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Last Updated: December 24, 2024

Details for Patent: 7,229,636


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Which drugs does patent 7,229,636 protect, and when does it expire?

Patent 7,229,636 protects NASCOBAL and is included in one NDA.

Summary for Patent: 7,229,636
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: Nastech Pharmaceutical Company Inc. (Bothell, WA)
Application Number:10/787,385
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,229,636
Patent Claim Types:
see list of patent claims
Formulation; Compound; Use;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 7,229,636

Introduction

Understanding the scope and claims of a patent is crucial for innovators, particularly in the pharmaceutical and biotechnology industries, where patent protection is a cornerstone of commercialization strategies. This article delves into the specifics of United States Patent 7,229,636, examining its claims, scope, and the broader patent landscape it operates within.

Patent Overview

Patent Number: 7,229,636 Title: Methods for Determining Positions of Reaction Chambers in a Microfluidic Device Assignee: Fluidigm Corporation Inventors: Simant Dube, Gang Sun, Lian-She Zhao Filed: September 13, 2007 Date of Patent: November 1, 2011

Claims and Scope

The patent 7,229,636 pertains to methods for determining the positions of reaction chambers in a microfluidic device. Here are the key aspects of its claims:

Method of Determining Positions

  • The method involves providing a baseline image and a template image of a reaction chamber.
  • It includes selecting a region of the baseline image and performing a matching process to match the template image to portions of the selected region.
  • The position of the first chamber is determined, and subsequent chambers' positions are predicted by repeating the matching process[1].

Key Claims

  • Claim 1: A method of determining a plurality of positions associated with a plurality of reaction chambers of a microfluidic device, including providing a baseline image and a template image, selecting a region, and performing a matching process.
  • Claim 2-10: Various embodiments and steps involved in the method, including predicting the position of subsequent chambers and repeating the process for multiple chambers.

Technical Details

The patent describes a detailed process for image analysis and data processing to accurately determine the positions of reaction chambers. This involves:

Image Analysis

  • Capturing and analyzing images of the microfluidic device to identify the reaction chambers.
  • Using a template image to match against the baseline image to locate the chambers[1].

Data Processing

  • Performing data analysis on the captured images to determine the optical intensities and threshold values associated with each chamber.
  • This data is crucial for ensuring the accurate positioning and functioning of the microfluidic device[1].

Patent Landscape

The patent landscape for microfluidic devices and related technologies is complex and highly competitive.

Industry Context

  • Microfluidic devices are critical in various biomedical and pharmaceutical applications, including PCR (Polymerase Chain Reaction), DNA sequencing, and drug discovery.
  • The market for microfluidic devices is growing rapidly, driven by advancements in technology and increasing demand for precise and efficient analytical tools[3].

Legal and Regulatory Aspects

  • Patents in this field must navigate stringent disclosure requirements under 35 U.S.C. ยง 112(a), which mandates that the specification must be in "such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same"[3].
  • The Federal Circuit's recent jurisprudence on genus claims has made it challenging to obtain broad patent protection, as claims must be narrowly defined to avoid invalidation[3].

Impact on Innovators

For innovators in the microfluidic and biotechnology sectors, this patent highlights several key considerations:

Patent Strategy

  • Drafting patent claims that are neither too broad nor too narrow is crucial. Broad claims risk being invalidated, while narrow claims can be easily designed around[3].
  • The process of drafting claims involves a delicate balance between capturing the full scope of the invention and ensuring that the claims are commensurate with what is taught in the patent application[3].

Competitive Landscape

  • Companies like Fluidigm Corporation, which holds this patent, must continuously innovate and protect their intellectual property to maintain a competitive edge.
  • The ability to accurately determine reaction chamber positions is a critical aspect of microfluidic technology, and patents like 7,229,636 play a significant role in safeguarding this intellectual property[1].

Industry Expert Insights

Industry experts emphasize the importance of robust patent protection in the biotechnology and pharmaceutical sectors.

"Billions of dollars are necessary to move a novel scientific finding forward to the point of bringing a product to market. Robust and predictable patent protection is essential to support these commercialization strategies."[3]

Statistics and Market Trends

  • The market for therapeutic antibodies, a significant area where microfluidic devices are used, is projected to reach $300 billion by 2025[3].
  • The increasing demand for precise analytical tools in biomedical research and drug development drives the growth of the microfluidic device market.

Key Takeaways

  • Patent Claims: The patent 7,229,636 focuses on methods for determining reaction chamber positions in microfluidic devices, emphasizing the importance of accurate image analysis and data processing.
  • Industry Context: The patent operates within a highly competitive and technologically advanced field, where robust patent protection is crucial.
  • Legal Considerations: Innovators must navigate stringent disclosure requirements and the challenges posed by recent jurisprudence on genus claims.
  • Market Impact: The patent contributes to the growing market for microfluidic devices, driven by advancements in technology and increasing demand for precise analytical tools.

FAQs

Q1: What is the primary focus of United States Patent 7,229,636? A1: The primary focus is on methods for determining the positions of reaction chambers in a microfluidic device.

Q2: Who are the inventors of this patent? A2: The inventors are Simant Dube, Gang Sun, and Lian-She Zhao.

Q3: What are the key steps involved in the method described in the patent? A3: The method involves providing a baseline image and a template image, selecting a region, performing a matching process, and predicting the positions of subsequent chambers.

Q4: Why is accurate positioning of reaction chambers important in microfluidic devices? A4: Accurate positioning is crucial for ensuring the precise functioning of microfluidic devices, which are used in various biomedical and pharmaceutical applications.

Q5: How does the recent jurisprudence on genus claims affect patents in the biotechnology sector? A5: The recent jurisprudence makes it challenging to obtain broad patent protection, as claims must be narrowly defined to avoid invalidation, and innovators must balance between capturing the full scope of the invention and ensuring compliance with disclosure requirements.

Sources

  1. Justia Patents: Cobalamin (i.e., Vitamin B12, Lld Factor) Patents and Patent Applications.
  2. Robins Kaplan LLP: ANDA Litigation Settlements.
  3. DigitalCommons@NYLS: Eviscerating Patent Scope.

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Drugs Protected by US Patent 7,229,636

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 7,229,636 ⤷  Subscribe Y NASAL ADMINISTRATION OF CYANOCOBALAMIN ⤷  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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