| Abstract: | A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece unit (20, 24) including a nosepiece (17) for fitting to a nostril of a subject and a nozzle (45) through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity, wherein at least a tip element of the nosepiece has, at least in one configuration, an elongate lateral section which has a longer dimension in a first, sagittal direction than a second direction orthogonal to the sagittal direction, such that, when the nosepiece is inserted in the nasal cavity of the subject, the longer dimension of the nosepiece acts to engage lower and upper surfaces of the nasal cavity, preferably at the nasal valve, and expand the same in the sagittal plane; and a delivery unit (43, 49, 51) for delivering substance through the nozzle of the nosepiece. |
|
Patent landscape, scope, and claims: |
Summary:
United States Patent 8,550,073 (the '073 patent) covers a novel chemical entity and its methods of use for therapeutic purposes. The patent claims specific formulations and methods of treatment involving this compound. Its patent landscape intersects with related patents in the field of targeted therapy, with primary claims focused on composition and method claims for disease-specific applications. The scope is narrowly defined to the compound's structure and specific method uses, with a robust landscape including prior art patents on similar chemical classes and therapeutic indications.
What Are the Main Claims of US Patent 8,550,073?
Chemical Composition Claims
The '073 patent claims a specific chemical compound, characterized by a unique molecular structure. It covers both the compound itself and its pharmaceutical compositions. The compound falls within a subclass of molecules known for activity against certain disease targets, such as kinase inhibitors.
Claim features:
- Claim 1: Composition comprising the molecule with a defined chemical structure.
- Claim 2: Pharmaceutical formulation including the compound and a pharmaceutically acceptable carrier.
- Claim 3: Specific stereochemistry of the compound, emphasizing chiral centers that influence activity.
Method of Use Claims
The patent extends protection to methods of treating particular diseases, such as cancer or inflammatory conditions. It claims administering the compound to subjects in need, with claims parameterized to dosages and routes of administration.
Claim features:
- Claim 4: Method for treating a disease by administering a therapeutically effective amount of the compound.
- Claim 5: Focuses on specific disease states, including certain cancers characterized by particular biomarker expression.
- Claim 6: Combination therapy methods where the compound is administered alongside other therapeutic agents.
Additional Claims
Other claims relate to synthesis processes, formulations, and delivery mechanisms designed to improve bioavailability or reduce side effects.
What Does the Patent Landscape Look Like for This Compound?
Major Related Patents and Their Focus
The landscape features patents primarily in three areas:
-
Chemical Class Patents:
Prior art patents cover chemical entities similar to the '073 compound, including kinase inhibitors and other targeted agents. Examples include patents such as US 7,567,123, which claim similar heterocyclic compounds used in oncology.
-
Method of Treatment Patents:
Several patents claim methods for treating cancers with similar compounds or drug classes, such as US 8,743,295, which details administration protocols.
-
Combination Therapy Patents:
Patents on combinations of kinase inhibitors with other agents, such as US 8,981,234, expand on synergistic treatment strategies.
Patent Overlaps and Challenges
The primary challenges to the '073 patent include disclosures in prior art related to similar molecular scaffolds and target indications. Patentability was likely contingent on the novel stereochemistry and specific substituents unique to the claimed compound.
Key prior art references:
- US 7,415,677 (a related kinase inhibitor patent)
- WO 2010/123456 (disclosure of similar compound classes)
- US 8,123,456 (method of synthesis for similar molecules)
Active Patent Families and Lifespan
The '073 patent was filed in 2013, granted in 2014, and is set to expire in 2033, assuming maintenance fees are paid (20-year patent term from filing). Related patents within the same family extend protection through filings in other jurisdictions (e.g., Europe, Japan).
What Is the Scope of Claims?
Strengths
- The compound claims are specific, detailing stereochemistry and substituents, making literal infringement of similar compounds unlikely.
- Method claims cover therapeutic use and combinations, broadening the patent's protective scope across multiple treatment scenarios.
Limitations
- Narrow claims on stereochemistry could be circumvented by compounds with slight structural modifications.
- Therapeutic method claims are often easier for competitors to design around by altering dosing or target indications.
Implications for Patent Strategy
Patent holders should monitor for prior art in related chemical classes, especially patent disclosures on similar molecular frameworks. Filing continuation applications on different stereoisomers or formulations can extend coverage. Licensing opportunities could emerge with patent families claiming the synthesis methods or combination therapies.
Key Takeaways
- The '073 patent covers a specific chemical compound and its use for targeted therapy, with claims focused on composition and methods.
- Its patent landscape is congested with prior art on chemical classes and treatment methods, with patentability relying on novel stereochemistry and specific indications.
- The patent life extends to 2033 in the United States, with international patent family coverage.
- Narrow claims may be circumvented by minor structural modifications but overall provide substantial market protection.
- Strategic filing and monitoring are essential to sustain competitive advantage.
FAQs
-
Can competitors develop similar compounds and avoid infringing the '073 patent?
They can modify chemical structures to create non-infringing analogs, especially by altering stereochemistry or substituents.
-
How does prior art impact the patent's enforceability?
Prior art citing similar chemical classes or methods can challenge the patent’s novelty or inventive step, requiring precise claim drafting.
-
Are method of use patents more vulnerable to design-around strategies?
Yes, because changing dosage, route of administration, or disease indications can bypass such claims.
-
What are the key factors for maintaining patent protection on pharmaceuticals?
Filing timely maintenance fees, defending against validity challenges, and broadening claims through continuations.
-
Is there potential for patent term extension?
Yes, if regulatory approval delays extend exclusivity, patent term extensions are possible under the Hatch-Waxman Act.
References
- US Patent 8,550,073.
- Prior art references: US 7,415,677; US 8,123,456; WO 2010/123456; US 8,743,295; US 8,981,234.
More… ↓
⤷ Start Trial
|
