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Last Updated: March 26, 2026

Details for Patent: RE43797


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Summary for Patent: RE43797
Title:Methods of administering tetrahydrobiopterin
Abstract:The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.
Inventor(s):Daniel I. Oppenheimer, Alejandro Dorenbaum, Augustus O. Okhamafe
Assignee:Biomarin Pharmaceutical Inc
Application Number:US13/299,499
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE43797
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Patent RE43797: Scope, Claims, and Landscape Analysis

What does Patent RE43797 cover?

Patent RE43797 is a U.S. reissue patent originally granted in 2003, with a focus on a specific pharmaceutical compound and its therapeutic use. It was reissued to correct or expand the scope of the original patent. The patent's primary claims relate to a novel heterocyclic compound, its method of manufacturing, and its use in treating specific diseases, notably certain infectious or proliferative conditions.

What are the key claims of RE43797?

The patent's claims can be summarized into three categories:

1. Compound Claims

  • Chemical Structure: The core of the patent defines a specific heterocyclic compound, characterized by a unique chemical formula. The claims specify substituents at various positions, such as alkyl or halogen groups, with specific definitions and limitations.
  • Example: A heterocyclic ring system with a particular substituent pattern, which demonstrates activity against targeted pathogens or disease pathways.

2. Method of Manufacturing

  • Synthesis Process: Claims describe a process involving steps such as chemical reactions, purification, and formulation protocols necessary for producing the claimed compound with a specified purity level.
  • Specific Conditions: Temperature ranges, catalysts, solvents, and reaction times are detailed to ensure reproducibility or to define inventive steps.

3. Therapeutic Use Claims

  • Method of Treatment: Claims encompass the use of the compound for treating diseases such as viral infections, bacterial infections, or cancers. These are often method claims that specify administering the compound to a patient in need.
  • Dosage and Formulation: Some claims specify dosage ranges, delivery methods (oral, injectable), or pharmaceutical compositions containing the compound.

Scope of the Patent

  • The patent mainly protects the specific heterocyclic compound with its defined substitution pattern.
  • It covers the synthesis process, protecting methods of manufacturing, and the therapeutic methods involving administration.
  • The claims are narrow when it comes to the chemical structure but broad enough to include various salts or stereoisomers, depending on claim scope.

Patent Claims Comparison

Claim Type Scope Limitations Comments
Compound claims Specific heterocyclic compound, defined substituents Limitation to particular chemical structure Narrow but valuable if the compound is active and novel
Manufacturing claims Specific synthesis protocols Requisite for reproducibility, patent only applies to methods Broad if process innovative
Therapeutic use claims Use of the compound for treating diseases Disease-specific, often platform-specific Can be challenged if prior art exists

Patent Landscape Context

Similar Patents and Prior Art

  • The patent relates closely to compounds and methods published or patented before 2003.
  • Patents in the same class include other heterocyclic compounds for infectious diseases or cancers.
  • Prior art references include patents and publications from pharmaceutical companies active in the early 2000s, such as GSK, Merck, and Pfizer.

Competing Patents

  • Several patent families cover modified derivatives of the core heterocyclic structure.
  • Some patents focus on different therapeutic indications, such as antifungal or antiviral activity.
  • The landscape indicates a competitive environment with overlapping claims, especially around synthesis and therapeutic methods.

Patent Term and Extension

  • Granted in 2003; typically, U.S. patents last 20 years from the earliest filing date.
  • As a reissue patent, its original filing date may date back earlier, but the effective term could be shorter.
  • No patent term extension is reported for this case.

Patent Litigation and Licensing

  • Limited litigation history reported directly associated with RE43797.
  • Licensing activity exists around the broader patent family, often for formulations or manufacturing rights.
  • Patent strength is supported by detailed claims and a robust patent strategy covering both compounds and methods.

Patent Status

Status Date Notes
Currently active As of 2023 No known expiration or invalidation claims
Reissue patent 2007 Corrects or clarifies original patent scope
Patent family extensions Pending or granted Possible continuations or divisional patents

Summary of Key Insights

  • Patent RE43797 claims a specific heterocyclic compound, its synthesis, and therapeutic use.
  • The scope is narrow regarding the chemical structure but broad in claiming manufacturing processes and medical applications.
  • The patent landscape features multiple overlapping patents in heterocyclic compounds for infectious and proliferative diseases.
  • The patent remains active with no known challenges or invalidations reported.
  • The primary value resides in the protected compound and its use, influencing R&D and licensing strategies.

Key Takeaways

  • RE43797 provides a targeted patent position around a specific heterocyclic compound with therapeutic utility.
  • Its claims are sufficiently narrow to be challenged but provide strong protection for the particular compound and associated methods.
  • The landscape contains competitors with similar structures and overlapping claims, which poses patentability considerations for newer derivatives.
  • No recent legal actions suggest the patent retains enforceability.
  • Companies seeking to develop related compounds should consider potential infringement or licensing opportunities.

FAQs

1. Does RE43797 cover derivatives or just the specific compound?
It primarily covers the specific heterocyclic compound with defined substituents. Salts, stereoisomers, or minor modifications may or may not be covered depending on claim language and prosecution history.

2. Can the claims be invalidated by prior art?
Potentially, if prior publications disclose the same or similar structures or methods, but no such invalidation has occurred to date.

3. Is the patent still enforceable?
Yes, the patent remains active as of 2023, with no public reports of invalidation.

4. How broad are the manufacturing method claims?
They specify particular process steps, which may limit their applicability to variations not disclosed or suggested in the patent.

5. How does this patent influence freedom to operate?
It potentially restricts the use of the covered compound and process in the U.S., requiring licensing or design-around strategies for related activities.


References

[1] U.S. Patent RE43797. (2007). Reissue of U.S. Patent 6,586,286.
[2] Mazzariol, G., et al. (2006). Pharmaceutical patent landscapes in heterocyclic chemistry. Journal of Intellectual Property Law & Practice, 1(2), 134-150.
[3] U.S. Patent and Trademark Office (USPTO). Patent database.
[4] European Patent Office (EPO). Patent landscape reports on heterocyclic compounds.

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Drugs Protected by US Patent RE43797

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent RE43797

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008240259 ⤷  Start Trial
Australia 2008347005 ⤷  Start Trial
Brazil PI0809470 ⤷  Start Trial
Brazil PI0821970 ⤷  Start Trial
Canada 2682598 ⤷  Start Trial
Canada 2711160 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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