United States Patent 9,155,705: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,155,705, titled "DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation," is a significant patent in the field of diabetes management. This patent, assigned to Boehringer Ingelheim International GmbH, pertains to the combination of a DPP-4 inhibitor, specifically linagliptin, with other antidiabetic agents, such as metformin.
Background
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to manage hyperglycemia in patients with type 2 diabetes mellitus. The combination of linagliptin with other antidiabetic agents like metformin is a common therapeutic approach to enhance glycemic control[1].
Patent Overview
Inventors and Assignee
The patent was invented by Thomas Friedl, Michael Braun, Kenji Egusa, Hikaru Fujita, Megumi Maruyama, and Takaaki Nishioka, and is assigned to Boehringer Ingelheim International GmbH[4].
Filing and Grant Dates
The patent application was filed on August 27, 2015, and granted on August 16, 2016. It is a continuation of application No. 12/935,634, filed as application No. PCT/EP2009/053978 on April 2, 2009[4].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Key claims include:
- Formulations: The patent describes oral solid dosage forms for fixed dose combinations of a DPP-4 inhibitor (linagliptin) and a further antidiabetic agent (such as metformin)[4].
- Tablets: Specific formulations of tablets comprising these combinations are detailed, including their composition and preparation processes[4].
- Use: The patent outlines the therapeutic use of these formulations for managing type 2 diabetes mellitus[4].
Independent Claims
The independent claims are crucial as they define the core of the invention. For example, Claim 1 might specify the composition of the tablet, while subsequent claims might detail the process of preparation and the therapeutic applications[4].
Patent Landscape
Related Patents
The patent 9,155,705 is part of a broader patent portfolio related to linagliptin and its combinations. Other relevant patents include:
- US 7,407,955: Expiring on May 2, 2025, this patent also pertains to DPP-4 inhibitors and their combinations[2].
- US 8,673,927: Expiring on May 4, 2027, this patent covers similar formulations and uses[2].
Patent Expiration Dates
Understanding the expiration dates of related patents is crucial for assessing the competitive landscape and potential generic entries:
- US 9,155,705: This patent expires on May 21, 2030[2].
Litigation and Certifications
The patent has been involved in litigation, particularly with respect to paragraph IV certifications under the FD&C Act. For instance, Mylan Pharmaceuticals Inc. had filed an ANDA with paragraph IV certifications challenging the validity and enforceability of several patents, including this one. However, the court decided that the '927 and '859 patents are invalid, while the claims regarding the '695 patent were dismissed[2].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can indicate the breadth and clarity of the patent. Narrower claims with fewer words and fewer independent claims are often associated with a higher probability of grant and a shorter examination process[3].
Claim Clarity and Validity
The clarity and validity of patent claims are significant concerns. Broader or unclear claims can lead to increased litigation costs and diminished innovation incentives. The examination process tends to narrow the scope of patent claims, ensuring that granted patents have more defined and valid claims[3].
Therapeutic Significance
DPP-4 Inhibitors and Antidiabetic Agents
The combination of linagliptin with metformin is clinically significant as it provides a synergistic effect in managing blood glucose levels. This combination is often prescribed for patients who do not achieve adequate glycemic control with monotherapy[1].
Clinical Benefits
The therapeutic benefits of this combination include improved glycemic control, reduced risk of hypoglycemia, and a favorable safety profile. These benefits are crucial for the long-term management of type 2 diabetes[1].
Market Impact
Competitive Landscape
The expiration of related patents and the entry of generic versions can significantly impact the market. Generic competitors must navigate the patent landscape carefully to avoid infringement, often relying on paragraph IV certifications to challenge the validity of existing patents[2].
Economic Considerations
The economic implications of this patent include the potential for cost savings with generic entries and the impact on the revenue streams of the patent holder. The patent's expiration date and the status of related litigation are key factors in this analysis[2].
Key Takeaways
- Patent Scope: The patent covers specific formulations and uses of linagliptin combined with other antidiabetic agents.
- Expiration Dates: The patent expires on May 21, 2030, with related patents expiring at various dates.
- Litigation: The patent has been involved in litigation, with some claims being dismissed or declared invalid.
- Therapeutic Significance: The combination of linagliptin and metformin is clinically significant for managing type 2 diabetes.
- Market Impact: The patent's expiration and related litigation can significantly impact the market and economic considerations.
FAQs
What is the main subject of United States Patent 9,155,705?
The main subject of this patent is the combination of a DPP-4 inhibitor (linagliptin) with a further antidiabetic agent (such as metformin) in oral solid dosage forms.
Who is the assignee of this patent?
The assignee of this patent is Boehringer Ingelheim International GmbH.
What are the key claims of this patent?
The key claims include the formulations of tablets comprising linagliptin and another antidiabetic agent, the process of preparation, and their therapeutic use.
What is the expiration date of this patent?
The patent expires on May 21, 2030.
Has this patent been involved in any litigation?
Yes, the patent has been involved in litigation, particularly with respect to paragraph IV certifications under the FD&C Act.
Sources
- DrugBank Online: Linagliptin: Uses, Interactions, Mechanism of Action.
- FDA: ANDA 208430 Tentative Approval.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: US 9,415,016 B2.