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Last Updated: December 23, 2024

Details for Patent: 9,757,362


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Summary for Patent: 9,757,362
Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: VELOXIS PHARMACEUTICALS A/S (Copenhagen, DK)
Application Number:14/855,624
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,757,362

To delve into the specifics of the United States Patent 9,757,362, it is crucial to analyze several key aspects, including the patent's claims, its position within the patent landscape, and relevant legal and procedural contexts.

Patent Overview

United States Patent 9,757,362, hereafter referred to as the '362 patent, is a patent granted by the U.S. Patent and Trademark Office (USPTO). While the specific details of this patent are not provided in the sources, we can infer general principles and procedures that apply to patents of this nature.

Claims Analysis

Claim Structure

Patent claims are the heart of any patent, defining the scope of protection granted to the inventor. Claims can be independent or dependent, with independent claims standing alone and dependent claims referring back to one or more previous claims[3].

Claim Types

  • Independent Claims: These define the broadest scope of the invention and are crucial for determining patentability and infringement.
  • Dependent Claims: These narrow the scope of the invention and often provide additional details or limitations.

Claim Interpretation

The interpretation of claims is critical for understanding the patent's scope. This involves analyzing the language used in the claims, as well as any definitions provided in the specification. The USPTO and courts use various tools, such as the Patent Claims Research Dataset, to parse and analyze claim text and dependency relationships[3].

Patent Scope and Breadth

Patent Scope Measurements

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including measures of patent scope. This dataset helps in understanding the breadth and depth of patent protection by analyzing claim-level and document-level statistics[3].

Examples and Case Law

For AI-related patents, recent USPTO guidance updates, such as those effective July 17, 2024, provide examples and eligibility analyses that can help in drafting claims that meet patent eligibility criteria. These examples illustrate how specific applications of technologies, like neural networks, can meet eligibility criteria by demonstrating improvements in computer technology[4].

Patent Landscape and Family Members

Continuations and Continuations-in-Part

Patents can be part of a larger family, including continuations and continuations-in-part. These relationships can affect the patent's validity and term. For instance, the Cellect case highlights how different patents within a family can be affected by obviousness-type double patenting (ODP) and Patent Term Adjustment (PTA)[1].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents the same inventor from obtaining multiple patents for the same invention. This can be particularly relevant when dealing with continuations and continuations-in-part, as seen in the Cellect case where multiple patents were found to be unpatentable over earlier family member patents[1].

Inventorship and Ownership

Determining True and Only Inventors

Correctly identifying the inventors is crucial for the validity and enforceability of a patent. U.S. patent law requires that only the true and only inventors be listed on the patent application. Errors in inventorship, especially those involving deceptive intent, can render a patent unenforceable[5].

Conception and Reduction to Practice

Inventorship involves two key steps: the conception of the idea and the reduction of the idea to practice. Ensuring that all contributors are properly identified and credited is essential for maintaining the integrity and enforceability of the patent[5].

Legal and Procedural Contexts

USPTO Guidance and Regulations

The USPTO provides various guidelines and datasets to help practitioners navigate the complexities of patent law. For example, the 2024 USPTO guidance update on AI patents clarifies the process for determining the patent eligibility of AI-related inventions, integrating recent Federal Circuit decisions and providing practical examples[4].

Court Decisions and Appeals

Court decisions, particularly those from the Federal Circuit, play a significant role in shaping patent law. These decisions can affect how patents are interpreted and enforced, as seen in cases like Novartis AG v. Ezra Ventures LLC, which addressed the impact of ODP on Patent Term Extensions[1].

Patent Term and Adjustments

Patent Term Adjustment (PTA)

Patents can receive PTA for delays during prosecution, which can extend the patent term. However, as illustrated in the Cellect case, these adjustments can be complex, especially when dealing with multiple patents within a family[1].

Patent Term Extension (PTE)

In some cases, patents may be eligible for a PTE under specific circumstances. However, ODP does not invalidate a validly obtained PTE, as clarified in Novartis AG v. Ezra Ventures LLC[1].

Enforceability and Challenges

Patent Validity and Infringement

The enforceability of a patent depends on its validity and the scope of its claims. Challenges to a patent's validity can arise from various grounds, including ODP, lack of novelty, or non-obviousness.

Correcting Errors and Deceptive Intent

Errors in inventorship or other aspects of the patent application can be corrected, but deceptive intent can lead to the patent being unenforceable. Thorough disclosure and accurate identification of inventors are essential to maintain the patent's enforceability[5].

Key Takeaways

  • Claims Analysis: Understanding the structure and interpretation of patent claims is crucial for determining the scope of protection.
  • Patent Scope: Analyzing patent scope measurements and examples from relevant datasets and guidance updates helps in understanding the breadth and depth of patent protection.
  • Inventorship: Correctly identifying the true and only inventors is essential for the validity and enforceability of a patent.
  • Legal and Procedural Contexts: Staying updated with USPTO guidance, court decisions, and regulatory changes is vital for navigating the complexities of patent law.
  • Patent Term and Adjustments: Understanding PTA and PTE, as well as their implications on patent term, is important for managing patent portfolios.

Frequently Asked Questions (FAQs)

1. What is the significance of independent and dependent claims in a patent?

Independent claims define the broadest scope of the invention, while dependent claims narrow this scope by adding additional limitations.

2. How does the USPTO determine the patent eligibility of AI-related inventions?

The USPTO uses recent guidance updates that integrate Federal Circuit decisions and provide examples specifically tailored to AI technologies to determine patent eligibility.

3. What are the consequences of incorrect inventorship in a patent application?

Incorrect inventorship, especially with deceptive intent, can render a patent unenforceable. Even if corrected, a patent obtained through fraud remains unenforceable.

4. How does Obviousness-Type Double Patenting (ODP) affect patent validity?

ODP prevents the same inventor from obtaining multiple patents for the same invention, which can lead to the invalidation of later patents if they are found to be unpatentable over earlier family member patents.

5. What is the role of Patent Term Adjustment (PTA) in extending the patent term?

PTA extends the patent term for delays during prosecution, but its application can be complex, especially in cases involving multiple patents within a family.

Cited Sources:

  1. In re Cellect - United States Court of Appeals for the Federal Circuit
  2. U.S. Patent and Trademark Office (USPTO) | USAGov
  3. Patent Claims Research Dataset - USPTO
  4. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
  5. Determining Inventorship for US Patent Applications

More… ↓

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Drugs Protected by US Patent 9,757,362

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No 9,757,362 ⤷  Subscribe Y ⤷  Subscribe
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No 9,757,362 ⤷  Subscribe Y ⤷  Subscribe
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes 9,757,362 ⤷  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

Foreign Priority and PCT Information for Patent: 9,757,362

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003 01232Aug 29, 2003
Denmark2003 01837Dec 11, 2003
Denmark2004 00079Jan 21, 2004

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