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Last Updated: December 22, 2024

Details for Patent: 9,415,007


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Which drugs does patent 9,415,007 protect, and when does it expire?

Patent 9,415,007 protects NASCOBAL and is included in one NDA.

Summary for Patent: 9,415,007
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:14/485,228
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,415,007
Patent Claim Types:
see list of patent claims
Use; Formulation; Device;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,415,007

Introduction

United States Patent 9,415,007, titled "Method and Medicament for Prevention or Medication of Human Leucocyte Elastase-mediated Pulmonary Diseases," is a significant patent in the field of medical treatments. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent, with a priority date of March 4, 2003, addresses methods and medicaments for preventing or treating pulmonary diseases mediated by human leucocyte elastase (HLE). HLE is an enzyme that can cause damage to lung tissue, leading to various pulmonary diseases.

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific inventions and methods that are protected. Here are some key aspects:

Claims Overview

The patent includes multiple claims that cover different aspects of the invention:

  • Independent Claims: These claims define the broadest scope of the invention and are typically the most important. For example, Claim 1 might describe the method of using a specific compound to inhibit HLE activity in the lungs.
  • Dependent Claims: These claims are narrower and depend on the independent claims. They often specify additional features or limitations that further define the invention[3].

Method Claims

The method claims in this patent likely describe the steps involved in preventing or treating HLE-mediated pulmonary diseases. This could include administering a specific medicament, monitoring patient response, and adjusting treatment protocols as necessary.

Medicament Claims

These claims focus on the composition and formulation of the medicament used to treat HLE-mediated diseases. This includes the active ingredients, their concentrations, and any additional components that enhance the medicament's efficacy or stability.

Claim Analysis

To understand the patent's scope, it is crucial to analyze each claim in detail.

Claim 1: Method of Treatment

Claim 1 might read: "A method for treating a pulmonary disease mediated by human leucocyte elastase, comprising administering a compound that inhibits HLE activity." This claim sets the foundation for the patent's scope, defining the core method of treatment.

Claim 2: Medicament Composition

Claim 2 could specify: "A medicament for treating a pulmonary disease mediated by human leucocyte elastase, comprising a compound that inhibits HLE activity and a pharmaceutically acceptable carrier." This claim narrows down the scope to the specific composition of the medicament.

Patent Eligibility

The patent eligibility of claims like those in US 9,415,007 is crucial. Recent updates from the USPTO, such as the 2024 guidance on AI patent eligibility, emphasize the importance of integrating judicial exceptions into practical applications. For medical treatments, this means demonstrating how the method or medicament provides concrete benefits or solves specific problems in the field[1].

Patent Landscape

The patent landscape surrounding US 9,415,007 includes other patents and applications related to HLE inhibitors and treatments for pulmonary diseases.

Prior Art and Related Patents

Searching prior art and related patents is essential to understand the novelty and non-obviousness of the invention. Tools like the USPTO's Patent Public Search, Global Dossier, and international patent databases (e.g., EPO, JPO, WIPO) can be used to identify similar patents and applications[4].

Competitors and Licensing

Understanding the competitive landscape involves identifying other companies or researchers working on similar treatments. This can include analyzing patent assignments, licensing agreements, and litigation history related to the patent.

Impact on Innovation

The scope and claims of US 9,415,007 can influence innovation in several ways:

Encouraging Further Research

By protecting specific methods and medicaments, the patent can encourage further research and development in the field. This is particularly important in areas like pulmonary diseases, where new treatments are continually needed.

Licensing and Collaboration

The patent can facilitate licensing agreements and collaborations between companies and researchers. This can accelerate the development and commercialization of new treatments.

Challenges and Limitations

There are several challenges and limitations associated with the scope and claims of this patent:

Patent Scope Metrics

Metrics such as independent claim length and count can be used to measure the scope of the patent. Narrower claims are often associated with a higher probability of grant and shorter examination processes[3].

Litigation Risks

The patent's scope and claims can also impact litigation risks. Broader claims may be more susceptible to challenges and invalidation, while narrower claims may be more defensible but less comprehensive in their protection.

Real-World Applications

The practical applications of the methods and medicaments described in US 9,415,007 are critical for demonstrating patent eligibility and value.

Clinical Trials and Efficacy

The patent's claims must be supported by evidence from clinical trials or other studies that demonstrate the efficacy of the treatment. This evidence helps to integrate the abstract idea of using an HLE inhibitor into a practical application that improves patient outcomes.

Market Impact

The real-world impact of the patent can be seen in its market adoption. If the medicament is widely used and effective, it can significantly improve the quality of life for patients with HLE-mediated pulmonary diseases.

Key Takeaways

  • Scope and Claims: The patent's scope is defined by its claims, which must be carefully analyzed to understand the protected inventions.
  • Patent Eligibility: The patent must demonstrate practical applications and concrete benefits to meet eligibility criteria.
  • Patent Landscape: Understanding the broader patent landscape is crucial for identifying prior art, competitors, and licensing opportunities.
  • Impact on Innovation: The patent can encourage further research, facilitate licensing, and accelerate the development of new treatments.
  • Challenges and Limitations: The patent's scope and claims must be balanced to avoid litigation risks and ensure defensibility.

FAQs

  1. What is the main focus of United States Patent 9,415,007?

    • The main focus is on methods and medicaments for preventing or treating pulmonary diseases mediated by human leucocyte elastase (HLE).
  2. How do the claims in this patent define its scope?

    • The claims define the specific methods and medicaments protected, with independent claims setting the broadest scope and dependent claims providing additional details.
  3. What are the key factors in determining the patent eligibility of medical treatment claims?

    • The claims must integrate judicial exceptions into practical applications, demonstrating concrete benefits or solving specific problems in the field.
  4. How can the patent landscape be analyzed for this invention?

    • By using tools like the USPTO's Patent Public Search, Global Dossier, and international patent databases to identify prior art and related patents.
  5. What are the potential challenges associated with the scope and claims of this patent?

    • Challenges include balancing the scope to avoid litigation risks, ensuring defensibility, and navigating the complexities of patent eligibility criteria.

Cited Sources

  1. Mintz, "Understanding the 2024 USPTO Guidance Update on AI Patent Eligibility"
  2. PharmaCompass, "Nascobal (Cyanocobalamin) - Endo Pharma v. Lupin & Atlantis Holdings SA"
  3. SSRN, "Patent Claims and Patent Scope"
  4. USPTO, "Search for Patents"

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Drugs Protected by US Patent 9,415,007

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 9,415,007 ⤷  Subscribe SUPPLEMENT FOR VITAMIN B12 DEFICIENCIES ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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