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Last Updated: December 22, 2024

Details for Patent: 6,939,971


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Summary for Patent: 6,939,971
Title: Benzimidazole compound crystal
Abstract:A novel crystal of (R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1 H-benzimidazole or a salt thereof of the present invention is useful for an excellent antiulcer agent.
Inventor(s): Fujishima; Akira (Sanda, JP), Aoki; Isao (Kawanishi, JP), Kamiyama; Keiji (Ibaraki, JP)
Assignee: Takeda Pharmaceutical Company, Ltd. (Osaka, JP)
Application Number:10/655,114
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,939,971
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

United States Patent 6,939,971: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 6,939,971, hereafter referred to as the '971 Patent, is a significant patent in the pharmaceutical domain, particularly related to benzimidazole compounds. This patent has been at the center of several legal disputes and is crucial for understanding the intellectual property landscape in the field of medicinal chemistry.

Background of the Patent

The '971 Patent, titled "Benzimidazole compound crystal," was granted to Takeda Pharmaceutical Company. It pertains to specific crystalline forms of benzimidazole compounds, which are used in the formulation of drugs such as Dexilant®, a medication for treating gastroesophageal reflux disease (GERD) and other gastrointestinal conditions[2].

Scope of the Patent

The '971 Patent covers the crystalline forms of benzimidazole compounds, including their preparation methods, formulations, and uses. Here are some key aspects of the patent's scope:

Crystalline Forms

The patent describes the crystalline forms of benzimidazole compounds, including their physical and chemical properties. These forms are critical for the stability, bioavailability, and efficacy of the drug[1].

Preparation Methods

The patent outlines various methods for preparing these crystalline forms, including specific conditions for crystallization, such as the use of solvents like hexane and ethanol, and the employment of high-performance liquid chromatography (HPLC) for analysis[1].

Pharmaceutical Formulations

The patent also covers the formulation of these compounds into pharmaceutical preparations, such as tablets, capsules, and other oral dosage forms. It includes details on excipients, disintegrants, binders, and lubricants used in these formulations[1].

Claims of the Patent

The claims of the '971 Patent are detailed and specific, defining the scope of protection for the invention. Here are some key claims:

Independent Claims

  • The patent claims specific crystalline forms of benzimidazole compounds.
  • It claims methods for preparing these crystalline forms.
  • It also claims pharmaceutical compositions containing these crystalline forms[1].

Dependent Claims

  • These claims further specify the conditions under which the crystalline forms are prepared, such as the use of particular solvents and HPLC conditions.
  • They also detail the types of excipients and other additives that can be used in the pharmaceutical formulations[1].

Patent Landscape and Litigation

The '971 Patent has been involved in several patent infringement cases, particularly against generic drug manufacturers.

Takeda vs. Mylan

One notable case is Takeda Pharmaceutical Company vs. Mylan Inc., where Takeda asserted the '971 Patent, along with other patents, against Mylan's Abbreviated New Drug Application (ANDA) for generic versions of Dexilant®. The case involved the construction of several disputed terms in the claims of the asserted patents[2].

Claim Construction

The court held a technology tutorial and claim construction hearing to interpret the disputed terms. This process is crucial as it determines the scope of protection afforded by the patent and whether the generic versions infringe on Takeda's patents[2].

Impact on the Pharmaceutical Industry

The '971 Patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of generic drugs.

Barriers to Generic Entry

The patent acts as a barrier to entry for generic manufacturers, as they must ensure that their products do not infringe on Takeda's patented crystalline forms and formulations. This can delay the market entry of generic versions, allowing the branded drug to maintain market exclusivity for a longer period[2].

Innovation and Research

The patent also incentivizes innovation by protecting Takeda's investment in research and development. This protection allows companies to recoup their investment and continue to innovate in the field of medicinal chemistry[3].

Key Takeaways

  • Crystalline Forms: The '971 Patent covers specific crystalline forms of benzimidazole compounds, which are crucial for drug stability and efficacy.
  • Preparation Methods: The patent details methods for preparing these crystalline forms, including specific solvents and analytical techniques.
  • Pharmaceutical Formulations: It includes formulations and additives used in preparing pharmaceutical products.
  • Litigation: The patent has been involved in several infringement cases, particularly against generic drug manufacturers.
  • Industry Impact: The patent affects the timing of generic drug entry and incentivizes innovation in pharmaceutical research.

FAQs

What is the main subject of United States Patent 6,939,971?

The main subject of the '971 Patent is the crystalline forms of benzimidazole compounds, their preparation methods, and pharmaceutical formulations.

Which company holds the '971 Patent?

The '971 Patent is held by Takeda Pharmaceutical Company.

What is the significance of the crystalline forms in the '971 Patent?

The crystalline forms are significant because they affect the stability, bioavailability, and efficacy of the drug.

How has the '971 Patent been involved in litigation?

The '971 Patent has been involved in several patent infringement cases, particularly against generic drug manufacturers like Mylan Inc.

What is the impact of the '971 Patent on the pharmaceutical industry?

The patent acts as a barrier to entry for generic manufacturers, delays the market entry of generic versions, and incentivizes innovation in pharmaceutical research.

Sources

  1. US6939971B2 - Benzimidazole compound crystal - Google Patents
  2. Takeda Pharm. Co. v. Mylan Inc. - Case Law - vLex
  3. Patent Claims Research Dataset - USPTO
  4. Search for patents - USPTO
  5. UNITED STATES DISTRICT COURT - GovInfo

More… ↓

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Drugs Protected by US Patent 6,939,971

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: 6,939,971

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan11-171509Jun 17, 1999

International Family Members for US Patent 6,939,971

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1129088 ⤷  Subscribe PA2014014 Lithuania ⤷  Subscribe
European Patent Office 1129088 ⤷  Subscribe PA2014014,C1129088 Lithuania ⤷  Subscribe
European Patent Office 1129088 ⤷  Subscribe 2014/008 Ireland ⤷  Subscribe
European Patent Office 1129088 ⤷  Subscribe C01129088/01 Switzerland ⤷  Subscribe
European Patent Office 1129088 ⤷  Subscribe 1490004-7 Sweden ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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