United States Patent 9,937,075: A Comprehensive Analysis
Overview of the Patent
United States Patent 9,937,075, titled "Apparatus and methods for ocular injection," was issued on April 10, 2018, to Clearside Biomedical, Inc. This patent is crucial in the field of ophthalmic therapies, particularly for the delivery of therapeutic agents to the eye.
Inventors and Assignees
The patent was invented by a team that includes Rafael Victor Andino, Vladimir Zarnitsyn, Jesse Yoo, Christopher John Brooks, Trent John Kahute, Justin William Arsenault, David Jackson Trettin, Andrew Kent Bauer, and Stephanie Elaine Lewis. The assignee is Clearside Biomedical, Inc.[2].
Patent Claims and Scope
The patent covers apparatuses and methods for the non-surgical administration of drug formulations directly into the eye, specifically targeting the suprachoroidal space (SCS) and other ocular tissues.
Key Claims
- The method involves inserting a hollow microneedle into the eye at a specific insertion site.
- The drug formulation is infused through the microneedle into the suprachoroidal space, allowing the drug to distribute away from the insertion site during infusion[2].
Device Description
The apparatus includes a housing coupled to a medicament container, which is connected to a needle. The injection assembly is disposed within the housing, facilitating precise and controlled delivery of the therapeutic agent[1].
Technical Details
- Microneedle Technology: The patent utilizes microneedle devices for transdermal and intraocular drug delivery. This technology is particularly important for delivering substances to the posterior region of the eye, an area challenging to reach with conventional methods[1].
- Suprachoroidal Space: The method targets the suprachoroidal space, a region between the sclera and choroid, which is critical for treating posterior ocular disorders and choroidal maladies[2].
Patent Expiration and Status
The patent is set to expire on May 2, 2034, based on the standard 20-year term from the filing date of the patent application. As of the current date, the patent remains active[5].
Related Patents and Exclusivities
- Other Relevant Patents: Clearside Biomedical, Inc. holds other patents related to ocular drug delivery, such as US Patent 9,636,332, which also deals with methods and devices for treating ocular diseases using microneedles. These patents collectively protect the company's intellectual property in this field[2][5].
- Generic Launch Date: The generic launch date for drugs protected by these patents is estimated to be around May 2, 2034, considering the patent expiration dates and any applicable exclusivities[5].
Market and Clinical Implications
- Therapeutic Applications: The technology described in this patent is used for treating various ocular conditions, including posterior ocular disorders and choroidal maladies. This is significant because it provides a non-surgical method for delivering drugs directly to the affected areas, potentially improving treatment outcomes and reducing side effects[2].
- Clinical Trials and Development: The development of such devices and methods involves extensive clinical trials to ensure safety and efficacy. The patent landscape in this area is crucial for companies like Clearside Biomedical, Inc. to protect their investments in research and development[3].
Legal and Regulatory Aspects
- Patent Protection: The patent provides exclusive rights to Clearside Biomedical, Inc. to manufacture, use, and sell the described apparatus and methods. This protection is essential for the company to recoup its investment in research and development[2].
- Regulatory Approvals: The FDA plays a critical role in approving these devices and methods. The patent filings and approvals are closely tied to the regulatory process, ensuring that the devices meet safety and efficacy standards[5].
Industry Impact
- Innovation in Ophthalmology: This patent represents a significant innovation in ophthalmic therapies, offering a precise and controlled method for drug delivery. It highlights the ongoing efforts in the medical device industry to improve treatment options for ocular diseases[1].
- Market Competition: The patent landscape in this field influences market competition. Companies with robust patent protection can maintain a competitive edge, while generic manufacturers must wait for patent expirations or find alternative methods to enter the market[5].
Challenges and Future Directions
- Regulatory Challenges: The pharmaceutical and biotechnology industries face challenges in obtaining and maintaining patent protection due to stringent regulatory requirements. The scope of patent claims must be carefully defined to ensure they meet the enablement and written description requirements[3].
- Technological Advancements: Future advancements in microneedle technology and ocular drug delivery will likely build upon the foundation laid by this patent. Continuous innovation is necessary to address the evolving needs in ophthalmic therapies[1].
Key Takeaways
- Innovative Drug Delivery: The patent describes an innovative method for delivering therapeutic agents to the eye using microneedle technology.
- Suprachoroidal Space Targeting: The method specifically targets the suprachoroidal space, enhancing treatment efficacy for posterior ocular disorders.
- Patent Protection: The patent provides Clearside Biomedical, Inc. with exclusive rights until May 2, 2034.
- Clinical and Market Impact: The technology has significant implications for treating ocular diseases and influences market competition in the ophthalmic therapy sector.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 9,937,075?
The main focus of this patent is on apparatuses and methods for the non-surgical administration of drug formulations directly into the eye, specifically targeting the suprachoroidal space.
Who are the inventors and assignees of this patent?
The inventors include Rafael Victor Andino, Vladimir Zarnitsyn, Jesse Yoo, and others, with Clearside Biomedical, Inc. as the assignee.
What is the significance of microneedle technology in this patent?
Microneedle technology is used for transdermal and intraocular drug delivery, particularly for reaching the posterior region of the eye, which is challenging with conventional methods.
When is the patent set to expire?
The patent is set to expire on May 2, 2034.
How does this patent impact the treatment of ocular diseases?
This patent provides a non-surgical method for delivering drugs directly to the affected areas of the eye, potentially improving treatment outcomes and reducing side effects for ocular diseases.
