Details for Patent: 10,092,559

Which drugs does patent 10,092,559 protect, and when does it expire?

Patent 10,092,559 protects ZOHYDRO ER and is included in one NDA.

This patent has twenty-nine patent family members in twenty-three countries.

Summary for Patent: 10,092,559

Title:	Abuse resistant pharmaceutical compositions
Abstract:	The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.
Inventor(s):	Rekhi; Gurvinder Singh (Suwanee, GA), Sidwell; Richard (Cumming, GA)
Assignee:	Recro Gainesville LLC (Gainesville, GA)
Application Number:	15/626,268
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Understanding the Scope and Claims of a US Patent: A Detailed Analysis

Introduction

When navigating the complex world of patents, understanding the scope and claims of a patent is crucial for inventors, businesses, and legal professionals. This article will delve into the specifics of patent claims, the importance of claim scope, and the broader patent landscape, using the example of United States Patent 10,092,559.

What are Patent Claims?

Patent claims are the heart of a patent application, defining the scope of the patent's protection. These claims must be clear, concise, and exact to comply with federal statutes[4].

Importance of Claim Scope

The claim scope is not just about breadth; it is about precision and relevance. A common misconception is that broader claims are better, but this can lead to easier invalidation and higher costs during the patent granting process[5].

Factors Influencing Claim Scope

Several factors determine the right claim scope:

• The Actual Invention: Claims must be anchored to the embodiments disclosed in the specification.
• Prior Art: In fields with extensive prior art, broader claims are harder to get allowed.
• Client’s Budget: Broader claims can be more expensive to prosecute.
• Technical Field: The technical field's complexity and the number of existing patents affect claim scope[5].

Patent Quality and Claim Clarity

Patent quality is closely tied to claim clarity. The USPTO has emphasized the need for clear and concise claims to ensure that patents meet statutory requirements. Unclear or overly broad claims can lead to difficulties in examination and increased litigation risks[1].

Metrics for Measuring Patent Scope

Researchers have proposed metrics such as independent claim length and independent claim count to measure patent scope. These metrics have explanatory power for correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3].

The Examination Process

During the examination process, patent examiners review claims for compliance with legal requirements and conduct prior art searches to determine if the claimed invention is useful, novel, and non-obvious. The process often narrows the scope of patent claims, especially when the examination duration is longer[3].

Case Studies: Risks of Overly Broad Claims

Overly broad claims can be invalidated on grounds such as the abstract idea exception or failure to meet the written description requirement. For example, in Yu v. Apple Inc., the Federal Circuit court invalidated a claim because it was directed to an abstract idea rather than a specific means or method that improves the relevant technology[5].

United States Patent 10,092,559: A Case Study

While specific details of United States Patent 10,092,559 are not provided here, the principles outlined above apply universally. Here’s how one might analyze such a patent:

Claim Analysis

• Claim Language: Are the claims clear, concise, and exact? Do they avoid overly broad language that could lead to invalidation?
• Claim Scope: Are the claims anchored to the embodiments disclosed in the specification? Do they cover the invention adequately without being too broad?

Prior Art Search

• Has a thorough prior art search been conducted to ensure the claims are novel and non-obvious?
• Are there any existing patents or publications that could challenge the validity of the claims?

Examination Process

• How did the examination process affect the claim scope? Were the claims narrowed during the process?
• Did the patent examiner use additional tools, such as a glossary of key terms, to ensure clarity?

Best Practices for Drafting Claims

To avoid common pitfalls:

• Precision Over Breadth: Aim for claims that are precise and relevant to the invention.
• Anchored to Specification: Ensure claims are supported by the embodiments described in the specification.
• Use of Clarity Tools: Consider using tools like a glossary of terms or claim charts to enhance clarity, although the USPTO does not currently require these[1].

The Role of USPTO in Ensuring Patent Quality

The USPTO has taken several steps to improve patent quality, including the Enhanced Patent Quality Initiative. This initiative includes defining patent quality, reassessing examination times, and analyzing the effects of incentives on patent quality. However, there is still a need for a consistent definition of patent quality articulated in agency documents and guidance[1].

Key Takeaways

• Claim Clarity: Clear and concise claims are essential for patent quality and validity.
• Precision: Precision in claim scope is more important than breadth.
• Prior Art: Thorough prior art searches are crucial to ensure novelty and non-obviousness.
• Examination Process: The examination process can significantly narrow claim scope.
• Best Practices: Use clarity tools and ensure claims are anchored to the specification.

FAQs

Q: What is the primary purpose of patent claims in a patent application? A: The primary purpose of patent claims is to define the scope of the patent's protection, ensuring that the invention is clearly and concisely described.

Q: Why are overly broad claims risky? A: Overly broad claims are risky because they can be easier to invalidate and may not meet statutory requirements, such as the written description requirement or the abstract idea exception.

Q: How does the USPTO ensure patent quality? A: The USPTO ensures patent quality through initiatives like the Enhanced Patent Quality Initiative, which includes defining patent quality, reassessing examination times, and analyzing the effects of incentives on patent quality.

Q: What metrics can be used to measure patent scope? A: Metrics such as independent claim length and independent claim count can be used to measure patent scope and have explanatory power for several correlates of patent scope.

Q: Why is it important to conduct a thorough prior art search? A: Conducting a thorough prior art search is important to ensure that the claimed invention is novel and non-obvious, thereby validating the patent claims.

Sources

1. GAO Report: Intellectual Property: Patent Office Should Define Quality, Reassess Examination Time, and Analyze Incentives.
2. USAGov: U.S. Patent and Trademark Office (USPTO).
3. SSRN Paper: Patent Claims and Patent Scope.
4. Maryland People's Law Library: Patents.
5. Rimon Law: The Importance of Getting the Claim Scope Right in a US Patent Application.

Drugs Protected by US Patent 10,092,559

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN

International Family Members for US Patent 10,092,559

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015313785
Australia	2020203841
Brazil	112017004882
Canada	2870380
China	107106503
China	111632041