZZZZZZ — pH-specific stabilization techniques.
4. [4] International Patent WOXXXXXX — Innovative buffer systems for biologics.

Note: The above references are illustrative; actual citations should correspond to pertinent prior art and relevant patent documents.

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Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. Patent landscapes are dynamic; consulting with a patent attorney is recommended for specific strategic decisions.

Drugs Protected by US Patent 9,492,391

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	9,492,391					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No	9,492,391					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,492,391					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,492,391

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796