Details for Patent: 8,653,033

Which drugs does patent 8,653,033 protect, and when does it expire?

Patent 8,653,033 protects PRIALT and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 8,653,033

Title:	Method for administering omega-conopeptide
Abstract:	The present invention is directed to a method of producing analgesia in a mammalian subject. The method includes administering to the subject an omega conopeptide, preferably ziconotide, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil, or its pharmaceutically acceptable salts thereof, wherein the .omega.-conopeptide retains its potency and is physically and chemically compatible with the analgesic compound. A preferred route of administration is intrathecal administration, particularly continuous intrathecal infusion. The present invention is also directed to a pharmaceutical formulation comprising an omega conopeptide, preferably ziconotide, an antioxidant, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil.
Inventor(s):	Ellis; David J. (Los Altos, CA), Miljanich; George P. (Redwood City, CA), Shields; David E. (San Lorenzo, CA)
Assignee:	Jazz Pharmaceuticals International Limited (Hamilton, BM)
Application Number:	13/791,715
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Understanding the Scope and Claims of United States Patent 8,653,033: A Comprehensive Analysis

Introduction

When analyzing a patent, particularly one like United States Patent 8,653,033, it is crucial to delve into its scope, claims, and the broader patent landscape. This analysis will help in understanding the patent's validity, its position within the industry, and potential implications for innovation and litigation.

Patent Search and Retrieval

To begin, one must locate and retrieve the patent document. The USPTO provides several tools for this purpose, including the Patent Public Search tool, which has replaced legacy search tools like PubEast and PubWest. This modern interface offers enhanced access to prior art and is essential for conducting a thorough patent search[1].

Patent Details: United States Patent 8,653,033

Patent Title and Abstract

The title and abstract of the patent provide a preliminary understanding of the invention. For example, if the patent is related to a specific technological innovation, the title and abstract will outline the key aspects of this innovation.

Claims

The claims section is the most critical part of a patent, as it defines the scope of the invention. There are two types of claims: independent and dependent. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The number and complexity of claims can indicate the breadth and specificity of the patent[3].

Claim Construction

Claim construction is the process of interpreting the meaning of the claims. This is often a point of contention in patent litigation, as the interpretation can significantly affect the patent's scope. The courts use various tools, including the patent specification and prosecution history, to determine the correct interpretation of the claims[2].

Patent Scope and Breadth

Metrics for Measuring Patent Scope

Research has identified simple metrics to measure patent scope, such as independent claim length and independent claim count. These metrics can indicate the breadth of the patent and have been shown to correlate with other indicators of patent scope, such as patent maintenance payments, forward citations, and the breadth of patent classes[3].

Narrowing Claims During Examination

The patent examination process often results in the narrowing of claims to ensure they are specific and valid. Studies have shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This process helps in refining the patent scope to avoid overly broad claims that could lead to litigation[3].

Prior Art and Written Description

Prior Art Search

Conducting a thorough prior art search is essential to ensure the novelty and non-obviousness of the invention. Tools like the Common Citation Document (CCD) and international patent databases (e.g., EPO's esp@cenet, JPO, and WIPO's PATENTSCOPE) help in identifying relevant prior art[1].

Written Description Requirement

The written description requirement, as outlined in 35 U.S.C. § 112, ensures that the patent application describes the invention in sufficient detail. This requirement prevents applicants from asserting claims they did not actually invent. The Board's analysis in cases like Regents of the University of Minnesota v. Gilead Sciences, Inc. highlights the importance of this requirement in determining patent validity[2].

Patent Landscape and Industry Impact

International Patent Offices

The global patent landscape is crucial when assessing the impact of a U.S. patent. Databases from international patent offices, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO), provide insights into similar inventions and prior art worldwide[1].

Litigation and Licensing

The scope and claims of a patent can significantly affect litigation and licensing strategies. Overly broad patents can lead to increased litigation costs, while well-defined patents can facilitate licensing agreements. The study on small claims patent courts by the Administrative Conference of the United States (ACUS) also highlights the need for efficient dispute resolution mechanisms in the patent system[5].

Case Studies and Legal Precedents

Inter Partes Review (IPR)

Cases like Regents of the University of Minnesota v. Gilead Sciences, Inc. illustrate the importance of inter partes review (IPR) in challenging patent claims. IPR proceedings can result in the invalidation of claims if they are found to be anticipated by prior art or lack sufficient written description[2].

Key Takeaways

• Thorough Search: Conduct a comprehensive prior art search using tools like the Patent Public Search and international patent databases.
• Claim Construction: Carefully interpret claims to understand the patent's scope and potential for litigation.
• Patent Scope Metrics: Use metrics like independent claim length and count to assess the breadth of the patent.
• Global Landscape: Consider the global patent landscape to understand the invention's novelty and non-obviousness.
• Litigation and Licensing: Well-defined patents can reduce litigation costs and facilitate licensing agreements.

FAQs

What is the importance of the written description requirement in patent law?

The written description requirement ensures that the patent application describes the invention in sufficient detail, preventing applicants from asserting claims they did not actually invent.

How can one measure the scope of a patent?

Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent. These metrics correlate with other indicators like patent maintenance payments and forward citations.

What is the role of inter partes review (IPR) in patent law?

IPR is a process that allows parties to challenge the validity of patent claims. It can result in the invalidation of claims if they are found to be anticipated by prior art or lack sufficient written description.

How does the global patent landscape affect U.S. patents?

The global patent landscape is crucial as it provides insights into similar inventions and prior art worldwide. This helps in ensuring the novelty and non-obviousness of the invention.

What are the potential implications of overly broad patents?

Overly broad patents can lead to increased litigation costs and diminish the incentives for innovation due to licensing and litigation complexities.

Sources

1. USPTO: Search for patents - USPTO
2. CAFC: Regents of the University of Minnesota v. Gilead Sciences, Inc.
3. SSRN: Patent Claims and Patent Scope
4. Federal Register: Request for Comments on USPTO Initiatives To Ensure the ...
5. ACUS: U.S. Patent Small Claims Court

Drugs Protected by US Patent 8,653,033

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes	8,653,033					ANALGESIA
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes	8,653,033					TREATMENT OF PAIN
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No	8,653,033					ANALGESIA
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No	8,653,033					TREATMENT OF PAIN
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004		RX	Yes	Yes	8,653,033					TREATMENT OF PAIN
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004		RX	Yes	Yes	8,653,033					ANALGESIA
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes	8,653,033					TREATMENT OF PAIN

International Family Members for US Patent 8,653,033

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2540895
Canada	2930900
European Patent Office	1689401
Japan	2007507538
Japan	2011173931
World Intellectual Property Organization (WIPO)	2005032556