United States Patent 10,376,499: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,376,499 is a significant patent in the pharmaceutical sector, particularly protecting the drug XACDURO (COPACKAGED). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent 10,376,499. While the specific title of the patent is not provided in the sources, it is associated with the protection of XACDURO (COPACKAGED), a pharmaceutical product.
Drug Protection
This patent protects XACDURO (COPACKAGED), which is included in one New Drug Application (NDA)[5].
Scope of the Patent
Claims
The claims of a patent define the scope of the invention and what is protected. For U.S. Patent 10,376,499, the specific claims are not detailed in the provided sources, but they would typically include descriptions of the composition, method of manufacture, and any specific uses or applications of XACDURO (COPACKAGED).
Claim Types
Patent claims can be categorized into different types, such as composition claims, method claims, and use claims. Composition claims would cover the specific formulation of XACDURO, method claims would cover the process of making it, and use claims would cover the therapeutic uses of the drug.
Patent Claims Analysis
Claim Construction
The construction of claims is crucial as it determines the breadth of protection. Claims that are too broad may be challenged for being overly vague or covering prior art, while claims that are too narrow may not provide sufficient protection against infringement.
Dependency and Relationship Between Claims
Claims in a patent can be independent or dependent. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit an independent claim. Understanding the dependency relationship between claims helps in comprehending the overall scope of the patent[3].
Patent Landscape
Related Patents and Patent Family
To understand the broader patent landscape, it is essential to identify related patents and the patent family. This includes continuations, continuations-in-part, and divisional applications. For example, in the case of the Cellect patents, multiple patents within the same family were analyzed for obviousness-type double patenting (ODP)[1].
Expiration and Patent Term
The expiration date of a patent is critical for understanding when the protection ends. Patents typically have a term of 20 years from the earliest filing date, but this can be adjusted due to Patent Term Adjustment (PTA) or Patent Term Extension (PTE). For U.S. Patent 10,376,499, the expiration date would be 20 years from its filing date, unless adjusted by PTA or PTE[1].
Obviousness-Type Double Patenting (ODP)
ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from an earlier patent. This is particularly relevant in cases where multiple patents from the same family are involved, as seen in the Cellect case[1].
Patent Eligibility Under 35 U.S.C. § 101
While U.S. Patent 10,376,499 is a pharmaceutical patent and thus likely to be eligible under 35 U.S.C. § 101, it is important to note that patent eligibility can be a complex issue. Patents must cover a new and useful process, machine, manufacture, or composition of matter, or any improvement thereof. Abstract ideas, laws of nature, and natural phenomena are excluded from patent eligibility[2].
Litigation and Enforcement
Patent litigation can significantly impact the value and enforceability of a patent. For instance, in the case of AI Visualize, Inc. v. Nuance Communications, Inc., the court dismissed the patent infringement claims due to the asserted claims being directed to patent-ineligible subject matter under 35 U.S.C. § 101[2].
Key Takeaways
- Patent Protection: U.S. Patent 10,376,499 protects XACDURO (COPACKAGED), a pharmaceutical product.
- Claims Analysis: Understanding the claims is crucial for determining the scope of protection.
- Patent Landscape: Identifying related patents and the patent family helps in understanding the broader landscape.
- Expiration and Adjustments: The patent term can be adjusted by PTA or PTE.
- ODP Considerations: Ensuring that the patent does not fall under ODP is essential.
- Patent Eligibility: The patent must be eligible under 35 U.S.C. § 101.
FAQs
What is the primary drug protected by U.S. Patent 10,376,499?
The primary drug protected by U.S. Patent 10,376,499 is XACDURO (COPACKAGED).
How long does a typical U.S. patent last?
A typical U.S. patent lasts for 20 years from the earliest filing date, unless adjusted by Patent Term Adjustment (PTA) or Patent Term Extension (PTE).
What is Obviousness-Type Double Patenting (ODP)?
ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from an earlier patent.
How are patent claims constructed and analyzed?
Patent claims are constructed to define the scope of the invention. They are analyzed for their breadth, dependency, and relationship to ensure they provide adequate protection without being overly broad or vague.
What is the significance of 35 U.S.C. § 101 in patent law?
35 U.S.C. § 101 defines what subject matter is eligible for patent protection, excluding abstract ideas, laws of nature, and natural phenomena.
How can the expiration date of a patent be adjusted?
The expiration date of a patent can be adjusted due to Patent Term Adjustment (PTA) for delays during prosecution or Patent Term Extension (PTE) for regulatory delays.
Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit
- AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - United States Court of Appeals for the Federal Circuit
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Pharmaceutical drugs covered by patent 10,376,499 - DrugPatentWatch
