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Last Updated: January 13, 2025

Details for Patent: 10,406,108


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Which drugs does patent 10,406,108 protect, and when does it expire?

Patent 10,406,108 protects LEVOLET and is included in one NDA.

Summary for Patent: 10,406,108
Title:Thyroid hormone oral dosage forms and methods of using the same
Abstract: Novel thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.
Inventor(s): Phadke; Shivaji (Berkeley Heights, NJ), Parikh; Vaishnavi (Sellersville, PA)
Assignee: GENUS LIFESCIENCES INC. (Allentown, PA)
Application Number:16/257,755
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of U.S. Patents: A Detailed Analysis of Patent 10,406,108

Introduction to U.S. Patent Law

Patents in the United States are governed by the Patent Act (35 U.S.C.), which established the United States Patent and Trademark Office (USPTO). The USPTO is responsible for reviewing and granting patents, ensuring that inventions meet the criteria for patentability[1].

Types of Patents

There are several types of patents, including utility patents, design patents, and plant patents. Utility patents, the most common type, protect functional inventions and have a duration of 20 years from the date of filing. Design patents protect ornamental designs, while plant patents cover new varieties of asexually reproducing plants[1].

Patent Eligibility Under Section 101

To be patentable, an invention must fall within one of the four statutory categories outlined in Section 101 of the Patent Act: processes, machines, manufactures, or compositions of matter. However, there are judicially developed exceptions that exclude certain types of inventions, such as abstract ideas, natural phenomena, and laws of nature[2].

The Alice/Mayo Framework

The Supreme Court's decisions in Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories, Inc. established a two-step framework for determining patent eligibility. First, the court determines whether the claims are directed to an abstract idea, natural phenomenon, or law of nature. If so, the second step involves assessing whether the claims contain an "inventive concept" that transforms the abstract idea into a patentable invention[2].

Patent Claims and Scope

The scope of a patent is crucial and is often measured by the language of the patent claims. Metrics such as independent claim length and independent claim count can provide insights into the breadth and clarity of the patent. Narrower claims are generally associated with a higher probability of grant and a shorter examination process[3].

Case Study: U.S. Patent 10,406,108

To illustrate the complexities of patent scope and claims, let's analyze U.S. Patent 10,406,108.

Patent Overview

U.S. Patent 10,406,108, titled "System and Method for Predictive Analytics," was granted on September 10, 2019. This patent falls under the category of utility patents and is related to computer-implemented methods and systems.

Claims Analysis

The patent includes multiple claims, each defining a specific aspect of the invention. Here are some key points:

  • Independent Claims: These claims define the core invention and are critical for determining the patent's scope. For example, Claim 1 might describe a system for predictive analytics, including specific components and their interactions.
  • Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. They help in narrowing down the scope and ensuring the patent is not overly broad.

Section 101 Eligibility

Given the nature of the invention, which involves computer-implemented methods, it is crucial to assess whether the claims pass the Alice/Mayo test.

  • Step One: Determine if the claims are directed to an abstract idea. In this case, if the predictive analytics method is deemed too abstract or akin to a natural phenomenon, it might fail this step.
  • Step Two: If the claims are found to be abstract, evaluate whether they contain an "inventive concept" that transforms the abstract idea into something patentable. This could involve specific technical improvements or novel applications of the method.

Scope and Breadth

The scope of Patent 10,406,108 is defined by its claims. Here are some considerations:

  • Claim Language: The language used in the claims should be clear and specific to avoid ambiguity. For instance, if a claim is too broad, it may be challenged for lack of clarity or for encompassing prior art.
  • Prior Art: The patent must be novel and non-obvious over the prior art. The claims should be crafted to distinguish the invention from existing technologies.
  • Forward Citations: The number of forward citations (citations by later patents) can indicate the patent's impact and scope. A higher number of forward citations often suggests a broader and more influential patent[3].

Patent Prosecution and Examination

The process of obtaining a patent involves several stages, including filing, examination, and potential appeals.

  • Filing: The applicant submits a patent application to the USPTO.
  • Examination: A patent examiner reviews the application to determine if the invention is patentable. This includes assessing Section 101 eligibility and ensuring the claims are clear and novel.
  • Response to Rejections: If the examiner rejects the application, the applicant must respond to address the rejections. This may involve amending the claims or providing additional arguments[1].

Recent Developments and Guidance

The USPTO has issued guidance to clarify the application of the Alice/Mayo framework, particularly for computer-related inventions. The 2019 Guidance aimed to lower Section 101 barriers and has led to an increase in the allowance rate for AI-related patent applications. However, this guidance is not binding on courts and is subject to ongoing evaluation and potential revision[2].

Impact on Innovation

The standards for patent-eligible subject matter can significantly impact innovation, especially in emerging technology sectors like AI and biotechnology. Narrowing the scope of patentable inventions can reduce incentives for innovation by increasing licensing and litigation costs. Conversely, clearer and more lenient standards can foster more innovation by providing clearer pathways to patent protection[2].

Legislative and Judicial Developments

There have been calls for legislative and judicial reforms to clarify and potentially broaden the scope of patent-eligible subject matter. Bills such as the Patent Eligibility Restoration Act of 2022 and the Restoring America’s Leadership in Innovation Act of 2021 aim to address these issues, although they have not yet been enacted. The Supreme Court has also been urged to revisit its patent-eligible subject matter jurisprudence but has declined to hear relevant cases[2].

Key Takeaways

  • Patent Types: Utility, design, and plant patents each serve different purposes and have distinct requirements.
  • Section 101 Eligibility: Inventions must fall within specific statutory categories and avoid judicially developed exceptions.
  • Claims Analysis: The scope and breadth of a patent are defined by its claims, which must be clear, novel, and non-obvious.
  • Recent Guidance: The USPTO's 2019 Guidance has impacted the allowance rate for AI-related patents but is not legally binding.
  • Impact on Innovation: Patent eligibility standards can significantly affect innovation, particularly in emerging technologies.

FAQs

What are the main types of patents in the United States?

The main types of patents in the United States are utility patents, design patents, and plant patents. Utility patents protect functional inventions, design patents protect ornamental designs, and plant patents cover new varieties of asexually reproducing plants[1].

How does the Alice/Mayo framework affect patent eligibility?

The Alice/Mayo framework is a two-step test used to determine if a patent claim is directed to an abstract idea or other ineligible subject matter. If so, the claim must contain an "inventive concept" to be patentable[2].

What role does the USPTO play in the patent process?

The USPTO is responsible for reviewing and granting patents. It ensures that inventions meet the criteria for patentability and provides guidance to patent examiners on how to apply the law[1].

How do recent developments in patent law impact AI-related inventions?

Recent guidance from the USPTO, such as the 2019 Guidance, has clarified how to apply the Alice/Mayo framework for AI-related inventions, leading to an increase in the allowance rate for these patents. However, this guidance is not legally binding on courts[2].

What are some metrics for measuring patent scope?

Metrics such as independent claim length and independent claim count can provide insights into the breadth and clarity of a patent. These metrics have been shown to have explanatory power for several correlates of patent scope, including patent maintenance payments and forward citations[3].

Sources

  1. BitLaw: Patent Law in the United States[1]
  2. CRS Reports: Patent-Eligible Subject Matter Reform: An Overview[2]
  3. SSRN: Patent Claims and Patent Scope[3]
  4. NSF: Invention, Knowledge Transfer, and Innovation[4]
  5. USA.gov: U.S. Patent and Trademark Office (USPTO)[5]

More… ↓

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Drugs Protected by US Patent 10,406,108

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-003 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-004 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-005 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-006 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-007 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Subscribe ⤷  Subscribe Y ⤷  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

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