United States Patent 8,637,451: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,637,451, titled "Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis," is a significant patent in the field of pharmaceuticals, particularly in the treatment of inflammatory and pre-cancerous conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Context
The patent, filed on May 25, 2011, and granted on January 28, 2014, is assigned to Salix Pharmaceuticals, Inc. (now part of Bausch Health Companies Inc.) and MPI Research, Inc.[4].
Scope of the Patent
The patent covers methods and compositions related to the use of guanylate cyclase receptor agonists. These agonists are used for the treatment of inflamed, pre-cancerous, or cancerous tissues or polyps in mammalian subjects. The treatment involves the administration of specific peptides that activate guanylate cyclase receptors, leading to the production of cyclic guanosine monophosphate (cGMP), which has therapeutic effects on tissue inflammation and carcinogenesis[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: A method of treating inflamed, pre-cancerous, or cancerous tissue or polyps in a mammalian subject, comprising administering a guanylate cyclase receptor agonist.
- Claim 2: The method of claim 1, where the guanylate cyclase receptor agonist is a peptide.
- Claim 3: The method of claim 2, where the peptide is selected from a specific list of sequences.
- Claim 4: A composition comprising a guanylate cyclase receptor agonist and a pharmaceutically acceptable carrier.
These claims are designed to protect the specific methods and compositions related to the use of these agonists, ensuring that any similar treatments or products would infringe on this patent unless they fall outside the defined scope[4].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding US 8,637,451 includes several related patents and applications. For instance, other patents by Salix Pharmaceuticals and MPI Research cover similar guanylate cyclase receptor agonists and their therapeutic applications. These patents often overlap in their claims but may differ in specific details such as the peptide sequences or the exact methods of administration[1][4].
Competitors and Litigation
The pharmaceutical industry is highly competitive, and patents like US 8,637,451 are often at the center of litigation. For example, generic drug sponsors may challenge the validity or enforceability of such patents through paragraph IV certifications as part of the Abbreviated New Drug Application (ANDA) process. This was seen in cases where MPI and other companies were involved in patent infringement disputes related to similar pharmaceutical products[1].
Regulatory Environment
The Hatch-Waxman Act plays a crucial role in the patent landscape for pharmaceuticals. This act allows generic drug sponsors to submit ANDAs, which can lead to earlier market entry if the generic drug is shown to be bioequivalent to the brand drug. However, this process also involves patent certifications and potential litigation, as seen in the context of US 8,637,451[1].
Patent Eligibility and Abstract Ideas
The patentability of inventions like US 8,637,451 must comply with the requirements of 35 U.S.C. § 101, which excludes abstract ideas, laws of nature, and natural phenomena from patent eligibility. The "Alice test" is a two-step process used to determine if a patent claim is directed to patent-eligible subject matter. For US 8,637,451, the claims are specific to the use of guanylate cyclase receptor agonists, which are tangible and have a clear application, thus likely passing the Alice test[2].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides insights into the scope and trends of patent claims, including those related to pharmaceuticals. This dataset can help in understanding the broader economic and research implications of patents like US 8,637,451. For instance, it can show how patent scope measurements and claim-level statistics impact the development and commercialization of new drugs[3].
Industry Expert Insights
Industry experts often highlight the importance of robust patent protection in the pharmaceutical sector. According to Dr. Alan Marco, Chief Economist at the USPTO, "Patent claims are a critical component of the patent system, as they define the scope of protection for an invention."[3]
Statistics and Trends
The pharmaceutical industry is one of the most patent-intensive sectors. Statistics from the USPTO show that patents related to pharmaceuticals have been increasing over the years, reflecting the ongoing innovation and competition in this field. For example, the Patent Claims Research Dataset indicates a significant number of patents granted between 1976 and 2014, with a notable increase in the number of claims related to pharmaceutical inventions[3].
Examples and Case Studies
A notable example of the impact of patent litigation in the pharmaceutical sector is the case of Contour IP Holding LLC v. GoPro, Inc., where the court's interpretation of patent claims and their eligibility under 35 U.S.C. § 101 was crucial. While this case is not directly related to US 8,637,451, it highlights the complexities and challenges involved in patent litigation in the tech and pharmaceutical industries[2].
Key Takeaways
- Specific Claims: US 8,637,451 covers specific methods and compositions related to guanylate cyclase receptor agonists.
- Patent Landscape: The patent is part of a broader landscape involving related patents, generic drug applications, and potential litigation.
- Regulatory Compliance: The patent must comply with the Hatch-Waxman Act and 35 U.S.C. § 101.
- Economic Impact: The patent contributes to the economic and research landscape of the pharmaceutical industry.
- Industry Insights: Robust patent protection is crucial for innovation in the pharmaceutical sector.
FAQs
What is the main subject of US Patent 8,637,451?
The main subject of US Patent 8,637,451 is the use of guanylate cyclase receptor agonists for the treatment of inflamed, pre-cancerous, or cancerous tissues or polyps.
How does the Hatch-Waxman Act affect this patent?
The Hatch-Waxman Act allows generic drug sponsors to submit ANDAs, which can challenge the validity or enforceability of patents like US 8,637,451, potentially leading to earlier market entry for generic versions.
What is the Alice test, and how does it apply to this patent?
The Alice test is a two-step process to determine if a patent claim is directed to patent-eligible subject matter. For US 8,637,451, the claims are specific and tangible, likely passing the Alice test.
What is the economic significance of this patent?
This patent is economically significant as it protects a valuable therapeutic method, influencing the development and commercialization of new drugs in the pharmaceutical industry.
How does the Patent Claims Research Dataset relate to this patent?
The Patent Claims Research Dataset provides insights into the scope and trends of patent claims, including those related to pharmaceuticals, helping to understand the broader economic and research implications of patents like US 8,637,451.
Cited Sources
- United States District Court for the District of New Jersey. NOT FOR PUBLICATION UNITED STATES DISTRICT COURT.
- United States Court of Appeals for the Federal Circuit. CONTOUR IP HOLDING LLC v. GOPRO, INC.
- United States Patent and Trademark Office. Patent Claims Research Dataset.
- Google Patents. US8637451B2 - Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis.
