Understanding the Scope and Claims of United States Patent 10,449,164: A Detailed Analysis
Introduction
United States Patent 10,449,164, associated with the drug MIEBO (perfluorohexyloctane ophthalmic solution), is a significant patent in the field of ophthalmology, particularly for the treatment of dry eye disease (DED). This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Overview of MIEBO
MIEBO is the first and only ophthalmic solution containing perfluorohexyloctane, used to treat the signs and symptoms of dry eye disease. It is owned by Bausch and Lomb Inc.[2][4].
Patent Details
Patent Number and Title
The patent in question is US Patent 10,449,164, titled "Methods of treating ocular disorders using semifluorinated alkanes."
Patent Expiration Date
This patent is set to expire on September 12, 2033[2][4].
Patent Use Code
The patent use code for this patent is U-1900, indicating its use for the treatment of a specific condition, in this case, ocular disorders[2][4].
Scope of the Patent
Claim Coverage
The patent covers methods of treating ocular disorders, specifically dry eye disease, using semifluorinated alkanes like perfluorohexyloctane. The claims are broad enough to encompass various methods of administration and treatment protocols but are narrowly focused on the use of semifluorinated compounds for ocular health[5].
Independent Claim Length and Count
The scope of the patent can also be measured by the length and count of independent claims. While the specific details of claim length and count are not provided in the sources, research suggests that longer and more numerous independent claims can indicate a broader patent scope. However, the validity and clarity of these claims are crucial for determining the actual scope[3].
Claims Analysis
Drug Substance Claim
The patent does not specifically claim the drug substance itself but rather the methods of using semifluorinated alkanes for treating ocular disorders. This distinction is important as it protects the therapeutic application rather than the compound's composition[2][4].
Drug Product Claim
The patent claims cover the drug product, specifically the ophthalmic solution containing perfluorohexyloctane. This includes the formulation, dosage, and administration methods for treating dry eye disease[5].
Patent Landscape
Related Patents
MIEBO is protected by multiple patents, including US10507132, US11357738, US10576154, US10058615, and US10449164. These patents cover various aspects such as topical administration methods, semifluorinated compound compositions, and methods of treating ocular disorders[4].
Litigations and Challenges
The patent has been subject to legal proceedings, including a challenge to its validity initiated on April 17, 2018. Novaliq GmbH was the respondent in this proceeding, which was decided on January 17, 2019. Such challenges are common in the pharmaceutical industry and can impact the patent's enforceability and the market exclusivity of the drug[4].
Exclusivities
In addition to patent protection, MIEBO has been granted exclusivities by the FDA. These exclusivities prevent other companies from marketing generic or bioequivalent versions of MIEBO until they expire, further extending the market exclusivity beyond the patent expiration dates[4].
Impact on Market Exclusivity
The combination of patent protection and FDA-granted exclusivities ensures that MIEBO maintains market exclusivity for an extended period. This is crucial for Bausch and Lomb Inc. as it allows them to recoup their investment in research and development without immediate generic competition[4].
Regulatory Review Period
Recent communications with regulatory agencies, such as the second letters to determine the regulatory review period, indicate ongoing interactions to ensure compliance and maintain the patent's validity[4].
Conclusion
United States Patent 10,449,164 is a pivotal patent in the treatment of dry eye disease, protecting the methods of using semifluorinated alkanes like perfluorohexyloctane. The patent's scope is defined by its claims on treatment methods and drug product formulations. The broader patent landscape, including related patents, litigations, and exclusivities, further solidifies MIEBO's market position.
Key Takeaways
- Patent Scope: Covers methods of treating ocular disorders using semifluorinated alkanes.
- Patent Expiration: Set to expire on September 12, 2033.
- Related Patents: Multiple patents protect various aspects of MIEBO.
- Litigations: The patent has faced challenges to its validity.
- Exclusivities: FDA-granted exclusivities extend market exclusivity beyond patent expiration.
- Regulatory Interactions: Ongoing communications with regulatory agencies ensure compliance.
FAQs
Q: What is the primary use of MIEBO?
A: MIEBO is used for the treatment of the signs and symptoms of dry eye disease (DED).
Q: When does the patent for MIEBO expire?
A: The patent (US10449164) is set to expire on September 12, 2033.
Q: What are the FDA-granted exclusivities for MIEBO?
A: The FDA has granted exclusivities that prevent other companies from marketing generic or bioequivalent versions of MIEBO until they expire.
Q: Have there been any legal challenges to the patent?
A: Yes, there have been legal proceedings challenging the validity of the patent, including a challenge initiated on April 17, 2018.
Q: How does the patent landscape impact MIEBO's market exclusivity?
A: The combination of patent protection and FDA-granted exclusivities ensures that MIEBO maintains market exclusivity for an extended period.
Sources
- PharmaCompass: 1-(Perfluorohexyl)octane - PharmaCompass.com
- PharmaCompass: Perfluorohexyloctane - Uses, DMF, Dossier, Manufacturer, Supplier ...
- Hoover Institution: Patent Claims and Patent Scope
- Pharsight: Miebo patent expiration
- FDA: Food and Drug Administration CDER, Office of Regulatory Policy ...
