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Last Updated: December 21, 2024

Details for Patent: 9,364,485


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Which drugs does patent 9,364,485 protect, and when does it expire?

Patent 9,364,485 protects SERNIVO and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 9,364,485
Title:Topical formulations comprising a steroid
Abstract: The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
Inventor(s): Ubaidulla; Udhumansha (Namakkal, IN), Kandavilli; Sateesh (Hyderbad, IN), Vairale; Ajay Sunil (Hyderbad, IN), Wayne; Jeffrey A. (Markham, CA), Nalamothu; Vijendra (Basking Ridge, NJ), Meghal; Mistry (Ahmedabad, IN), Pakunlu; Refika Isil (Highland Park, NJ)
Assignee: DR. REDDY'S LABORATORIES LTD. (Hyderabad, IN)
Application Number:13/391,972
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,364,485
Patent Claim Types:
see list of patent claims
Composition; Use;
Patent landscape, scope, and claims:

United States Patent 9,364,485: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,364,485, hereafter referred to as the '485 patent, is a significant intellectual property asset that requires a thorough analysis to understand its scope, claims, and position within the broader patent landscape. This article will delve into the key aspects of the patent, including its claims, the technological context, and the legal framework that governs its validity and enforcement.

Patent Overview

Title and Abstract

The title and abstract of the '485 patent provide the initial insight into its subject matter. While the specific details of this patent are not provided in the sources, a general understanding can be derived from typical patent structures. Patents usually describe an invention, its background, and the problems it solves.

Claims Analysis

Independent and Dependent Claims

Patent claims are the heart of any patent, defining the scope of the invention. Independent claims stand alone and define the invention broadly, while dependent claims build upon the independent claims and narrow down the scope[3].

  • Independent Claims: These claims are crucial as they define the broadest scope of the invention. They typically include the essential elements of the invention.
  • Dependent Claims: These claims are subsidiary to the independent claims and add specific limitations or features to the invention.

Claim Construction

Claim construction is a critical process in patent litigation, where the court interprets the meaning of the claims. This process can significantly impact the scope of the patent and its enforceability. For example, in the case of Contour IP Holding LLC v. GoPro, Inc., the court's construction of disputed claim terms was pivotal in determining patent infringement[2].

Technological Context

Field of the Invention

Understanding the field of the invention is essential to place the '485 patent within the broader technological landscape. This involves identifying the industry, the specific technology, and how the invention contributes to or innovates within that field.

Prior Art and Novelty

The '485 patent must demonstrate novelty and non-obviousness over prior art to be valid. Prior art includes all publicly available information before the patent's filing date. The patent's claims must be significantly different from what was known before to be considered novel and non-obvious.

Legal Framework

35 U.S.C. § 101: Patent Eligibility

The patent eligibility of the '485 patent is governed by 35 U.S.C. § 101, which states that any new and useful process, machine, manufacture, or composition of matter, or any improvement thereof, may be patented. However, laws of nature, natural phenomena, and abstract ideas are not patentable. The Alice test is often used to determine if claims are directed to patent-ineligible subject matter[2].

35 U.S.C. § 282: Presumption of Validity

Each claim of the '485 patent is presumed valid under 35 U.S.C. § 282. This presumption can be challenged during litigation, but the burden of proof lies with the party challenging the patent's validity[5].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is not patentably distinct from a first patent. This is relevant if the '485 patent is part of a family of patents, as seen in the In re Cellect case, where the court addressed ODP in the context of patent term adjustments and terminal disclaimers[1].

Patent Term Adjustments (PTA) and Extensions

The '485 patent's term could be affected by Patent Term Adjustments (PTA) or extensions. PTA adjusts the patent term to account for delays during the prosecution process, while extensions can be granted due to regulatory review periods. The interaction between these adjustments and the patent's expiration date is crucial, as illustrated in the In re Cellect case[1].

Patent Landscape and Competitors

Understanding the patent landscape involves identifying other patents in the same field and assessing potential competitors. Tools like the USPTO's Global Dossier and Public Search Facility can be used to analyze related applications and patents filed at various IP offices[4].

Patent Family and Global Dossier

The '485 patent may be part of a larger patent family, with related applications filed in different jurisdictions. The Global Dossier service provided by the USPTO allows users to view the file histories of related applications, which can be invaluable in understanding the broader patent landscape[4].

Litigation and Enforcement

Patent litigation often involves claim construction, infringement analysis, and validity challenges. The '485 patent's enforceability would depend on its ability to withstand these challenges. Cases like Contour IP Holding LLC v. GoPro, Inc. highlight the complexities involved in patent litigation and the importance of thorough claim construction and analysis[2].

Key Takeaways

  • Claims Analysis: Understanding the independent and dependent claims is crucial for defining the scope of the invention.
  • Technological Context: Placing the patent within its technological field helps in assessing its novelty and non-obviousness.
  • Legal Framework: Compliance with 35 U.S.C. § 101 and § 282 is essential for the patent's validity.
  • ODP and PTA: Ensuring compliance with ODP and understanding the impact of PTA on the patent term is vital.
  • Patent Landscape: Analyzing the broader patent landscape helps in identifying competitors and related patents.

Frequently Asked Questions (FAQs)

What is the significance of claim construction in patent litigation?

Claim construction is critical in patent litigation as it determines the scope of the patent and can significantly impact infringement and validity analyses.

How does the Alice test affect patent eligibility?

The Alice test is used to determine if patent claims are directed to abstract ideas, which are not patentable. It involves a two-step process to assess whether the claims are patent-eligible.

What is the role of Patent Term Adjustments (PTA) in patent term?

PTA adjusts the patent term to account for delays during the prosecution process, ensuring that the patent holder does not lose time due to USPTO delays.

How can the Global Dossier service help in patent analysis?

The Global Dossier service allows users to view the file histories of related applications from participating IP offices, providing a comprehensive view of the patent family and landscape.

What is the presumption of validity under 35 U.S.C. § 282?

Under 35 U.S.C. § 282, each claim of a patent is presumed valid, and the burden of proof lies with the party challenging the patent's validity.

Cited Sources:

  1. In re Cellect - United States Court of Appeals for the Federal Circuit
  2. Contour IP Holding LLC v. GoPro, Inc. - United States Court of Appeals for the Federal Circuit
  3. Patent Claims Research Dataset - USPTO
  4. Search for patents - USPTO
  5. 35 USC 282: Presumption of validity; defenses - US Code

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Drugs Protected by US Patent 9,364,485

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Primus Pharms SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079-001 Feb 5, 2016 RX Yes Yes 9,364,485 ⤷  Subscribe Y TREATMENT OF PLAQUE PSORIASIS ⤷  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: 9,364,485

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India2111/CHE/2009Aug 31, 2009
PCT Information
PCT FiledAugust 31, 2010PCT Application Number:PCT/US2010/047240
PCT Publication Date:March 03, 2011PCT Publication Number: WO2011/026076

International Family Members for US Patent 9,364,485

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2473161 ⤷  Subscribe
Japan 2013503203 ⤷  Subscribe
Japan 5833007 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2011026076 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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