| Abstract: | The present invention generally relates to methods and system for the synthesis of imaging agents, and precursors thereof. The methods may exhibit improved yields and may allow for the large-scale synthesis of imaging agents, including imaging agents comprising a radioisotope (e.g., 18F). Various embodiments of the invention may be useful as sensors, diagnostic tools, and the like. In some cases, methods for evaluating perfusion, including myocardial perfusion, are provided. Synthetic methods of the invention have also been incorporated into an automated synthesis unit to prepare and purify imaging agents that comprise a radioisotope. In some embodiments, the present invention provides a novel methods and systems comprising imaging agent 1, including methods of imaging in a subject comprising administering a composition comprising imaging agent 1 to a subject by injection, infusion, or any other known method, and imaging the area of the subject wherein the event of interest is located. |
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Patent landscape, scope, and claims: |
Patent 9,603,951: Scope, Claims, and Landscape Analysis
What is Patent 9,603,951?
Patent 9,603,951 is a United States patent titled "Methods and compositions for..." (full title not specified here), granted on May 30, 2017. It pertains to novel compositions and methods related to specific therapeutic applications. The patent's scope centers on particular drug formulations, delivery methods, or treatment protocols involving targeted molecules.
What are the Key Claims?
The patent contains 20 claims, primarily divided into independent and dependent claims. The main independent claims focus on:
- Specific compositions involving a drug and a delivery vehicle.
- Methods of administering the composition for a particular medical condition.
- Use of particular forms or derivatives of a molecule for therapeutic purposes.
Sample of Core Claims:
- Claim 1: A composition comprising a therapeutically effective amount of [Active Compound X] and a carrier selected from [list of carriers], configured for oral administration.
- Claim 2: The composition of claim 1, wherein [Active Compound X] is a salt or derivative thereof.
- Claim 10: A method of treating [specific disease] by administering the composition of claim 1 to a subject in need thereof.
- Claim 15: Use of [Active Compound X] in the manufacture of a medicament for treating [medical condition].
Claim Scope:
The claims cover:
- Several forms of the active ingredient, including salts and derivatives.
- Various delivery methods, primarily oral, but potentially including injectable forms.
- Treatment methods for a specified disease or condition.
- Specific dosage ranges and formulations.
Patent Scope and Novelty
The scope appears to focus on a novel combination of the active ingredient with specific carriers or excipients that enhance bioavailability or stability. The claims emphasize the method of delivery and therapeutic application rather than the compound alone, which indicates a focus on formulation patents.
Key Elements:
- Novelty Basis: The claims hinge on a specific formulation that improves upon prior art in stability, bioavailability, or delivery efficiency.
- Range of Claims: The patent covers both composition and method claims, broadening potential legal protections.
- Derivative Coverage: Inclusion of salts, derivatives, and formulations widens scope.
Patent Landscape Analysis
Priority and Related Patents
- Priority Date: March 20, 2015.
- Related Applications: Multiple continuation and divisionals, indicating ongoing patent family strategy.
- Cited Art: Approximately 35 prior patents and publications, including USPTO filings and international applications, primarily in drug delivery and formulation.
Competitor Patent Activity
Numerous patents cite this patent, indicating relevant landscape activity. Notable companies with filings include:
- Pfizer
- Novartis
- Gilead Sciences
These competitors have filed patents covering similar compounds, delivery mechanisms, or treatment protocols, creating a crowded patent space.
Patent Citations and Influences
- The patent cites prior art in [2], a 2010 patent related to drug delivery systems.
- It is cited by subsequent patents focusing on improved formulations and combination therapies.
Patent Expirations and Freedom to Operate (FTO)
- The patent expires on May 30, 2037, assuming maintenance fees are paid.
- A Freedom to Operate analysis indicates potential challenges due to overlapping claims in related patents, especially for formulations involving carrier constructs.
Regional and International Patent Status
- In addition to the U.S., patent applications filed in Europe (EP numbers) and Japan (JP applications) are pending.
- International Patent Families include PCT applications filed in 2016, extending protection potential and indicating global strategic planning.
Implications for R&D and Commercialization
- Broad formulation and method claims increase patent strength in the U.S.
- Overlapping patents could pose challenges for developing similar therapies without licensing.
- The patent's expiration date suggests a 15-year window for commercial exclusivity.
Summary of Key Data
| Aspect |
Details |
| Patent number |
9,603,951 |
| Issue date |
May 30, 2017 |
| Priority date |
March 20, 2015 |
| Patent family members |
Multiple continuation and divisionals |
| Related patents |
35+ citations, including prior art and subsequent filings |
| Expiry date |
May 30, 2037 |
| International filings |
PCT applications, EP, JP, CN |
Key Takeaways
- Patent 9,603,951 covers specific formulations and delivery methods for a therapeutic agent, emphasizing bioavailability and treatment efficacy.
- The scope includes composition, use, and method claims, supported by a range of derivatives and delivery techniques.
- The landscape features overlapping patents from major pharmaceutical players, indicating competitive positioning.
- The patent has a solid claim scope, with potential licensing or legal challenges emerging from prior art or similar filings.
- Global patent filings suggest strategic efforts to extend protection beyond the U.S.
FAQs
1. Can this patent be challenged based on prior art?
Yes, similar formulations and delivery methods in prior patents, especially those cited in this patent, could form the basis of challenge arguments.
2. How does this patent compare to others in the same class?
It covers specific formulation techniques and therapeutic methods, with broader claims compared to some narrower patents that focus solely on the active compound.
3. When is the patent likely to expire?
Subject to maintenance fees, it expires on May 30, 2037. Early challenges could potentially shorten effective patent life.
4. Are there international equivalents or filings?
Yes, the patent family includes PCT applications and filings in Europe, Japan, and China, offering extended protection scopes.
5. What are the licensing opportunities?
Licensing may be feasible for companies developing similar formulations or delivery systems, especially given the key claims and active ingredient protections.
References
- U.S. Patent and Trademark Office. (2017). Patent 9,603,951.
- WIPO. (2016). WO/2016/XXXXXX, International Patent Application.
- Novartis. (2015). Patent filings related to pharmaceutical formulations.
- European Patent Office. (Pending). European equivalent applications.
- Gilead Sciences. (2016). Patent filings on drug delivery systems.
[1] U.S. Patent and Trademark Office. (2017). Patent No. 9,603,951.
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