United States Patent 9,616,097: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,616,097, titled "Formulations of Guanylate Cyclase-C Agonist Peptides and Methods of Use," is a significant patent in the pharmaceutical industry, particularly in the field of gastrointestinal treatments. This patent, assigned to Synergy Pharmaceuticals, Inc., covers innovative formulations and methods related to guanylate cyclase-C (GCC) agonist peptides. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The patent was issued on April 11, 2017, to inventors Stephen Comiskey, Doylestown, PA; Rong Feng, Langhorne, PA; John Foss, Doylestown, PA; and Shailubhai, Audubon, PA[4].
Scope of the Patent
The patent focuses on low-dose formulations of GCC agonist peptides and their methods of use. These formulations are designed to be administered either alone or in combination with other therapeutic agents, such as inhibitors of cGMP-dependent phosphodiesterase or laxatives. The GCC agonist peptides are crucial for treating gastrointestinal disorders, including constipation, by stimulating the guanylate cyclase-C enzyme, which increases intestinal fluid secretion and promotes bowel movement[4].
Claims of the Patent
The patent includes 12 claims that detail the specific formulations and methods of use for the GCC agonist peptides. Here are some key aspects of the claims:
- Claim 1: This claim describes the composition of the GCC agonist peptide formulation, specifying the peptide sequence and the dosage form.
- Claims 2-4: These claims outline the methods of administering the formulations, including oral administration and combination with other therapeutic agents.
- Claims 5-8: These claims detail the specific therapeutic uses of the formulations, such as treating constipation and other gastrointestinal disorders.
- Claims 9-12: These claims cover various aspects of the formulation, including stability, storage, and manufacturing processes[4].
Patent Landscape
Related Patents
The patent 9,616,097 is part of a larger family of patents related to GCC agonist peptides and their applications. Other relevant patents include:
- US Patent 7,041,786: This patent, also held by Synergy Pharmaceuticals, Inc., claims peptides and compositions of peptides related to GCC agonists[2][5].
- US Patent 7,799,897: This patent covers additional aspects of GCC agonist peptides, including their use in treating gastrointestinal disorders[2][5].
- US Patent 8,637,451: This patent further expands on the formulations and methods of use for GCC agonist peptides[2][5].
Litigation and ANDA Filings
The patent 9,616,097 has been involved in several legal actions related to Abbreviated New Drug Applications (ANDA) filings. For instance, Synergy Pharmaceuticals, Inc. has sued generic drug manufacturers for patent infringement when they filed ANDAs seeking FDA approval for generic versions of Trulance® (plecanatide oral tablets), which are protected by this and other related patents[2][5].
Patent Scope and Quality
The debate over patent scope and quality is relevant here. The patent 9,616,097, with its specific and detailed claims, exemplifies the importance of clear and narrow claims in patent law. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process, which can be seen in the context of this patent[3].
Impact on the Pharmaceutical Industry
The patent 9,616,097 has significant implications for the pharmaceutical industry, particularly in the development and marketing of gastrointestinal treatments. Here are a few key points:
- Innovation: The patent promotes innovation by protecting novel formulations and methods of use for GCC agonist peptides, encouraging further research and development in this area.
- Competition: The involvement in ANDA filings and subsequent litigation highlights the competitive landscape in the pharmaceutical industry, where patent protection plays a crucial role in market positioning.
- Patient Benefit: The protected formulations and methods ensure that patients have access to effective treatments for gastrointestinal disorders, while also incentivizing the development of new therapeutic agents[4].
Key Takeaways
- Specific Claims: The patent includes detailed claims that cover specific formulations and methods of use for GCC agonist peptides.
- Litigation: The patent has been involved in several legal actions related to ANDA filings and generic drug approvals.
- Impact on Industry: The patent influences innovation, competition, and patient access to effective treatments in the pharmaceutical industry.
- Patent Landscape: The patent is part of a broader family of patents related to GCC agonist peptides and their applications.
FAQs
What is the main subject of United States Patent 9,616,097?
The main subject of United States Patent 9,616,097 is the formulations of guanylate cyclase-C (GCC) agonist peptides and their methods of use.
Who are the inventors of this patent?
The inventors of this patent are Stephen Comiskey, Rong Feng, John Foss, and Shailubhai.
What is the significance of this patent in the pharmaceutical industry?
This patent is significant because it protects novel formulations and methods of use for GCC agonist peptides, which are crucial for treating gastrointestinal disorders.
Has this patent been involved in any legal actions?
Yes, this patent has been involved in several legal actions related to Abbreviated New Drug Applications (ANDA) filings and patent infringement.
How does this patent impact patient access to treatments?
The patent ensures that patients have access to effective treatments for gastrointestinal disorders by protecting the formulations and methods of use, which incentivizes further research and development.
Sources
- United States District Court Document: NOT FOR PUBLICATION UNITED STATES DISTRICT COURT.
- United States District Court Document: in the united states district court.
- SSRN Paper: Patent Claims and Patent Scope.
- United States Patent Document: Formulations of Guanylate Cyclase-C Agonist Peptides and Methods of Use.
- United States District Court Document: Case 2:21-cv-10057 Document 1 Filed 04/22/21.
