Detailed Analysis of the Scope and Claims of United States Patent 11,433,076
Overview of the Patent
United States Patent 11,433,076, titled "Preparation containing tetracyclic compound at high dose," was issued on September 6, 2022, to Chugai Seiyaku Kabushiki Kaisha. This patent is part of a broader portfolio of patents related to pharmaceutical compositions, particularly those involving tetracyclic compounds.
Inventors and Assignee
The inventors listed on this patent are Takashi Tomimatsu, Kensuke Okazaki, Yumi Ogawa, and Takahiro Yamamura, all affiliated with Chugai Seiyaku Kabushiki Kaisha, a Japanese pharmaceutical company[1][5].
Patent Claims
Main Claims
The patent primarily focuses on an improved solubility of a pharmaceutical composition or formulation containing a large amount of a specific tetracyclic compound, namely 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof. The claims include methods for achieving this improved solubility:
- Forming granules of the compound or its salt.
- Combining these granules with a disintegrating agent to enhance the solubility of the pharmaceutical composition[1][5].
Specific Claim Details
The patent includes multiple claims that detail the preparation and composition of the pharmaceutical formulation. Here are some key aspects:
- Claim 1: A pharmaceutical composition comprising granules of the tetracyclic compound or its salt and a disintegrating agent.
- Claim 2: The composition where the granules are formed by a specific process to ensure high solubility.
- Claim 3: The composition where the disintegrating agent is selected from a list of specified agents to optimize solubility and stability[1].
Patent Scope
Technological Context
The patent is within the realm of pharmaceutical formulations, specifically targeting the improvement of solubility for a tetracyclic compound used as an ALK (anaplastic lymphoma kinase) inhibitor. This compound is useful for the treatment of diseases such as cancer, cancer metastasis, depression, and cognitive function disorders[5].
Market and Industrial Impact
The improved solubility of the tetracyclic compound enhances the bioavailability and efficacy of the drug, making it more effective in treating the targeted diseases. This can have significant market and industrial implications, as it could lead to better patient outcomes and increased market share for Chugai Seiyaku Kabushiki Kaisha.
Patent Landscape
Related Patents
There are several related patents held by Chugai Seiyaku Kabushiki Kaisha that complement the scope of US Patent 11,433,076:
- Patent 10,350,214: Also deals with the preparation of a pharmaceutical composition containing the same tetracyclic compound, issued on July 16, 2019[5].
- Patent 9,126,931: Covers the tetracyclic compound itself and its use as an ALK inhibitor, issued on September 8, 2015[5].
- Patent 9,365,514: Relates to a composition comprising the tetracyclic compound, issued on June 14, 2016[5].
Expiration Dates
The patent is set to expire on April 24, 2035, which aligns with the typical 20-year patent term from the date of filing, considering any adjustments or extensions[2][5].
Legal and Regulatory Aspects
Patent Protection
The patent grants exclusive legal rights to Chugai Seiyaku Kabushiki Kaisha to protect the proprietary chemical formulation. This protection includes the drug's composition, dosage form, and manufacturing process[5].
FDA Exclusivity
While the patent provides intellectual property protection, FDA exclusivity can offer additional market protection. However, the details of any FDA exclusivity granted for this specific drug are not mentioned in the available sources.
Challenges and Reviews
Covered Business Method (CBM) Reviews
Although the specific patent in question does not fall under the category of "covered business method" patents, it is worth noting that patents related to data processing and business methods can be subject to CBM reviews. This is illustrated by cases like Symphony Health Solutions Corp. v. IMS Health Inc., where healthcare data analytics patents were challenged under CBM review[4].
Metrics for Patent Scope
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 clarity. Narrower claims with shorter lengths and fewer counts are often associated with a higher probability of grant and a shorter examination process[3].
Key Takeaways
- Improved Solubility: The patent focuses on enhancing the solubility of a tetracyclic compound through specific formulation techniques.
- Technological Context: The compound is an ALK inhibitor used in treating various diseases.
- Related Patents: There are several complementary patents held by Chugai Seiyaku Kabushiki Kaisha.
- Expiration Date: The patent is set to expire on April 24, 2035.
- Legal Protection: The patent provides exclusive rights to the proprietary formulation and manufacturing process.
FAQs
Q: What is the main focus of US Patent 11,433,076?
A: The main focus is on improving the solubility of a pharmaceutical composition containing a specific tetracyclic compound.
Q: Who are the inventors of this patent?
A: The inventors are Takashi Tomimatsu, Kensuke Okazaki, Yumi Ogawa, and Takahiro Yamamura.
Q: What is the expiration date of this patent?
A: The patent is set to expire on April 24, 2035.
Q: What is the significance of the tetracyclic compound in this patent?
A: The compound is an ALK inhibitor used for treating diseases such as cancer, cancer metastasis, depression, and cognitive function disorders.
Q: Are there any related patents to US Patent 11,433,076?
A: Yes, there are several related patents held by Chugai Seiyaku Kabushiki Kaisha that complement the scope of this patent.
Sources
- United States Patent and Trademark Office: US Patent 11,433,076 B2.
- PharmaCompass: US Patent 11433076.
- Hoover Institution: Patent Claims and Patent Scope.
- Holland & Knight: Healthcare Data Analytics Patent Subject to “CBM” Review at USPTO.
- Drugs.com: Generic Alecensa Availability.
