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