United States Patent 9,101,637: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,101,637, hereafter referred to as the '637 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent protects a specific formulation and method of use related to the drug Vazalore. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Abstract
The '637 patent is titled "Pharmaceutical Compositions and Methods of Use Thereof" and pertains to novel formulations and methods for delivering a specific active ingredient. The abstract outlines the invention's focus on improving the bioavailability and stability of the drug, enhancing patient compliance, and reducing side effects.
Scope of the Patent
Claims
The '637 patent includes multiple claims that define the scope of the invention. These claims can be categorized into several types:
Independent Claims
- Claim 1 typically defines the broadest scope of the invention, often describing the composition or method in general terms.
- For example, Claim 1 might describe a pharmaceutical composition comprising a specific active ingredient, a carrier, and optional excipients, along with the method of preparing and administering the composition[5].
Dependent Claims
- These claims narrow down the scope by adding specific limitations to the independent claims.
- For instance, dependent claims might specify particular ratios of active ingredients to carriers, specific excipients, or detailed methods of administration.
Method Claims
- These claims focus on the process of preparing the pharmaceutical composition or the method of treating a condition using the composition.
- Method claims are crucial as they protect the unique steps and procedures developed by the inventors.
Scope Concepts
To analyze the scope effectively, it is helpful to categorize the claims by overarching scope concepts. This approach, as described in patent analytics, involves grouping claims based on similar technological or methodological aspects. This helps in identifying gaps in coverage and potential future directions[3].
Patent Landscape
Related Patents and Prior Art
The '637 patent exists within a broader landscape of related patents and prior art. Here are some key points:
Prior Art
- The patent office and the applicant would have considered prior art during the examination process. This includes earlier patents, publications, and other publicly available information that could affect the patentability of the '637 patent.
- For example, if similar formulations or methods were disclosed in earlier patents or publications, they would be considered as prior art[1].
Family Patents
- The '637 patent may be part of a patent family, which includes other patents and applications that share a common priority date or are related through continuation or divisional applications.
- These family patents can provide additional protection and extend the scope of the invention[2].
Competitor Patents
- Competitors in the pharmaceutical industry may hold patents that are similar or overlapping with the '637 patent.
- Analyzing these competitor patents is crucial for understanding the competitive landscape and identifying potential infringement risks or opportunities for collaboration[3].
Exclusivity and Market Impact
FDA Approval and Orange Book Listing
The '637 patent is likely listed in the FDA's Orange Book, which compiles patent information for approved drug products. This listing is critical for understanding the exclusivity period and potential generic competition.
Exclusivity Periods
- The patent's listing in the Orange Book indicates the exclusivity period during which generic versions of the drug cannot be approved.
- For Vazalore, the exclusivity periods and patent expirations are closely monitored to predict when generic competition might arise[2].
Generic Competition
- The expiration dates of the '637 patent and related patents are significant for generic drug manufacturers.
- Once the patent expires, generic versions can be approved, potentially changing the market dynamics and pricing strategies[5].
Maintenance and Expiration
Patent Maintenance Fees
To keep the '637 patent in force, the patent owner must pay maintenance fees at specified intervals (e.g., 3.5, 7.5, and 11.5 years after grant).
- Failure to pay these fees can result in the patent lapsing or expiring prematurely[5].
Expiration Date
The '637 patent has a specific expiration date, after which the invention enters the public domain.
- For Vazalore, the critical patent expiration dates have been tracked, with some patents already expired and others set to expire in the near future[5].
Strategic Analysis
Claim Coverage Matrix
Using a Claim Coverage Matrix, as described in patent analytics, helps in understanding which patents and claims are actively protecting the intellectual property.
- This matrix can highlight gaps in coverage and identify future design opportunities, ensuring that the company's products are adequately protected[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can facilitate a quick and accurate review of patent coverage.
- These charts help technical experts, engineers, and management to determine whether a particular scope concept is applicable to a target product or method, and to spot areas where claim coverage is lacking[3].
Key Takeaways
- Scope and Claims: The '637 patent's scope is defined by its claims, which include independent, dependent, and method claims.
- Patent Landscape: The patent exists within a broader landscape of related patents, prior art, and competitor patents.
- Exclusivity and Market Impact: Listing in the FDA's Orange Book and exclusivity periods are crucial for understanding market dynamics.
- Maintenance and Expiration: Regular maintenance fees and expiration dates are vital for maintaining patent validity.
- Strategic Analysis: Tools like Claim Coverage Matrix and claim charts are essential for strategic patent management.
FAQs
Q: What is the significance of the '637 patent in the pharmaceutical industry?
A: The '637 patent protects a novel formulation and method of use for the drug Vazalore, enhancing its bioavailability and stability, and is significant for maintaining market exclusivity.
Q: How does the FDA's Orange Book impact the '637 patent?
A: The Orange Book listing indicates the exclusivity period and patent expiration dates, affecting when generic versions of the drug can be approved.
Q: What happens if the maintenance fees for the '637 patent are not paid?
A: Failure to pay maintenance fees can result in the patent lapsing or expiring prematurely.
Q: How can a Claim Coverage Matrix help in managing the '637 patent?
A: A Claim Coverage Matrix helps in identifying which patents and claims are actively protecting the intellectual property, highlighting gaps and future design opportunities.
Q: What is the role of claim charts in patent analysis?
A: Claim charts facilitate a quick and accurate review of patent coverage, helping to determine if there are gaps in current coverage and highlighting future design opportunities.
Sources
- Sotera v. Masimo Wireless IPR2020-01019 - USPTO
- USPTO-FDA Report on Drug Patent and Exclusivity - USPTO
- Patent Analytics - Schwegman
- US6011991A - Communication system and method including brain activity - Google Patents
- Vazalore patent expiration - Pharsight
