Detailed Analysis of the Scope and Claims of United States Patent 11,090,323
Introduction
The United States Patent 11,090,323, titled "Pharmaceutical composition, methods for treating and uses thereof," was granted on August 17, 2021, to Boehringer Ingelheim International GmbH. This patent is significant in the field of pharmaceuticals, particularly for the treatment of metabolic disorders such as type 1 and type 2 diabetes mellitus.
Background and Inventors
The patent was invented by Uli Christian Broedl, Sreeraj Macha, Maximilian von Eynatten, and Hans-Juergen Woerle. It is part of a series of continuations from earlier patent applications, indicating a thorough and iterative development process[2][4].
Scope of the Patent
Pharmaceutical Composition
The patent focuses on certain sodium-glucose cotransporter 2 (SGLT-2) inhibitors. These inhibitors are crucial for treating and preventing metabolic disorders, including type 1 and type 2 diabetes mellitus. The composition includes specific compounds and their derivatives, which are designed to improve glycemic control and reduce the risk of cardiovascular events[4].
Methods for Treating
The patent outlines various methods for using these SGLT-2 inhibitors in therapeutic settings. This includes administering the inhibitors alone or in combination with other antidiabetic agents to patients with diabetes. The methods also cover the treatment of patients with chronic kidney disease, highlighting the versatility and broad applicability of the invention[4].
Claims
Independent Claims
The patent contains multiple independent claims that define the maximum protection scope. These claims are critical as they determine the breadth of patent protection and the flexibility in defending against patent challenges. The independent claims focus on the specific chemical structures of the SGLT-2 inhibitors, the pharmaceutical compositions containing these inhibitors, and the methods for their use in treating metabolic disorders[4].
Dependent Claims
In addition to the independent claims, the patent includes several dependent claims that further specify and narrow down the scope of the invention. These claims often detail specific aspects of the composition, dosage forms, and treatment protocols, providing a comprehensive coverage of the invention[4].
Patent Landscape
Related Patents and Expiration Dates
The patent is part of a larger portfolio of patents related to SGLT-2 inhibitors. Other relevant patents include US 8,119,648, US 8,178,541, and US 10,258,637, among others. The expiration dates of these patents range from 2023 to 2034, indicating a strategic approach to maintaining patent protection over an extended period[2].
Evergreening and Patent Abuses
The patent landscape in the pharmaceutical sector is often complex due to practices such as evergreening, where companies extend the life of their patents through various legal and strategic maneuvers. This can delay the entry of generic and biosimilar competitors, affecting patient access and healthcare costs. The patent in question, while not explicitly mentioned in discussions of evergreening, operates within this broader context where patent strategies significantly impact market dynamics[5].
Technical and Commercial Significance
Clinical Impact
The SGLT-2 inhibitors covered by this patent have significant clinical implications. They are associated with improved glycemic control, weight loss, and reduced cardiovascular risk in patients with diabetes. The inclusion of these inhibitors in treatment protocols can substantially improve patient outcomes[4].
Market and Competitive Landscape
The pharmaceutical market for diabetes treatments is highly competitive, with several major players. Boehringer Ingelheim's patent positions the company favorably in this market by providing exclusive rights to these specific SGLT-2 inhibitors until the patent expires in 2034. This exclusivity can influence market share and revenue, as well as the company's ability to innovate and expand its product portfolio[2].
Challenges and Future Directions
Patent Challenges
Like any patent, US 11,090,323 could face challenges from competitors or generic manufacturers. The Patent Trial and Appeal Board (PTAB) plays a crucial role in such challenges, and the outcome can significantly affect the patent's validity and the market landscape[5].
Regulatory Environment
The regulatory environment, including laws and policies aimed at curbing patent abuses, can also impact the patent's lifespan and effectiveness. Initiatives such as the Affordable Prescriptions for Patients Act of 2023 and the PREVAIL Act could influence how pharmaceutical patents are managed and challenged[5].
Key Takeaways
- Pharmaceutical Composition: The patent covers specific SGLT-2 inhibitors for treating metabolic disorders.
- Methods for Treating: It outlines methods for using these inhibitors alone or in combination with other antidiabetic agents.
- Claims: Multiple independent and dependent claims define the scope of protection.
- Patent Landscape: Part of a broader portfolio with strategic patent expiration dates.
- Clinical and Commercial Significance: Substantial impact on patient outcomes and market dynamics.
- Challenges and Future Directions: Potential for patent challenges and regulatory impacts.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 11,090,323?
The primary focus is on certain SGLT-2 inhibitors for treating and preventing metabolic disorders such as type 1 and type 2 diabetes mellitus.
Who are the inventors of this patent?
The inventors are Uli Christian Broedl, Sreeraj Macha, Maximilian von Eynatten, and Hans-Juergen Woerle.
What is the significance of the independent claims in this patent?
The independent claims define the maximum protection scope and provide flexibility in defending against patent challenges.
How does this patent fit into the broader patent landscape in the pharmaceutical sector?
It is part of a strategic portfolio with extended patent protection, potentially influencing market dynamics and patient access to treatments.
What are the potential challenges this patent might face?
It could face challenges from competitors or generic manufacturers through the PTAB, and be impacted by regulatory changes aimed at curbing patent abuses.
Cited Sources:
- United States Patent and Trademark Office - US11090323B2.
- FDA - Approved Drug Products with Therapeutic Equivalence Evaluations.
- King & Wood Mallesons - Patent Landscape Analysis of GPU Design Technology in China.
- Google Patents - US11090323B2.
- Citizen.org - Using the Inflation Reduction Act to Rein in Patenting Evergreening Abuses.
