Understanding the Scope and Claims of United States Patent 9,642,911
Introduction
United States Patent 9,642,911, titled "Pharmaceutical dosage forms comprising valganciclovir hydrochloride," is a significant patent in the pharmaceutical industry. This patent, granted to inventors who developed novel solid pharmaceutical dosage forms, is crucial for understanding the protection and application of intellectual property in the field of medicine.
What is the Patent About?
The patent focuses on novel solid pharmaceutical dosage forms designed for oral administration of valganciclovir hydrochloride. Valganciclovir hydrochloride is an antiviral medication used to treat cytomegalovirus (CMV) infections. The dosage forms are constituted in water, making them easier to administer, especially for patients who have difficulty swallowing tablets or capsules[1].
Scope of the Patent
The scope of the patent is defined by its claims, which are essential for determining the protection granted to the inventors. Here are the key aspects of the scope:
Claims
The claims in a patent application define the scope of the patent's protection. For US Patent 9,642,911, the claims would include specific descriptions of the novel dosage forms, their composition, and the method of their preparation. These claims ensure that the inventors have exclusive rights to make, use, offer for sale, or sell these specific dosage forms in the United States[2].
Novelty and Non-Obviousness
To be patentable, the invention must be novel, non-obvious, and useful. The dosage forms described in this patent must be new and not previously known or used. Additionally, they must be non-obvious, meaning they would not be immediately apparent to a person with ordinary skill in the relevant field[2][5].
Composition and Preparation
The patent details the composition of the dosage forms, which include valganciclovir hydrochloride and other excipients necessary for stability and efficacy. The preparation method involves specific steps to ensure the dosage forms are consistent and effective when constituted in water[1].
Intellectual Property Protection
The patent grants the inventors the exclusive right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States. This protection is crucial for pharmaceutical companies to recoup their investment in research and development[2].
Patent Landscape
Types of Patents
US Patent 9,642,911 is a utility patent, which is the most common type of patent application filed with the USPTO. Utility patents cover new and useful processes, machines, manufactures, or compositions of matter, or any new and useful improvement thereof[2].
Filing Process
The patent application process involves several steps, including filing a provisional application to establish an early filing date, followed by a non-provisional application within 12 months. The application includes a specification, drawings if necessary, an oath or declaration, an application data sheet, a transmittal letter, and fees[2][5].
Patent Prosecution
The patent prosecution process can take several years and involves the patent examiner reviewing the application to determine if the claimed invention is patentable. If the application is not patentable as submitted, the inventors may need to present arguments and amended claims to overcome objections. If the patent examiner does not accept these arguments, the inventors can appeal the decision to an appeal board or the U.S. court system[5].
Economic and Technological Impact
Innovation and Invention Trends
Patents like US 9,642,911 are indicators of innovation and invention in the pharmaceutical industry. They provide valuable technological and geographic detail, helping to track trends in patenting focus over time. For instance, the classification of patent data into technology areas, such as pharmaceuticals, can help analyze the focus of innovation in different fields[4].
Commercial Value
The commercial value of such patents is significant. The cost of drafting and filing a non-provisional patent application can range from $8,000 to $20,000 for a U.S. patent, and even more for international patents. However, these costs can be recovered through licensing agreements or commercial partnerships, making the patent a valuable asset for pharmaceutical companies[5].
Key Takeaways
- Novel Dosage Forms: The patent covers novel solid pharmaceutical dosage forms of valganciclovir hydrochloride for oral administration.
- Claims and Scope: The claims define the scope of protection, ensuring exclusivity for the inventors.
- Intellectual Property Protection: The patent grants exclusive rights to make, use, offer for sale, or sell the invention in the United States.
- Patent Landscape: The patent is a utility patent, filed through a process involving provisional and non-provisional applications.
- Economic Impact: The patent has significant commercial value and contributes to innovation trends in the pharmaceutical industry.
FAQs
Q: What is the main subject of US Patent 9,642,911?
A: The main subject is novel solid pharmaceutical dosage forms of valganciclovir hydrochloride for oral administration.
Q: Why are claims important in a patent application?
A: Claims define the scope of the patent's protection, determining what is covered by the patent.
Q: What types of patents can be filed with the USPTO?
A: The three main types are utility, design, and plant patents, with utility patents being the most common.
Q: How long does the patent prosecution process typically take?
A: The process can take two to five years, involving review by a patent examiner and potential appeals.
Q: What is the commercial significance of a pharmaceutical patent like US 9,642,911?
A: Such patents can be highly valuable, allowing companies to recoup their R&D investments through licensing and commercial partnerships.
Sources
- US9642911B2 - Pharmaceutical dosage forms comprising valganciclovir hydrochloride - Google Patents
- Patents | The Maryland People's Law Library
- Patent Claims Research Dataset - USPTO
- Invention: U.S. and Comparative Global Trends - NCSES
- Intellectual Property Protection - KU Office of Research
