United States Patent 11,033,552: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,033,552, titled "DPP IV inhibitor formulations," is a significant patent in the pharmaceutical industry, particularly in the treatment of diabetes mellitus. This patent, assigned to Boehringer Ingelheim International GmbH, covers innovative formulations of DPP IV inhibitors, which are crucial for managing blood sugar levels. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Issuance and Assignee
The patent was issued on June 15, 2021, to Boehringer Ingelheim International GmbH, a leading pharmaceutical company known for its research and development in various therapeutic areas, including diabetes[4].
Invention Description
The patent pertains to pharmaceutical compositions of DPP IV inhibitors, which are enzymes that play a key role in glucose metabolism. The invention specifically relates to formulations of DPP IV inhibitors with an amino group, their preparation, and their use in treating diabetes mellitus. These formulations are designed to enhance the efficacy and stability of the DPP IV inhibitors, making them more effective in managing diabetes[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims cover:
- Pharmaceutical Compositions: The patent claims specific formulations of DPP IV inhibitors, including the active ingredients, excipients, and the methods of preparing these compositions.
- Methods of Treatment: The claims also include methods for treating diabetes mellitus using these formulations.
- Specific Compounds: The patent specifies certain DPP IV inhibitors with an amino group, detailing their chemical structures and how they are incorporated into the pharmaceutical compositions[4].
Exclusivity
The patent grants Boehringer Ingelheim exclusive rights to manufacture, use, and sell these specific DPP IV inhibitor formulations in the United States. This exclusivity period typically lasts for 20 years from the date of filing, although it can be variable based on factors such as patent litigation and the development of new formulations[2].
Patent Expiration Dates
The patent is set to expire on May 4, 2027, and another related patent with similar claims is set to expire on November 4, 2027. These dates are critical as they determine when generic versions of the drug can be introduced into the market[2].
Patent Landscape
Related Patents
Boehringer Ingelheim holds several related patents that cover various aspects of DPP IV inhibitors and other diabetes treatments. For example:
- Patent 10,258,637: This patent, also assigned to Boehringer Ingelheim, covers SGLT-2 inhibitors for treating metabolic disorders, including diabetes and pre-diabetes. It expires on April 3, 2034, and October 3, 2034, for different claims[2].
- Patent 7,407,955: This patent covers earlier formulations of DPP IV inhibitors and is set to expire on May 2, 2025, and November 2, 2025, for different claims[2].
Double Patenting Issues
The landscape of pharmaceutical patents is complex, and issues such as double patenting can arise. Double patenting occurs when two or more patents cover the same invention or very similar inventions, potentially extending the exclusivity period beyond what is statutorily allowed. The Federal Circuit has addressed this in cases like Gilead, where the focus is on the expiration dates of the patents rather than the issue dates to determine if there is an unjustified extension of patent term[3].
Government Funding and March-In Rights
Some pharmaceutical patents, including those related to diabetes treatments, may have been developed using federal funding. The Bayh-Dole Act allows the government to retain march-in rights, enabling it to issue additional licenses if the patent holder is not taking effective steps to achieve practical application of the invention or to alleviate health or safety needs. However, these rights have never been exercised, although the threat of march-in has led to voluntary price reductions in the past[1].
Practical Applications and Impact
Treatment of Diabetes
The DPP IV inhibitors covered by this patent are crucial in the treatment of diabetes mellitus. These inhibitors help increase the levels of incretin hormones, enhancing the release of insulin and decreasing the release of glucagon, thereby lowering blood glucose levels. The specific formulations patented here are designed to improve the efficacy, stability, and patient compliance of these treatments[4].
Market Impact
The exclusivity granted by this patent allows Boehringer Ingelheim to maintain a competitive edge in the diabetes treatment market. Once the patent expires, generic versions of the drug can enter the market, potentially reducing costs for patients and increasing access to these treatments.
Key Takeaways
- Patent Scope: The patent covers specific formulations of DPP IV inhibitors with an amino group, their preparation, and their use in treating diabetes.
- Exclusivity: The patent grants Boehringer Ingelheim exclusive rights until May 4, 2027, and November 4, 2027, for related claims.
- Related Patents: Boehringer Ingelheim holds several related patents covering various diabetes treatments.
- Double Patenting: The patent landscape must be carefully managed to avoid double patenting issues.
- Government Funding: Some patents may be subject to march-in rights if developed with federal funding.
FAQs
What is the main focus of United States Patent 11,033,552?
The main focus of this patent is on pharmaceutical compositions of DPP IV inhibitors with an amino group, their preparation, and their use in treating diabetes mellitus.
Who is the assignee of this patent?
The assignee of this patent is Boehringer Ingelheim International GmbH.
When does the patent expire?
The patent is set to expire on May 4, 2027, and another related patent with similar claims expires on November 4, 2027.
What is the significance of DPP IV inhibitors in diabetes treatment?
DPP IV inhibitors help increase the levels of incretin hormones, enhancing the release of insulin and decreasing the release of glucagon, thereby lowering blood glucose levels.
Can the government intervene in the use of this patent?
Yes, if the patent was developed using federal funding, the government retains march-in rights under the Bayh-Dole Act to ensure the invention is practically applied or to alleviate health or safety needs.
Sources
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research[1].
- Generic Glyxambi Availability - Drugs.com[2].
- US Update: Double Patenting - Finnegan[3].
- DPP IV inhibitor formulations - Google Patents[4].
