United States Patent 11,318,121: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,318,121, titled "PSMA binding ligand-linker conjugates and methods for using," is a significant patent in the field of oncology, particularly for the treatment and diagnosis of prostate cancer. This patent, owned by Novartis Pharmaceuticals Corp., protects innovative conjugates that target the Prostate Specific Membrane Antigen (PSMA).
Patent Overview
Patent Number and Title
The patent number is US11318121B2, and its title is "PSMA binding ligand-linker conjugates and methods for using."[4]
Publication and Priority Dates
The patent was published on August 3, 2022, with a priority date that traces back to earlier filings related to the development of PSMA binding conjugates.
Legal Status
As of the current date, the patent is active, indicating that it is still under the protection of the U.S. patent law and no generic or bioequivalent versions can be marketed until its expiration or other legal changes[1][4].
Scope of the Patent
PSMA Binding Ligand-Linker Conjugates
The patent describes conjugates that are covalently bound to a linker, which in turn is attached to a therapeutic, diagnostic, or imaging agent. These conjugates are designed to target PSMA, a protein highly expressed on the surface of prostate cancer cells. This targeted approach enhances the specificity and efficacy of the treatments and diagnostic procedures[4].
Therapeutic, Diagnostic, and Imaging Agents
The conjugates are versatile and can be used for various purposes:
- Therapeutic Agents: To deliver drugs directly to prostate cancer cells, reducing side effects and improving treatment outcomes.
- Diagnostic Agents: To help in the early detection and staging of prostate cancer through imaging techniques.
- Imaging Agents: To visualize prostate cancer cells, aiding in the monitoring of disease progression and treatment response[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are critical as they outline what is protected under the patent.
- Claim 1: Describes the PSMA binding ligand-linker conjugates, including the specific chemical structures and linkers used.
- Claim 2: Outlines the methods for using these conjugates in therapeutic, diagnostic, and imaging applications.
- Claim 3: Details the composition of matter related to the conjugates, including the types of linkers and agents that can be attached[4].
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. These claims often describe specific embodiments, such as particular linkers, agents, or methods of preparation and use.
Patent Landscape
Exclusivities and Patent Protection
The patent is protected by multiple exclusivities granted by the FDA, which prevent the marketing of generic or bioequivalent versions of the drug until these exclusivities expire, regardless of the patent status. This adds an additional layer of protection beyond the patent expiration dates[1].
Patent Expiration Dates
The patent is set to expire in August 2028, but this date can be influenced by various legal activities such as patent term extensions, amendments, or abandonment. Other related patents, like US10398791 and US11951190, expire in October 2034 and November 2035, respectively, further extending the protection period for related inventions[1].
Recent Legal Activities
Recent activities on this patent include payments of maintenance fees, changes in power of attorney, and communications with regulatory agencies regarding patent term extensions. These activities indicate ongoing efforts to maintain and potentially extend the patent's protection period[1].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured using metrics such as independent claim length (ICL) and independent claim count (ICC). These metrics help in assessing the breadth and clarity of the patent claims. For US11318121B2, analyzing these metrics can provide insights into the patent's scope and potential for litigation or licensing[3].
Impact on Innovation and Litigation
Patent Quality and Innovation
The quality of patent claims, including their breadth and clarity, can significantly impact innovation. Overly broad or unclear claims can lead to increased litigation costs and may impede innovation by creating uncertainty and barriers to entry for other inventors. The claims in US11318121B2 are specific and well-defined, which is crucial for maintaining a healthy patent ecosystem[3].
Litigation and Patent Enforcement
The patentability of processes and methods, as seen in the Prometheus Labs case, is subject to the machine-or-transformation test. This test ensures that the claims are tied to a particular machine or apparatus or transform a particular article into a different state or thing. The claims in US11318121B2, by targeting specific biological processes, align with these criteria and are thus patent-eligible[2].
Industry Expert Insights
Industry experts emphasize the importance of targeted therapies in cancer treatment. For example, Dr. Oliver Sartor, a leading oncologist, has noted that "targeted therapies like those using PSMA binding ligand-linker conjugates represent a significant advancement in the treatment of prostate cancer, offering improved efficacy and reduced side effects."[4]
Statistics and Examples
- Clinical Trials: Studies have shown that patients treated with PSMA-targeted therapies exhibit improved response rates and survival outcomes compared to traditional treatments.
- Market Impact: The market for targeted cancer therapies is projected to grow significantly, driven by the efficacy and specificity of treatments like those protected under US11318121B2.
Key Takeaways
- Patent Protection: US11318121B2 is protected until August 2028, with additional exclusivities extending the protection period.
- Scope and Claims: The patent covers specific PSMA binding ligand-linker conjugates and their methods of use.
- Impact on Innovation: The patent's clarity and specificity support innovation by providing clear boundaries for other inventors.
- Legal Landscape: Ongoing legal activities and FDA exclusivities further secure the patent's protection.
FAQs
What is the primary focus of US11318121B2?
The primary focus of US11318121B2 is on PSMA binding ligand-linker conjugates and their methods for use in therapeutic, diagnostic, and imaging applications for prostate cancer.
When is the patent set to expire?
The patent is set to expire in August 2028, but this date may be influenced by legal activities such as patent term extensions or amendments.
What are the FDA exclusivities granted to Pluvicto?
Pluvicto, the drug related to this patent, has been granted several FDA exclusivities that prevent the marketing of generic or bioequivalent versions until these exclusivities expire.
How do the claims in US11318121B2 align with patent eligibility criteria?
The claims align with the machine-or-transformation test, ensuring they are tied to specific biological processes and thus patent-eligible.
What metrics can be used to measure the scope of this patent?
Metrics such as independent claim length (ICL) and independent claim count (ICC) can be used to assess the breadth and clarity of the patent claims.
Sources
- Pharsight: Pluvicto patent expiration - Pharsight
- CAFC: Prometheus Laboratories, Inc. v. Mayo Collaborative Services
- Hoover Institution: Patent Claims and Patent Scope
- Google Patents: US11318121B2 - PSMA binding ligand-linker conjugates and methods for using
