You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 2, 2025

Details for Patent: 8,846,718


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,846,718 protect, and when does it expire?

Patent 8,846,718 protects ORKAMBI and is included in two NDAs.

This patent has fifty-nine patent family members in twenty-eight countries.

Summary for Patent: 8,846,718
Title:Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Abstract: The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s): Keshavarz-Shokri; Ali (San Diego, CA), Zhang; Beili (San Diego, CA), Krawiec; Mariusz (Marlborough, MA)
Assignee: Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:13/933,223
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Patent 8,846,718: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 8,846,718, titled "Solid state forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid," is a patent that protects specific solid state forms of a chemical compound. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

Publication and Priority

The patent was published on September 30, 2014, with the application number US13/933,223. It claims priority to earlier filed applications, which is a common practice to establish an earlier effective filing date[4].

Scope of the Patent

Subject Matter

The patent pertains to solid state forms, including crystalline forms, of a specific chemical compound: 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid. This compound is likely used in pharmaceutical or chemical applications, given the complexity of its structure.

Claims

The claims in a patent application are crucial as they define the scope of the patent's protection. For US Patent 8,846,718, the claims would typically include:

  • Independent Claims: These define the broadest scope of the invention. For example, claims might cover the specific crystalline forms of the compound, methods of preparing these forms, and their use in various applications.
  • Dependent Claims: These narrow down the scope by adding additional limitations to the independent claims. They might specify particular conditions under which the crystalline forms are prepared or used[2].

Types of Claims

Utility Patents

This patent falls under the category of utility patents, which are the most common type of patent. Utility patents protect new and useful processes, machines, manufactures, or compositions of matter, or any improvement thereof[2].

Claim Structure

The claims would be structured to include:

  • Composition Claims: These would cover the specific chemical structure and its solid state forms.
  • Method Claims: These might include methods for preparing the crystalline forms or methods for using these forms in various applications.
  • Use Claims: These would specify the intended use of the crystalline forms, such as in pharmaceutical formulations.

Patent Landscape

First-to-File System

The patent was filed and granted under the first-inventor-to-file system, which was introduced by the America Invents Act (AIA) in 2011. This system prioritizes the first person to file a patent application over the first person to invent, which can impact the strategy for filing and defending patents[5].

Prior Art and Novelty

To be patentable, the invention must be novel, non-obvious, and useful. The patent office would have conducted a search for prior art to ensure that the claimed solid state forms were not previously known or obvious to those skilled in the art[2].

Interference Proceedings

Although the AIA eliminated interference proceedings for patents filed after March 16, 2013, understanding the historical context is important. Interference proceedings were administrative contests to determine priority of invention, but they are no longer applicable under the first-inventor-to-file system[5].

Economic and Strategic Implications

Patent Scope Measurements

The scope of a patent, as defined by its claims, is crucial for determining its economic and strategic value. The USPTO's Patent Claims Research Dataset provides tools to analyze the scope and dependency of claims, which can help in understanding the patent's breadth and potential impact on the market[3].

Competitive Landscape

In the pharmaceutical and chemical industries, patents like US 8,846,718 can provide significant competitive advantages. By protecting specific solid state forms of a compound, the patent holder can control the production and distribution of these forms, potentially limiting competition and ensuring market dominance.

Key Takeaways

  • Scope and Claims: The patent protects specific solid state forms of a chemical compound, with claims defining the scope of protection.
  • First-to-File System: The patent was granted under the AIA's first-inventor-to-file system, emphasizing the importance of timely filing.
  • Novelty and Non-Obviousness: The invention must meet the criteria of novelty, non-obviousness, and usefulness to be patentable.
  • Economic and Strategic Value: The patent's scope and claims are critical for its economic and strategic implications in the market.

FAQs

What is the main subject matter of US Patent 8,846,718?

The main subject matter is the solid state forms, including crystalline forms, of the chemical compound 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid.

What type of patent is US 8,846,718?

It is a utility patent, which protects new and useful processes, machines, manufactures, or compositions of matter.

Under which system was this patent filed and granted?

The patent was filed and granted under the first-inventor-to-file system introduced by the America Invents Act (AIA).

Why are claims important in a patent application?

Claims define the scope of the patent's protection and are essential for determining what is protected by the patent.

How does the patent landscape impact the strategic value of US 8,846,718?

The patent's scope and claims provide a competitive advantage by controlling the production and distribution of specific solid state forms of the compound, potentially limiting competition and ensuring market dominance.

What are the criteria for an invention to be patentable?

An invention must be novel, non-obvious, and useful to be patentable.

Sources

  1. US Patent and Trademark Office. Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  2. The Maryland People's Law Library. Patents. Retrieved from https://www.peoples-law.org/patents
  3. Google Patents. US8846718B2. Retrieved from https://patents.google.com/patent/US8846718B2/en
  4. United States Court of Appeals for the Federal Circuit. SNIPR TECHNOLOGIES LIMITED v. ROCKEFELLER UNIVERSITY. Retrieved from https://cafc.uscourts.gov/opinions-orders/22-1260.OPINION.7-14-2023_2157777.pdf

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 8,846,718

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-003 Sep 2, 2022 RX Yes No 8,846,718 ⤷  Subscribe TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR ⤷  Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No 8,846,718 ⤷  Subscribe TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR ⤷  Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes 8,846,718 ⤷  Subscribe TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR ⤷  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 8,846,718

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2225230 ⤷  Subscribe 2017009 Norway ⤷  Subscribe
European Patent Office 3170818 ⤷  Subscribe 301060 Netherlands ⤷  Subscribe
European Patent Office 3170818 ⤷  Subscribe PA2020525 Lithuania ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.