Detailed Analysis of the Scope and Claims of United States Patent 11,072,577
Introduction
The United States Patent 11,072,577, titled "Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use," was granted on July 27, 2021, to Orphalan S.A. This patent introduces a new crystalline form of triethylenetetramine tetrahydrochloride (TETA.4HCl) with enhanced room temperature stability, which is crucial for pharmaceutical applications.
Patent Scope and Claims
Invention Overview
The patent describes a novel crystalline form of TETA.4HCl, characterized by specific X-ray Powder Diffraction (XRPD) and Raman spectroscopy patterns. This new form exhibits improved stability at room temperature compared to known forms and the dichloride salt[1][4].
Key Characteristics
- XRPD Pattern: The crystalline form is identified by peaks in the XRPD spectrum at 22.9, 25.4, 25.8, 26.6, 34.6, and 35.3 ± 0.1° 2θ[1][4].
- Raman Spectrum: The Raman spectrum shows shifts at 943, 1173, 1527, and 1612 cm⁻¹. The presence of at least two, preferably three, or all four of these peaks is a defining feature[1][4].
Stability
The patent emphasizes the stability of the new crystalline form under various storage conditions:
- Room Temperature Stability: The crystalline form retains its structure when stored at 20°C for up to 12 months[4].
- High Temperature and Humidity Stability: The form remains stable when stored at 40°C and 75% humidity for up to six months, with at least 90%, preferably 95%, or more preferably 98% of the sample retaining the crystalline form[4].
Pharmaceutical Use
The patent specifies the pharmaceutical use of this new crystalline form of TETA.4HCl, which is particularly important for treating conditions such as Wilson's disease. The stability and purity of the compound are critical for its efficacy and safety in medical applications[1].
Claim Structure
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: Describes the new crystalline form of TETA.4HCl characterized by the specific XRPD and Raman spectroscopy patterns[1][4].
- Claim 2: Specifies the pharmaceutical composition comprising the new crystalline form of TETA.4HCl[1][4].
Dependent Claims
Dependent claims further detail the invention by specifying various aspects such as the method of preparation, storage conditions, and purity levels of the crystalline form[1][4].
Patent Landscape
Prior Art and Related Patents
The patent references several prior art documents and related patents, including those related to the synthesis and use of triethylenetetramine and its salts. These references highlight the novelty of the new crystalline form and its improved stability[1].
Expiration Date
The patent is set to expire in May 2039, approximately 14 years from the issue date, assuming no extensions or adjustments[5].
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents like this one play a crucial role in protecting intellectual property. The stability and efficacy of the new crystalline form of TETA.4HCl could provide a significant advantage over existing treatments, making it a valuable asset for Orphalan S.A.[1].
Implications for Pharmaceutical Industry
Treatment of Wilson's Disease
The new crystalline form of TETA.4HCl has significant implications for the treatment of Wilson's disease, a genetic disorder that leads to copper accumulation in the body. The improved stability of this compound ensures consistent and reliable treatment outcomes[1].
Regulatory Compliance
The patent's emphasis on stability and purity aligns with stringent regulatory requirements in the pharmaceutical industry. This ensures that the product meets the necessary standards for safety and efficacy[4].
Future Developments and Challenges
Further Research and Development
Future research may focus on optimizing the production process, exploring other medical applications, and ensuring long-term stability under various conditions. These efforts could further enhance the value of the patent and expand its use in pharmaceuticals[1].
Litigation and Patent Disputes
As seen in other patent cases, disputes over patent validity and infringement can arise. The clarity and specificity of the claims in this patent are crucial in preventing or resolving such disputes[2].
Key Takeaways
- Novel Crystalline Form: The patent introduces a new crystalline form of TETA.4HCl with improved room temperature stability.
- Characterization: The form is characterized by specific XRPD and Raman spectroscopy patterns.
- Pharmaceutical Use: The compound is particularly useful for treating Wilson's disease.
- Stability: The crystalline form exhibits high stability under various storage conditions.
- Patent Expiration: The patent is set to expire in May 2039.
- Competitive Advantage: The patent provides a significant competitive advantage in the pharmaceutical industry due to the improved stability and efficacy of the compound.
FAQs
What is the main innovation of United States Patent 11,072,577?
The main innovation is the discovery of a new crystalline form of triethylenetetramine tetrahydrochloride (TETA.4HCl) with improved room temperature stability.
How is the new crystalline form characterized?
The new crystalline form is characterized by specific peaks in the XRPD spectrum and shifts in the Raman spectrum.
What are the implications of this patent for the treatment of Wilson's disease?
The improved stability of the new crystalline form ensures consistent and reliable treatment outcomes for Wilson's disease.
When is the patent set to expire?
The patent is set to expire in May 2039.
Why is the stability of the crystalline form important?
The stability is crucial for ensuring the efficacy and safety of the pharmaceutical product under various storage conditions.
Cited Sources
- United States Patent and Trademark Office, "Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use," US11072577B2.
- United States Court of Appeals for the Federal Circuit, "ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD."
- SSRN, "Patent Claims and Patent Scope."
- Google Patents, "Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use," US11072577B2.
- Pharsight - GreyB, "Cuvrior patent expiration."
