Detailed Analysis of the Scope and Claims of United States Patent 10,793,893
Introduction
United States Patent 10,793,893, titled "Methods of Administering 3,4-Diaminopyridine," is a crucial patent in the field of pharmaceuticals, particularly for the treatment of rare neuromuscular diseases such as Lambert-Eaton Myasthenic Syndrome (LEMS). This patent is owned by SERB SA and exclusively licensed to Catalyst Pharmaceuticals, Inc.
Background and Ownership
The patent was issued on October 6, 2020, by the United States Patent and Trademark Office (USPTO). It was originally filed by BioMarin, but the ownership was transferred to SERB at the Patent Office in April 2020. Catalyst Pharmaceuticals holds an exclusive license for this patent in the United States[1][2].
Scope of the Patent
The patent concerns methods of administering the drug 3,4-diaminopyridine, also known as amifampridine, which is used to treat amifampridine-sensitive diseases. Here are the key aspects of the patent's scope:
Methods of Administration
The patent describes specific methods for determining the NAT (N-acetyltransferase) acetylation status of a subject with a 3,4-DAP-sensitive disease. It also outlines methods for selecting a dose of 3,4-DAP based on this acetylation status. This personalized approach aims to optimize the efficacy and safety of the treatment[4].
Disease Treatment
The primary focus is on treating LEMS, a rare autoimmune disease characterized by muscle weakness and fatigue. The methods described in the patent are designed to improve the management and treatment outcomes for patients with this condition[5].
Claims of the Patent
The patent includes several claims that define the boundaries of the invention:
Claim Structure
The claims are structured to cover various aspects of administering 3,4-diaminopyridine, including:
- Methods for determining NAT acetylation status.
- Methods for selecting and administering a dose based on the acetylation status.
- Specific dosing regimens and monitoring protocols[4].
Validity and Enforceability
Each claim of the '893 patent is asserted to be valid and enforceable. Catalyst and SERB have taken legal actions to protect these claims against alleged infringement by other pharmaceutical companies[2].
Patent Landscape and Litigation
The patent landscape surrounding U.S. Patent 10,793,893 is complex and involves ongoing litigation:
Infringement Lawsuits
Catalyst Pharmaceuticals has filed patent infringement lawsuits against several companies, including Jacobus Pharmaceuticals and PantherRX Rare LLC, alleging that their products infringe on the '893 patent. These lawsuits are part of Catalyst's efforts to protect its intellectual property and patent rights[2][5].
Allegations of Inequitable Conduct
Jacobus Pharmaceuticals has alleged that Catalyst and its affiliates engaged in inequitable conduct during the patent prosecution process. This includes claims that material prior art was withheld and that highly material information was not disclosed to the Patent Office. However, the court has found that the allegedly withheld prior art was not but-for material to the patentability of the claims[1].
Regulatory and Legal Context
The patent is part of a broader regulatory and legal framework:
Orphan Drug Act
Catalyst's interpretation of the Orphan Drug Act has been a point of contention. Despite a legal loss in one case where the judge adopted the FDA's interpretation of the statute, Catalyst continues to assert its rights under this act[5].
FDA Approval
The drug Firdapse (amifampridine), which is the subject of this patent, is the first drug approved in the United States for the treatment of LEMS. The FDA's approval and subsequent labeling requirements have been central to the legal disputes surrounding this patent[2].
Subject Matter Eligibility
The patent's claims must comply with the subject matter eligibility criteria under U.S. patent law:
Natural Principles and Abstract Ideas
The claims do not merely recite natural principles or abstract ideas but instead describe specific, practical applications of administering a man-made drug. This ensures that the claims are eligible under the subject matter eligibility analysis[3].
Conclusion
U.S. Patent 10,793,893 is a significant patent in the pharmaceutical industry, particularly for the treatment of rare neuromuscular diseases. Its scope includes specific methods for administering 3,4-diaminopyridine, and the claims are designed to ensure personalized and effective treatment. The patent is part of ongoing litigation and regulatory discussions, highlighting the complexities and challenges in protecting intellectual property in the pharmaceutical sector.
Key Takeaways
- Ownership and Licensing: The patent is owned by SERB SA and exclusively licensed to Catalyst Pharmaceuticals, Inc.
- Scope: The patent covers methods of administering 3,4-diaminopyridine for treating amifampridine-sensitive diseases like LEMS.
- Claims: The claims include methods for determining NAT acetylation status and selecting doses based on this status.
- Litigation: Ongoing lawsuits against alleged infringers, including Jacobus Pharmaceuticals and PantherRX Rare LLC.
- Regulatory Context: Involves interpretations of the Orphan Drug Act and FDA approval and labeling requirements.
- Subject Matter Eligibility: The claims are eligible as they describe practical applications of a man-made drug.
FAQs
What is the primary use of the drug covered by U.S. Patent 10,793,893?
The primary use is for treating Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disease.
Who owns and licenses U.S. Patent 10,793,893?
The patent is owned by SERB SA and exclusively licensed to Catalyst Pharmaceuticals, Inc.
What are the key claims of the patent?
The claims include methods for determining NAT acetylation status and selecting doses of 3,4-diaminopyridine based on this status.
What legal challenges has Catalyst faced regarding this patent?
Catalyst has faced allegations of inequitable conduct and has been involved in lawsuits against alleged infringers, including Jacobus Pharmaceuticals and PantherRX Rare LLC.
How does the patent comply with subject matter eligibility criteria?
The claims describe specific, practical applications of administering a man-made drug, ensuring they are eligible under subject matter eligibility analysis.
Cited Sources
- Catalyst Pharm. v. Jacobus Pharm. Co. - Casetext
- Case 2:23-cv-22461 Document 1 Filed 11/17/23 - Insight.RPXCorp
- 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature - USPTO
- US10793893B2 - Methods of administering 3,4-diaminopyridine - Google Patents
- Catalyst Continues Legal War Against Jacobus Pharmaceuticals - BioSpace
