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Last Updated: December 22, 2024

Details for Patent: 11,173,110


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Summary for Patent: 11,173,110
Title:Risperidone or paliperidone implant formulation
Abstract:The present invention is directed to an injectable intramuscular depot composition suitable for forming an in situ solid implant in a body, comprising a drug which is risperidone and/or paliperidone or any pharmaceutically acceptable salt thereof in any combination, a biocompatible copolymer based on lactic and glycolic acid having a monomer ratio of lactic to glycolic acid of about 50:50 and a DMSO solvent, wherein the composition releases the drug with an immediate onset of action and continuously for at least 4 weeks and wherein the composition has a pharmacokinetic profile in vivo that makes it suitable to be administered each 4 weeks or even longer periods.
Inventor(s):Gutierro Aduriz Ibon, Franco Rodriguez Guillermo
Assignee:Laboratorios Farmacéuticos Rovi, S.A.
Application Number:US16368258
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,173,110: A Comprehensive Analysis

Introduction

When analyzing a patent, it is crucial to delve into its scope, claims, and the broader patent landscape to understand its validity, potential challenges, and strategic implications. This article will provide a detailed analysis of the United States Patent 11,173,110, focusing on its claims, the legal framework governing patent validity, and the context within which it operates.

Patent Claims and Scope

What are Patent Claims?

Patent claims define the scope of protection granted to an inventor. They are the legal boundaries that distinguish the invention from prior art and other existing technologies[3].

Analyzing Claims of U.S. Patent 11,173,110

To analyze the claims of U.S. Patent 11,173,110, one must review the patent document itself. Here are some key steps:

  • Identify Independent and Dependent Claims: Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.
  • Understand Claim Language: Each claim must be clear, concise, and fully supported by the patent's specification.
  • Determine Claim Scope: The scope of the claims defines what is protected and what is not. This is critical for determining infringement and validity.

Legal Framework: Obviousness-Type Double Patenting (ODP)

Definition and Purpose

Obviousness-type double patenting (ODP) is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from an earlier patent. This ensures that inventors do not extend the patent term indefinitely by filing multiple patents on the same invention[1][2].

Relevance to U.S. Patent 11,173,110

If U.S. Patent 11,173,110 is part of a family of patents, it is essential to check for ODP issues. This involves comparing the claims of the patent with those of its parent or sibling patents to ensure they are patentably distinct.

Patent Term Adjustments (PTA) and Terminal Disclaimers

Patent Term Adjustments

PTA extends the term of a patent to compensate for delays in the patent prosecution process. However, this adjustment does not extend the term beyond the date specified in a terminal disclaimer[1].

Terminal Disclaimers

A terminal disclaimer is a statement by the patent owner that the term of the later patent will not extend beyond the term of an earlier patent. This is often used to overcome ODP rejections[1][2].

Patent Landscape and Related Patents

Continuation and Divisional Applications

Patents like U.S. Patent 11,173,110 may be part of a series of continuation or divisional applications. Understanding the filing and issuance dates of these related patents is crucial for determining their expiration dates and potential ODP issues[2].

Example from Allergan USA, Inc. v. MSN Laboratories Private Ltd.

In the case of Allergan USA, Inc. v. MSN Laboratories Private Ltd., the court dealt with similar issues where multiple patents were filed as continuations and divisionals. The court's decision highlighted the importance of the filing and issuance dates in determining ODP validity[2].

Written Description and Enablement

35 U.S.C. § 112

The written description and enablement requirements under 35 U.S.C. § 112 are critical for patent validity. The claims must be fully supported by the specification, and the specification must enable one skilled in the art to make and use the invention[5].

Strategic Implications

Patent Portfolio Management

Understanding the scope and claims of U.S. Patent 11,173,110 is essential for managing a patent portfolio. This includes ensuring that the patent does not infringe on other patents and that it is not vulnerable to ODP or other validity challenges.

Litigation and Enforcement

In the event of litigation, a clear understanding of the patent's claims and scope is vital for defending against invalidity claims or asserting infringement claims.

Key Takeaways

  • Patent Claims Define Scope: Claims are the legal boundaries of a patent and must be clear and fully supported.
  • ODP Prevention: Ensure that the patent is not subject to ODP by comparing claims with related patents.
  • PTA and Terminal Disclaimers: Understand how PTA and terminal disclaimers affect the patent term.
  • Related Patents: Analyze the filing and issuance dates of related patents to avoid ODP issues.
  • Written Description and Enablement: Ensure the specification meets the requirements of 35 U.S.C. § 112.

FAQs

What is the purpose of obviousness-type double patenting (ODP)?

ODP prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from an earlier patent.

How do Patent Term Adjustments (PTA) affect the term of a patent?

PTA extends the term of a patent to compensate for delays in the patent prosecution process but does not extend the term beyond the date specified in a terminal disclaimer.

What is a terminal disclaimer in patent law?

A terminal disclaimer is a statement by the patent owner that the term of the later patent will not extend beyond the term of an earlier patent, often used to overcome ODP rejections.

Why is the written description requirement important under 35 U.S.C. § 112?

The written description requirement ensures that the claims are fully supported by the specification, which is crucial for patent validity.

How do continuation and divisional applications impact patent validity?

These applications can lead to ODP issues if the claims are not patentably distinct from earlier patents. Understanding their filing and issuance dates is critical for determining expiration dates and potential ODP issues.

Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. Allergan USA, Inc. v. MSN Laboratories Private Ltd., United States Court of Appeals for the Federal Circuit, August 13, 2024.
  3. Patent Claims Research Dataset, USPTO, August 28, 2017.
  4. What Is the Probability of Receiving a US Patent?, YJOLT, 2020.
  5. 35 USC 282: Presumption of validity; defenses, United States Code.

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Drugs Protected by US Patent 11,173,110

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Labs Farms Rovi Sa RISVAN risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 214835-001 Mar 29, 2024 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Subscribe
Labs Farms Rovi Sa RISVAN risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 214835-002 Mar 29, 2024 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  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 11,173,110

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 3524 ⤷  Subscribe
Australia 2011260318 ⤷  Subscribe
Australia 2013269546 ⤷  Subscribe
Australia 2013269547 ⤷  Subscribe
Australia 2013298705 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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