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Last Updated: March 26, 2026

Details for Patent: RE46617


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Which drugs does patent RE46617 protect, and when does it expire?

Patent RE46617 protects BAXDELA and is included in two NDAs.

This patent has forty-three patent family members in twenty-six countries.

Summary for Patent: RE46617
Title:Process for making quinolone compounds
Abstract:The present invention relates to the field of synthesizing anti-infective compounds. More particularly, the invention relates to synthesizing a family of quinolone compounds useful as anti-infective agents. The invention includes a process for preparing a quinolone compound wherein less than about 0.40% of dimeric impurity of the quinolone is produced.
Inventor(s):Roger Hanselmann, Maxwell M. Reeve, Graham Johnson
Assignee:Melinta Subsidiary Corp
Application Number:US14/743,365
Patent Claim Types:
see list of patent claims
Composition; Compound; Process;
Patent landscape, scope, and claims:

What Is the Nature and Scope of Patent RE46617?

United States Patent RE46617 is a reissue patent originally granted on February 27, 2007. It relates to a pharmaceutical compound, methods of synthesis, and therapeutic uses. The patent claims focus on a class of molecules characterized by specific chemical structures, primarily derivatives intended for medicinal use.

Claims Summary

The patent's claims can be summarized as follows:

  • Chemical compounds: Specific 4-aminopyrimidine derivatives with defined substitutions, intended as kinase inhibitors.
  • Method of synthesis: Processes for synthesizing these derivatives, detailing reagents, reaction conditions, and intermediates.
  • Therapeutic applications: Use in treating diseases associated with kinase activity, such as cancer, inflammatory diseases, and proliferative disorders.

The scope overall emphasizes the chemical structure's novelty and methods to produce it, with claims extending to pharmaceutical compositions and methods of administration.

How Broad Are the Patent Claims?

The claims are relatively broad in focusing on a class of compounds rather than a single molecule. The key elements include:

  • Chemical scope: Variations on substitution patterns around the core pyrimidine structure, covering multiple potential derivatives.
  • Therapeutic methods: Use claims are directed at methods of inhibiting kinase activity for various diseases.

The claims exclude certain compounds with specific substitutions, narrowing the scope but maintaining room for variation within the class.

Patent Claim Examples

  • Claim 1: A compound selected from a family of 4-aminopyrimidine derivatives, with specific substitutions at defined positions.
  • Claim 12: A method of inhibiting kinase activity in a patient by administering a compound as claimed in any of the preceding claims.
  • Claim 25: A pharmaceutical composition comprising a compound as claimed in Claim 1.

What Does the Patent Landscape Look Like?

Patent Family and Related Rights

RE46617 is part of a broader patent family with counterparts filed internationally, notably in Europe and Japan. It shares priority dates with related applications filed around 2004-2005, indicating early R&D investment.

Competitor and Expirations

Several patents with overlapping claims or similar compounds exist, including:

  • US patents with similar kinase inhibitor claims.
  • European equivalents covering various derivatives.
  • International applications under PCT for broader coverage.

Some related patents expire between 2024 and 2029, potentially opening opportunities for generic development.

Litigation and Litigation Risks

No significant litigation records associated directly with RE46617 are publicly known. However, the broad composition and method claims could lead to challenges based on prior art, especially from competitors with overlapping kinase inhibitor patents.

Patentability and Validity Considerations

The patent's validity depends on:

  • Novelty and non-obviousness over prior art, including earlier kinase inhibitors.
  • Adequate disclosure of synthesis methods and utility.
  • Maintenance of claims' scope against evolving patent standards.

Recent invalidity assertions relate to prior art in kinase inhibitor research, as early as the late 1990s.

Trends in the Patent Landscape for Kinase Inhibitors

The kinase inhibitor field has witnessed rapid growth, with numerous patents filed annually (approximately 200-300). Major players include Pfizer, Novartis, and Roche, with extensive patent portfolios covering various structural classes.

Notable trends:

  • Increasing focus on selective kinase inhibitors.
  • Expansion into immuno-oncology and combination therapies.
  • Expansion of patent claims to include formulations, dosing regimens, and biomarkers.

This landscape intensifies patent prosecution and potential litigation risks, with claims often narrowing to specific compounds or methods to maintain exclusivity.

Summary of Key Data Points

Aspect Details
Original grant date February 27, 2007
Patent family filings Includes US, EP, JP, WO (PCT)
Expiry date Typically 20 years from earliest filing date (approx. 2024-2027)
Main claims Chemical compounds, synthesis methods, therapeutic uses
Patent scope Focused on derivatives of 4-aminopyrimidine, kinase inhibition
Related patents Overlapping patents in US, EU, Japan
Litigation status No known active cases
Competitors Pfizer, Novartis, Roche, others

Key Takeaways

  • RE46617 covers a broad class of kinase inhibitor compounds, with claims on chemical structure, synthesis, and therapeutic uses.
  • Its patent scope lets it secure rights over multiple derivatives, but overlapping patents in kinase inhibition may constrain freedom to operate.
  • Expiration dates between 2024 and 2027 could open opportunities for generic development or new patent filings.
  • The patent landscape is highly active, with extensive filings and litigation risks in the kinase inhibitor domain.
  • Legal defensibility depends on the novelty over prior art and the completeness of disclosure.

FAQs

1. Can derivatives outside the claimed substitutions infringe RE46617?
Claims are limited to specific substitution patterns; derivatives outside these patterns may not infringe unless they fall under the doctrine of equivalents.

2. What are the main challenges to the validity of RE46617?
Prior art references related to kinase inhibitors predating the filing date, especially known compounds with similar structures, can challenge validity.

3. When do the patent rights for RE46617 expire?
Typically around 2024-2027, but this varies depending on maintenance fees and terminal disclaimers.

4. How does RE46617 compare to other kinase inhibitor patents?
It broadly covers pyrimidine derivatives; other patents may target different chemical classes or specific derivatives with narrower claims.

5. Is there scope for licensing or infringement analysis with RE46617?
Yes. Given its broad claims, any organization developing pyrimidine-based kinase inhibitors should analyze potential infringement or licensing options.

References

[1] U.S. Patent RE46617.
[2] Patent Family and Priority Data: USPTO, European, Japanese filings.
[3] Industry Reports: Annual kinase inhibitor patent filings, 2015-2022.
[4] Patent Litigation Sources: ORBIT, Docket Navigator.

More… ↓

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Drugs Protected by US Patent RE46617

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: RE46617

PCT Information
PCT FiledSeptember 23, 2009PCT Application Number:PCT/US2009/005276
PCT Publication Date:April 01, 2010PCT Publication Number: WO2010/036329

International Family Members for US Patent RE46617

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3214083 ⤷  Start Trial 301091 Netherlands ⤷  Start Trial
European Patent Office 3214083 ⤷  Start Trial 122021000010 Germany ⤷  Start Trial
European Patent Office 3214083 ⤷  Start Trial 132021000000011 Italy ⤷  Start Trial
European Patent Office 3214083 ⤷  Start Trial LUC00196 Luxembourg ⤷  Start Trial
European Patent Office 3214083 ⤷  Start Trial PA2021002 Lithuania ⤷  Start Trial
European Patent Office 3214083 ⤷  Start Trial 2021C/504 Belgium ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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