United States Patent 11,060,128: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,060,128, issued to Catalyst Pharmaceuticals, is a method of use patent that covers specific methods of administering the drug 3,4-diaminopyridine (3,4-DAP), also known as amifampridine, particularly for the treatment of amifampridine-sensitive diseases. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent was issued by the United States Patent and Trademark Office (USPTO) on July 13, 2021, and is owned by SERB, with Catalyst Pharmaceuticals holding the exclusive license[2][4].
Scope of the Patent
The scope of U.S. Patent 11,060,128 is narrowly defined and focuses on the administration of 3,4-DAP to patients with specific genetic profiles. Here are the key aspects:
Disease Treatment
The patent pertains to the treatment of amifampridine-sensitive diseases, most notably Lambert-Eaton myasthenic syndrome (LEMS)[1][4].
Patient Selection
The method involves selecting patients based on their N-acetyl transferase 2 (NAT2) acetylation status. Specifically, it targets NAT2 slow acetylators who metabolize 3,4-DAP more slowly compared to those without the specific mutations[1][4].
Dosage Administration
The patent claims cover the administration of a total daily dose of about 7.5 mg to about 40 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt, optionally provided as a series of divided doses[1][4].
Claims of the Patent
The claims of U.S. Patent 11,060,128 are detailed and specific, ensuring a clear definition of the patented method.
Representative Claim
Claim 1 of the '128 patent is illustrative:
- "A method of treating a human patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS) in need of treatment thereof comprising administering a total daily dose of about 7.5 mg to about 40 mg of 3,4-diaminopyridine (3,4-DAP), or an equivalent amount of a pharmaceutically acceptable salt thereof, to a human patient who is a N-acetyl transferase 2 (NAT2) slow acetylator, wherein the total daily dose is optionally provided as a series of divided doses."[1]
Patent Landscape
The patent landscape surrounding U.S. Patent 11,060,128 is complex and involves several key elements:
Related Patents
The '128 patent is part of a series of patents related to the administration of 3,4-DAP. It claims priority to earlier applications, including a National Stage Entry of PCT/US2012/044904 and two provisional applications (61/553,045 and 61/503,553) with an earliest priority date of June 30, 2011[1].
Litigation and Disputes
The patent is involved in ongoing litigation with Jacobus Pharmaceuticals, which has raised counterclaims including allegations of inequitable conduct during the patent prosecution process. Jacobus argues that Catalyst Pharmaceuticals withheld material prior art references, although the Patent Office considered these references and issued the patent nonetheless[1].
Intellectual Property Strategy
The issuance of this patent bolsters Catalyst Pharmaceuticals' intellectual property portfolio for Firdapse®, their brand name for 3,4-DAP. This strategy aims to protect their market position and ensure exclusivity in the treatment of LEMS and other amifampridine-sensitive diseases[2].
Patent Scope Metrics
Research on patent scope metrics suggests that narrower claims, such as those in U.S. Patent 11,060,128, are associated with a higher probability of grant and a shorter examination process. This is because narrower claims reduce the likelihood of conflicts with prior art and make the patent more defensible[3].
Impact on Innovation and Litigation
The specificity of the claims in U.S. Patent 11,060,128 can influence innovation and litigation in several ways:
Innovation Incentives
Narrow and well-defined claims can encourage innovation by providing clear boundaries and reducing the risk of litigation. This clarity can also facilitate licensing agreements and collaborations[3].
Litigation Costs
The detailed nature of the claims may reduce litigation costs by making it clearer what is and is not covered by the patent. However, the ongoing litigation with Jacobus Pharmaceuticals highlights the complexities and challenges that can still arise[1].
Expert Insights
Industry experts often emphasize the importance of patent scope and claim clarity. For instance, "narrower claims at publication are associated with a higher probability of grant and a shorter examination process," which underscores the strategic value of patents like U.S. Patent 11,060,128[3].
Statistics and Trends
- Patent Examination Process: The examination process tends to narrow the scope of patent claims, which is evident in the case of U.S. Patent 11,060,128 where the claims are highly specific and targeted[3].
- Litigation Frequency: The frequency of litigation involving patents with broad claims is higher compared to those with narrower claims, highlighting the importance of claim specificity in reducing legal disputes[3].
Key Takeaways
- Specific Claims: U.S. Patent 11,060,128 has highly specific claims related to the administration of 3,4-DAP to NAT2 slow acetylators.
- Patent Landscape: The patent is part of a broader intellectual property strategy for Firdapse® and is involved in ongoing litigation.
- Innovation and Litigation: Narrow claims can encourage innovation and reduce litigation costs, but complexities can still arise.
- Expert Insights: Industry experts emphasize the importance of patent scope and claim clarity.
FAQs
What is the primary focus of U.S. Patent 11,060,128?
The primary focus is on methods of administering 3,4-diaminopyridine (3,4-DAP) to treat Lambert-Eaton myasthenic syndrome (LEMS) in patients who are NAT2 slow acetylators.
Who owns U.S. Patent 11,060,128?
The patent is owned by SERB, with Catalyst Pharmaceuticals holding the exclusive license.
What are the key claims of the patent?
The key claims involve administering a total daily dose of about 7.5 mg to about 40 mg of 3,4-DAP to NAT2 slow acetylators, optionally in divided doses.
Is the patent involved in any litigation?
Yes, the patent is involved in ongoing litigation with Jacobus Pharmaceuticals, which includes allegations of inequitable conduct.
How does the patent impact innovation and litigation?
The patent's narrow and specific claims can encourage innovation by providing clear boundaries and reduce litigation costs, although it is still involved in complex legal disputes.
Cited Sources
- Catalyst Pharm. v. Jacobus Pharm. Co. - Casetext
- Catalyst Pharmaceuticals Announces Issuance of U.S. Patent 11,060,128 - Catalyst Pharmaceuticals
- Patent Claims and Patent Scope - SSRN
- US11060128B2 - Methods of administering 3,4-diaminopyridine - Google Patents
