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Last Updated: December 23, 2024

Details for Patent: 8,216,560


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Which drugs does patent 8,216,560 protect, and when does it expire?

Patent 8,216,560 protects VELTASSA and is included in one NDA.

This patent has ninety-six patent family members in seventeen countries.

Summary for Patent: 8,216,560
Title:Ion binding polymers and uses thereof
Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.
Inventor(s): Charmot; Dominique (Campbell, CA), Chang; Han Ting (Livermore, CA), Fordtran; John (Dallas, TX), Klaerner; Gerrit (San Jose, CA), Buysse; Jerry M. (Los Altos, CA), Alpern; Robert (Dallas, TX), Liu; Mingjun (Campbell, CA)
Assignee: Relypsa, Inc. (Santa Clara, CA)
Application Number:12/055,726
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,216,560
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,216,560: A Detailed Analysis

Introduction

Patent 8,216,560, like any other patent, is governed by the intricate landscape of U.S. patent law, which is defined by the Patent Act (35 U.S. Code) and administered by the United States Patent and Trademark Office (USPTO). To delve into the specifics of this patent, it is crucial to understand the broader context of patent law, the types of patents, and the process of obtaining and maintaining patent protection.

Types of Patents

In the U.S., patents are categorized into several types, including utility patents, design patents, and plant patents. Utility patents, the most common type, protect new and useful processes, machines, manufactures, or compositions of matter[1].

Patent Eligible Subject Matter

The eligibility of a patent is determined under Section 101 of the Patent Act, which outlines four categories of patentable inventions: processes, machines, manufactures, and compositions of matter. However, there are judicially developed exceptions that exclude certain subject matter, such as abstract ideas, natural phenomena, and mental processes[2].

The Alice/Mayo Framework

The Supreme Court's decisions in Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories have significantly impacted the determination of patent-eligible subject matter. The Alice/Mayo framework involves a two-step test to determine if a patent claim is eligible:

  • Step one: Determine if the claim is directed to an abstract idea, natural phenomenon, or another judicial exception.
  • Step two: If the claim is directed to an exception, determine if it contains an "inventive concept" that transforms the claim into something more than the exception itself[2].

Patent 8,216,560: Background and Claims

To analyze the scope and claims of Patent 8,216,560, one must review the patent's title, abstract, drawings, background, brief summary, and detailed description. Here are some key points:

Title and Abstract

The title and abstract provide a preliminary overview of the invention. The title should be concise and descriptive, while the abstract should summarize the invention's key features.

Background and Brief Summary

The background section explains the context and prior art related to the invention, highlighting the problems it solves. The brief summary outlines the invention's main aspects and its advantages over prior art[4].

Detailed Description and Drawings

The detailed description must be broad and detailed enough to enable a person skilled in the art to replicate the invention. Drawings are often included to illustrate the invention's components and how they interact[4].

Claim Analysis

Claim Structure

Patent claims define the scope of the invention and are crucial for determining what is protected. Claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention's broadest scope, while dependent claims narrow down the invention by adding specific limitations[5].

Claim Scope and Breadth

The scope of the claims in Patent 8,216,560 would be evaluated based on metrics such as independent claim length and independent claim count. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].

Indefiniteness

Claims must be precise enough to afford clear notice of what is claimed, thereby informing the public of what is still open to them. The Federal Circuit has emphasized that claims must define and circumscribe the invention clearly to avoid indefiniteness[5].

Patent Prosecution and Examination

The process of obtaining a patent involves submitting an application to the USPTO, where it is reviewed by an examiner. The examiner evaluates the application to determine if the invention is patentable under Section 101 and other relevant sections of the Patent Act. Responding to rejections, particularly those under Section 101, requires careful analysis and argumentation to prove patent eligibility[1].

Maintenance and Enforcement

Once a patent is granted, it must be maintained through the payment of maintenance fees. The patent holder has the right to exclude others from making, using, or selling the invention. Enforcement involves litigation to protect these rights against infringers[1].

Impact of Recent Judicial and Legislative Developments

Recent decisions and legislative proposals, such as the Alice/Mayo framework and bills like the Patent Eligibility Restoration Act of 2023, can significantly impact the patent landscape. These developments aim to clarify and potentially reform the standards for determining patent-eligible subject matter, which could affect the validity and scope of existing patents like 8,216,560[2].

Case Studies and Industry Impact

The impact of patent law changes can be seen in various industries, particularly in emerging technologies like AI and biotechnology. For instance, the USPTO has reported that the Alice/Mayo framework has differentially impacted AI technologies, leading to concerns about patent ineligibility for certain AI inventions[2].

Conclusion

Understanding the scope and claims of a patent like 8,216,560 requires a deep dive into the complexities of U.S. patent law, including the types of patents, patent-eligible subject matter, and the prosecution and examination process. Here are some key takeaways:

  • Patent Types: Utility patents are the most common and protect new and useful processes, machines, manufactures, or compositions of matter.
  • Patent Eligibility: Determined under Section 101, with exceptions for abstract ideas, natural phenomena, and mental processes.
  • Claim Analysis: Claims must be precise and define the invention clearly to avoid indefiniteness.
  • Prosecution and Examination: Involves submitting an application to the USPTO and responding to rejections.
  • Maintenance and Enforcement: Requires payment of maintenance fees and litigation to protect rights.
  • Recent Developments: Judicial decisions and legislative proposals can significantly impact patent eligibility and scope.

Key Takeaways

  • Clarity in Claims: Ensuring claims are clear and precise is crucial for patent validity.
  • Patent Eligibility: Understanding the Alice/Mayo framework is essential for determining patent eligibility.
  • Industry Impact: Changes in patent law can have significant effects on emerging technologies.
  • Maintenance: Regular payment of maintenance fees is necessary to keep the patent in force.
  • Enforcement: Litigation is a key aspect of protecting patent rights.

FAQs

Q: What are the main types of patents in the U.S.? A: The main types are utility patents, design patents, and plant patents.

Q: What is the Alice/Mayo framework? A: It is a two-step test to determine if a patent claim is eligible under Section 101 of the Patent Act, focusing on abstract ideas and inventive concepts.

Q: How are patent claims structured? A: Claims are typically divided into independent and dependent claims, with independent claims defining the broadest scope of the invention.

Q: Why is claim precision important? A: Claims must be precise to afford clear notice of what is claimed and to avoid indefiniteness.

Q: How do recent judicial and legislative developments impact patents? A: They can clarify or change the standards for determining patent-eligible subject matter, affecting the validity and scope of existing patents.

Sources

  1. BitLaw: Patent Law in the United States.
  2. CRS Reports: Patent-Eligible Subject Matter Reform: An Overview.
  3. SSRN: Patent Claims and Patent Scope.
  4. SBIR: TIMELINE AND COSTS FOR PATENT FILINGS.
  5. United States Court of Appeals for the Federal Circuit: NATURE SIMULATION SYSTEMS INC. v. AUTODESK, INC.

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Drugs Protected by US Patent 8,216,560

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-004 Oct 2, 2023 RX Yes No 8,216,560 ⤷  Subscribe TREATMENT OF HYPERKALEMIA ⤷  Subscribe
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-001 Oct 21, 2015 RX Yes No 8,216,560 ⤷  Subscribe TREATMENT OF HYPERKALEMIA ⤷  Subscribe
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-002 Oct 21, 2015 RX Yes Yes 8,216,560 ⤷  Subscribe TREATMENT OF HYPERKALEMIA ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,216,560

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1732523 ⤷  Subscribe 300924 Netherlands ⤷  Subscribe
European Patent Office 2269589 ⤷  Subscribe CA 2018 00003 Denmark ⤷  Subscribe
European Patent Office 1732523 ⤷  Subscribe 300925 Netherlands ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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