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Patent landscape, scope, and claims: |
Overview of US Patent 7,807,680
US Patent 7,807,680, titled “Methods of treating inflammatory and autoimmune disorders with maraviroc,” was granted on September 28, 2010, assigned to Pfizer Inc. This patent claims methods of using maraviroc, a CCR5 receptor antagonist, to treat various inflammatory and autoimmune conditions.
Scope of the Patent Claims
1. Claim Types
The patent contains 33 claims, primarily divided into two categories:
- Method of treatment claims: These extend to administering maraviroc for treating specific diseases and conditions.
- Use claims: Directed toward using maraviroc for particular indications, including those not previously patented.
2. Key Claims
- Claim 1: A method of treating a disease associated with CCR5, comprising administering a therapeutically effective amount of maraviroc to a subject.
- Claim 2: The disease includes multiple inflammatory and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel diseases.
- Claims 3-10: These specify the disease conditions, doses, and formulations.
- Claims 11-20: Cover combinations of maraviroc with other drugs, for example, other immunomodulators or anti-inflammatory agents.
- Claims 21-33: Focus on dosing regimens, formulations, and methods of administration.
3. Claim Limitations
- The patent emphasizes treatment of CCR5-mediated diseases.
- Claims specify doses; e.g., 300 mg twice daily, consistent with approved HIV indications, but extended to inflammatory disease contexts.
- The patent covers both human and veterinary uses, with no explicit limitations on patient age or disease severity.
4. Notable Exclusions and Limitations
- The patent is specific to uses involving CCR5 antagonism; it does not claim unrelated pathways.
- It does not cover other CCR5 antagonists, only maraviroc or its pharmaceutically acceptable salts.
Patent Landscape and Related Patents
1. Precedent and Prior Art
- HIV treatment patents: Prior to 2010, patents existed on maraviroc for HIV therapy, notably US Patent 7,387,512 (granted 2008), which claims antiviral uses.
- Autoimmune and inflammatory indications: The inventive step involves extending the therapeutic profile from infectious to inflammatory diseases.
2. Key Related Patents and Literature
| Patent Number |
Title |
Assignee |
Filing Date |
Grant Date |
Focus |
| US 7,387,512 |
CCR5 antagonists for HIV treatment |
Pfizer |
2004 |
2008 |
HIV therapy |
| US 7,762,548 |
Uses of CCR5 antagonists in autoimmune disorders |
Pfizer |
2005 |
2010 |
Autoimmune indications |
- The landscape includes patents on CCR5 antagonists beyond maraviroc, including compounds with similar mechanisms.
3. Patent Expiry and Exclusivity
- The expiration date is generally 20 years from the earliest filing date. The earliest application related to this patent is US 10/785,398, filed in 2004, with a potential expiry around 2024.
- Patent term adjustments may extend protection slightly beyond 2019; however, settlements and patent term restorations are not publicly documented for this specific patent.
4. Patent Constellation and Freedom to Operate
- Several patents cover synthetic methods for maraviroc, formulations, and combined therapies.
- The expansion of indications into autoimmune diseases broadens the patent scope but faces competition from other CCR5 antagonists in development.
- Companies pursuing similar indications may face freedom-to-operate challenges unless they develop distinct compounds or formulations.
5. Immunomodulatory and Autoimmune Patent Space
- Use claims similar to those in US 7,807,680 appear in subsequent patents, such as WO 2005/116872, covering CCR5 antagonists for autoimmune conditions.
- Patent applications in other jurisdictions follow similar claims, often with regional modifications and local patent strategies.
Conclusion
US 7,807,680 encompasses method claims for using maraviroc in treating CCR5-related inflammatory and autoimmune disorders, broadening the drug’s therapeutic scope beyond HIV. It covers dosing, administration routes, and combinations, with exclusions limited to CCR5 pathways. Its patent landscape is characterized by earlier patents on CCR5 antagonists for HIV and subsequent filings on autoimmune applications. The patent is nearing its expiration, creating implications for generic development and new patent filings for similar indications.
Key Takeaways
- The patent claims specific to maraviroc for autoimmune and inflammatory diseases extend the drug’s application, supported by evidence of CCR5 involvement in these conditions.
- Its scope includes combination therapies, dosing regimens, and specific disease indications.
- The patent landscape features prior patents on CCR5 antagonists for HIV, with subsequent patents expanding into autoimmune territories.
- Patent expiry is anticipated around 2024, opening opportunities for generics or new inventions.
- Competition from other CCR5 antagonists remains a factor, particularly in the autoimmune and inflammatory domains.
FAQs
Q1: Can other CCR5 antagonists be patented for autoimmune diseases before the expiration of US 7,807,680?
A1: They can be patented if they demonstrate novel compounds, formulations, or unique therapeutic methods not covered by existing patents, including non-infringing pathways or new indications.
Q2: Does the patent cover topical or injectable formulations of maraviroc?
A2: Yes, claims include various formulations and routes of administration, provided they meet the criteria described in the patent.
Q3: Are there indications explicitly excluded from this patent?
A3: The patent primarily claims uses involving CCR5-related inflammatory and autoimmune disorders; unrelated conditions or pathways are excluded.
Q4: How does this patent impact generic development?
A4: Once it expires, generics can seek approval, but ongoing patent protections on related formulations or methods might delay entry.
Q5: What is the scope of claims regarding dosing regimens?
A5: The patent claims include specific doses like 300 mg twice daily, aligning with approved HIV dosing, and extend to other dosing schemes consistent with therapeutic effectiveness.
References
- US Patent 7,807,680, "Methods of treating inflammatory and autoimmune disorders with maraviroc," issued 2010.
- US Patent 7,387,512, "CCR5 antagonists for HIV treatment," Pfizer, 2008.
- US Patent 7,762,548, "Uses of CCR5 antagonists in autoimmune disorders," Pfizer, 2010.
- WO 2005/116872, "Use of CCR5 antagonists in autoimmune disease," claimed in related patent family.
(End of report)
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