United States Patent 10,072,013: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,072,013, titled "Selective PI3K delta inhibitors," is a significant patent in the pharmaceutical sector, particularly in the field of oncology and immunology. This patent covers selective inhibitors of the PI3K delta protein kinase, methods for preparing these inhibitors, and pharmaceutical compositions containing them.
Background and Context
The PI3K delta protein kinase is a key enzyme in the phosphoinositide 3-kinase (PI3K) family, which plays a crucial role in cell signaling pathways involved in cell growth, differentiation, and survival. Inhibitors of PI3K delta are of interest for treating various diseases, including cancers and autoimmune disorders[1].
Patent Scope and Claims
Overview of Claims
The patent includes multiple claims that define the scope of the invention. These claims are categorized into several types:
- Compound Claims: These claims specify the chemical structures of the selective PI3K delta inhibitors. The patent describes a range of compounds, including those with fluoro, fluorophenyl, and chromen moieties[1].
- Method Claims: These claims cover the methods of preparing the selective PI3K delta inhibitors. This includes various synthetic routes and processes to obtain the desired compounds[1].
- Composition Claims: These claims relate to pharmaceutical compositions containing the selective PI3K delta inhibitors. These compositions can be formulated for various administration routes, such as oral or parenteral administration[1].
Claim Language and Scope
The claim language is critical in defining the patent's scope. The patent uses specific terminology to describe the compounds, methods, and compositions, ensuring that the claims are clear and distinct. For instance, the use of "selective" indicates that these inhibitors are designed to target PI3K delta specifically, minimizing off-target effects on other PI3K isoforms[1].
Patent Term Extension (PTE)
Application and Approval
The patent holder has filed an application for a patent term extension (PTE) under 35 U.S.C. 156, based on the FDA's approval of the human drug product UKONIQ® (umbralisib tosylate), which is covered by this patent. The application was filed on March 18, 2021, and is subject to a regulatory review period (RRP) before its commercial marketing or use[2][5].
Regulatory Review Period (RRP)
The RRP is a critical factor in determining the eligibility for a PTE. The FDA's approval of UKONIQ® and the subsequent commercial marketing or use after the RRP are key considerations. The patent term extension is intended to compensate for the time spent in regulatory review, ensuring that the patent holder has a reasonable period to exploit the invention commercially[2][5].
Pharmaceutical Product: UKONIQ® (Umbralisib Tosylate)
Active Ingredient and Approval
UKONIQ® (umbralisib tosylate) is the pharmaceutical product associated with this patent. The FDA approved this drug on February 5, 2021, for specific indications. The active ingredient is confirmed as umbralisib tosylate, although there was a minor discrepancy in the FDA's approval letter that mentioned umbralisib as the active ingredient[5].
Clinical Use
Umbralisib tosylate is used in the treatment of certain types of cancers and autoimmune diseases. Its selective inhibition of PI3K delta makes it a valuable therapeutic option, as it can target specific pathways involved in disease progression while minimizing side effects associated with non-selective PI3K inhibition[2].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,072,013 includes other related patents, such as U.S. Patent Nos. 9,150,579, 9,669,033, and 10,570,142. These patents also cover aspects of the same drug product, UKONIQ®, and were filed concurrently for PTE under the same regulatory review period[2][5].
Competitive Environment
The PI3K inhibitor market is competitive, with several pharmaceutical companies developing similar compounds. The selective nature of the inhibitors covered by this patent provides a competitive edge, as it addresses the need for targeted therapies with reduced side effects.
Legal and Regulatory Considerations
Patent Term Extension Process
The process for obtaining a PTE involves several steps, including the filing of the application within 60 days of the FDA's approval of the drug product. The USPTO must then determine whether the product was subject to an RRP and whether the first commercial marketing or use occurred after this period[5].
Compliance with Statutory Requirements
The application must comply with all statutory requirements under 35 U.S.C. 156. This includes confirming that the product was subject to an RRP and that the permission for commercial marketing or use was the first permitted under the relevant law[5].
Impact on Innovation and Industry
Innovation Incentives
The granting of this patent and the potential for a PTE can incentivize further innovation in the field of PI3K inhibitors. By providing a longer period of exclusivity, the patent holder is encouraged to invest in research and development, leading to potential new treatments and improvements in existing therapies.
Market Domination
The selective PI3K delta inhibitors covered by this patent can help the patent holder achieve market dominance in the treatment of specific diseases. The unique properties of these inhibitors, combined with the regulatory approvals, position the product favorably in a competitive market.
Key Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope metrics suggests that independent claim length and count can be useful indicators of patent breadth. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Conclusion
United States Patent 10,072,013 is a pivotal patent in the pharmaceutical industry, particularly in the development of selective PI3K delta inhibitors. The patent's scope, claims, and the associated patent term extension application highlight its significance in the treatment of cancers and autoimmune diseases.
Key Takeaways
- Selective Inhibition: The patent covers selective inhibitors of PI3K delta, which are crucial for targeted therapies.
- Pharmaceutical Compositions: The patent includes claims for pharmaceutical compositions containing these inhibitors.
- Patent Term Extension: The patent is eligible for a PTE based on the FDA's approval of UKONIQ® (umbralisib tosylate).
- Regulatory Compliance: The application complies with statutory requirements under 35 U.S.C. 156.
- Market Impact: The patent can incentivize innovation and help the patent holder achieve market dominance.
FAQs
Q1: What is the main subject of United States Patent 10,072,013?
The main subject of this patent is selective inhibitors of the PI3K delta protein kinase.
Q2: What is UKONIQ® (umbralisib tosylate), and how is it related to this patent?
UKONIQ® (umbralisib tosylate) is a pharmaceutical product approved by the FDA, and it is covered by this patent. The patent term extension application is based on this approval.
Q3: Why is the selective inhibition of PI3K delta important?
Selective inhibition of PI3K delta is important because it allows for targeted therapies with reduced side effects, as it minimizes off-target effects on other PI3K isoforms.
Q4: What is the regulatory review period (RRP), and how does it affect the patent term extension?
The RRP is the period during which the FDA reviews the drug product before its commercial marketing or use. The PTE compensates for this time, ensuring the patent holder has a reasonable period to exploit the invention commercially.
Q5: How does this patent impact innovation in the pharmaceutical industry?
This patent can incentivize further innovation by providing a longer period of exclusivity, encouraging the patent holder to invest in research and development.
Sources
- US10072013B2 - Selective PI3K delta inhibitors - Google Patents
- Food and Drug Administration CDER, Office of Regulatory Policy - Regulations.gov
- Patent Claims and Patent Scope - SSRN
- Section 512 of Title 17 - U.S. Copyright Office
- March 8, 2022 - Regulations.gov
