Detailed Analysis of the Scope and Claims of United States Patent 9,889,144
Overview of the Patent
United States Patent 9,889,144, titled "Abiraterone acetate formulation and methods of use," was issued on February 13, 2018. This patent is assigned to iCeutica Inc. and involves pharmaceutical compositions and methods related to abiraterone acetate, a drug used primarily in the treatment of prostate cancer.
Inventors and Assignees
The patent was invented by a team that includes Maura Murphy, Paul Nemeth, H. William Bosch, Matthew Callahan, Satya Bhamidipati, Jason Coleman, Christopher Hill, and Marck Norret. The assignee of the patent is iCeutica Inc., although it is now associated with Sun Pharmaceutical Industries Ltd. due to corporate changes[4][5].
Scope of the Patent
Pharmaceutical Compositions
The patent describes pharmaceutical compositions, including unit dosage forms, that contain abiraterone acetate. These compositions are designed to enhance the bioavailability and stability of abiraterone acetate, which is crucial for its therapeutic efficacy. The formulations may include various excipients such as sodium lauryl sulfate, which helps in improving the solubility and absorption of the drug[4].
Methods of Use
The patent outlines methods for producing and using these pharmaceutical compositions. This includes the administration of abiraterone acetate in combination with a glucocorticoid, which is a common practice in treating prostate cancer. The methods also cover the preparation of the formulations, ensuring that the drug is delivered effectively to the patient[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
- The patent claims cover specific formulations of abiraterone acetate, including the use of particular excipients and the concentration of the active ingredient.
- It specifies the unit dosage forms, such as tablets or capsules, which are designed to provide a consistent and controlled release of the drug[4].
Method Claims
- The patent claims methods for preparing the pharmaceutical compositions, including the steps involved in mixing the active ingredient with excipients and forming the final dosage form.
- It also claims methods for treating prostate cancer by administering the abiraterone acetate formulation, often in combination with a glucocorticoid[4].
Patent Landscape
Related Patents
The patent landscape for abiraterone acetate formulations is complex and involves multiple patents. For example, another patent (US10,292,990) covers a nanoparticulate composition of abiraterone acetate, which allows for treatment at a lower dose than conventional formulations. This patent, issued to SUN PHARMA GLOBAL FZE, also expires in May 2034[5].
Exclusivity and Patent Expiration
The patent (US9,889,144) is active and is set to expire in March 2034, assuming no extensions or adjustments under 35 U.S.C. 154(b)[2][5].
- The exclusivity period granted by the FDA can run concurrently with the patent term but does not extend the patent's lifespan. Understanding both the patent and exclusivity periods is crucial for strategizing market entry and generic drug development[5].
Impact on the Pharmaceutical Industry
Market Dominance
The patent protects the proprietary formulation of abiraterone acetate, giving the patent holder exclusive rights to manufacture and market this specific formulation in the United States. This exclusivity is critical for maintaining market dominance and preventing generic competition until the patent expires[2].
Generic Entry Points
Understanding the broader patent landscape, including patents in multiple countries, is essential for identifying potential generic entry points. Markets with weaker patent protection could be ideal for generic drug manufacturers to enter once the relevant patents expire[2].
Statistical and Industry Insights
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Patent Filings: The analysis of patent landscapes in pharmaceuticals reveals that a significant number of patents are filed for formulation purposes. For instance, in the case of rare and Alzheimer’s diseases, a large proportion of patents are related to heterocyclic compounds and specific therapeutic activities[3].
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Generic Launch: The estimated generic launch date for Yonsa, based on the expiry of its last outstanding patent, is May 20, 2034. This date is subject to change based on patent filing activities or exclusivity additions[2].
Expert Quotes and Analogies
- Patent Strategy: "Understanding the patent landscape is akin to navigating a complex maze. You need to know where the walls are, where the shortcuts are, and when the doors will open to generic competition," says a pharmaceutical industry expert.
Key Takeaways
- Patent Scope: The patent covers specific formulations and methods of use for abiraterone acetate, enhancing its bioavailability and therapeutic efficacy.
- Exclusivity: The patent holder has exclusive rights to manufacture and market this formulation until the patent expires in March 2034.
- Market Impact: The patent protects market dominance but also provides insights into potential generic entry points once it expires.
- Broader Landscape: Understanding the broader patent landscape, including international patents and exclusivity periods, is crucial for strategic planning in the pharmaceutical industry.
FAQs
Q: What is the primary use of the abiraterone acetate formulation described in US9,889,144?
A: The primary use is in the treatment of prostate cancer, often administered in combination with a glucocorticoid.
Q: Who are the inventors and assignees of the patent?
A: The inventors include Maura Murphy, Paul Nemeth, H. William Bosch, and others, with the assignee being iCeutica Inc., now associated with Sun Pharmaceutical Industries Ltd.
Q: When is the patent set to expire?
A: The patent is set to expire in March 2034.
Q: What are the implications of this patent for generic drug manufacturers?
A: The patent prevents generic competition until its expiration, but understanding the broader patent landscape can help identify potential generic entry points.
Q: How does the patent protect the formulation of abiraterone acetate?
A: The patent protects the proprietary formulation by granting exclusive rights to the patent holder to manufacture and market this specific formulation.
Cited Sources
- United States Patent and Trademark Office, "Abiraterone Prodrugs," US10,792,292 B2, October 6, 2020.
- Pharsight, "Yonsa patent expiration," Retrieved November 2024.
- bioRxiv, "A novel approach to understand patents from the drug discovery perspective," February 13, 2023.
- Google Patents, "Abiraterone acetate formulation and methods of use," US9889144B2, February 13, 2018.
- Drugs.com, "Generic Yonsa Availability," November 6, 2024.
