Detailed Analysis of the Scope and Claims of United States Patent 10,226,423
Introduction
United States Patent 10,226,423, issued on March 12, 2019, is a significant patent in the pharmaceutical sector, particularly in the treatment of gout flares using oral colchicine solutions. This patent, assigned to RxOMEG Therapeutics LLC, is one of several patents held by the company related to colchicine formulations and their interactions with other therapeutics.
Background
The patent was invented by Dr. Indu Muni and Dr. Naomi Visnhupad, who are also key figures in the management and legal affairs of RxOMEG Therapeutics LLC and Avion Pharmaceuticals, LLC[1][2].
Patent Scope
Claims Overview
The patent 10,226,423 focuses on the use of oral colchicine solutions in combination with other therapeutics, with an emphasis on minimizing toxic drug-to-drug interactions. The claims include:
- Composition Claims: The patent describes specific compositions of oral colchicine solutions that are designed to be used in conjunction with other medications.
- Method Claims: It outlines methods for the concomitant administration of colchicine with other active agents, ensuring the minimization of adverse interactions[2][4].
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For patent 10,226,423, the independent claims are detailed and specific, indicating a focused scope rather than overly broad claims. This is consistent with the trend that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Key Claims and Descriptions
Colchicine Drug-to-Drug Interactions
The patent provides detailed descriptions of how oral colchicine solutions can be used in combination with other therapeutics, such as ketoconazole and ritonavir, while minimizing toxic interactions. This is crucial for patients who require multiple medications and helps in managing potential adverse effects[4].
Related Compositions
The patent also includes descriptions of related compositions that are designed to enhance the efficacy and safety of colchicine when used with other medications. These compositions are tailored to reduce the risk of drug interactions, making the treatment regimen more manageable for patients[2][4].
Patent Expiration Dates
The patent 10,226,423 is set to expire on December 20, 2037. This expiration date is significant as it marks the period during which the patent holders have exclusive rights to the proprietary formulations and methods described in the patent[2].
Regulatory and Litigation Context
FDA Approval and ANDA Filings
The patent is closely tied to the regulatory approval process, particularly the Abbreviated New Drug Application (ANDA) filings. The patent holders have been involved in litigation related to the infringement of these patents by generic drug manufacturers, such as Granules Pharm., Inc.[1].
Confidentiality and Protective Orders
In the context of litigation, there are protective orders in place to ensure that confidential information is not misused. For instance, the protective order in the case involving Granules Pharm., Inc. prohibits the use of confidential information for any purpose outside of the litigation, including regulatory submissions to the FDA[1].
Impact on the Pharmaceutical Industry
Innovation and Licensing
The patent 10,226,423 contributes to the ongoing innovation in the treatment of gout flares by providing specific and safe methods for using colchicine in combination with other medications. However, the existence of such patents can also increase licensing and litigation costs, which may affect the overall incentives for innovation in the pharmaceutical industry[3].
Market Competition
The exclusive rights granted by this patent until its expiration in 2037 will influence market competition. Generic manufacturers will need to wait until the patent expires or develop non-infringing alternatives to enter the market. This can impact the availability and pricing of generic versions of colchicine solutions[2].
Expert Insights
Industry experts emphasize the importance of balancing patent protection with public health needs. For example, Dr. Indu Muni and Dr. Naomi Visnhupad's work highlights the need for safe and effective treatment options while navigating the complex landscape of patent law and regulatory approvals.
Statistics and Trends
- Patent Maintenance Payments: Patents with narrower claims, like 10,226,423, tend to have lower maintenance payments and a shorter examination process, which can be more cost-effective for the patent holders[3].
- Forward Citations: The number of forward citations can indicate the impact and relevance of a patent. While specific data for this patent is not provided here, it is generally observed that patents with focused claims receive more forward citations, indicating their influence on subsequent innovations[3].
Key Takeaways
- Focused Claims: The patent 10,226,423 has specific and focused claims related to the use of oral colchicine solutions in combination with other therapeutics.
- Regulatory Impact: The patent is closely tied to FDA approvals and ANDA filings, influencing the regulatory landscape for generic drug manufacturers.
- Litigation Context: Protective orders and confidentiality agreements play a crucial role in ensuring that confidential information is not misused during litigation.
- Market Impact: The patent affects market competition by granting exclusive rights to the patent holders until its expiration in 2037.
- Innovation: The patent contributes to innovation in gout treatment but also highlights the challenges of balancing patent protection with public health needs.
FAQs
What is the primary focus of United States Patent 10,226,423?
The primary focus of this patent is the use of oral colchicine solutions in combination with other therapeutics, with an emphasis on minimizing toxic drug-to-drug interactions.
Who are the inventors of this patent?
The inventors of this patent are Dr. Indu Muni and Dr. Naomi Visnhupad.
What is the expiration date of this patent?
The patent is set to expire on December 20, 2037.
How does this patent impact the pharmaceutical industry?
This patent influences innovation, licensing, and market competition by granting exclusive rights to the patent holders and affecting the availability of generic versions of colchicine solutions.
What are the key claims described in this patent?
The key claims include compositions and methods for the concomitant administration of colchicine with other active agents, ensuring the minimization of adverse interactions.
What is the significance of the protective orders in the litigation context of this patent?
Protective orders ensure that confidential information is not misused during litigation, preventing actions such as submitting citizen petitions to the FDA based on non-public information.
Sources
- Avion Pharm., LLC v. Granules Pharm., Inc. - Casetext
- Generic Gloperba Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- US10226423B1 - Colchicine drug-to-drug interactions - Google Patents
