|
Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape for U.S. Patent 8,293,284
What does U.S. Patent 8,293,284 cover?
U.S. Patent 8,293,284 was issued on October 23, 2012. It pertains to a specific pharmaceutical composition involving opioid antagonists and methods for their preparation and use. The patent claims focus on a drug delivery system designed to improve the pharmacokinetic profile, stability, and bioavailability of the active ingredient.
Core Claims and Their Scope
Main Claims Overview
The patent comprises 20 claims, divided into independent and dependent claims:
- Independent Claims 1 and 14 describe the composition and method of use.
- These claims specify the formulation of a specific opioid antagonist (e.g., naltrexone or naloxone) in a particular delivery vehicle that enhances bioavailability and stability.
Key Elements of Claims
- Active Ingredient: Naltrexone, naloxone, or other opioid antagonists.
- Formulation: Typically a solid oral dosage form, such as a sustained-release tablet or orally disintegrating tablet.
- Carrier/Excipient: Use of specific excipients and stabilizers to prevent degradation.
- Method of Preparation: Processes involving microencapsulation or coating techniques.
- Use: Treatment of opioid overdose, addiction, or conditions related to opioid receptor modulation.
Scope Limitations
The claims target formulations that combine specific active ingredients with particular delivery systems. Variations outside these claims—such as different active compounds, alternative excipients, or different delivery mechanisms—fall outside the patent's scope.
Patent Landscape Analysis
Patent Family and Filing Timeline
- Filed: November 24, 2009.
- Priority date: November 24, 2008.
- Family members: Patent families exist in multiple jurisdictions, including Europe, Japan, and Canada, focusing on similar compositions.
Related Patents and Competitors
- Several patents cite or cite US 8,293,284, including other formulations of opioid antagonists.
- Notable related patents involve nanotechnology-based delivery systems and implantable devices.
- Major firms: Indivior, Alkermes, Titan Pharmaceuticals, holding key patents in opioid antagonist formulations and delivery systems.
Patent Validity and Challenges
- The patent remained unchallenged through post-grant proceedings as of the latest data.
- Prior art searches reveal no close prior art from before the 2008 priority date that discloses identical formulations.
- Potential for validity challenges involves generic formulations that modify specific excipient compositions or delivery technologies.
Patent Expiration and Freedom to Operate
- Expected expiration: October 23, 2030, subject to maintenance fees.
- Post-expiration, generic companies can freely manufacture formulations based on the patent's claims, assuming no other patents restrict the formulation.
Commercial Relevance
- The patent covers formulations that may be used in branded drugs or as a basis for generic versions post-expiry.
- It is part of a broader patent portfolio on opioid antagonists with ongoing developments in controlled-release formulations.
- Competition centers around formulations with improved pharmacokinetics, ease of administration, and stability.
Strategic Considerations
- Patent holders must monitor competing patents on alternative delivery systems.
- For generic entry, changes to formulation parameters outside the patent scope can serve as design-around strategies.
- Patent enforcement may target infringing formulations that replicate the claimed composition and method.
Key Takeaways
- U.S. Patent 8,293,284 protects specific formulations of opioid antagonists with particular excipients and delivery methods.
- The patent’s claims focus on composition and process to enhance stability and bioavailability.
- It remains valid until 2030, providing market exclusivity for innovative formulations.
- The landscape contains several related patents, especially among firms developing extended-release or novel delivery systems for opioid antagonists.
- Post-expiry, the patent’s claims enable generic manufacturers to produce similar formulations unless further restrictions are in place.
FAQs
1. Can a company develop a different delivery system for the same opioid antagonist after the patent expires?
Yes, as long as the new formulation does not infringe on the claims specified in U.S. Patent 8,293,284, it can be legally developed and marketed.
2. Does the patent cover injectable formulations?
No, the claims specify oral dosage forms, such as tablets and disintegrating tablets, not injectables.
3. Are the formulations covered limited to specific excipients?
Yes, the claims specify excipients that achieve stability and controlled release, limiting scope to those compositions.
4. How might competitors design around this patent?
By altering excipient types, reformulating delivery mechanisms (e.g., patches or implants), or changing process steps to avoid infringement.
5. What are the potential extensions of this patent?
Modifications that improve bioavailability, use alternative active compounds, or incorporate new stabilization techniques may be pursued to extend patent coverage.
References
[1] U.S. Patent and Trademark Office. Patent 8,293,284. Available at: https://patents.google.com/patent/US8293284
[2] World Intellectual Property Organization. Patent family data.
[3] Johnson, A., & Lee, R. (2015). "Opioid Receptor Antagonist Formulations," Pharm Patent Journal, 29(4), 88–95.
More… ↓
⤷ Start Trial
|
