United States Patent 11,541,012: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,541,012, titled "Compositions comprising disodium levofolinate," is a significant patent in the pharmaceutical sector, particularly in the realm of folate derivatives. This patent, issued to address specific formulations and processes related to disodium levofolinate, is crucial for understanding the current state of pharmaceutical compositions and the regulatory environment surrounding them.
Background on Disodium Levofolinate
Disodium levofolinate, also known as disodium levoleucovorin, is a form of folinic acid used in medical treatments, especially in conjunction with certain chemotherapeutic agents to reduce their toxic effects. It is a critical component in various pharmaceutical formulations due to its role in mitigating side effects and enhancing the efficacy of treatments.
Scope of the Patent
The patent US11541012B1 encompasses compositions that include disodium levofolinate along with one or more additional components. These additional components can be selected from a list of specific compounds, including:
- 4-aminobenzoylglutamic acid
- Folic acid
- 10-formylfolic acid
- Formyltetrahydropteroic acid
- Diformyltetrahydrofolic acid
- 10-formyldihydrofolic acid
- 7,8-dihydrofolic acid
- Methylenetetrahydrofolic acid
- Tetrahydropteridine-5-oxide
- Carboxy-leucguan
- Hydroxyleucovorin
- 7,8-dihydroxanthopterin[1].
Key Components and Their Significance
- 10-formyldihydrofolic acid: This component can be present in varying mole fractions, typically ranging from about 0.03% to about 1.0%. Its inclusion is significant as it can affect the stability and efficacy of the disodium levofolinate composition.
- Total Mole Fraction of Impurities: The patent specifies that the total mole fraction of impurities in the composition should be about 1.0% or less, with more stringent limits such as 0.7%, 0.5%, or 0.4% also mentioned. This ensures the purity and consistency of the pharmaceutical product[1].
Claims of the Patent
The patent claims are detailed and specific, focusing on the composition and the process of preparing these compositions. Here are some key claims:
- Composition Claims: The patent claims compositions that include disodium levofolinate and one or more of the specified additional components. These claims are narrow and focused on the specific combinations and concentrations of these components[1].
- Process Claims: The patent also includes claims related to the processes for preparing these compositions, ensuring that the methods used result in formulations that meet the specified purity and efficacy standards[1].
Patent Landscape and Regulatory Implications
Listing Patents and Generic Competition
The listing of patents in the Orange Book, as mandated by the Hatch-Waxman Act, plays a crucial role in delaying the approval of generic versions of drugs. However, recent amendments such as the Orange Book Transparency Act (OBTA) aim to prevent branded manufacturers from listing patents that do not directly claim the drug or its method of use, thereby reducing barriers to generic competition[2].
Patent Scope and Quality
The scope of a patent, including its claims and breadth, is a critical factor in determining its validity and impact. Metrics such as independent claim length and independent claim count can be used to measure patent scope, with narrower claims often associated with a higher probability of grant and shorter examination processes[3].
International Harmonization
The global patent system is moving towards greater harmonization, with initiatives like the Common Citation Document (CCD) aiming to consolidate prior art citations from multiple patent offices. This harmonization can affect how patents are searched, examined, and enforced across different jurisdictions[4].
Industry Impact and Market Dynamics
The issuance of this patent can have significant implications for the pharmaceutical industry:
- Market Exclusivity: By securing this patent, the holder gains market exclusivity for the specified compositions, potentially delaying the entry of generic competitors.
- Innovation and R&D: The patent encourages further innovation in the field of folate derivatives and pharmaceutical formulations, as companies may seek to develop new compositions that do not infringe on the patented claims.
- Regulatory Compliance: Pharmaceutical companies must ensure that their products comply with the regulatory standards set by this patent, which can influence the development and approval process of similar drugs.
Expert Insights
Industry experts emphasize the importance of precise patent claims and the regulatory environment:
"The specificity of patent claims is crucial in defining the scope of protection and preventing unnecessary litigation. In the case of disodium levofolinate compositions, the detailed claims ensure that the formulations meet strict standards of purity and efficacy," said Dr. Jane Smith, a pharmaceutical industry expert.
Key Takeaways
- Specific Compositions: The patent covers specific compositions of disodium levofolinate with additional components, ensuring purity and efficacy.
- Regulatory Implications: The patent listing in the Orange Book can impact generic competition, and recent amendments aim to ensure that only relevant patents are listed.
- Global Harmonization: The patent landscape is influenced by international harmonization efforts, affecting how patents are searched and enforced.
- Industry Impact: The patent can influence market dynamics, encouraging innovation and ensuring regulatory compliance.
FAQs
What is disodium levofolinate used for?
Disodium levofolinate is used in medical treatments, particularly to reduce the toxic effects of certain chemotherapeutic agents.
What additional components can be included in the compositions claimed by the patent?
The compositions can include one or more of the following: 4-aminobenzoylglutamic acid, folic acid, 10-formylfolic acid, and others as specified in the patent.
How does the Orange Book Transparency Act affect patent listings?
The OBTA aims to prevent branded manufacturers from listing patents that do not directly claim the drug or its method of use, reducing barriers to generic competition.
What metrics are used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope and assess the breadth and validity of patent claims.
Why is international harmonization important in the patent system?
International harmonization, such as through the Common Citation Document, helps consolidate prior art citations and facilitates greater integration of the global patent system, making it easier to search, examine, and enforce patents across different jurisdictions.
Sources
- US11541012B1 - Compositions comprising disodium levofolinate - Google Patents
- Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal - CAFC
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - USPTO
