Detailed Analysis of the Scope and Claims of United States Patent 11,369,590
Introduction
The United States Patent 11,369,590, titled "PSMA binding ligand-linker conjugates and methods for using," is a significant patent in the field of medical diagnostics and therapeutics. This patent, held by Novartis Pharmaceuticals Corp., protects innovative conjugates designed to target the Prostate Specific Membrane Antigen (PSMA) and methods for their use.
Patent Overview
Publication and Status
The patent was issued on June 28, 2022, and is currently active, with an expiration date set for August 15, 2028[2][4].
Claims and Scope
PSMA Binding Ligand-Linker Conjugates
The patent describes conjugates that combine a PSMA binding ligand with a linker, which can be attached to various therapeutic, diagnostic, or imaging agents. These conjugates are designed to specifically target PSMA, a protein overexpressed in prostate cancer cells, allowing for precise delivery of therapeutic or diagnostic agents[1].
Chemical Structure and Components
The claims detail the chemical structure of these conjugates, including the types of linkers, metal complexes, and radioactive isotopes that can be used. For example, the conjugates may include sulfhydrylalkyl groups, aryl groups, and alkyl groups, among others. The patent also specifies the use of radioactive isotopes such as Gallium-68 for positron emission tomography (PET) imaging[1].
Therapeutic and Diagnostic Applications
The patent covers a broad range of applications, including the delivery of therapeutic agents to treat prostate cancer and other diseases where PSMA is overexpressed. It also includes methods for using these conjugates in diagnostic imaging, such as PET scans, to detect and monitor cancer progression[1].
Patent Landscape
Exclusivity and Protection
The patent provides exclusive rights to Novartis Pharmaceuticals Corp. to use the described conjugates and methods until its expiration in 2028. This exclusivity prevents other companies from launching products that use the same active ingredients and methods protected by the patent[2][4].
Related Patents and Exclusivities
In addition to this patent, Locametz, the drug associated with these conjugates, is protected by another patent (US12109277) that expires in March 2036. There are also exclusivity periods granted by the FDA, which can run concurrently with the patent but may expire earlier, such as the new product exclusivity set to expire on March 23, 2025[2][4].
Legal and Regulatory Aspects
Patent Activities and Oppositions
The patent has undergone several critical activities, including issue notifications and fee payments, which are documented in the patent records. Additionally, Locametz has faced oppositions in the European Patent Office, which can impact the broader patent landscape and potential generic entry points[2].
Impact on Generic Launch
The expiration dates of these patents are crucial for determining when generic versions of the drug can be launched. Any changes in the patent landscape, such as term extensions or opposition outcomes, can affect the generic launch date[2][4].
Analytical Tools and Strategies
Patent Analytics
To fully understand the scope and claims of this patent, companies can use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape. Claim Coverage Matrices and Claim Charts can be particularly useful in this context[3].
Future Implications and Opportunities
Design and Development
The patent's scope concepts can guide future design and development strategies. By analyzing the claims and scope, companies can identify potential future directions and areas where they may need to enhance their claim coverage. This can also highlight opportunities for new product development and innovation[3].
Key Takeaways
- Patent Expiration: The patent expires on August 15, 2028.
- Exclusive Rights: Novartis holds exclusive rights to the PSMA binding ligand-linker conjugates and methods until the patent expires.
- Therapeutic and Diagnostic Applications: The patent covers therapeutic and diagnostic uses, including cancer treatment and PET imaging.
- Related Patents and Exclusivities: Additional patents and FDA exclusivities protect the drug Locametz.
- Patent Analytics: Tools like Claim Coverage Matrices and Claim Charts are essential for understanding the patent landscape.
FAQs
What is the primary focus of United States Patent 11,369,590?
The primary focus is on PSMA binding ligand-linker conjugates and methods for their use in delivering therapeutic, diagnostic, and imaging agents.
When does the patent expire?
The patent expires on August 15, 2028.
What are the therapeutic applications of the conjugates described in the patent?
The conjugates are designed for the treatment of prostate cancer and other diseases where PSMA is overexpressed.
How do the conjugates work in diagnostic imaging?
The conjugates can be radiolabeled with isotopes like Gallium-68 for use in PET scans to detect and monitor cancer progression.
What other protections are in place for the drug Locametz?
In addition to the patent, Locametz is protected by another patent expiring in 2036 and FDA exclusivities.
Cited Sources:
- US11369590B2 - PSMA binding ligand-linker conjugates and methods for using - Google Patents
- Locametz patent expiration - Pharsight
- Patent Analytics - Schwegman
- Generic Locametz Availability - Drugs.com
