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Last Updated: April 7, 2025

Details for Patent: 8,980,327


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Which drugs does patent 8,980,327 protect, and when does it expire?

Patent 8,980,327 protects FOSRENOL and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 8,980,327
Title:Capsule and powder formulations containing lanthanum compounds
Abstract: The present invention includes an oral pharmaceutical capsule comprising a shell, lanthanum carbonate or lanthanum carbonate hydrate, and a lubricant such as talc, wherein the shell encapsulates the lanthanum carbonate or its hydrate and the lubricant. Capsule shells comprise, for example, gelatin. The present invention also includes an oral pharmaceutical powder comprising lanthanum carbonate or lanthanum carbonate hydrate and a pharmaceutically acceptable excipient. The oral pharmaceutical capsules and powders of the present invention can be administered to treat a patient at risk of or suffering from hyperphosphatemia, at risk of or suffering from chronic kidney disease (CKD), at risk of or suffering from soft tissue calcification associated with CKD, or at risk of or suffering from secondary hyperparathyroidism.
Inventor(s): Pierce; David (Hertfordshire, GB), Ferdinando; Josephine Christine (Tadley, GB), Davies; Peter Neil (Basingstoke, GB)
Assignee: Shire LLC (Florence, KY)
Application Number:14/507,439
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,980,327
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

United States Patent 8,980,327: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,980,327, titled "Pharmaceutical Capsules and Powders," was granted on October 6, 2014. This patent is significant in the pharmaceutical industry, particularly in the treatment of chronic kidney disease (CKD) and other related conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Inventors and Assignees

The patent was invented by a team of researchers and assigned to a pharmaceutical company. Understanding the inventors and assignees is crucial as it often reflects the expertise and resources behind the invention[5].

Background of the Invention

The patent addresses the need for effective pharmaceutical formulations, specifically targeting patients at risk of or suffering from chronic kidney disease. CKD is a significant health issue, and innovative treatments are continually sought after.

Scope of the Invention

Claims

The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional details.

  • Independent Claims: These claims outline the core components of the pharmaceutical capsules and powders, including the active ingredients, excipients, and the method of preparation.
  • Dependent Claims: These claims specify additional features such as dosage forms, administration methods, and specific applications in treating CKD and other conditions[5].

Detailed Description

The detailed description section provides a comprehensive overview of the invention, including the materials used, the manufacturing process, and the intended use. This section is crucial for understanding the technical aspects of the patent and how it differs from prior art.

Claims Analysis

Claim Construction

Claim construction is the process of interpreting the meaning and scope of the claims. This is a critical step in determining the patent's validity and enforceability. The claims in this patent are constructed to cover a range of pharmaceutical formulations and their applications.

Claim Types

  • Composition Claims: These claims cover the specific composition of the pharmaceutical capsules and powders, including the active ingredients and excipients.
  • Method Claims: These claims cover the methods of preparing and administering the pharmaceutical formulations.
  • Use Claims: These claims specify the intended use of the pharmaceutical formulations, such as treating CKD[5].

Patent Landscape

Prior Art

Understanding the prior art is essential to assess the novelty and non-obviousness of the invention. The patent landscape includes a review of existing patents and publications related to pharmaceutical formulations for CKD treatment.

Related Patents

  • Family Members: The patent may have family members, such as continuations, continuations-in-part, or divisional applications, which can provide additional insights into the inventor's strategy and the scope of protection.
  • Cited References: The patent may cite other patents or publications that are relevant to the invention. These citations can help in understanding the state of the art at the time of the invention[5].

International Patent Filings

To understand the global reach of the invention, it is important to look at international patent filings. This includes searching databases such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[4].

Enforcement and Litigation

Patent Term Adjustment (PTA)

The patent term can be adjusted due to delays in the prosecution process. Understanding the PTA and its implications is crucial, especially in cases where obviousness-type double patenting (ODP) is a concern. The USPTO's stance on PTA and ODP, as seen in cases like In re Cellect, highlights the importance of considering the adjusted expiration date of the patent[1].

Terminal Disclaimers

Terminal disclaimers may be required to overcome ODP rejections. This involves disclaiming the term of a later patent to ensure that it does not extend beyond the term of an earlier patent. This is particularly relevant in cases where multiple patents are part of the same family and claim priority from the same application[1].

Economic and Market Impact

Market Demand

The demand for effective treatments for CKD is significant, and this patent addresses a critical need in the market. Understanding the market demand and the competitive landscape is essential for assessing the economic impact of the patent.

Competitive Analysis

A competitive analysis involves looking at other patents and products in the market that address similar needs. This helps in understanding the unique selling points of the patented invention and its potential market share.

Key Takeaways

  • Scope and Claims: The patent covers specific pharmaceutical formulations and their applications in treating CKD and other conditions.
  • Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and international filings.
  • Enforcement and Litigation: Understanding PTA, ODP, and terminal disclaimers is crucial for enforcing the patent.
  • Economic and Market Impact: The patent addresses a significant market need and has the potential for substantial economic impact.

FAQs

What is the primary use of the pharmaceutical formulations described in US Patent 8,980,327?

The primary use is in treating patients at risk of or suffering from chronic kidney disease (CKD).

How are the claims in this patent constructed?

The claims are constructed to cover the composition, method of preparation, and intended use of the pharmaceutical formulations.

What is the significance of Patent Term Adjustment (PTA) in this context?

PTA is significant because it affects the expiration date of the patent, especially in cases involving obviousness-type double patenting (ODP).

Can terminal disclaimers be required for this patent?

Yes, terminal disclaimers may be required to overcome ODP rejections and ensure that the patent term does not extend beyond the term of an earlier patent.

How can one search for related patents and prior art?

One can use resources such as the USPTO's Patent Public Search tool, Global Dossier, and international patent databases like the EPO and WIPO to search for related patents and prior art[4].

Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. U.S. Patent and Trademark Office (USPTO), USAGov.
  3. Patent Claims Research Dataset, USPTO.
  4. Search for patents, USPTO.
  5. United States Patent 8,980,327 B2, October 6, 2014.

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Drugs Protected by US Patent 8,980,327

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Takeda Pharms Usa FOSRENOL lanthanum carbonate POWDER;ORAL 204734-002 Sep 24, 2014 RX Yes Yes 8,980,327 ⤷  Try for Free Y ⤷  Try for Free
Takeda Pharms Usa FOSRENOL lanthanum carbonate POWDER;ORAL 204734-001 Sep 24, 2014 RX Yes No 8,980,327 ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 2 of 2 entries

International Family Members for US Patent 8,980,327

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2011336602 ⤷  Try for Free
Brazil 112013013469 ⤷  Try for Free
Canada 2816626 ⤷  Try for Free
China 103237543 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 4 of 4 entries

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