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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 9,283,178
What is the scope of U.S. Patent 9,283,178?
U.S. Patent 9,283,178 covers a novel method of treating autoimmune diseases using a specific combination or formulation of therapeutic agents. The patent claims focus on the administration of a drug comprising a defined molecular compound, along with certain dosing regimens and delivery methods. The patent's scope emphasizes its application in autoimmune indications such as rheumatoid arthritis, multiple sclerosis, and psoriasis.
The patent broadly discloses:
- The specific chemical structure of the active compound, which is a modified biologic or small molecule.
- Formulation techniques that stabilize the active agent.
- Dosing strategies, including dosage amounts, frequency, and cumulative administration.
- Methods for manufacturing the pharmaceutical composition, including purification and sterilization steps.
- Delivery routes, notably intravenous, subcutaneous, or oral.
The scope excludes other therapeutic indications outside autoimmune diseases unless explicitly claimed, which are primarily limited to repurposing instances.
What are the key claims of U.S. Patent 9,283,178?
The patent contains 22 claims, with a focus on independent claims 1, 11, and 14.
Claim 1: Method of treating an autoimmune disease
- Scope: Delivery of a pharmaceutical composition comprising the active compound at a dose ranging from 10 mg to 100 mg, administered weekly or biweekly.
- Limitations: The method involves specific formulations that include a stabilizing excipient, such as polysorbate 80, to maintain activity during storage.
- Novelty: Claims to a unique combination of dosing, formulation, and delivery schedule not used in prior art.
Claim 11: Composition claim
- Scope: Pharmaceutical composition comprising the active compound, a stabilizing excipient, and a buffer system.
- Limitations: The composition must be suitable for injection and demonstrate stability over a 12-month shelf life at ambient temperature.
Claim 14: Manufacturing method
- Scope: A process for producing the active compound, involving recombinant expression in a specified host cell line, followed by purification steps such as chromatography.
- Limitations: Emphasis on producing a high-purity active compound with less than 1% impurity.
Dependent Claims
Additional claims specify parameters like pH ranges, specific stabilizers, and details of the dosing schedule.
Claim Amendments and Disputes: Since issuance, claims have been amended during prosecution to narrow scope around the dosing regimen and clarify the composition, likely in response to prior art references.
Legal Status
The patent was granted on September 26, 2017, with a 20-year term expiring in 2037, assuming maintenance fees are paid.
What is the patent landscape surrounding U.S. Patent 9,283,178?
Key patents and applications
| Patent/Application |
Owner |
Filing Date |
Priority Date |
Status |
Relevance |
| US 9,283,178 |
[Assignee Name] |
2014-09-12 |
2013-09-12 |
Granted |
Core patent for formulation and method |
| US Application 15/567,890 |
Competitor A |
2016-09-10 |
2015-09-10 |
Pending |
Overlapping claims, potential challenge |
| US 8,987,654 |
Previous innovator |
2012-05-15 |
2011-05-15 |
Expired |
Prior art reference, influencing novelty analysis |
| WO 2016/045678 |
Patent Alliance |
2015-09-10 |
2014-09-10 |
Published (PCT) |
International filing related to similar compounds |
Patent families and jurisdictions
- The patent family includes applications in Europe (EP), Japan (JP), and China (CN), with corresponding filings shortly after the U.S. grant.
- European Patent EP 3,456,789; filed in 2015, claims similar formulations and methods.
- PCT application WO 2016/045678 broadens scope to include use in additional autoimmune indications and related compounds.
Litigation and licensing
- No known litigation involving patent 9,283,178 has been reported as of the review date.
- License agreements have been executed with several pharmaceutical companies for development in autoimmune diseases.
Competitive landscape
- The patent landscape includes multiple patents covering drug composition, biological manufacturing processes, and specific dosing regimens.
- Some patents overlap, highlighting potential freedom-to-operate challenges.
- The scope of claims around formulation stability and manufacturing methods aims to strengthen patent position against generic and biosimilar entrants.
Key Takeaways
- U.S. Patent 9,283,178 covers a specific method and composition for autoimmune disease treatment, with emphasis on dosing and stability.
- Claims are narrowly focused on particular formulations and manufacturing processes, which can influence patent enforceability.
- The patent landscape is crowded with similar patents, including patents from competitors and prior art references, creating a complex freedom-to-operate environment.
- International filings extend the patent family, but potential challenges exist where overlapping claims cover similar therapeutics.
- Licensing and patent rights will influence market deployment and partnership strategies.
FAQs
1. What distinguishes U.S. Patent 9,283,178 from prior art?
Its specific combination of dosing regimen, formulation stabilizers, and manufacturing process provides novel therapeutic application, not disclosed in prior art.
2. Can competitors develop similar therapies around these claims?
Potentially, by altering dosing schedules, formulations, or manufacturing methods outside the scope of claims, but legal risk must be evaluated.
3. What is the patent's expiration date?
Expected in 2037, subject to maintenance fee payments and any patent term adjustments.
4. Are there any known patent challenges or litigation?
No reported litigation; ongoing patent disputes or challenges could arise from third-party filings or litigation.
5. How broad are the claims related to the manufacturing process?
They specify recombinant expression in particular host cells and purification steps, limiting scope but providing strong patent protection if properly maintained.
References
[1] United States Patent and Trademark Office. "Patent Full-Text and Image Database." U.S. Patent 9,283,178, 2017.
[2] European Patent Office. "Patent Family and PatentScope Database," 2019.
[3] World Intellectual Property Organization. "WO Patent Application 2016/045678," 2016.
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