United States Patent 9,457,093: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,457,093, titled "Solid dispersions of a ERB2 (HER2) inhibitor," is a significant patent in the field of pharmaceuticals, particularly in the treatment of breast cancer and other hyperproliferative diseases. This patent, issued on October 4, 2016, is assigned to Array Biopharma, Inc. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent focuses on solid dispersions of a HER2 inhibitor, which is crucial for treating HER2-positive breast cancer. HER2 (Human Epidermal Growth Factor Receptor 2) is a protein that promotes the growth of cancer cells, and inhibitors targeting this receptor have been a cornerstone in the treatment of HER2-positive breast cancer.
Scope of the Patent
The scope of the patent encompasses the formulation, preparation, and use of solid dispersions containing a HER2 inhibitor. Here are the key aspects:
Formulation
The patent describes the preparation of solid dispersions using various techniques such as spray drying, evaporation, and other methods to improve the solubility and bioavailability of the HER2 inhibitor[1][4].
Components
The solid dispersions include the active pharmaceutical ingredient (API), which is the HER2 inhibitor, along with various excipients such as hydroxypropyl methylcellulose phthalate, cellulose acetate propionate, and sodium bicarbonate. These excipients help in stabilizing the API and enhancing its dissolution properties[1][4].
Methods of Preparation
The patent details several methods for preparing the solid dispersions, including spray drying and evaporation. These methods are crucial for achieving the desired physical and chemical properties of the final product[1][4].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the invention while also providing clarity on what is covered.
Independent Claims
The independent claims focus on the composition of the solid dispersion, the method of preparation, and the use of the solid dispersion in treating diseases such as breast cancer. For example, Claim 1 describes a solid dispersion comprising a HER2 inhibitor and a polymer, such as hydroxypropyl methylcellulose phthalate[1][4].
Dependent Claims
The dependent claims further specify the components, their proportions, and the methods of preparation. These claims provide additional details on the excipients, the process conditions, and the physical characteristics of the solid dispersions[1][4].
Patent Landscape
The patent landscape surrounding US 9,457,093 is complex and involves several related patents and regulatory considerations.
Related Patents
There are several related patents that cover different aspects of HER2 inhibitors and their formulations. For example, patents such as US 8,648,087 and US 9,693,989 also cover N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors[5].
Patent Expiration Dates
The patent expiration dates are critical for understanding the timeline of exclusivity. The patent US 9,457,093 is set to expire on April 27, 2038, although other related patents may have different expiration dates, such as US 8,648,087 expiring on April 12, 2031, and US 9,693,989 expiring on May 9, 2027[5].
Regulatory Considerations
The regulatory review period and any extensions play a significant role in the patent landscape. For instance, the FDA's determination of the regulatory review period for Tukysa, a drug related to this patent, involved a detailed analysis of the testing and approval phases, which can impact patent term extensions[2].
Impact on Innovation and Competition
The scope and claims of this patent have significant implications for innovation and competition in the pharmaceutical industry.
Innovation
The patent encourages innovation by protecting the specific formulations and methods of preparation, allowing the patent holder to invest in further research and development without immediate competition. However, it also narrows the scope for other innovators who might be working on similar formulations[3].
Competition
The expiration of related patents and the eventual generic availability of therapeutically equivalent versions will increase competition. Currently, there is no generic version of Tukysa available in the United States, but as patents expire, generic manufacturers will be able to enter the market[5].
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For US 9,457,093, the claims are detailed and specific, indicating a well-defined scope that is less likely to be overly broad or ambiguous[3].
Regulatory Review and Patent Term Extensions
The regulatory review period and any subsequent patent term extensions are crucial for understanding the full lifespan of the patent. The FDA's determination of the regulatory review period for related drugs can lead to patent term extensions, which can further protect the exclusivity of the patent holder[2].
Key Takeaways
- Formulation and Preparation: The patent covers solid dispersions of a HER2 inhibitor with specific formulations and preparation methods.
- Claims: The claims are detailed and specific, covering the composition, method of preparation, and use in treating diseases.
- Patent Landscape: The patent is part of a broader landscape involving related patents and regulatory considerations.
- Impact on Innovation and Competition: The patent protects innovation but also narrows the scope for other innovators and delays generic competition.
- Regulatory Considerations: The regulatory review period and patent term extensions are critical for the patent's lifespan.
FAQs
Q: What is the main focus of United States Patent 9,457,093?
A: The main focus is on solid dispersions of a HER2 inhibitor for treating breast cancer and other hyperproliferative diseases.
Q: What methods are described for preparing the solid dispersions?
A: The patent describes methods such as spray drying and evaporation to prepare the solid dispersions.
Q: What are the key components of the solid dispersions?
A: The key components include the HER2 inhibitor and various excipients like hydroxypropyl methylcellulose phthalate and sodium bicarbonate.
Q: When is the patent set to expire?
A: The patent is set to expire on April 27, 2038.
Q: Are there any generic versions of Tukysa available?
A: No, there are currently no generic versions of Tukysa available in the United States.
Cited Sources
- US9457093B2 - Solid dispersions of a ERB2 (HER2) inhibitor - Google Patents.
- Federal Register, Volume 88 Issue 228 - U.S. Government Publishing Office.
- Patent Claims and Patent Scope - SSRN.
- US9457093B2 - Solid dispersions of a ERB2 (HER2) inhibitor - Google Patents.
- Generic Tukysa Availability - Drugs.com.
