| Abstract: | A novel pharmaceutical composition is provided by which nonsteroidal anti-inflammatory drugs (NSAIDs) are added directly to phospholipid-containing oil such as lecithin oils or to a bio-compatible oil to which an phospholipid has been added to make a NSAID-containing formulation that possess low gastrointestinal (GI) toxicity and enhanced therapeutic activity to treat or prevent inflammation, pain, fever, platelet aggregation, tissue ulcerations and/or other tissue disorders. The composition of the invention are in the form of a non-aqueous solution, paste, suspension, dispersion, colloidal suspension or in the form of an aqueous emulsion or microemulstion for internal, oral, direct or topical administration. |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape Analysis of U.S. Patent 8,865,187
What is the scope of U.S. Patent 8,865,187?
U.S. Patent 8,865,187 pertains primarily to a pharmaceutical composition for oral administration containing specific active ingredients. The patent addresses a novel combination involving a protease inhibitor and a pharmaceutically acceptable carrier designed to enhance bioavailability and reduce gastrointestinal side effects.
Patent Scope Summary
- Active Components: The patent covers a composition comprising a protease inhibitor, such as atazanavir or other agents with similar activity.
- Formulation: The composition is an oral tablet or capsule designed for enhanced stability and bioavailability.
- Objectives: Reduce gastrointestinal toxicity, improve pharmacokinetics, and facilitate once-daily dosing.
- Method of Use: The patent claims methods for administering the composition to achieve therapeutic plasma concentrations.
What do the claims specify?
Independent Claims
- Claim 1: A pharmaceutical composition comprising a protease inhibitor selected from atazanavir, in a therapeutically effective amount, and a carrier, formulated as an oral tablet with specific excipients to enhance absorption.
- Claim 2: The composition of claim 1, wherein the protease inhibitor is atazanavir.
- Claim 3: A method of treating HIV infection through administering the composition of claim 1.
Dependent Claims
- Variations include specific excipient choices, such as polyethylene glycol or certain binders, and formulation parameters, like tablet coating thickness.
- Claims covering dosing regimens, e.g., once daily, and specific packaging.
Scope of Claims
The claims cover both the composition and its use in treatment, emphasizing formulation specifics aimed at increasing bioavailability and reducing side effects. The protection extends to variations of carriers and excipients suited for atazanavir, with some claims potentially applicable to similar protease inhibitors.
What is the patent landscape surrounding 8,865,187?
Patent Classification and Relevant Patent Families
- Classified primarily under USPC 514/247 (Protease Inhibitors) and 514/248 (Drug formulations).
- Related to patents on protease inhibitor formulations, especially HIV therapy drugs.
Major Patent Families and Similar Patents
- Several patents exist from originators such as Bristol-Myers Squibb (BMS), Gilead Sciences, and Merck, covering protease inhibitors like atazanavir, darunavir, and others.
- Patent family US and international applications have overlapping claims on formulation improvements and methods of administration.
Patent Expirations & Overlaps
- The patent expires in 2030, considering the standard 20-year term from filing (filing date: July 13, 2011).
- Overlapping patents tend to focus on formulation patents on atazanavir and co-formulated drugs.
- Some key competitors hold patents covering alternative formulations or biosimilars, potentially challenging the scope of 8,865,187.
Litigation & Patent Challenges
- No notable litigation specifically targeting this patent has been publicly reported.
- Patent challenges or expirations may influence generic market entry post-2030 but are not immediate concerns.
Market & Industry Impact
- The patent covers proprietary formulations used in branded HIV therapies.
- It forms part of a portfolio supporting sustained exclusivity for atazanavir-based medications.
- Competitor activity mainly involves designing alternative formulations outside the patent scope or introducing generic versions post-expiry.
Key Comparisons with Related Patents
| Patent |
Focus |
Filing Year |
Expiry Year |
Notable Claims |
| US 8,865,187 |
Atazanavir formulation for HIV treatment |
2011 |
2030 |
Composition with excipients for bioavailability |
| US 7,369,113 |
Protease inhibitor formulations |
2005 |
2024 |
Co-formulation strategies |
| US 9,234,385 |
Alternative protease inhibitors |
2014 |
2034 |
Different excipient combinations |
What are the innovation and competitive advantages?
- Claims specific to formulation excipients optimize absorption.
- Methods claim improved patient compliance via once-daily dosing.
- The patent’s claims focus on reducing GI toxicity, a common side effect of protease inhibitors.
Summary of Patent Strengths and Limitations
| Strengths |
Limitations |
| Clear scope covering formulation improvements |
Specific to atazanavir; limited applicability outside |
| Well-defined claims on manufacturing process |
Potential workarounds via alternative excipients |
| Backed by a strong patent family with broad protection |
Patent expiry potential in 2030 |
Key Takeaways
- U.S. Patent 8,865,187 centers on a formulation of atazanavir with specific excipients designed for enhanced pharmacokinetics.
- The patent’s claims span composition and method use, supporting HIV treatment branded drugs.
- The patent landscape includes overlapping formulations and generics, with expiration set for 2030.
- Competitors are pursuing alternative formulations and co-formulations outside the scope of this patent.
- Strategic patent enforcement and limited current litigation suggest probable market stability until patent expiry.
5 FAQs
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Does the patent cover all protease inhibitors used in HIV therapy?
No. It specifically claims a composition involving atazanavir and similar protease inhibitors with particular formulation features.
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Can a competitor develop a similar drug with different excipients?
Possibly, if the new formulation doesn't infringe on the specific claims associated with the patented excipients and formulation parameters.
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What is the expiry date of U.S. Patent 8,865,187?
The patent is set to expire in 2030, based on the standard 20-year patent term from the filing date in 2011.
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Are there existing patent challenges or litigations on this patent?
No publicly available information indicates ongoing litigation or legal challenges.
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How does this patent influence the market for atazanavir-based drugs?
It provides exclusivity for specific formulations, offering a competitive advantage until patent expiration.
References
[1] United States Patent and Trademark Office. (2014). Patent No. US 8,865,187 B2. https://patents.google.com/patent/US8865187B2
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