United States Patent 4,801,577: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 4,801,577, titled "Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists," is a significant patent in the field of pharmaceuticals, particularly in the development of Luteinizing Hormone-Releasing Hormone (LHRH) antagonists. This patent, filed by Nestor et al., outlines various aspects of these analogs, their pharmaceutical compositions, and their therapeutic applications.
Patent Overview
Publication and Authority
- Publication Number: US4801577A
- Authority: United States Patent and Trademark Office (USPTO)
- Prior Art Date: The patent was filed on January 11, 1988, and granted on October 31, 1989[4].
Legal Status
The patent has expired, as indicated by its legal status, which is a common outcome for patents that have reached the end of their 20-year term from the filing date.
Scope of the Patent
Claims and Inventions
The patent encompasses several key claims and inventions related to nonapeptide and decapeptide analogs of LHRH, which are designed to act as LHRH antagonists. Here are some of the main aspects:
-
Chemical Structure: The patent describes specific chemical structures of these analogs, including the use of D-Nal, 4-Cl-D-Phe, D-Pal, N-Me-Tyr, D-Asn, Lys(iPr), and D-Ala in the peptide sequence. These modifications are crucial for the antagonistic activity against LHRH[4].
-
Pharmaceutical Compositions: The patent details pharmaceutical compositions containing these analogs, which can be administered in various forms to achieve therapeutic effects. These compositions are designed to inhibit ovulation, treat endometriosis, prostatic hypertrophy, precocious puberty, and other conditions[4].
Therapeutic Applications
The patent outlines several therapeutic applications for these LHRH antagonists:
-
Inhibiting Ovulation: The compounds can be used to prevent ovulation in female mammals, which is useful in fertility control and other reproductive health applications[4].
-
Treating Endometriosis: The LHRH antagonists are effective in treating endometriosis by reducing the levels of gonadotropins, thereby alleviating symptoms associated with the condition[4].
-
Prostatic Hypertrophy: These compounds can be used to treat prostatic hypertrophy in male mammals by reducing the levels of testosterone, which is a key factor in the growth of prostate tissue[4].
-
Precocious Puberty: The patent includes methods for treating precocious puberty by administering these LHRH antagonists to delay the onset of puberty in children[4].
-
Other Applications: Additional therapeutic uses include interrupting heat in animals, terminating pregnancy, inhibiting spermatogenesis, preventing ovarian hyperstimulation, and treating premenstrual syndrome[4].
Patent Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they specify what is considered novel and non-obvious about the invention.
-
Claim 1: This claim typically defines the broadest scope of the invention, often describing the general structure of the LHRH analogs and their use as antagonists[4].
-
Dependent Claims: These claims build upon the independent claims, providing more specific details about the chemical structures, pharmaceutical compositions, and methods of administration.
Patent Landscape
Related Patents
The patent landscape surrounding US4801577A includes several related patents that also deal with LHRH antagonists and their applications:
-
European Patent EP0952843B1: This patent discusses pharmaceutical formulations for sustained drug delivery, including LHRH antagonists, which are relevant to the sustained release formulations mentioned in US4801577A[1].
-
Other U.S. Patents: Patents such as US5,470,947 and US5,413,990 also describe LHRH antagonists and their therapeutic uses, indicating a robust patent landscape in this area[1][4].
Impact on Innovation and Litigation
Patent Scope and Quality
The scope and quality of patents like US4801577A are critical in the broader debate about patent quality. Narrower claims, as seen in this patent, are generally associated with higher probabilities of grant and shorter examination processes. This is in line with research indicating that narrower claims tend to have better outcomes during the patent examination process[3].
Licensing and Litigation
The clarity and specificity of claims in this patent can influence licensing and litigation costs. Clear and well-defined claims reduce the likelihood of disputes and litigation, thereby promoting innovation by providing clear boundaries for what is protected and what is not[3].
Key Takeaways
- Specific Chemical Structures: The patent details specific chemical modifications to LHRH analogs that confer antagonistic activity.
- Therapeutic Applications: The LHRH antagonists have a wide range of therapeutic applications, including fertility control, treatment of endometriosis, prostatic hypertrophy, and more.
- Pharmaceutical Compositions: The patent describes various pharmaceutical compositions and methods of administration for these analogs.
- Patent Landscape: The patent is part of a larger landscape of related patents focusing on LHRH antagonists and sustained drug delivery.
- Impact on Innovation: Clear and specific claims in this patent contribute to reducing licensing and litigation costs, promoting innovation.
FAQs
Q: What is the primary focus of United States Patent 4,801,577?
A: The primary focus is on nonapeptide and decapeptide analogs of LHRH that act as LHRH antagonists.
Q: What are some of the therapeutic applications of these LHRH antagonists?
A: They include inhibiting ovulation, treating endometriosis, prostatic hypertrophy, precocious puberty, and other conditions.
Q: How do the chemical structures of these analogs differ from natural LHRH?
A: The analogs include specific modifications such as D-Nal, 4-Cl-D-Phe, D-Pal, N-Me-Tyr, D-Asn, Lys(iPr), and D-Ala in the peptide sequence.
Q: What is the significance of the patent's expiration?
A: The expiration means that the inventions described in the patent are now in the public domain and can be freely used without infringing on the original patent.
Q: How does the clarity of claims in this patent impact innovation and litigation?
A: Clear and specific claims reduce the likelihood of disputes and litigation, promoting innovation by providing clear boundaries for what is protected and what is not.
Sources
- EP0952843B1 - Pharmaceutical formulations for sustained drug delivery - Google Patents
- US4801577A - Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists - Google Patents
- Patent Claims and Patent Scope - Hoover Institution
- US4801577A - Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists - USPTO
