United States Patent 7,332,472: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,332,472, titled "Cyclosporine analogue mixtures and their use as immunomodulating agents," is a significant patent in the field of immunosuppressive therapy. This patent, held by Aurinia Pharmaceuticals Inc., pertains to the use of isomeric mixtures of cyclosporine analogues for enhanced immunosuppressive effects.
Background of Cyclosporine
Cyclosporine, a cyclic peptide, is widely used as an immunosuppressant to prevent the rejection of transplanted organs and to treat autoimmune diseases. The invention described in this patent builds upon the existing knowledge of cyclosporine by identifying specific isomeric mixtures that offer superior therapeutic benefits.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:
Isomeric Mixtures
The patent focuses on isomeric mixtures of cyclosporine analogues that are structurally similar to cyclosporine A. These mixtures have been found to possess enhanced efficacy and potentially fewer side effects compared to traditional cyclosporine formulations[1][5].
Immunomodulating Agents
The patent claims cover the use of these isomeric mixtures as immunomodulating agents. This includes their application in treating various immune-related disorders, such as lupus nephritis and other autoimmune diseases[2].
Pharmaceutical Compositions
The patent also describes pharmaceutical compositions containing these isomeric mixtures, including formulations suitable for oral, intravenous, or other routes of administration[1].
Claims of the Patent
The claims of the patent are crucial as they define the boundaries of what is protected.
Independent Claims
The patent includes independent claims that describe the isomeric mixtures, their preparation, and their use in medical treatments. For example, one independent claim might specify the particular ratio of isomers in the mixture and another might detail the method of synthesizing these mixtures[1].
Dependent Claims
Dependent claims further specify the scope by detailing particular aspects of the independent claims, such as specific dosages, administration methods, or additional components in the pharmaceutical compositions[1].
Patent Landscape
The patent landscape surrounding US 7,332,472 is complex and involves several related patents and regulatory milestones.
Related Patents
Other patents related to this invention include those focused on the treatment of lupus nephritis using voclosporin, a specific cyclosporine analogue. For instance, Patent 10,286,036 describes a pharmacodynamic dosing regimen for voclosporin to maximize its effectiveness while minimizing side effects[2].
Patent Expiration Dates
The patent 7,332,472 is set to expire on October 17, 2025. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder, allowing for the potential entry of generic versions of the drug[2].
Exclusivity and Generic Availability
Following the patent expiration, generic versions of the drug may become available. The FDA grants exclusivity periods to manufacturers, which can run concurrently with patent protection. For drugs like those covered by this patent, generic availability is anticipated after the exclusivity period ends[2].
Regulatory Milestones
Regulatory milestones play a crucial role in the lifecycle of a patented drug.
FDA Approval
The drug covered by this patent, such as voclosporin (marketed as Lupkynis), has undergone rigorous FDA approval processes. These processes include clinical trials and the submission of an Abbreviated New Drug Application (ANDA) for generic versions[2].
Patent Term Extension
In some cases, patents can be extended through mechanisms like the Hatch-Waxman Act, which allows for patent term extensions under certain conditions. However, this patent does not appear to have been extended beyond its original term[4].
Impact on Innovation and Competition
The scope and claims of this patent have significant implications for innovation and competition in the pharmaceutical industry.
Innovation
The patent encourages innovation by protecting the intellectual property of the inventors, allowing them to recoup their investment in research and development. However, it also raises concerns about the breadth of patent claims and their potential to stifle further innovation[3].
Competition
As the patent nears expiration, competition is expected to increase with the entry of generic versions. This competition can drive down prices and improve access to the drug, but it also poses challenges for the original patent holder in maintaining market share[2].
Metrics for Patent Scope
Research on patent scope often uses metrics such as independent claim length and independent claim count to assess the breadth and clarity of patent claims. Narrower claims are generally associated with a higher probability of grant and a shorter examination process[3].
Conclusion
United States Patent 7,332,472 is a critical patent in the field of immunosuppressive therapy, particularly for the treatment of autoimmune diseases like lupus nephritis. The patent's scope, defined by its claims, protects the use of isomeric mixtures of cyclosporine analogues as immunomodulating agents. As the patent approaches its expiration date, the landscape is set for increased competition and potentially improved access to these life-saving medications.
Key Takeaways
- Isomeric Mixtures: The patent covers isomeric mixtures of cyclosporine analogues with enhanced efficacy.
- Immunomodulating Agents: These mixtures are used as immunomodulating agents for treating autoimmune diseases.
- Patent Expiration: The patent is set to expire on October 17, 2025.
- Regulatory Milestones: FDA approval and potential generic availability post-patent expiration are significant milestones.
- Impact on Innovation and Competition: The patent protects intellectual property but may also influence future innovation and competition.
FAQs
What is the main subject of United States Patent 7,332,472?
The main subject of this patent is the use of isomeric mixtures of cyclosporine analogues as immunomodulating agents.
What are the potential benefits of these isomeric mixtures?
These mixtures have been found to possess enhanced efficacy and potentially fewer side effects compared to traditional cyclosporine formulations.
When is the patent set to expire?
The patent is set to expire on October 17, 2025.
What happens after the patent expires?
After the patent expires, generic versions of the drug may become available, increasing competition and potentially improving access to the medication.
How does this patent impact innovation in the pharmaceutical industry?
The patent protects the intellectual property of the inventors, encouraging innovation, but it also raises concerns about the breadth of patent claims and their potential to stifle further innovation.
Sources
- US7332472B2 - Cyclosporine analogue mixtures and their use as immunomodulating agents - Google Patents
- Generic Lupkynis Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- Aurinia Pharmaceuticals Regulatory Milestones - GlobalData
- Details for Patent: 7332472 - DrugPatentWatch
