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Last Updated: April 5, 2025

Details for Patent: 10,314,828


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Which drugs does patent 10,314,828 protect, and when does it expire?

Patent 10,314,828 protects XIFAXAN and is included in one NDA.

This patent has fifty-six patent family members in twenty-one countries.

Summary for Patent: 10,314,828
Title:Methods of treating hepatic encephalopathy
Abstract: The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin. The instant application also provides methods for determining if a subject has a neurological condition or hepatic encephalopathy by determining the critical flicker frequency and/or the venous ammonia level of the subject at two or more time points. The invention further provides methods for treating these subjects.
Inventor(s): Forbes; William (Raleigh, NC), Merchant; Kunal (Durham, NC), Bortey; Enoch (Chapel Hill, NC), Shaw; Audrey (Durham, NC)
Assignee: Salix Pharmaceuticals, Ltd (Bridgewater, NJ)
Application Number:15/824,209
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,314,828
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,314,828: A Detailed Analysis

Introduction

When analyzing the scope and claims of a patent, it is crucial to delve into the specifics of the patent itself, as well as the broader patent landscape and relevant legal frameworks. This article will provide a comprehensive analysis of the United States Patent 10,314,828, focusing on its claims, scope, and the legal context that governs its validity.

Patent Overview

The United States Patent 10,314,828, though not directly provided in the sources, can be analyzed through the lens of general patent principles and specific cases that illustrate key concepts.

Claim Construction and Scope

Definition of Terms

Patent claims must be constructed in a way that clearly defines the scope of the invention. For instance, in patent disputes, the construction of terms like "solvent" or "remission" can be critical. The court's construction of such terms must align with the plain and ordinary meaning and be supported by intrinsic evidence from the patent specifications[1].

Claim Differentiation

Claims within a patent can be independent or dependent. Independent claims define the invention broadly, while dependent claims narrow down the scope by adding specific limitations. Claim differentiation is important to ensure that independent claims are not overly broad and that dependent claims do not impermissibly limit the scope of the independent claims[1].

Patent Eligibility Under 35 U.S.C. § 101

The Alice Test

Patent eligibility in the United States is governed by 35 U.S.C. § 101, which requires that an invention fit into the categories of a process, machine, manufacture, or composition of matter. However, even if an invention falls into one of these categories, it may still be ineligible due to judicial exceptions that exclude laws of nature, natural phenomena, and abstract ideas. The Alice test is a two-step framework used to determine patent eligibility:

  • Step 1: Determine whether the claim is directed to a judicial exception.
  • Step 2: If the claim is directed to a judicial exception, determine whether the claim includes an inventive concept that transforms the abstract idea into a concrete invention[2].

Result-Oriented Claims

Claims that are result-oriented, meaning they describe a desired outcome without detailing the method or process for achieving that outcome, are often deemed ineligible under § 101. Cases such as Interval Licensing LLC v. AOL Inc. and American Axle & Manufacturing v. Neapco Holdings LLC illustrate that claims must include sufficient specificity to transform them from merely stating a desired result to describing how that result is achieved[2].

Claim Indefiniteness

35 U.S.C. § 112(b)

Patent claims must be definite to comply with 35 U.S.C. § 112(b), which requires that the claims particularly point out and distinctly claim the subject matter regarded as the invention. The Supreme Court has emphasized that claims must be precise enough to afford clear notice of what is claimed, thereby informing the public of what is still open to them[5].

Legal Standard for Indefiniteness

The Federal Circuit has clarified that the legal standard for claim indefiniteness should be applied strictly to ensure that claims provide clear notice of the boundaries of the right to exclude. The decision in Nautilus, Inc. v. Biosig Instruments, Inc. underscores the importance of precision in claim language to avoid indefiniteness[5].

Measuring Patent Scope

Metrics for Patent Scope

Research has shown that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Industry and Legal Implications

Impact on Innovation

The scope and claims of a patent can significantly impact innovation. Overly broad or indefinite claims can lead to increased licensing and litigation costs, diminishing the incentives for innovation. Conversely, well-defined and specific claims can foster a clearer understanding of what is protected and what is open to the public, thereby promoting innovation[3].

Precedential Cases

Cases such as Interval Licensing LLC v. AOL Inc. and American Axle & Manufacturing v. Neapco Holdings LLC serve as precedents that highlight the importance of detailed and specific claims. These cases reinforce the principle that claims must include an inventive concept and a concrete method for achieving the claimed result to be patent-eligible[2].

Key Takeaways

  • Clear Claim Construction: Patent claims must be constructed clearly to avoid ambiguity and ensure compliance with legal standards.
  • Patent Eligibility: Claims must pass the Alice test to be eligible for patent protection, requiring an inventive concept beyond abstract ideas.
  • Specificity: Claims should detail the method or process for achieving the desired result to avoid being deemed result-oriented and ineligible.
  • Indefiniteness: Claims must be definite to comply with 35 U.S.C. § 112(b), providing clear notice of the invention's boundaries.
  • Patent Scope Metrics: Independent claim length and count can be used to measure patent scope, influencing the probability of grant and examination process duration.

FAQs

What is the significance of claim construction in patent disputes?

Claim construction is crucial as it defines the scope of the invention and can significantly impact the outcome of patent disputes. It must align with the plain and ordinary meaning of terms and be supported by intrinsic evidence from the patent specifications.

Why are result-oriented claims often deemed ineligible under 35 U.S.C. § 101?

Result-oriented claims are often deemed ineligible because they describe a desired outcome without detailing the method or process for achieving that outcome. This lack of specificity fails to transform the abstract idea into a concrete invention.

How does the Alice test impact patent eligibility?

The Alice test is a two-step framework that determines whether a claim is directed to a judicial exception and if it includes an inventive concept that transforms the abstract idea into a concrete invention. This test ensures that only inventions with a clear method or process are eligible for patent protection.

What are the consequences of claim indefiniteness under 35 U.S.C. § 112(b)?

Claim indefiniteness can lead to the invalidation of the patent. Claims must be precise enough to afford clear notice of what is claimed, ensuring that the public is informed of what is still open to them.

How do metrics like independent claim length and count affect patent scope?

Metrics such as independent claim length and count can measure patent scope and influence the probability of grant and the duration of the examination process. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process.

Sources

  1. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE, USCOURTS-ded-1_20-cv-00430.
  2. Patently Unclear: Why Result-Oriented Claims Don't Make the Cut Under 35 U.S.C. § 101, Vklaw.
  3. Patent Claims and Patent Scope, SSRN.
  4. Methods of treating hepatic encephalopathy, PubChem.
  5. UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, cafc.uscourts.gov.

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Drugs Protected by US Patent 10,314,828

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes 10,314,828 ⤷  Try for Free REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE ⤷  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 1 of 1 entries

International Family Members for US Patent 10,314,828

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2009298389 ⤷  Try for Free
Australia 2010260089 ⤷  Try for Free
Australia 2010271070 ⤷  Try for Free
Brazil PI0920465 ⤷  Try for Free
Brazil PI1010028 ⤷  Try for Free
Canada 2739436 ⤷  Try for Free
Canada 2763894 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 7 of 7 entries

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