Comprehensive Analysis of US Patent 10,105,374: Scope, Claims, and Patent Landscape
The United States Patent 10,105,374, titled "Controlled release oral pharmaceutical compositions of budesonide," represents a significant development in the field of pharmaceutical formulations. This patent, which is part of the "Villa I patents" family, claims priority to a 1999 application and focuses on controlled release budesonide formulations with a tablet core inside a gastro-resistant coating[1]. Let's delve into the intricacies of this patent, exploring its scope, claims, and the broader patent landscape it inhabits.
Understanding the Patent's Core Technology
At its heart, US Patent 10,105,374 revolves around a novel approach to delivering budesonide, a corticosteroid used to treat various inflammatory conditions. The key innovation lies in the controlled release mechanism, which allows for a more targeted and efficient delivery of the active ingredient.
The Matrix Structure: A Key Component
One of the central elements of this patent is the concept of a "matrix" structure. This term has been a point of contention in legal proceedings, with different interpretations proposed by various parties[2].
The Court agrees it must consider the post-allowance statements as intrinsic evidence but also concludes that their context should be considered as well.[2]
The court's interpretation of the matrix structure as "a homogeneous structure in all its volume" has significant implications for the patent's scope and potential infringement cases.
Analyzing the Patent Claims
The claims of a patent define the boundaries of the invention's legal protection. In the case of US Patent 10,105,374, the claims focus on several key aspects:
1. Controlled Release Mechanism
The patent claims a specific method of controlling the release of budesonide, which is crucial for its therapeutic efficacy.
2. Tablet Core Composition
The composition of the tablet core, including the matrix structure, is detailed in the claims.
3. Gastro-resistant Coating
The patent describes a gastro-resistant coating, which plays a vital role in ensuring the drug reaches its intended target in the gastrointestinal tract.
The Patent Landscape: Contextualizing US Patent 10,105,374
To fully appreciate the significance of this patent, it's essential to consider the broader patent landscape in which it exists.
Recent Trends in Pharmaceutical Patents
The pharmaceutical industry has seen a surge in patent filings, with a particular focus on drug delivery systems and controlled release formulations. In 2024, there was a notable increase in patent litigation filings, reaching approximately 3,667 cases[3].
Venue Shifts in Patent Litigation
Interestingly, 2024 saw a shift in the preferred venues for patent litigation. The Eastern District of Texas experienced a significant increase in filings, while the Western District of Texas saw a decrease[3]. This shift can be attributed to changes in court policies, particularly regarding the assignment of patent cases to judges.
The Impact of USPTO Fee Changes
In January 2025, the USPTO implemented new patent fee changes, which have implications for patent applicants and holders[3]. These changes include:
- An increase in design issue fees from $740 to $1,300
- Requests for continued examination (RCE) fees rising from $2,000 to $2,860
- Patent term extension application fees increasing from $1,180 to $2,500
These fee adjustments are designed to enhance patent examination quality and achieve pendency goals, but they also represent an additional cost consideration for patent applicants.
Measuring Patent Scope: Insights from Recent Research
Recent studies have proposed simple metrics for measuring patent scope based on claim language. Two key metrics are:
- Independent claim length
- Independent claim count
These metrics have shown explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[6].
The Importance of Claim Scope in US Patent Applications
While broader claims may seem desirable, they often face more challenges during the examination process and are more vulnerable to invalidation attempts. The ideal claim scope depends on various factors, including:
- The nature of the invention
- The level of prior art
- The applicant's budget
- The specific technical field[9]
Balancing Breadth and Validity
Finding the right balance between claim breadth and validity is crucial. In fields with numerous patent applications, broader claims are more likely to encounter prior art references, making them harder to obtain and more expensive to prosecute[9].
The Role of AI in Patent Examination
As we look to the future, the role of artificial intelligence in patent examination is becoming increasingly significant. In 2024, the USPTO released guidance on patent subject matter eligibility, including considerations for AI-related inventions[4]. This development reflects the growing importance of AI in various fields of innovation and the need for patent systems to adapt accordingly.
Key Takeaways
- US Patent 10,105,374 represents a significant innovation in controlled release budesonide formulations.
- The interpretation of the "matrix" structure is crucial to understanding the patent's scope.
- Recent changes in patent litigation venues and USPTO fees impact the broader patent landscape.
- Measuring patent scope through claim language metrics can provide valuable insights.
- Finding the right claim scope balance is essential for effective patent protection.
- The role of AI in patent examination is an emerging area of focus for the USPTO.
FAQs
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Q: What is the primary innovation claimed in US Patent 10,105,374?
A: The patent claims a controlled release oral pharmaceutical composition of budesonide, featuring a tablet core with a specific matrix structure inside a gastro-resistant coating.
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Q: How has the patent litigation landscape changed in recent years?
A: There has been a shift in preferred venues, with the Eastern District of Texas seeing an increase in filings while the Western District of Texas experienced a decrease.
-
Q: What are some simple metrics for measuring patent scope?
A: Recent research suggests using independent claim length and independent claim count as metrics for measuring patent scope.
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Q: How do the recent USPTO fee changes affect patent applicants?
A: The fee changes, implemented in January 2025, represent an overall increase in USPTO fees, which may impact patent prosecution strategies and costs for applicants.
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Q: What role is AI playing in patent examination?
A: The USPTO has released guidance on patent subject matter eligibility that includes considerations for AI-related inventions, reflecting the growing importance of AI in innovation and patent systems.
Sources cited:
[1] https://www.pharmaipcircle.com/uncategorized/budesonide-usa/
[2] https://casetext.com/case/valeant-pharm-intl-v-actavis-labs-fl-inc
[3] https://www.jdsupra.com/legalnews/2024-patent-landscape-year-in-review-9676906/
[4] https://www.federalregister.gov/documents/2024/07/17/2024-15377/2024-guidance-update-on-patent-subject-matter-eligibility-including-on-artificial-intelligence
[6] https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
[9] https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
