Details for Patent: 8,003,353

Which drugs does patent 8,003,353 protect, and when does it expire?

Patent 8,003,353 protects NASCOBAL and is included in one NDA.

Summary for Patent: 8,003,353

Title:	Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Abstract:	A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum.times.100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Inventor(s):	Quay; Steven C. (Edmonds, WA), Aprile; Peter C. (East Northport, NY), Go; Zenaida O. (Clifton, NJ), Sileno; Anthony P. (Brookhaven Hamlet, NY)
Assignee:	Par Pharmaceutical, Inc. (Woodcliff Lake, NJ)
Application Number:	12/142,240
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,003,353
Patent Claim Types: see list of patent claims	Use; Formulation;

Understanding the Scope and Claims of United States Patent 8,003,353

Introduction

United States Patent 8,003,353, titled "Cyanocobalamin Low Viscosity Aqueous Formulations for Intranasal Delivery," is a patent held by Endo Pharmaceuticals Inc. This patent is part of a broader landscape of intellectual property related to pharmaceutical formulations, particularly those involving cyanocobalamin (vitamin B12) for intranasal delivery. Here, we will delve into the details of this patent, its claims, and the surrounding patent landscape.

Patent Overview

The patent 8,003,353 was issued by the United States Patent and Trademark Office (USPTO) on August 23, 2011. It pertains to low viscosity aqueous formulations of cyanocobalamin designed for intranasal administration, which is a method of delivering the vitamin directly through the nasal passages[5].

Claims of the Patent

The patent includes several claims that define the scope of the invention. Here are some key aspects:

Independent Claims

• Claim 1 typically defines the broadest scope of the invention, which in this case might include the composition of the aqueous formulation, the concentration of cyanocobalamin, and any specific additives or preservatives.
• Subsequent claims may narrow down the scope by specifying particular concentrations, pH ranges, or other formulation characteristics.

Dependent Claims

• These claims build upon the independent claims and provide additional details or limitations. For example, a dependent claim might specify a particular viscosity range or the presence of a specific excipient.

Method Claims

• The patent may also include method claims related to the preparation, administration, or use of the intranasal formulation.

Detailed Analysis of Claims

To understand the full scope of the patent, it is crucial to analyze each claim individually and in the context of the entire patent.

Claim Construction

Claim construction involves interpreting the language of the claims to determine their scope. This process is critical in patent litigation to determine whether an accused product or process infringes the patent. For example, the claims in patent 8,003,353 would be analyzed to determine what constitutes an infringing formulation and what variations are allowed without infringing the patent[5].

Claim Limitations

Each claim has specific limitations that define what is covered by the patent. For instance, if a claim specifies that the formulation must have a viscosity below a certain threshold, any formulation with a higher viscosity would not be considered an infringement.

Patent Landscape

The patent landscape surrounding 8,003,353 includes other related patents and applications in the field of pharmaceutical formulations, particularly those involving intranasal delivery systems.

Related Patents

• Other patents held by Endo Pharmaceuticals Inc., such as U.S. Patent No. 7,229,636, U.S. Patent No. 7,404,489, and U.S. Patent No. 7,879,349, also relate to cyanocobalamin formulations and delivery methods. These patents collectively form a portfolio that protects various aspects of the technology[5].

International Patents

• The global patent landscape may include equivalent patents or applications filed in other jurisdictions. For example, the European Patent Office (EPO) or the Japan Patent Office (JPO) may have corresponding patents that protect similar formulations or delivery methods in those regions[1].

Litigation and Enforcement

Patent 8,003,353 has been involved in litigation, as seen in the case of Endo Pharmaceuticals Inc. v. Lupin Atlantis Holdings SA. In this case, Endo alleged that Lupin's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the intranasal cyanocobalamin formulation infringed several claims of the patent, including claims 1, 9, and 17 of the '349 patent and other related patents[5].

Impact on the Market

The issuance and enforcement of this patent can significantly impact the market for intranasal cyanocobalamin formulations.

Market Exclusivity

• The patent grants Endo Pharmaceuticals Inc. exclusive rights to manufacture, use, sell, offer for sale, or import the specified formulations until the patent expires. This exclusivity can prevent generic competitors from entering the market, allowing Endo to maintain a monopoly on the product[5].

Innovation

• The protection afforded by the patent can incentivize further innovation in the field. By securing exclusive rights, companies are more likely to invest in research and development to improve existing formulations or develop new ones.

Search and Analysis Tools

To conduct a thorough analysis of the patent landscape, several tools and resources are available:

USPTO Patent Public Search

• This tool allows users to search for existing patents, published patent applications, and other patent documentation. It is particularly useful for identifying prior art and understanding the scope of existing patents[1].

Global Dossier

• This service provides access to the file histories of related applications from participating IP Offices, which can help in understanding the global patent family and any office actions related to the patent[1].

Patent Claims Research Dataset

• This dataset, provided by the USPTO, contains detailed information on claims from U.S. patents and patent applications. It can be used to analyze trends and patterns in patent claims, including those related to pharmaceutical formulations[3].

Key Takeaways

• Patent Scope: The patent 8,003,353 covers specific low viscosity aqueous formulations of cyanocobalamin for intranasal delivery.
• Claims Analysis: Understanding each claim and its limitations is crucial for determining the scope of the patent and potential infringement.
• Patent Landscape: The patent is part of a broader portfolio of related patents and applications, both domestically and internationally.
• Litigation: The patent has been involved in litigation to enforce its claims against potential infringers.
• Market Impact: The patent grants exclusive rights, affecting market competition and innovation in the field.

FAQs

1. What is the main subject of U.S. Patent 8,003,353?

   • The main subject is low viscosity aqueous formulations of cyanocobalamin for intranasal delivery.

2. Who is the holder of U.S. Patent 8,003,353?

   • The patent is held by Endo Pharmaceuticals Inc.

3. What are the key claims of the patent?

   • The key claims include the composition of the aqueous formulation, specific concentrations of cyanocobalamin, and any additional components or characteristics.

4. How does the patent impact the market?

   • The patent grants exclusive rights to Endo Pharmaceuticals Inc., preventing generic competitors and allowing the company to maintain a monopoly on the product.

5. What tools can be used to analyze the patent landscape?

   • Tools such as the USPTO Patent Public Search, Global Dossier, and the Patent Claims Research Dataset can be used to analyze the patent landscape.

Sources

1. USPTO - Search for patents

   • https://www.uspto.gov/patents/search

2. Federal Circuit Ruling: False Patent Claims Can Lead to Lanham Act Violations

   • https://www.bipc.com/federal-circuit-ruling-false-patent-claims-can-lead-to-lanham-act-violations

3. Patent Claims Research Dataset - USPTO

   • https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset

4. U.S. Patent and Trademark Office | U.S. Department of Commerce

   • https://www.commerce.gov/bureaus-and-offices/uspto

5. IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION

   • https://www.pharmacompass.com/pdf/news/nascobal-cyanocobalamin-endo-pharma-v-lupin-atlantis-holdings-sa-1529990695.pdf

Drugs Protected by US Patent 8,003,353

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	8,003,353					NASAL ADMINISTRATION OF CYANOCOBALAMIN