United States Patent 10,034,877: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,034,877, titled "Treatment for diabetes in patients inappropriate for metformin therapy," is a significant patent in the field of diabetes treatment, particularly involving the use of DPP-4 inhibitors. This patent, held by Boehringer Ingelheim, is crucial for understanding the intellectual property landscape surrounding diabetes medications.
Patent Overview
Inventors and Issuance
The patent was issued on July 31, 2018, to inventors Klaus Dugi, Eva Ulrike Graefe-Mody, Ruth Harper, and Hans-Juergen Woerle[2].
Patent Title and Description
The patent is specifically focused on the treatment of diabetes in patients who are not suitable for metformin therapy. It involves the use of a DPP-4 inhibitor, such as linagliptin, which is a key component of Boehringer Ingelheim's drug Tradjenta.
Claims and Scope
Primary Claims
The patent includes several claims that define the scope of the invention. The primary claims revolve around the method of treating type 2 diabetes in patients who are inappropriate for metformin therapy using a DPP-4 inhibitor. For example, the patent claims cover the administration of linagliptin in combination with other antidiabetic agents, such as sulphonylureas, insulin, or insulin analogues[2][4].
Method of Use Claims
The patent includes method-of-use claims that specify how the DPP-4 inhibitor should be administered. These claims are critical as they define the therapeutic regimen and the patient population for which the treatment is intended. For instance, the patent specifies that the treatment can be used in drug-naive patients as well as in patients who have been pre-treated with other antidiabetic agents[4].
Combination Therapy Claims
The patent also covers combination therapies involving the DPP-4 inhibitor and other conventional antihyperglycemic agents. This includes combinations with sulphonylureas and insulin or insulin analogues, which are common in the treatment of type 2 diabetes[4].
Patent Landscape and Litigation
Patent Expiration Date
The patent is set to expire on August 5, 2029, which is a critical date for generic manufacturers seeking to enter the market with similar products[1][5].
Litigation and Infringement Cases
Boehringer Ingelheim has been involved in several patent infringement cases related to this patent. For example, the company has sued generic drug manufacturers such as HEC, Mylan, and Dr. Reddy's Laboratories Limited for submitting Abbreviated New Drug Applications (ANDAs) that allegedly infringe on this and other related patents[2][4][5].
Paragraph IV Certifications
Generic manufacturers have filed Paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the FD&C Act, stating that the patents are invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of generic versions of linagliptin tablets[5].
Claim Construction and Prosecution History
Claim Differentiation
The construction of the claims in this patent has been a subject of litigation. Boehringer Ingelheim has argued that the claims should not be limited to the specific embodiments described in the specification but should be interpreted broadly to include various methods of treatment. This argument is supported by the prosecution history of the patent, where the company clarified the scope of the claims to the Examiner[4].
Prosecution History
The prosecution history of the patent is instructive in understanding the intended scope of the claims. During the prosecution, Boehringer Ingelheim clarified that the claims included specific limitations, such as the 5 mg dose of linagliptin without the need for dose adjustment. This clarification was crucial in distinguishing the claimed methods from prior art[4].
Impact on Generic Manufacturers
Barriers to Entry
The patent and associated litigation create significant barriers to entry for generic manufacturers. Generic companies must either wait for the patent to expire or successfully challenge the patent's validity or enforceability to enter the market[5].
Litigation Costs and Complexity
The complexity and costs associated with patent litigation can deter generic manufacturers from entering the market. The need to navigate through multiple patents and claims, as well as the potential for lengthy and costly legal battles, can be a significant deterrent[3].
Industry Impact
Innovation and Competition
The patent landscape around diabetes treatments influences innovation and competition in the pharmaceutical industry. Patents like the 10,034,877 patent can protect innovative treatments but also limit competition by preventing generic entry. This balance is crucial for ensuring both innovation and affordability in healthcare[3].
Patient Access
The availability of generic versions of diabetes medications can significantly impact patient access to affordable treatments. The expiration of this patent and the entry of generic competitors could lead to lower prices and improved access to care for patients with type 2 diabetes[5].
Key Takeaways
- Patent Scope: The patent covers the treatment of type 2 diabetes in patients inappropriate for metformin therapy using a DPP-4 inhibitor like linagliptin.
- Claims: The patent includes method-of-use and combination therapy claims that specify the administration and patient population.
- Litigation: Boehringer Ingelheim has been involved in several patent infringement cases related to this patent.
- Expiration Date: The patent is set to expire on August 5, 2029.
- Industry Impact: The patent affects innovation, competition, and patient access to affordable diabetes treatments.
FAQs
What is the main focus of the United States Patent 10,034,877?
The main focus of the patent is the treatment of type 2 diabetes in patients who are not suitable for metformin therapy using a DPP-4 inhibitor.
Who are the inventors of the patent?
The inventors of the patent are Klaus Dugi, Eva Ulrike Graefe-Mody, Ruth Harper, and Hans-Juergen Woerle.
What is the expiration date of the patent?
The patent is set to expire on August 5, 2029.
What are the implications of this patent for generic manufacturers?
The patent creates significant barriers to entry for generic manufacturers, requiring them to either wait for the patent to expire or successfully challenge its validity or enforceability.
How does this patent impact patient access to diabetes treatments?
The patent's expiration and the subsequent entry of generic competitors could lead to lower prices and improved access to care for patients with type 2 diabetes.
Cited Sources
- FDA Approval Letter for Linagliptin Tablets - U.S. Food & Drug Administration[1].
- Case 2:20-cv-02545 Document 1 Filed 05/29/20 - Insight.RPXCorp[2].
- Patent Claims and Patent Scope - SSRN[3].
- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF WEST VIRGINIA - GovInfo[4].
- FDA Approval Letter for Linagliptin Tablets - U.S. Food & Drug Administration[5].
