United States Patent 8,828,430: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 8,828,430, titled "3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)," is associated with the pharmaceutical compound eltrombopag olamine. This patent was issued on September 9, 2014, to GlaxoSmithKline LLC, with inventors Francis X. Muller and Shivakumar G. Kapsi[2][4].
Scope of the Patent
The patent primarily covers novel pharmaceutical compositions and processes for preparing eltrombopag olamine, a thrombopoietin receptor agonist used to treat thrombocytopenia and aplastic anemia. Here are the key aspects of the patent's scope:
Pharmaceutical Compositions
The patent describes various pharmaceutical formulations, including granules and solid oral dosage forms such as tablets and capsules. These formulations include the active ingredient eltrombopag olamine, along with excipients like mannitol, microcrystalline cellulose, maltodextrin, and starch. The compositions are designed to enhance the stability, bioavailability, and patient compliance of the drug[4].
Manufacturing Processes
The patent outlines detailed manufacturing processes for the preparation of these pharmaceutical compositions. This includes methods for granulation, tablet formation, and film coating, ensuring the final product meets the required standards for efficacy and safety[4].
Claims of the Patent
The claims of the patent are crucial as they define the boundaries of the patent owner’s rights. Here are some key claims:
Composition Claims
- The patent claims cover specific formulations of eltrombopag olamine, including the combination of the active ingredient with various excipients and the specific ratios in which they are used[4].
Process Claims
- Claims also include the methods for preparing these formulations, such as the steps involved in granulation, compression into tablets, and the application of film coatings[4].
Dosage Form Claims
- The patent specifies the types of dosage forms that are covered, including tablets and capsules, and the characteristics of these forms, such as weight and disintegration properties[4].
Patent Expiration Dates
The patent expiration dates are critical for understanding the timeline of exclusive rights. For this patent:
- The primary patent is set to expire on August 1, 2027. However, due to pediatric exclusivity, the actual expiration date is extended to February 1, 2028[2][4].
Patent Landscape and Industry Impact
Pharmaceutical and Biotechnology Industry
The patent landscape for pharmaceuticals and biotechnology is complex and highly regulated. Patents like US 8,828,430 are essential for innovators to protect their intellectual property and recoup the significant investments made in drug development. However, recent jurisprudence, particularly around Section 112(a) of the U.S. patent law, has made it challenging to obtain and maintain broad patent claims, especially for genus claims that cover a class of compounds rather than specific embodiments[3].
Challenges in Patent Protection
- The Federal Circuit’s rigid stance on genus claims has made it difficult for pharmaceutical and biotechnology companies to claim the full scope of their inventions without violating the enablement and written description requirements. This has led to a situation where innovators are caught between claiming too broadly and risking invalidation or claiming too narrowly and allowing competitors to design around their patents[3].
Market and Economic Considerations
The market for therapeutic drugs, including those like eltrombopag, is substantial and growing. For instance, the market for therapeutic antibodies is projected to reach $300 billion by 2025. Robust and predictable patent protection is crucial for companies to commercialize their products effectively and recover their significant development costs[3].
Key Components and Excipients
The patent details various components and excipients used in the formulations:
- Mannitol: Used as a diluent and to improve the flow of the powder during the manufacturing process[4].
- Microcrystalline Cellulose: Acts as a binder and filler in the tablet formulations[4].
- Maltodextrin: Used as a disintegrant to help the tablet dissolve in the body[4].
- Starch: Can be used as a binder or disintegrant depending on the formulation[4].
Conclusion
United States Patent 8,828,430 is a significant patent in the pharmaceutical industry, particularly for the treatment of thrombocytopenia and aplastic anemia using eltrombopag olamine. The patent's scope covers specific pharmaceutical compositions and manufacturing processes, and its claims are designed to protect these innovations. However, the broader patent landscape highlights the challenges faced by pharmaceutical and biotechnology companies in securing and maintaining meaningful patent protection.
Key Takeaways
- Patent Scope: Covers pharmaceutical compositions and manufacturing processes for eltrombopag olamine.
- Claims: Include composition, process, and dosage form claims.
- Expiration Dates: Primary expiration on August 1, 2027, extended to February 1, 2028, due to pediatric exclusivity.
- Industry Impact: Highlights the challenges in obtaining and maintaining broad patent claims in the pharmaceutical and biotechnology industries.
- Market Considerations: Emphasizes the importance of robust patent protection for commercialization and investment recovery.
FAQs
What is the primary use of the drug covered by US Patent 8,828,430?
The primary use of the drug covered by this patent is to treat thrombocytopenia and aplastic anemia.
Who are the inventors of US Patent 8,828,430?
The inventors are Francis X. Muller and Shivakumar G. Kapsi.
What is the significance of the patent expiration date extension?
The extension from August 1, 2027, to February 1, 2028, is due to pediatric exclusivity, which grants additional time for exclusive marketing rights.
What are the main excipients used in the formulations described in the patent?
The main excipients include mannitol, microcrystalline cellulose, maltodextrin, and starch.
How does recent jurisprudence affect pharmaceutical and biotechnology patents?
Recent jurisprudence, particularly around Section 112(a), has made it challenging to obtain and maintain broad patent claims, especially for genus claims, which can impact the commercialization strategies of pharmaceutical and biotechnology companies.
Sources
- DrugBank: Eltrombopag: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Promacta Availability.
- DigitalCommons@NYLS: Eviscerating Patent Scope.
- Google Patents: US8828430B2 - 3′-[(2Z)-[1-(3,4-dimethylphenyl) - Google Patents.
