Detailed Analysis of the Scope and Claims of United States Patent 11,185,535
Introduction
United States Patent 11,185,535, titled "Amorphous kinase inhibitor formulations and methods of use thereof," is a significant patent in the pharmaceutical industry, particularly in the realm of kinase inhibitors. This patent, held by Deciphera Pharmaceuticals, LLC, protects key formulations and methods related to the drug Qinlock (ripretinib).
Patent Overview
The patent was issued on September 21, 2021, and is part of a larger patent family with thirty-four members across nineteen countries[5].
Scope of the Patent
The patent covers amorphous formulations of a kinase inhibitor represented by a specific chemical formula (Formula I). These formulations are crucial for the treatment of disorders related to kinase activity, such as gastrointestinal stromal tumors (GIST) and other proliferative diseases.
Amorphous Formulations
The patent describes various amorphous forms of the compound, including those with no detectable amounts of any crystalline form and those containing not more than about 5% (w/w) of any crystalline form. These formulations are designed to maintain stability under different environmental conditions, such as exposure to 0-100% relative humidity at temperatures between 25-40°C for at least three months[4].
Claims of the Patent
The patent includes several claims that define the scope of protection:
Composition Claims
- Claims cover solid dispersions comprising an amorphous form of the compound and a pharmaceutically acceptable polymer.
- The compositions include intragranular and extragranular blends with various excipients such as fillers, disintegrants, glidants, and lubricants[4].
Method Claims
- The patent claims methods of treating disorders related to kinase activity by administering the amorphous formulations.
- Specific methods include the treatment of gastrointestinal stromal tumors by administering a therapeutically effective amount of the amorphous kinase inhibitor[4].
Patent Landscape
The patent landscape for US 11,185,535 is complex and involves multiple related patents and applications.
Related Patents
- Deciphera Pharmaceuticals, LLC, holds a series of patents related to dihydronaphthyridines and dihydropyridopyrimidinyl compounds, which are also kinase inhibitors. These patents have various expiration dates, with some extending until 2040 and 2042[2].
- The patent family includes international patent members, indicating a global strategy for intellectual property protection[5].
Patent Expiration Dates
- The primary patent expiration date for US 11,185,535 is August 12, 2040, aligning with other related patents held by Deciphera Pharmaceuticals[2].
Strategic Importance
The strategic importance of this patent lies in its ability to extend the market exclusivity of Qinlock.
Market Exclusivity
- By protecting the amorphous formulation, Deciphera Pharmaceuticals can prevent generic versions of Qinlock from entering the market until the patent expires. This is crucial for maintaining market share and revenue[2].
Polymorph Patents
- Similar to other drugs, the use of polymorph patents can extend the protection period beyond the original compound patent. For instance, polymorph patents for other drugs have been shown to extend protection by several years, sometimes over a decade[1].
Analytical Tools and Strategies
To manage and analyze the patent landscape effectively, companies like Deciphera Pharmaceuticals can use advanced patent analytics tools.
Claim Coverage Matrix
- Tools like the Claim Coverage Matrix help in categorizing patents by claims and scope concepts, making it easier to identify gaps and opportunities in the patent landscape[3].
Claim Charts
- Interactive claim charts generated by software like ClaimScape® facilitate the review of patent coverage with technical experts, ensuring that all aspects of the technology are protected and identifying areas for future development[3].
Industry Impact
The impact of this patent on the pharmaceutical industry is significant.
Innovation and Competition
- The protection of amorphous formulations discourages competitors from developing similar products, thereby maintaining Deciphera Pharmaceuticals' competitive edge in the market.
- It also incentivizes further innovation in the field of kinase inhibitors, as companies seek to develop new and differentiated products[4].
Patient Access
- While the patent protection ensures market exclusivity, it also means that patients may have limited access to generic alternatives until the patent expires. This highlights the balance between innovation and patient access in the pharmaceutical industry[2].
Key Takeaways
- Patent Scope: US 11,185,535 covers amorphous kinase inhibitor formulations and methods of use, specifically protecting Qinlock.
- Claims: The patent includes composition and method claims that define the scope of protection.
- Patent Landscape: The patent is part of a larger family with global protection and has a complex landscape involving related patents.
- Strategic Importance: The patent extends market exclusivity for Qinlock, maintaining Deciphera Pharmaceuticals' market share.
- Analytical Tools: Advanced tools like Claim Coverage Matrix and Claim Charts are essential for managing the patent landscape.
FAQs
Q: What is the primary compound protected by US 11,185,535?
A: The primary compound is an amorphous form of a kinase inhibitor represented by Formula (I), specifically ripretinib.
Q: What is the significance of amorphous formulations in this patent?
A: Amorphous formulations are crucial for maintaining stability and bioavailability of the drug, and they are protected to prevent generic versions.
Q: When does the patent for US 11,185,535 expire?
A: The primary patent expiration date is August 12, 2040.
Q: How does this patent impact the pharmaceutical industry?
A: It maintains Deciphera Pharmaceuticals' competitive edge, incentivizes innovation, but also limits patient access to generic alternatives.
Q: What tools can companies use to manage the patent landscape effectively?
A: Companies can use tools like Claim Coverage Matrix and Claim Charts to analyze and manage their patent landscape.
Cited Sources
- Crystal PharmaTech, "Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023."
- Drugs.com, "Generic Qinlock Availability."
- SLWIP, "Patent Analytics | Intellectual Property Law."
- Google Patents, "US11185535B2 - Amorphous kinase inhibitor formulations and methods of use thereof."
- DrugPatentWatch, "Patent 11,185,535."
