Details for Patent: 9,861,658

Which drugs does patent 9,861,658 protect, and when does it expire?

Patent 9,861,658 protects LOKELMA and is included in one NDA.

This patent has forty-six patent family members in twenty-nine countries.

Summary for Patent: 9,861,658

Title:	Microporous zirconium silicate for the treatment of hyperkalemia
Abstract:	The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.
Inventor(s):	Keyser; Donald Jeffrey (Southlake, TX), Guillem; Alvaro F. (Lantana, TX)
Assignee:	ZS PHARMA, INC. (Coppell, TX)
Application Number:	14/826,038
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,861,658
Patent Claim Types: see list of patent claims	Use; Composition;

Understanding the Scope and Claims of United States Patent 9,861,658

Introduction to Patents and Patent Claims

To delve into the specifics of the United States Patent 9,861,658, it is essential to understand the broader context of patents and patent claims. Patents are granted to inventors for new and useful processes, machines, manufactures, or compositions of matter, or any new and useful improvement thereof, as defined by Title 35 of the U.S. Code[2].

The Role of Claims in a Patent Application

The claims in a patent application are crucial as they define the scope of the patent's protection. These claims must be clear, concise, and definite to ensure that the public understands what is protected by the patent[2].

United States Patent 9,861,658 Overview

Patent Details

• Patent Number: 9,861,658
• Title: This information is not provided directly in the sources, but it is associated with a specific invention or improvement.
• Assignee: Typically, this would be the entity or individual to whom the patent is assigned, often the inventor or their employer.

Patent Claims

The patent claims of U.S. Patent 9,861,658 would be detailed in the patent specification. Here are some key aspects to consider:

• Claim Structure: Patent claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[2].
• Claim Scope: The scope of the claims determines what is protected by the patent. This includes the specific features, processes, or compositions of matter that are novel, non-obvious, and useful[2].

Patent Landscape and Related Patents

Context within the Patent Family

• U.S. Patent 9,861,658 is part of a larger family of patents that may include other related patents such as 9,592,253, 9,844,567, 9,913,860, 10,300,087, and others mentioned in the context of litigation documents[1].
• These patents likely cover various aspects of the same or related inventions, such as different methods of manufacture, use, or improvements.

Litigation and Enforcement

• The patent has been involved in litigation, as evidenced by the civil action for patent infringement. This indicates that the patent holder is actively enforcing the patent against potential infringers[1].
• The litigation involves Paragraph IV Certifications, which are certifications made by generic drug manufacturers that the patents listed in the Orange Book are invalid, unenforceable, or will not be infringed by the generic product[1].

Patentability Requirements

For a patent like 9,861,658 to be granted, it must meet the patentability requirements:

• Novelty: The invention must be new and not obvious from prior art[2].
• Non-obviousness: The invention must be significantly different from existing technology and not obvious to a person of ordinary skill in the relevant field[2].
• Usefulness: The invention must have a practical application and be capable of being made and used[2].

Filing and Prosecution Process

• Application Types: The patent could have been filed as a utility patent, which is the most common type of patent application. It may have started as a provisional application to establish an early filing date, followed by a non-provisional application within 12 months[2].
• Filing with USPTO: The application would have been filed with the U.S. Patent and Trademark Office (USPTO) through their electronic filing system or by mail/hand delivery[2].

Data and Statistics

• Patent Claims Research Dataset: While specific data on U.S. Patent 9,861,658 is not available in the dataset, the USPTO's Patent Claims Research Dataset provides insights into patent claims and scope measurements for patents granted between 1976 and 2014. This dataset can offer broader trends and statistics on patent claims[3].

Expert Insights and Case Law

• Claim Construction: The interpretation of claim terms is crucial in patent litigation. Cases like Network-1 Technologies, Inc. v. Hewlett-Packard Company highlight the importance of claim construction and how it can impact the outcome of infringement and validity determinations[5].
• Litigation Strategies: Industry experts often emphasize the importance of robust claim drafting and strategic litigation to protect patent rights. For example, a well-crafted claim can significantly impact the outcome of a patent infringement case[5].

Key Takeaways

• Patent Claims Define Protection: The claims in a patent application are essential for defining the scope of protection.
• Patent Landscape: Understanding the broader patent landscape, including related patents and litigation, is crucial for strategic patent management.
• Patentability Requirements: Patents must meet novelty, non-obviousness, and usefulness criteria.
• Filing and Prosecution: The process involves filing with the USPTO, either as a provisional or non-provisional application.
• Data and Statistics: Utilizing datasets and research can provide valuable insights into patent trends and scope measurements.

FAQs

Q1: What is the primary purpose of claims in a patent application?

• The primary purpose of claims in a patent application is to define the scope of the patent's protection.

Q2: How do you determine the scope of a patent?

• The scope of a patent is determined by the claims, which must be clear, concise, and definite.

Q3: What are the patentability requirements for a U.S. patent?

• The patentability requirements include novelty, non-obviousness, and usefulness.

Q4: Can a provisional patent application establish an early filing date?

• Yes, a provisional patent application allows one to establish an early filing date and has fewer formal requirements than a non-provisional application.

Q5: Why is claim construction important in patent litigation?

• Claim construction is crucial because it determines how the claims are interpreted, which can significantly impact the outcome of infringement and validity determinations.

Sources

1. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - [PDF]
2. Patents | The Maryland People's Law Library
3. Patent Claims Research Dataset - USPTO
4. U.S. Patent and Trademark Office (USPTO) | USAGov
5. Network-1 Technologies, Inc. v. Hewlett-Packard Company - [PDF]

Drugs Protected by US Patent 9,861,658

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No						TREATMENT OF HYPERKALEMIA IN ADULTS
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes						TREATMENT OF HYPERKALEMIA IN ADULTS

International Family Members for US Patent 9,861,658

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2673237		300976	Netherlands
European Patent Office	2673237		LUC00111	Luxembourg
European Patent Office	2673237		PA2019010	Lithuania
European Patent Office	2673237		CA 2019 00014	Denmark
European Patent Office	2673237		122019000036	Germany