United States Patent 9,421,184: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,421,184, issued on August 23, 2016, is a significant patent related to the use of givinostat, a drug with potential therapeutic applications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Inventors and Assignees
The patent was invented by Valentina Saccone, Silvia Consalvi, Pier Lorenzo Puri, and Paolo Mascagni, and is assigned to ITALFARMACO S.P.A.[1].
Patent Claims
The patent claims a method of using givinostat, specifically as the hydrochloride salt, for therapeutic purposes. The claims are detailed and specify the use of givinostat in various medical contexts.
Claim Structure
The claims are structured to define the method of using givinostat, including the dosage forms and the conditions it is intended to treat. The independent claims are crucial as they define the broadest scope of the invention, while dependent claims further narrow down the specifics of the method[2].
Claim Scope
The scope of the claims is an important aspect of patent analysis. For US Patent 9,421,184, the claims are designed to cover a specific method of using givinostat, ensuring that the patent holder has exclusive rights over this particular use. The scope is defined by the language of the claims, which must be clear and definite to avoid ambiguity and potential litigation[3].
Patent Scope Metrics
To measure the scope of a patent, metrics such as independent claim length and independent claim count can be used. These metrics help in understanding the breadth and clarity of the patent claims. For US Patent 9,421,184, the independent claims are detailed, indicating a focused scope rather than an overly broad one[3].
Regulatory Review and Approval
The patent is associated with the regulatory review process for the drug product DuvyzatTM, which contains givinostat as its active ingredient. The approval phase, from the initial submission of the New Drug Application (NDA) to the approval date, is a critical period that affects the patent term. The applicant has provided detailed information on the significant activities during this regulatory review period to support the patent term extension request[1].
Patent Term Extension
ITALFARMACO S.P.A. has petitioned for an extension of the patent term under 35 USC §156(d) and 37 CFR § 1.740. The requested extension is for 1,552 days, which would extend the patent term to May 4, 2036. This extension is based on the time spent in the regulatory review process, which is a common reason for patent term extensions in the pharmaceutical industry[1].
Patent Landscape
The patent landscape for US Patent 9,421,184 includes other related patents and applications in the field of therapeutic uses of givinostat. The Global Dossier service provided by the USPTO can be used to view the file histories of related applications from participating IP Offices, helping to understand the broader patent family and any office actions or citations related to these applications[4].
Prior Art and Citations
The Common Citation Document (CCD) application is useful for consolidating prior art cited by all participating offices for the family members of a patent application. This helps in identifying any overlapping or conflicting claims and in understanding the novelty and non-obviousness of the invention claimed in US Patent 9,421,184[4].
Patent Maintenance and Fees
The maintenance of the patent involves periodic fee payments to the USPTO. The second maintenance fee payment for US Patent 9,421,184 was made on February 23, 2024. No certificate of correction or reexamination certificate has been requested for this patent, indicating that the patent has been maintained in its original form[1].
Industry Impact
The therapeutic use of givinostat, as covered by US Patent 9,421,184, has significant implications for the pharmaceutical industry. Givinostat is being developed for various medical conditions, and the exclusive rights granted by this patent can influence market dynamics and innovation in this field.
"Patents allegedly diminish the incentives for innovation due to increased licensing and litigation costs. However, these debates often occur without well-defined measurements of patent scope."[3]
Conclusion on Patent Scope and Claims
The scope and claims of US Patent 9,421,184 are carefully defined to cover the specific method of using givinostat. The patent's landscape is influenced by regulatory review processes, prior art, and the broader patent family. Understanding these aspects is crucial for navigating the complex world of pharmaceutical patents.
Key Takeaways
- Inventors and Assignees: Valentina Saccone, Silvia Consalvi, Pier Lorenzo Puri, Paolo Mascagni, and assigned to ITALFARMACO S.P.A.
- Patent Claims: Method of using givinostat for therapeutic purposes.
- Patent Scope Metrics: Independent claim length and count indicate a focused scope.
- Regulatory Review: Associated with the approval of DuvyzatTM.
- Patent Term Extension: Requested extension of 1,552 days.
- Patent Landscape: Includes related patents and applications, prior art, and citations.
FAQs
What is the active ingredient in the drug product covered by US Patent 9,421,184?
The active ingredient is givinostat, specifically as the hydrochloride salt.
Who are the inventors of US Patent 9,421,184?
The inventors are Valentina Saccone, Silvia Consalvi, Pier Lorenzo Puri, and Paolo Mascagni.
What is the current status of the patent term for US Patent 9,421,184?
The patent term is set to expire on February 3, 2032, but an extension of 1,552 days has been requested.
How does the regulatory review process affect the patent term?
The time spent in regulatory review can be used to support a patent term extension, as seen in the request for US Patent 9,421,184.
What tools can be used to analyze the patent landscape for US Patent 9,421,184?
Tools such as the Global Dossier and Common Citation Document (CCD) can be used to analyze the patent landscape and prior art.
Sources
- US Patent No. 9,421,184 Patent Term Extension Request - Regulations.gov
- Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl ... - PubChem
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - USPTO.gov
