Understanding the Scope and Claims of United States Patent 10,695,365
Introduction
United States Patent 10,695,365 is a utility patent that has been involved in several significant legal and commercial activities, particularly in the pharmaceutical sector. To analyze the scope and claims of this patent, it is essential to delve into its background, the technology it covers, and the legal landscape surrounding it.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent 10,695,365. While the specific title of the patent is not provided in the sources, it is associated with pharmaceutical products, as evident from its involvement in ANDA (Abbreviated New Drug Application) litigation.
Inventors and Assignees
The patent is assigned to ZS Pharma, Inc., which is now part of AstraZeneca Pharmaceuticals LP. This indicates that the patent is part of a larger portfolio managed by a major pharmaceutical company[5].
Claims and Scope
Claims Structure
Patent claims define the scope of the invention and are crucial for determining what is protected by the patent. The Patent Claims Research Dataset by the USPTO provides insights into how claims are structured and analyzed. For U.S. Patent 10,695,365, the claims would typically include a set of independent and dependent claims that outline the novel and non-obvious aspects of the invention[3].
Specific Claims
The patent involves multiple claims related to the composition and use of a specific pharmaceutical product. For example, in the context of ANDA litigation, the patent is listed along with other related patents (e.g., 8,802,152, 8,808,750, 8,877,255) that cover various aspects of the drug, including its formulation, method of use, and manufacturing process[5].
Technology Field
The patent falls under the "Drugs and Medical Instruments" field, one of the broad technology categories defined by the USPTO. This field has seen significant changes in allowance rates over the years, with a notable decline in the approval rates for patent applications, particularly from 1996 to 2005[1].
Legal Landscape
ANDA Litigation
U.S. Patent 10,695,365 has been involved in ANDA litigation, which is a common legal battle in the pharmaceutical industry. ANDA litigation arises when a generic drug manufacturer seeks to enter the market before the expiration of the original patent. In this case, the patent holder (ZS Pharma, Inc. and AstraZeneca Pharmaceuticals LP) has taken legal action against generic manufacturers like Sandoz Inc. and Ascent Pharms. Inc. to prevent infringement[2][5].
Settlement Agreements
The litigation often results in settlement agreements that outline the terms under which the generic manufacturer can enter the market. For example, Sandoz Inc. and Ascent Pharms. Inc. are enjoined from infringing the patents-in-suit unless specifically authorized by the settlement agreements. These agreements typically include dismissal of all claims, counterclaims, and affirmative defenses without prejudice and without costs or attorneys’ fees[2].
Patent Prosecution History
The prosecution history of U.S. Patent 10,695,365 would be available through the USPTO's PAIR (Patent Application and Information Retrieval) system. This system provides detailed information on the application filing dates, pending application status, and continuation applications. The patent's history would show how it navigated the examination process, including any office actions, responses, and amendments made during the prosecution[1].
Allowance Rate and Trends
The allowance rate for patents in the "Drugs and Medical Instruments" field has declined over the years. According to a study by Carley, Hegde, and Marco, the overall allowance rate for utility patent applications filed between 1996 and 2005 was approximately 55.8%, with a notable decline in allowance rates for applications in this field[1].
Economic and Policy Implications
The patent system, including patents like U.S. Patent 10,695,365, plays a crucial role in innovation policy. Patents provide exclusive rights to inventors, which can drive innovation but also raise concerns about patent quality and validity. The U.S. patent system, governed by Title 35 of the United States Code, aims to balance the incentives for innovation with the need for public disclosure and access to technology[4].
Key Takeaways
- Patent Scope: U.S. Patent 10,695,365 covers specific pharmaceutical compositions and methods, with claims that define its scope and protect its novelty.
- Legal Involvement: The patent is involved in ANDA litigation, highlighting the legal battles in the pharmaceutical industry.
- Technology Field: It falls under the "Drugs and Medical Instruments" field, which has seen declining allowance rates.
- Prosecution History: Available through the USPTO's PAIR system, providing insights into its examination process.
- Economic Implications: Part of the broader patent system that balances innovation incentives with public disclosure.
FAQs
What is the significance of U.S. Patent 10,695,365 in the pharmaceutical industry?
U.S. Patent 10,695,365 is significant because it protects a specific pharmaceutical product, preventing generic manufacturers from entering the market without authorization, thus maintaining the exclusivity and profitability of the original drug.
How does ANDA litigation affect the patent holder and generic manufacturers?
ANDA litigation allows the patent holder to enforce their patent rights against generic manufacturers, potentially delaying the generic entry into the market. Settlement agreements can provide a structured timeline for generic entry, balancing the interests of both parties.
What is the current trend in allowance rates for patents in the "Drugs and Medical Instruments" field?
The allowance rate for patents in this field has declined substantially over the years, particularly from 1996 to 2005, indicating a more stringent examination process.
How can one access the prosecution history of U.S. Patent 10,695,365?
The prosecution history is available through the USPTO's PAIR system, which provides detailed information on the application filing dates, pending application status, and continuation applications.
What is the role of the USPTO in managing patents like U.S. Patent 10,695,365?
The USPTO examines and grants patents, publishes and disseminates patent information, records assignments, and maintains search files and a search room for public use, ensuring that patents are granted to entitled applicants and that the public has access to patent information.
Sources
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203-234.
- Robins Kaplan LLP. (2024). ANDA Litigation Settlements. Retrieved from https://www.robinskaplan.com/newsroom/insights/generically-speaking-hatch-waxman-bulletin-2024-q3-anda-litigation-settlements
- USPTO. (2017). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Congressional Research Service. (2022). Patents and Innovation Policy. Retrieved from https://crsreports.congress.gov/product/pdf/R/R47267/2
- United States District Court for the District of Delaware. (2022). ZS Pharma, Inc. v. Sandoz Inc.. Retrieved from https://insight.rpxcorp.com/litigation_documents/14952798
