United States Patent 10,183,020: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,183,020, titled "Pharmaceutical compositions comprising AZD9291," is a significant patent in the pharmaceutical industry, particularly in the field of cancer treatment. This patent, assigned to AstraZeneca AB, pertains to the development and formulation of a specific drug, AZD9291 (also known as Osimertinib), which is used to treat certain types of cancer.
Background
AZD9291 is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. It is designed to target specific mutations in the EGFR gene, such as the L858R activating mutant, the Exon19 deletion activating mutant, and the T790M resistance mutant. These mutations are commonly found in non-small cell lung cancer (NSCLC)[4].
Patent Scope
The patent scope of US 10,183,020 is defined by its claims, which outline the specific aspects of the invention that are protected.
Claims Overview
The patent includes several claims that cover various aspects of the pharmaceutical compositions containing AZD9291:
- Composition Claims: These claims describe the pharmaceutical compositions suitable for oral administration, including the specific amounts and types of ingredients such as microcrystalline cellulose and other pharmaceutical diluents like mannitol, sorbitol, isomalt, polydextrose, lactitol, or lactose[4].
- Formulation Claims: The patent details the formulation of the pharmaceutical compositions, including the use of disintegrants like low-substituted hydroxypropyl cellulose or sodium starch glycolate[4].
- Method Claims: These claims cover the methods of treating diseases mediated by EGFR mutations using the described compositions.
Key Components of the Patent
Active Ingredient: AZD9291
AZD9291 is the active ingredient in these pharmaceutical compositions. It is a potent inhibitor of the EGFR signaling pathways, particularly effective against the T790M resistance mutant, which is a common mutation in NSCLC patients who have developed resistance to first- and second-generation EGFR inhibitors[4].
Pharmaceutical Diluents
The patent specifies the use of microcrystalline cellulose as a primary diluent and allows for the inclusion of other diluents such as mannitol, sorbitol, isomalt, polydextrose, lactitol, or lactose. The composition can include these diluents in various weight percentages, ensuring the stability and efficacy of the formulation[4].
Disintegrants
The inclusion of disintegrants like low-substituted hydroxypropyl cellulose or sodium starch glycolate is crucial for the proper dissolution of the tablet in the gastrointestinal tract, enhancing the bioavailability of AZD9291[4].
Patent Expiration Dates
The patent is set to expire on January 2, 2035. This expiration date is significant as it marks the end of the exclusive rights granted to AstraZeneca AB for the specific formulations and methods described in the patent[2].
Patent Landscape
Related Patents
Several related patents cover similar compounds and formulations:
- Patent 11,524,951: This patent also relates to 2-(2,4,5-substituted-anilino)pyrimidine compounds and their use in treating EGFR-mediated diseases. It has a patent expiration date of July 25, 2032[2].
- Patent 8,946,235: Another patent covering similar compounds and their pharmaceutical compositions, with an expiration date of August 8, 2032[2].
Competitive Environment
The patent landscape in this area is highly competitive, with multiple pharmaceutical companies developing and patenting various EGFR inhibitors. The expiration of these patents will open up opportunities for generic versions of these drugs, potentially altering the market dynamics[2].
Impact on Innovation and Competition
Innovation
The patent encourages innovation by protecting the specific formulations and methods developed by AstraZeneca AB. This protection allows the company to recoup its investment in research and development, thereby incentivizing further innovation in the field[3].
Competition
The expiration of the patent will introduce competition from generic manufacturers, which can lead to lower drug prices and increased accessibility for patients. However, it also raises concerns about the quality and efficacy of generic versions, as they must meet the standards set by the original patent[2].
Litigation and Patent Quality
Patent quality and the scope of claims are critical in avoiding litigation. The USPTO's examination process tends to narrow the scope of patent claims, ensuring that they are clear and not overly broad. This helps in reducing the likelihood of patent infringement disputes and maintains the integrity of the patent system[3].
Conclusion
United States Patent 10,183,020 is a pivotal patent in the field of cancer treatment, particularly for NSCLC. It protects the formulation and use of AZD9291, a crucial drug in targeting specific EGFR mutations. Understanding the scope, claims, and patent landscape of this invention is essential for pharmaceutical companies, researchers, and regulatory bodies.
Key Takeaways
- AZD9291: A third-generation EGFR tyrosine kinase inhibitor targeting specific mutations.
- Patent Scope: Covers pharmaceutical compositions, formulations, and methods of treatment.
- Expiration Date: January 2, 2035.
- Related Patents: Several patents cover similar compounds and formulations.
- Impact on Innovation and Competition: Protects innovation and encourages further research; expiration introduces competition from generics.
FAQs
Q: What is the active ingredient in the pharmaceutical compositions described in US 10,183,020?
A: The active ingredient is AZD9291 (Osimertinib), a third-generation EGFR tyrosine kinase inhibitor.
Q: What are the primary diluents used in the pharmaceutical compositions?
A: The primary diluent is microcrystalline cellulose, with optional additional diluents such as mannitol, sorbitol, isomalt, polydextrose, lactitol, or lactose.
Q: When does the patent expire?
A: The patent is set to expire on January 2, 2035.
Q: How does the patent impact innovation in the pharmaceutical industry?
A: The patent protects the specific formulations and methods developed by AstraZeneca AB, allowing the company to recoup its investment and incentivizing further innovation.
Q: What happens when the patent expires?
A: The expiration of the patent will allow generic manufacturers to produce versions of the drug, potentially reducing prices and increasing accessibility for patients.
Cited Sources
- US10183020B2 - Pharmaceutical compositions comprising AZD9291 - Google Patents
- Generic Tagrisso Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- US10183020B2 - Pharmaceutical compositions comprising AZD9291 - Google Patents
