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Last Updated: December 23, 2024

Details for Patent: 8,981,103


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Which drugs does patent 8,981,103 protect, and when does it expire?

Patent 8,981,103 protects GENVOYA, STRIBILD, and VITEKTA, and is included in three NDAs.

Protection for GENVOYA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-four patent family members in twenty-eight countries.

Summary for Patent: 8,981,103
Title:Stable crystal of 4-oxoquinoline compound
Abstract: Provision of a stabilized crystal of 6-(3-chloro-2-fluorobenzyl)-1-[(S)-1-hydroxymethyl-2-methylpropyl]-7-meth- oxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (compound A). A crystal of compound A, which shows a particular X-ray powder diffraction pattern of a characteristic diffraction peaks at diffraction angles 2.theta.(.degree.) as measured by X-ray powder diffractometry.
Inventor(s): Ando; Koji (Osaka, JP), Matsuda; Koji (Osaka, JP), Miyake; Shuji (Osaka, JP), Uehara; Hideto (Osaka, JP)
Assignee: Japan Tobacco Inc. (Tokyo, JP)
Application Number:12/538,694
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,981,103
Patent Claim Types:
see list of patent claims
Compound; Composition; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,981,103

Introduction

United States Patent 8,981,103, titled "Stable crystal of 4-oxoquinoline compound," is a significant patent that delves into the development and characterization of a specific crystal form of a 4-oxoquinoline compound. This patent, assigned to Japan Tobacco Inc., is crucial for understanding the physical and chemical properties of this compound and its applications in pharmaceuticals.

Technical Field

The patent pertains to the field of pharmaceutical chemistry, specifically focusing on the synthesis, characterization, and stabilization of a particular 4-oxoquinoline compound known as compound A. This compound is identified as 6-(3-chloro-2-fluorobenzyl)-1-(S)-1-hydroxymethyl-2-methyl propyl-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid[1][4].

Background Art

The background art for this patent involves extensive research on quinoline compounds and their various applications in medicine. Previous patents and publications have explored different aspects of quinoline compounds, including their synthesis, stability, and pharmaceutical uses. This patent builds upon this existing knowledge by introducing a novel and stable crystal form of compound A[1].

Claims of the Patent

The patent includes several key claims that define the scope and novelty of the invention:

Crystal Form

The patent claims a stable crystal form of compound A, characterized by specific physical and chemical properties. This includes the crystal's morphology, powder X-ray diffraction (PXRD) pattern, and thermal analysis data[1][4].

Mixed Crystal

The patent also claims a mixed crystal form of compound A, which combines the stable crystal form with other substances to enhance its stability and pharmaceutical efficacy[1].

Pharmaceutical Composition

A significant claim is the pharmaceutical composition comprising the stable crystal or mixed crystal of compound A. This composition is designed to improve the bioavailability and therapeutic effectiveness of the compound[1][4].

Patent Scope

The scope of this patent is defined by the claims and the detailed description provided. Here are some key aspects:

Independent Claims

The patent includes independent claims that define the novel aspects of the invention. These claims are crucial for determining the patent's scope and distinguishing it from prior art. For instance, the independent claims specify the unique crystal form and its characteristics, which are not found in previous patents[1].

Claim Length and Count

Research on patent scope metrics suggests that the length and count of independent claims can influence the patent's breadth and validity. In this case, the patent's claims are detailed and specific, indicating a narrower scope that is more likely to be granted and less prone to litigation[3].

Examination Process

The examination process for this patent would have involved a thorough review of the claims to ensure they meet the criteria for novelty, non-obviousness, and utility. The patent's history shows that it is a continuation of a previous application, indicating that the inventors refined their claims based on feedback from patent examiners[1].

Economic and Innovation Impact

The patent's impact on innovation and the economy can be significant. By providing a stable and effective form of a pharmaceutical compound, this patent can lead to improved health outcomes and reduced production costs. The stability of the crystal form ensures consistent quality, which is crucial for pharmaceutical applications.

Statistical Analysis

Studies on patent scope, such as those using the Patent Claims Research Dataset, indicate that patents with narrower claims tend to have a higher probability of grant and shorter examination processes. This aligns with the characteristics of the claims in this patent, suggesting that it was carefully crafted to meet the stringent criteria of patent examiners[2][3].

Industry Expert Insights

Industry experts often emphasize the importance of precise and well-defined claims in patent applications. For example, experts from the USPTO highlight that understanding the role of claims is critical for inventors to protect their intellectual property effectively[5].

Illustrative Statistics

  • Patent Maintenance Payments: Patents with narrower claims, like those in this patent, tend to have lower maintenance payments over their lifetime, indicating a more focused and valuable invention[3].
  • Forward Citations: The number of forward citations a patent receives can indicate its impact on future innovations. Patents with well-defined claims are more likely to be cited by subsequent patents, reflecting their significance in the field[3].

Key Takeaways

  • Stable Crystal Form: The patent introduces a novel and stable crystal form of a 4-oxoquinoline compound.
  • Pharmaceutical Composition: The stable crystal or mixed crystal is part of a pharmaceutical composition with enhanced bioavailability and therapeutic effectiveness.
  • Narrow Claims: The patent's claims are specific and detailed, indicating a narrower scope that is more likely to be granted and less prone to litigation.
  • Economic Impact: The patent can lead to improved health outcomes and reduced production costs due to the consistent quality of the crystal form.

FAQs

Q: What is the main subject of United States Patent 8,981,103? A: The main subject is the stable crystal form of a 4-oxoquinoline compound known as compound A.

Q: What are the key claims of this patent? A: The key claims include the stable crystal form, mixed crystal form, and pharmaceutical composition comprising these crystals.

Q: How does the patent's scope impact its validity? A: The patent's scope, defined by its narrow and specific claims, makes it more likely to be granted and less prone to litigation.

Q: What is the significance of the crystal form in pharmaceutical applications? A: The stable crystal form ensures consistent quality, which is crucial for pharmaceutical applications, leading to improved health outcomes and reduced production costs.

Q: How does this patent align with broader trends in patent scope? A: The patent aligns with trends indicating that narrower claims are associated with a higher probability of grant and a shorter examination process.

Sources

  1. United States Patent and Trademark Office. Stable crystal of 4-oxoquinoline compound. US Patent 8,981,103 B2, March 17, 2015.
  2. United States Patent and Trademark Office. Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  3. Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles. Patent Claims and Patent Scope. USPTO Economic Working Paper 2016-04, October 2016.
  4. Google Patents. Stable crystal of 4-oxoquinoline compound. US Patent 8,981,103 B2, March 17, 2015.
  5. United States Patent and Trademark Office. The Path to a Patent, Part V: Understanding the role of claims in a patent application. Retrieved from https://www.uspto.gov/about-us/events/path-patent-part-v-understanding-role-claims-patent-application-8

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Drugs Protected by US Patent 8,981,103

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-001 Sep 24, 2014 DISCN Yes No ⤷  Subscribe ⤷  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: 8,981,103

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2004-150979May 20, 2004

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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.