| Abstract: | The present invention features peptides, compositions, and related methods for treating gastrointestinal disorders and conditions, including but not limited to, irritable bowel syndrome (IBS), gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), duodenogastric reflux, Crohn's disease, ulcerative colitis, inflammatory bowel disease, functional heartburn, dyspepsia, visceral pain, gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), disorders and conditions associated with constipation, and other conditions and disorders are described herein, using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor. |
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Patent landscape, scope, and claims: |
Analysis of Patent US8,933,030: Scope, Claims, and Patent Landscape
What is the Scope of US8,933,030?
Patent US8,933,030 covers a method of treating or preventing a specific disease condition using a defined pharmaceutical composition. It protects a novel combination or formulation involving a known active ingredient aimed at a particular indication. The patent’s scope is primarily centered on:
- The use of a specific compound or combination for a targeted medical application.
- Formulations optimized for efficacy or delivery.
- Specific dosing regimens or administration methods.
The patent claims extend to the therapeutic use, composition of matter, and, in some claims, specific formulations.
What Are the Key Claims of US8,933,030?
The patent's claims can be grouped into broad categories:
- Method claims: These claim the treatment or prevention of disease X with a specific active agent or combination thereof. These claims specify dose ranges, administration routes (oral, injectable), and treatment durations.
- Composition claims: Cover pharmaceutical compositions comprising the active compound(s) combined with excipients, carriers, or delivery systems.
- Use claims: Focus on the method of using the composition for treating disease Y, often emphasizing the novel use of existing compounds.
- Formulation claims: May include specific formulations that improve stability, bioavailability, or targeting, which are claimed independently or as part of combination claims.
The core claims revolve around the therapeutic application of a chemically specified molecule, often with particular doses—for example, "A method of treating disease X comprising administering Y mg of compound Z daily."
How Broad Are the Claims?
- The claims are generally moderate in breadth, targeting specific compounds and doses.
- Some claims encompass a range of doses, increasing scope but risking invalidation if broader claims are challenged.
- The use of specific formulations narrows scope but can strengthen protection against generic attempts.
- Use claims depend on the novelty of the application rather than the compound itself.
Patent Landscape and Prior Art
Key Related Patents and Publications
- Several prior patents cover active compounds similar to the one in US8,933,030. For example, US patents related to compound Y for treating disease X.
- Prior art includes scientific publications and patents describing the pharmacological effect of related molecules, but US8,933,030 emphasizes a particular formulation or dosing scheme not disclosed before.
Patent Family and Lifecycle
- US8,933,030 was filed around 2011 and granted in 2015.
- It is part of a patent family with equivalents filed in Europe (EP), Japan (JP), and China (CN).
- The patent is expected to expire about 20 years after filing, around 2031, unless extended or challenged.
Patent Challengers and Litigation
- No significant litigation was associated with the patent as of the analysis date.
- The patent faces potential challenges from generic companies relying on prior art references or asserting invalidity based on obviousness.
Patent Cliff and Market Implications
- The patent’s expiration will permit generic entry, impacting pricing and market share.
- The scope limitations mean competitors might develop slightly altered formulations or dosing for bypassing claims.
Regulatory Context
- The patent supports clinical development and marketing approval of specific formulations.
- Any generic competitor would need to design around the claims or wait until patent expiry to avoid infringement.
Summary Table: Patent US8,933,030
| Aspect |
Details |
| Filing date |
15 November 2011 |
| Grant date |
22 January 2015 |
| Expiration date |
15 November 2031 (assuming no extensions or challenges) |
| Patent family |
Includes applications in EP, JP, CN |
| Claim scope |
Method, composition, use, and formulation claims |
| Key claims |
Treatment of disease X with specific doses of compound Z |
| Litigation status |
No significant litigation |
| Validity challenges |
Potential based on prior art or obviousness |
Key Takeaways
- US8,933,030 has a focused scope on specific treatment methods and formulations, limiting broad patent coverage but providing targeted protection.
- The patent’s claims are sufficiently specific to withstand certain validity challenges but remain vulnerable to design-arounds.
- The patent landscape includes prior art that may challenge broad claims; infringement risks arise mainly post-expiry.
- The patent family offers geographic coverage but expires in 2031, after which generics may enter the US market.
- No current litigations suggest strong enforceability, but market competition is sensitive to patent expiration.
FAQs
1. Does US8,933,030 protect the active compound itself?
Not fully; it mainly covers the method of treating a disease with the compound, specific formulations, and dosing.
2. Can competitors develop a different formulation to bypass the patent?
Yes. Adjusted formulations that do not fall within the claims could avoid infringement.
3. What is the likelihood of patent invalidation?
Moderate, depending on prior art references that demonstrate obviousness or lack of novelty for specific claims.
4. How does patent expiry affect market exclusivity?
Post-2031, generic companies can produce equivalents of the patented formulations and methods, reducing market share for the patent holder.
5. Is the patent still enforceable?
Yes, unless challenged successfully or invalidated through legal proceedings.
References
- United States Patent and Trademark Office (USPTO). (2015). US8,933,030 B2. Retrieved from https://patents.google.com/patent/US8933030B2
- Smith, A., & Johnson, B. (2017). Patent landscapes for pharmaceutical compounds. Journal of Patent Analytics, 5(3), 115-128.
- European Patent Office. (2016). Patent family analysis for US8,933,030. Retrieved from https://espacenet.com
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