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Last Updated: December 22, 2024

Details for Patent: 8,618,172


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Summary for Patent: 8,618,172
Title:Galenical formulations of organic compounds
Abstract: The present invention relates to a solid oral dosage form comprising a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, a therapeutically effective amount of HCTZ and a hydrophilic filler selected from the group a carbohydrate or combinations thereof, e.g. sugars, sugar alcohols and starches or combinations of these.
Inventor(s): Willmann; Matthias (Basel, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:12/304,244
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,618,172
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,618,172

Introduction

United States Patent 8,618,172, titled "Galenical Formulations of Organic Compounds," is a patent that delves into the realm of pharmaceutical formulations. To comprehend the full extent of this patent, it is crucial to analyze its various components, including the specification, drawings, and most importantly, the claims.

Patent Structure and Components

Document Number and Type

The patent number, 8,618,172, is preceded by the prefix "US," indicating it is a U.S. patent. The "B2" code signifies that this patent has a previously published application[1].

Title and Abstract

The title of the invention is "Galenical Formulations of Organic Compounds," which provides a brief overview of the subject matter. The abstract, though not explicitly mentioned in the sources, typically summarizes the main aspects of the invention.

Specification

The specification is a detailed written description of the invention. It includes discussions of related prior art, descriptions of the drawings (if any), how the invention solves a specific technical problem, and the preferred embodiment of the invention. The specification must be clear, concise, and exact enough to enable anyone skilled in the field to understand and practice the invention[1][2].

Drawings

Unlike some patents, this particular patent does not include any drawings. This is indicated by the absence of any mention of drawings in the available sources[5].

Claims: The Heart of the Patent

Definition and Purpose

The claims section is critical as it defines the scope of protection for the patent. Claims must provide reasonable certainty in defining what is patented, in conformity with the requirements of 35 U.S.C. ยง 112. The primary function of claims is to provide notice of the boundaries of the right to exclude and to define the limits of the invention[2].

Structure of Claims

The claims in Patent 8,618,172 are structured to clearly outline what is being patented. Here is an example of how claims are typically structured:

  • Independent Claims: These claims stand alone and define the invention without reference to other claims.
  • Dependent Claims: These claims refer back to and further limit the independent claims.

Example of a Claim

While the specific claims of Patent 8,618,172 are not detailed in the sources, here is an example of how a claim might be structured:

1. A galenical formulation of an organic compound, comprising:
   - a therapeutically effective amount of the organic compound;
   - a carrier selected from the group consisting of starch, cellulose, and lactose;
   - and a stabilizer selected from the group consisting of magnesium stearate and silicon dioxide.

Claim Indefiniteness

Claims must be precise enough to afford clear notice of what is claimed, thereby informing the public of what is still open to them. The definiteness requirement mandates clarity, while recognizing that absolute precision is unattainable[2].

Patent Landscape and Trends

Technological Classification

Patents are classified technologically under the World Intellectual Property Organization (WIPO) classification, which includes 35 International Patent Classification (IPC) technical fields. For pharmaceutical formulations, the relevant IPC classifications would be related to chemistry and pharmaceuticals[4].

Patent Activity in Related Fields

In 2018, the USPTO awarded a significant number of patents in the fields of chemistry and pharmaceuticals. These patents are often allocated geographically according to patent inventorship information and are classified technologically under the WIPO classification system[4].

Global Trends

The landscape of patenting in pharmaceutical formulations is part of a broader trend in innovation. Patents in this field are indicators of technological advancements and provide exclusive rights to inventors to make, use, or sell their inventions. The U.S. patenting system, in particular, has seen a rise in patent applications and grants in the pharmaceutical sector over the years[4].

Legal and Judicial Aspects

Claim Construction and Indefiniteness

The construction of claims is a matter of law, and disputes over the meaning or scope of patent claims are resolved through judicial review. The standard for claim indefiniteness is that the claims must inform those skilled in the art about the scope of the invention with reasonable certainty, viewed in light of the specification and prosecution history[2].

Judicial Precedents

Cases such as Nautilus, Inc. v. Biosig Instruments, Inc. and Nature Simulation Systems Inc. v. Autodesk, Inc. have set precedents for the interpretation of claim definiteness. These cases emphasize the importance of clarity in claims while acknowledging that absolute precision is not always achievable[2].

Key Takeaways

  • Patent Structure: The patent includes a specification, claims, and sometimes drawings, each serving a distinct purpose.
  • Claims: Define the scope of protection and must provide reasonable certainty.
  • Technological Classification: Patents are classified under the WIPO classification system.
  • Patent Landscape: The pharmaceutical sector sees significant patent activity, reflecting technological advancements.
  • Legal Aspects: Claim construction and indefiniteness are critical legal issues, resolved through judicial review.

FAQs

What is the primary purpose of the claims section in a patent?

The primary purpose of the claims section is to define the scope of protection for the patent, providing reasonable certainty in defining what is patented.

How are claims structured in a patent?

Claims are structured into independent claims that stand alone and dependent claims that refer back to and further limit the independent claims.

What is the significance of the WIPO classification system in patenting?

The WIPO classification system categorizes patents into 35 technical fields, helping in the allocation and analysis of patents geographically and technologically.

How do judicial precedents impact the interpretation of patent claims?

Judicial precedents, such as Nautilus, Inc. v. Biosig Instruments, Inc., set standards for claim definiteness, emphasizing the need for clarity while recognizing the limitations of absolute precision.

What is the role of the specification in a patent?

The specification provides a detailed written description of the invention, including discussions of prior art, descriptions of drawings, and the preferred embodiment of the invention.

Sources

  1. How to Read a U.S. Patent - Patents and Designs - Research Guides[1]
  2. UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT - Nature Simulation Systems Inc. v. Autodesk, Inc.[2]
  3. Patent Claims Research Dataset - USPTO[3]
  4. Invention: U.S. and Comparative Global Trends - NCSES[4]
  5. United States Patent 8,618,172 - Google APIs[5]

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Drugs Protected by US Patent 8,618,172

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 DISCN Yes No 8,618,172 ⤷  Subscribe Y ⤷  Subscribe
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 DISCN Yes No 8,618,172 ⤷  Subscribe Y ⤷  Subscribe
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 DISCN Yes No 8,618,172 ⤷  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: 8,618,172

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0612540.5Jun 23, 2006
PCT Information
PCT FiledJune 21, 2007PCT Application Number:PCT/EP2007/005476
PCT Publication Date:December 27, 2007PCT Publication Number: WO2007/147596

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