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Last Updated: December 26, 2024

Details for Patent: 8,076,362


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Summary for Patent: 8,076,362
Title:Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof
Abstract: The invention relates to dosage forms and formulations comprising the novel crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide, wherein crystal modification A is characterized by characteristic lines with interplanar spacings (d values) of 10.5 .ANG., 5.14 .ANG., 4.84 .ANG., 4.55 .ANG., 4.34 .ANG., 4.07 .ANG., 3.51 .ANG., 3.48 .ANG., 3.25 .ANG., 3.19 .ANG., 3.15 .ANG., 3.07 .ANG., and 2.81 .ANG., determined by means of an X-ray powder pattern. Dosage forms of crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide may be for oral or parenteral administration, in the form of a solid or liquid, and in a dosage range of 20 mg to less than 500 mg. Solid dosage forms comprise a tablet or capsule, and further comprise a pharmaceutically-acceptable carrier and film-coat.
Inventor(s): Portmann; Robert (Pratteln, CH), Hofmeier; Urs Christoph (St. Pantaleon, CH), Burkhard; Andreas (Basel, CH), Scherrer; Walter (Rheinfelden, CH), Szelagiewicz; Martin (Munchenstein, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:12/767,003
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,076,362

Introduction

United States Patent 8,076,362, titled "Crystal modification A of 1-(2,6-difluorobenzyl)-1H-[1,2,4]triazole-3-carboxamide," is a patent that delves into the novel crystal modifications of a specific chemical compound. This article will provide a detailed analysis of the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, granted to an inventor or inventors, pertains to the discovery and characterization of new crystal modifications of the compound 1-(2,6-difluorobenzyl)-1H-[1,2,4]triazole-3-carboxamide. These modifications are crucial in pharmaceutical applications due to their unique physical and chemical properties.

Claims Definition

The claims in a patent application are essential as they define the scope of the patent's protection. For US Patent 8,076,362, the claims specify the novel crystal modifications A and A′, their preparation methods, and their use in pharmaceutical preparations[1].

Key Claims

  • Crystal Modification A: This claim includes the specific X-ray powder pattern characteristics of modification A, such as interplanar spacings (d values) of 10.5 Å, 5.14 Å, 4.84 Å, among others[1].
  • Preparation Methods: The patent claims include detailed methods for preparing these crystal modifications.
  • Pharmaceutical Use: The claims also cover the use of these crystal modifications in pharmaceutical preparations.

Patent Scope

The scope of the patent is defined by the claims and is limited to the specific crystal modifications and their applications described therein.

Novelty and Non-Obviousness

For a patent to be granted, the invention must be novel, non-obvious, and useful. The crystal modifications A and A′ must have been new and not obvious to those skilled in the art at the time of the invention. The unique X-ray powder patterns and thermal signals distinguish these modifications from prior art[1].

Usefulness

The patent must also demonstrate usefulness. In this case, the crystal modifications are useful in pharmaceutical preparations, which implies they have specific properties that make them suitable for drug formulations.

Patent Landscape

Prior Art

The patent application would have undergone a prior art search to ensure that the claimed invention was not already known or obvious. The prior art keywords mentioned include "modification," "crystal modification," and "triazole," indicating the areas where the inventors sought to differentiate their work[1].

Related Patents

The patent landscape for pharmaceutical compounds, especially those involving triazoles, is extensive. Other patents may cover similar compounds or different crystal modifications, but the specific claims of US Patent 8,076,362 are unique to this invention.

Patent Application Process

The application for this patent would have followed the standard process administered by the U.S. Patent and Trademark Office (USPTO).

Filing and Examination

The application would have included a specification, drawings if necessary, an oath or declaration, an application data sheet, a transmittal letter, and the required fees. The patent examiner would have reviewed the application to ensure compliance with legal requirements and conducted a prior art search to determine the novelty and non-obviousness of the claimed invention[2].

Prosecution

If the examiner found any issues, an Office Action would have been issued, detailing the reasons for rejection or objections. The applicant would then have had the opportunity to respond and amend the claims if necessary[2].

Economic and Legal Implications

Patent Infringement

The grant of this patent gives the inventor the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States. This can have significant economic implications, especially in the pharmaceutical industry where patent protection is crucial for innovation and investment[2].

Litigation Trends

The increase in patent infringement lawsuits, particularly in the pharmaceutical sector, highlights the importance of robust patent protection. The Leahy-Smith America Invents Act (AIA) has also influenced patent litigation trends, with changes affecting the number of defendants in lawsuits and the types of patents involved[4].

Future Considerations

Small Claims Patent Court

There have been discussions and studies on the feasibility of a small claims patent court, which could impact how patent disputes, including those related to pharmaceutical patents, are handled. Such a court could provide a more streamlined and cost-effective way to resolve patent infringement cases[5].

Key Takeaways

  • Unique Crystal Modifications: US Patent 8,076,362 covers novel crystal modifications A and A′ of a specific triazole compound.
  • Pharmaceutical Applications: These modifications are useful in pharmaceutical preparations due to their distinct physical and chemical properties.
  • Patent Scope: The claims define the scope of protection, ensuring the inventor’s right to exclude others from making, using, or selling the invention.
  • Economic Implications: Patent protection is crucial for innovation and investment in the pharmaceutical industry.
  • Legal Landscape: Changes in patent laws and litigation trends continue to shape the patent landscape.

FAQs

Q: What is the main subject of US Patent 8,076,362? A: The main subject is the novel crystal modifications A and A′ of the compound 1-(2,6-difluorobenzyl)-1H-[1,2,4]triazole-3-carboxamide.

Q: Why are the X-ray powder patterns important in this patent? A: The X-ray powder patterns are crucial for identifying and distinguishing the novel crystal modifications from other known forms.

Q: What is the significance of the thermal signals mentioned in the patent? A: The thermal signals, particularly the endothermic signal and weak thermal signal, serve as distinguishing features for the crystal modifications.

Q: How does the patent protect the inventor’s rights? A: The patent grants the inventor the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States.

Q: What are the potential economic implications of this patent? A: The patent can have significant economic implications by protecting the inventor’s investment in research and development, particularly in the pharmaceutical industry.

Sources

  1. US8076362B2 - Crystal modification A of 1-(2,6-difluorobenzyI)-1 H ...
  2. Patents | The Maryland People's Law Library
  3. Patent Claims Research Dataset - USPTO
  4. Assessing Factors That Affect Patent Infringement Litigation ... - GAO
  5. U.S. Patent Small Claims Court

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Drugs Protected by US Patent 8,076,362

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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: 8,076,362

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Switzerland1404/97Jun 10, 1997

International Family Members for US Patent 8,076,362

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 0994863 ⤷  Subscribe CA 2007 00037 Denmark ⤷  Subscribe
European Patent Office 0994863 ⤷  Subscribe 91345 Luxembourg ⤷  Subscribe
European Patent Office 0994863 ⤷  Subscribe 300284 Netherlands ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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