United States Patent 11,234,938: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,234,938, titled "Pharmaceutical composition, comprising phosphate binder particles," is a significant patent in the pharmaceutical industry, particularly in the realm of phosphate binders used in the treatment of conditions such as hyperphosphatemia. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent US11234938B2 describes a pharmaceutical composition comprising phosphate binder particles, specifically focusing on the particle size distribution of these binders. The invention is tailored for the preparation of improved tablets and other pharmaceutical formulations. The phosphate binders in question are primarily iron oxyhydroxide-based, stabilized by agents such as carbohydrates or humic acid[4].
Claims and Scope
Key Claims
The patent includes several key claims that define the scope of the invention:
- Particle Size Distribution: The claims specify a particular particle size distribution of the phosphate binder particles, which is crucial for the preparation of tablets and other pharmaceutical forms[4].
- Phosphate Binder Composition: The composition includes iron oxyhydroxide stabilized by a stabilization agent, such as carbohydrates or humic acid, which are not absorbed by the human body[4].
- Formulation Process: The patent details a process for preparing the pharmaceutical administration form, including blending the active ingredient with specific excipients and compressing or filling the formulations into final forms like tablets or sachets[4].
Scope of Protection
The scope of protection for this patent is broad enough to cover various aspects of the pharmaceutical composition, including the specific particle size distribution and the stabilization agents used. However, it is narrow enough to avoid overly broad claims that might be invalidated due to lack of enablement or written description, a common issue in pharmaceutical patents[3].
Patent Landscape
Related Patents
The patent US11234938B2 is part of a larger family of patents related to phosphate binders. Other patents, such as US6174442, which expired in June 2020, and US11446252, also focus on similar aspects of phosphate binder compositions and their administration[1].
Litigation and Settlements
Patent litigation in the pharmaceutical industry is common, and settlements often define the boundaries of patent protection. For example, settlements in ANDA (Abbreviated New Drug Application) litigation can impact the timing and terms under which generic versions of drugs can enter the market. While US11234938B2 is not specifically mentioned in recent ANDA litigation settlements, the broader context of patent disputes in the industry highlights the importance of robust patent protection[2].
Expiration and Maintenance
Patent Expiration
The patent US11234938B2 is set to expire in May 2035. This provides a significant period of exclusivity for the patent holder to commercialize the invention without generic competition[1].
Maintenance Fees
To maintain the patent's active status, the patent holder must pay periodic maintenance fees. Recent payments of these fees, such as those made in December 2023, ensure the patent remains in force until its expiration[1].
Industry Impact
Market Context
The market for pharmaceuticals, including biologics and therapeutic antibodies, is vast and growing. By 2025, the market for therapeutic antibodies alone is estimated to reach $300 billion. Robust and predictable patent protection is crucial for innovators to recoup their significant investment in drug development[3].
Challenges in Patent Protection
The pharmaceutical and biotechnology industries face unique challenges in obtaining and maintaining valuable patent protection. The Federal Circuit's rigid application of Section 112(a) of the patent laws has made it difficult for innovators to claim the full scope of their inventions without risking invalidation. This has led to a delicate balance between claiming too broadly and risking invalidation, or claiming too narrowly and allowing competitors to design around the claims[3].
Expert Insights
Industry experts emphasize the importance of carefully drafting patent claims to ensure they are commensurate with what is taught in the patent application. This balance is critical to avoid the pitfalls of either overly broad or overly narrow claims.
"The scope or breadth of patent claims determine what exactly the inventor is claiming as her invention. Traditionally, the broader the scope of the claim, the more meaningful patent protection in the pharmaceutical and biotechnology industries"[3].
Illustrative Statistics
- The global market for therapeutic antibodies is projected to reach $300 billion by 2025[3].
- Billions of dollars are invested to move a novel scientific finding to the point of bringing a product to market[3].
Examples and Analogies
To understand the complexity of patent claims in the pharmaceutical industry, consider the analogy of a map. A patent claim is like a map that defines the boundaries of the inventor's territory. If the map is too vague, it may not provide meaningful protection. If it is too detailed but inaccurate, it may be deemed invalid. The right balance is crucial.
Key Takeaways
- Patent Scope: The patent US11234938B2 has a well-defined scope focusing on the particle size distribution and stabilization agents of phosphate binder particles.
- Expiration: The patent is set to expire in May 2035, providing a significant period of exclusivity.
- Industry Impact: Robust patent protection is essential for innovators in the pharmaceutical and biotechnology industries to commercialize their inventions.
- Challenges: The industry faces challenges in drafting patent claims that are neither too broad nor too narrow, due to the Federal Circuit's strict application of patent laws.
Frequently Asked Questions (FAQs)
What is the main focus of the patent US11234938B2?
The main focus of the patent US11234938B2 is on a pharmaceutical composition comprising phosphate binder particles, specifically the particle size distribution and the use of stabilization agents.
When is the patent set to expire?
The patent US11234938B2 is set to expire in May 2035.
What are the challenges in obtaining patent protection in the pharmaceutical industry?
The challenges include drafting patent claims that are neither too broad nor too narrow, due to the Federal Circuit's strict application of Section 112(a) of the patent laws.
How does the patent landscape impact generic drug entry?
The patent landscape, including settlements in ANDA litigation, can define the timing and terms under which generic versions of drugs can enter the market.
Why is robust patent protection important in the pharmaceutical industry?
Robust patent protection is crucial for innovators to recoup their significant investment in drug development and to ensure meaningful commercialization of their inventions.
Cited Sources
- Pharsight: Velphoro patent expiration - Pharsight
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- DigitalCommons@NYLS: Eviscerating Patent Scope - DigitalCommons@NYLS
- Google Patents: US11234938B2 - Pharmaceutical composition, comprising phosphate binder particles - Google Patents
