United States Patent 10,988,436: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,988,436, titled "Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use," is a significant patent in the pharmaceutical industry, particularly in the realm of orphan drugs. This patent, held by Orphalan S.A., a French company specializing in orphan drug development and commercialization, protects a novel crystalline form of triethylenetetramine tetrahydrochloride. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent was granted on April 27, 2021, to inventors Timothy James Morley, Ronnie Maxwell Lawrence, and Naseem Amin, and is assigned to Orphalan S.A.[1][2][4].
Scope of the Patent
The patent describes a new crystalline form of triethylenetetramine tetrahydrochloride that exhibits improved room temperature stability compared to known forms and the dichloride salt. This stability is crucial for the pharmaceutical use of the compound, ensuring its efficacy and shelf life.
Pharmaceutical Use
The crystalline form is intended for pharmaceutical applications, specifically for the treatment of conditions where triethylenetetramine tetrahydrochloride is effective. The improved stability enhances the drug's performance and safety profile[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent claims cover the specific crystalline form of triethylenetetramine tetrahydrochloride, its method of preparation, and its pharmaceutical use. These claims are detailed and specific, ensuring that the protection is focused on the unique aspects of the invention[1].
Dependent Claims
- Dependent claims further specify the conditions and processes related to the crystalline form, such as the purity levels, methods of synthesis, and storage conditions. These claims provide additional layers of protection and clarity on what is covered under the patent[1].
Patent Landscape
Related Patents
The patent is part of a broader portfolio related to triethylenetetramine tetrahydrochloride. Another relevant patent is U.S. Patent 11,072,577, which also covers crystalline forms of the same compound and their pharmaceutical uses. These patents collectively protect the active ingredient and various aspects of its formulation and administration[2][4].
Litigation and Enforcement
Orphalan S.A. has been active in enforcing these patents against potential infringers. For instance, the company has filed a lawsuit against Novitium, alleging that Novitium's proposed ANDA (Abbreviated New Drug Application) product would infringe on the claims of both U.S. Patent 10,988,436 and U.S. Patent 11,072,577. This litigation underscores the importance of these patents in protecting Orphalan's intellectual property and market position[2].
Expiration and Status
Both U.S. Patent 10,988,436 and U.S. Patent 11,072,577 are set to expire in May 2039, approximately 14 years from the current date. Until then, these patents remain active and enforceable, giving Orphalan S.A. exclusive rights to the protected crystalline forms and their pharmaceutical uses[4].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patents protect Orphalan S.A.'s investment in research and development, allowing the company to recoup its costs and maintain a competitive edge in the market. This protection also incentivizes further innovation, as companies are more likely to invest in R&D when they can secure exclusive rights to their discoveries[3].
Generic Challenges
The litigation against Novitium highlights the challenges generic drug manufacturers face when trying to enter the market with products that could potentially infringe on existing patents. This scenario is common in the pharmaceutical industry, where patent disputes often delay the entry of generic drugs, affecting both the market dynamics and patient access to affordable medications[2].
Metrics for Patent Scope
Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and a shorter examination process. This metric can be applied to understand the scope of U.S. Patent 10,988,436, which has detailed and specific claims reflecting its focused protection[3].
Conclusion
U.S. Patent 10,988,436 is a critical asset for Orphalan S.A., protecting a novel and stable crystalline form of triethylenetetramine tetrahydrochloride. The patent's scope, defined by its claims, ensures exclusive rights for the company in the pharmaceutical use of this compound. The ongoing litigation and the patent's status within the broader landscape highlight its significance in maintaining Orphalan's market position and incentivizing further innovation.
Key Takeaways
- Patent Scope: The patent protects a specific crystalline form of triethylenetetramine tetrahydrochloride with improved stability.
- Claims: Detailed claims cover the compound's preparation, purity, and pharmaceutical use.
- Litigation: Orphalan S.A. is actively enforcing these patents against potential infringers.
- Expiration: The patents are set to expire in May 2039.
- Industry Impact: The patents protect Orphalan's investment and maintain its competitive edge, while also affecting the entry of generic drugs into the market.
FAQs
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What is the main subject of U.S. Patent 10,988,436?
- The main subject is a new crystalline form of triethylenetetramine tetrahydrochloride with improved room temperature stability.
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Who is the assignee of this patent?
- The assignee is Orphalan S.A., a French company specializing in orphan drug development and commercialization.
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What is the significance of the improved stability of the crystalline form?
- The improved stability enhances the drug's efficacy and shelf life, making it more suitable for pharmaceutical use.
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Why is Orphalan S.A. involved in litigation related to this patent?
- Orphalan S.A. is enforcing its patents against potential infringers, such as Novitium, to protect its exclusive rights and market position.
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When are the patents set to expire?
- The patents are set to expire in May 2039, approximately 14 years from the current date.
Sources
- United States Patent and Trademark Office. (2021). Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use. US 10,988,436 B2.
- United States District Court. (2023). Orphalan SA v. Novitium. Case 1:23-cv-01079-UNA.
- Hoover Institution. (2016). Patent Claims and Patent Scope. Working Paper Series No. 16001.
- Pharsight - GreyB. Cuvrior patent expiration. Retrieved from https://pharsight.greyb.com/drug/cuvrior-patent-expiration.
