Analyzing the Scope and Claims of United States Patent 9,987,285
Introduction
United States Patent 9,987,285, titled "High dosage strength tablets of rucaparib," is a patent that pertains to the formulation and preparation of high dosage strength tablets of the pharmaceutical compound rucaparib. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Rucaparib
Rucaparib is a small molecule inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, used primarily in the treatment of certain types of cancer, such as ovarian cancer. The development of high dosage strength tablets of rucaparib is crucial for improving patient compliance and efficacy.
Patent Overview
Publication Details
- Patent Number: US9,987,285B2
- Publication Date: February 25, 2016
- Application Number: US14/828,065
- Priority Date: August 21, 2014[4].
Scope of the Patent
The patent focuses on the formulation and manufacturing process of high dosage strength tablets of rucaparib. Here are the key aspects of the scope:
Formulation
The patent describes solid dosage forms of rucaparib, including rucaparib maleate and rucaparib camsylate. These formulations are designed to achieve high dosage strengths while maintaining stability and bioavailability[4].
Excipients and Inactive Ingredients
The patent specifies various excipients and inactive ingredients used in the formulation, such as organic compounds, inorganic compounds, and polysaccharides. These ingredients are crucial for the physical form and stability of the tablets[4].
Physical Form
The tablets are characterized by their special physical form, including pills, tablets, discs, and rods. The patent details the specific classifications under the International Patent Classification (IPC) system, such as A61K9/20 and A61K9/2004[4].
Claims of the Patent
The claims of the patent are the legal definitions of the invention and define the scope of protection.
Independent Claims
The independent claims typically define the broadest scope of the invention. For US9,987,285, these claims would include the composition of the high dosage strength tablets, the method of preparation, and the specific excipients used.
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. These might include specific ratios of active to inactive ingredients, particular manufacturing processes, or specific physical characteristics of the tablets.
Patent Landscape
Prior Art
The patent references prior art, such as U.S. Pat. No. 8,754,072, which discloses solid dosage forms of rucaparib maleate and rucaparib camsylate. The new patent builds upon this prior art by providing improved formulations and manufacturing processes[4].
International Classification
The patent is classified under various IPC categories, including A61K9/20 for pills, tablets, discs, and rods, and A61K9/2004 for excipients and inactive ingredients. This classification helps in understanding the broader technological field and related patents[4].
Global Patent Family
To understand the global reach of this patent, one would need to look into the patent family, which includes related applications filed in other countries. This can be done using tools like the Global Dossier provided by the USPTO, which allows users to see the patent family for a specific application across participating IP Offices[1].
Patent Prosecution and Examination
The process of patent prosecution for US9,987,285 would have involved a detailed examination by the U.S. Patent and Trademark Office (USPTO). This includes reviewing the patentability of the claims, ensuring the invention is novel, nonobvious, and enabled, and addressing any office actions or rejections[2].
Commercial and Licensing Aspects
The commercial value of this patent is significant, given the importance of rucaparib in cancer treatment. The costs associated with patenting, including drafting, filing, and prosecuting the patent, can be substantial, often ranging between $8,000 to $20,000 for a U.S. non-provisional patent application. International patents can cost several times more[2].
Key Takeaways
- Formulation and Manufacturing: The patent provides detailed formulations and manufacturing processes for high dosage strength tablets of rucaparib.
- Scope and Claims: The claims define the composition, method of preparation, and specific excipients used, with both independent and dependent claims.
- Patent Landscape: The patent is part of a broader technological field classified under IPC categories and builds upon prior art.
- Global Reach: Understanding the global patent family is crucial for assessing the international protection of the invention.
- Commercial Value: The patent has significant commercial value due to the importance of rucaparib in cancer treatment.
FAQs
Q: What is the primary focus of United States Patent 9,987,285?
A: The primary focus is on the formulation and manufacturing process of high dosage strength tablets of the pharmaceutical compound rucaparib.
Q: What are the key excipients mentioned in the patent?
A: The patent mentions various excipients, including organic compounds, inorganic compounds, and polysaccharides.
Q: How is the patent classified internationally?
A: The patent is classified under IPC categories such as A61K9/20 and A61K9/2004.
Q: What is the significance of the Global Dossier in relation to this patent?
A: The Global Dossier allows users to see the patent family for a specific application across participating IP Offices, providing a comprehensive view of the global protection.
Q: What are the typical costs associated with patenting a pharmaceutical invention like this?
A: The costs can range between $8,000 to $20,000 for a U.S. non-provisional patent application, with international patents costing several times more.
Sources
- USPTO - Search for patents
- KU Office of Research - Intellectual Property Protection
- SSRN - Patent Claims and Patent Scope
- Google Patents - US9987285B2
