United States Patent 10,919,881: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,919,881, titled "Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan," is a significant patent in the pharmaceutical field, particularly in the development of novel crystalline forms of a specific chemical compound. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Overview of the Patent
Invention Description
The patent describes novel crystalline forms of 5-(4-bromo-phenyl)-6 [2 (5 bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl-sulfamide, known as aprocitentan. These crystalline forms are crucial for the development of pharmaceuticals, as they can affect the stability, solubility, and bioavailability of the drug[4].
Publication and Legal Status
The patent was published on January 5, 2021, and is currently active. However, the legal status listed is an assumption and not a legal conclusion, as it has not been subject to a comprehensive legal analysis[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims are divided into independent and dependent claims.
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the novel crystalline form of aprocitentan, its chemical structure, and any specific characteristics such as X-ray powder diffraction patterns[4].
- Dependent Claims: These claims narrow down the scope by adding additional limitations to the independent claims. For instance, dependent claims might specify particular solvates, hydrates, or polymorphic forms of the crystalline structure[4].
Prior Art and Novelty
The patent must demonstrate novelty over prior art, meaning it must be significantly different from existing inventions. The prior art keywords listed, such as "ray powder," "powder diffraction," and "pyrimidin," indicate the areas where the invention differs from previous work[4].
Claims Analysis
Claim Structure
The claims are structured to ensure broad protection while also being specific enough to avoid invalidation. Here is an example of how a claim might be structured:
- Claim 1: A crystalline form of 5-(4-bromo-phenyl)-6 [2 (5 bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl-sulfamide characterized by an X-ray powder diffraction pattern.
- Dependent Claim 2: The crystalline form of Claim 1, wherein the X-ray powder diffraction pattern includes specific peaks at certain 2θ values[4].
Claim Scope and Limitations
The scope of the claims is crucial for determining the patent's enforceability and the extent of protection it offers. The claims must be clear, concise, and definite to avoid ambiguity. For example, the claims might specify the use of particular solvents or conditions for crystallization to ensure the novel crystalline form is distinct from prior art[4].
Patent Landscape
Global Patent Family
To understand the full scope of protection, it is essential to look at the global patent family. This involves searching databases from other International Intellectual Property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO)[1].
Related Patents and Applications
The Global Dossier service provided by the USPTO allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices. This helps in identifying similar inventions and understanding the competitive landscape[1].
Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is invaluable for understanding the prior art landscape and ensuring that the patent is novel and non-obvious[1].
Economic and Strategic Implications
Market Impact
The development of novel crystalline forms of aprocitentan can have significant market implications. These forms can improve the efficacy, stability, and manufacturing process of the drug, giving the patent holder a competitive edge in the pharmaceutical market.
Licensing and Collaboration
The patent can be a valuable asset for licensing or collaboration. Companies may seek to license the technology to gain access to the novel crystalline forms, which can enhance their own product offerings.
Search and Analysis Tools
USPTO Resources
The USPTO provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources are essential for conducting thorough patent searches and analyzing the patent landscape[1].
International Databases
Access to international patent databases such as esp@cenet (EPO), PATENTSCOPE (WIPO), and KIPRIS (Korea) is crucial for a comprehensive analysis. These databases provide insights into global patent filings and help in identifying potential competitors or collaborators[1].
Key Takeaways
- Novel Crystalline Forms: The patent describes novel crystalline forms of aprocitentan, which are critical for pharmaceutical development.
- Claims Structure: The claims are structured to ensure broad protection while being specific enough to avoid invalidation.
- Global Patent Family: Understanding the global patent family is essential for determining the full scope of protection.
- Economic Implications: The patent can have significant market implications and is a valuable asset for licensing or collaboration.
- Search and Analysis Tools: Utilizing USPTO and international databases is crucial for thorough patent searches and analysis.
FAQs
What is the main subject of United States Patent 10,919,881?
The main subject of United States Patent 10,919,881 is the novel crystalline forms of 5-(4-bromo-phenyl)-6 [2 (5 bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl-sulfamide, known as aprocitentan.
How can one search for related patents globally?
To search for related patents globally, one can use resources such as the Global Dossier service, European Patent Office's esp@cenet, Japan Patent Office's database, and World Intellectual Property Organization's PATENTSCOPE[1].
What is the significance of X-ray powder diffraction patterns in the patent?
X-ray powder diffraction patterns are significant as they characterize the novel crystalline forms of aprocitentan, distinguishing them from prior art and ensuring the patent's novelty[4].
How can the patent be used strategically in the pharmaceutical industry?
The patent can be used strategically for licensing, collaboration, and improving the manufacturing process of the drug, thereby giving the patent holder a competitive edge in the market.
What tools does the USPTO provide for patent searching and analysis?
The USPTO provides tools such as the Patent Public Search tool, Global Dossier, Patent Examination Data System (PEDS), and the Public Search Facility for patent searching and analysis[1].
Cited Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) - USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims Research Dataset - USPTO. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan. Retrieved from https://patents.google.com/patent/US10919881B2/en
