United States Patent 10,398,785: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,398,785, titled "Pharmaceutical compositions containing taxane compounds complexed with cyclodextrins and polyethylene glycol," is a significant patent in the pharmaceutical industry. This patent, granted to inventors in the field of pharmaceutical formulations, protects innovative compositions used in parenteral administration. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Patent
The patent covers pharmaceutical formulations designed for parenteral administration, specifically focusing on taxane compounds. Taxanes are a class of diterpenes known for their anti-cancer properties and are commonly used in chemotherapy. The patented compositions involve complexing taxane compounds with cyclodextrins and polyethylene glycol (PEG), which enhances the solubility and stability of these compounds, making them more effective and safer for administration[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim describes the pharmaceutical composition comprising a taxane compound complexed with a cyclodextrin and a polyethylene glycol.
- Dependent Claims: These claims further specify the types of taxane compounds, the molecular weight of the polyethylene glycol, and the ratio of the components in the composition.
- Method Claims: These claims cover the methods of preparing the pharmaceutical compositions and their use in treating various diseases, particularly cancer[4].
Patentability Criteria
For a patent to be granted, it must meet the criteria of novelty, usefulness, and nonobviousness. Here’s how US Patent 10,398,785 aligns with these criteria:
- Novelty: The invention must be new and not previously described in any patent or printed publication. The unique combination of taxane compounds with cyclodextrins and PEG ensures that this composition is novel.
- Usefulness: The invention must have a practical application. In this case, the composition is designed for parenteral administration, which is a practical and useful application in the medical field.
- Nonobviousness: The invention must be significantly different from existing knowledge and not obvious to someone skilled in the art. The specific combination and method of complexing taxane compounds with cyclodextrins and PEG would not be obvious to those in the pharmaceutical field[1].
Inventorship and Ownership
Determining the true and only inventors is crucial for the validity of a patent. US patent law requires that only those who conceived the idea and reduced it to practice be listed as inventors. In the case of US Patent 10,398,785, the inventors listed are those who contributed to the conception and reduction to practice of the pharmaceutical compositions[2].
Patent Landscape
The patent landscape surrounding US Patent 10,398,785 involves several key aspects:
- Related Patents: Other patents related to taxane compounds and their formulations are relevant. For example, patents like US Patent 8,058,069, which deals with similar pharmaceutical compositions, could be considered prior art or related inventions[5].
- Inter Partes Review (IPR): The patent landscape is also influenced by IPR proceedings. While US Patent 10,398,785 is not directly involved in any publicly known IPR cases, understanding how similar patents have been challenged can provide insights into potential vulnerabilities or strengths of the patent[5].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides insights into the economic and research implications of patents. For instance, the dataset can help analyze the scope and claims of patents, including those related to pharmaceutical compositions. This can be useful in understanding trends and the impact of such patents on the industry[3].
Expedited Examination and Maintenance
The patent process includes options for expedited examination, which can be crucial for pharmaceutical inventions that need rapid market entry. Additionally, maintenance fees are due at 3.5, 7.5, and 11.5 years after the patent grant to keep the patent in force[1].
International Filings and Publication
If the inventors intend to file the patent in other countries, the application will be published 18 months after filing. However, if there are no plans for international filings, the inventors can opt not to publish the application, preventing early disclosure of the technology[1].
Key Takeaways
- Innovative Composition: US Patent 10,398,785 protects a novel pharmaceutical composition involving taxane compounds complexed with cyclodextrins and PEG.
- Patentability Criteria: The patent meets the criteria of novelty, usefulness, and nonobviousness.
- Inventorship: Correct identification of inventors is crucial for the patent's validity.
- Patent Landscape: The patent is part of a broader landscape involving related patents and potential challenges.
- Economic and Research Implications: The patent contributes to the pharmaceutical industry's innovation and economic growth.
Frequently Asked Questions (FAQs)
What is the main subject matter of US Patent 10,398,785?
The main subject matter is pharmaceutical compositions containing taxane compounds complexed with cyclodextrins and polyethylene glycol for parenteral administration.
What are the key criteria for patentability that this patent must meet?
The patent must meet the criteria of novelty, usefulness, and nonobviousness.
Who are considered the true and only inventors in a US patent application?
The true and only inventors are those who conceived the idea and reduced it to practice.
Can the publication of a patent application be delayed or avoided?
Yes, if the inventors do not intend to file the patent in other countries, they can opt not to publish the application.
What is the significance of expedited examination in the patent process?
Expedited examination can accelerate the review process, which is particularly important for pharmaceutical inventions that need rapid market entry.
How often are maintenance fees due for a granted patent?
Maintenance fees are due at 3.5, 7.5, and 11.5 years after the patent grant.
Cited Sources
- THE U.S. PATENT APPLICATION PROCESS - SBIR
- Determining Inventorship for US Patent Applications - Oregon State University
- Patent Claims Research Dataset - USPTO
- US10398785B2 - Pharmaceutical compositions containing taxane compounds - Google Patents
- ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC. - Court of Appeals for the Federal Circuit
