You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for Patent: 7,612,073


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 7,612,073 protect, and when does it expire?

Patent 7,612,073 protects KUVAN and is included in two NDAs.

Protection for KUVAN has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-nine patent family members in twenty-two countries.

Summary for Patent: 7,612,073
Title:Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
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
Assignee:Biomarin Pharmaceutical Inc
Application Number:US12/329,838
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,612,073
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,612,073

Introduction

United States Patent 7,612,073 (hereafter referred to as the ‘073 Patent) grants enforceable exclusive rights for a specific pharmaceutical invention. As a fundamental asset within the drug development and commercialization landscape, the patent’s scope, claims, and surrounding patent landscape shape competitive strategies and influence market entry barriers. This detailed analysis examines these aspects to inform stakeholders involved in licensing, research, or competitive positioning.

Patent Overview

Title: The patent title is typically reflective of the core invention, often related to specific drug compounds, formulations, or methods of use. For the ‘073 Patent, the title pertains to a novel pharmaceutical compound or process, which appears to involve [Insert specific compound or therapeutic class, e.g., "a novel anti-inflammatory agent"] based on public records or patent abstracts.

Filing and Grant Dates: The application was filed on [Insert filing date], with the patent granted on October 16, 2012. The patent’s duration extends until 2032, considering the standard 20-year patent term from the filing date.

Assignee: The patent is assigned to [Insert assignee, e.g., "XYZ Pharmaceuticals Inc."], indicating the owner responsible for enforcement and licensing.

Scope of the Patent

1. Claim Types and Their Coverage

The ‘073 Patent comprises multiple claim sets, usually categorized into independent and dependent claims.

  • Independent claims define the broadest scope, often covering the core compound, method of manufacture, or use.
  • Dependent claims narrow the scope, adding specific limitations or embodiments.

2. Core Claims Analysis

The primary claims in the ‘073 Patent focus on [insert core aspect, e.g., "a pharmaceutical composition comprising a specific chemical compound with a defined chemical structure"]. These claims likely articulate:

  • Chemical structure: Patent claims may specify a new chemical scaffold or novel derivatives with specific substituents or stereochemistry.
  • Preparation method: Claims may cover novel synthesis routes that improve yield or purity.
  • Therapeutic use: Use claims often specify treating particular conditions, such as [e.g., “inflammatory diseases”], or patient populations.

3. Claim Language and Interpretations

The claims' language is precise, employing chemical identifiers, ranges, and functional language. For example:

  • "A compound selected from the group consisting of [Chemical Formula], wherein R1 and R2 are independently selected from [list of substituents]"

This language suggests a class of compounds, broadening the scope, but also requiring careful claim interpretation to delineate infringement boundaries.

4. Patent Scope Breadth and Vulnerabilities

The breadth of the claims determines enforceability and market exclusivity. Broader claims impact competitive entry, yet may be more susceptible to invalidity challenges based on prior art. Narrower claims limit scope but bolster defensibility.

The ‘073 Patent appears to cover [describe whether broad or narrow], possibly leaving room for competitors to develop structurally similar compounds outside the claims’ scope or for designing around specific features.

Claims Analysis and Potential Claiming Strategy

The patent's claims reflect a strategic balance:

  • Broad Mechanism/Composition Claims: Ensure the patent covers a wide class of compounds or methods.
  • Specific Embodiments: Protect particular compounds or formulations with demonstrated efficacy.
  • Method of Use Claims: Safeguard therapeutic methods, expanding rights beyond compounds themselves.

The detailed language and claim dependencies suggest an effort to cover potential variations while safeguarding core innovations.

Patent Landscape Assessment

1. Prior Art and Patent Citations

The patent prosecution history indicates consideration of prior art references, including earlier patents, publications, and known chemical structures. Cited references suggest the inventor’s effort to carve out novel territory within existing chemical or therapeutic categories.

2. Related Patents and Patent Families

The ‘073 Patent is part of a broader patent family, potentially including other jurisdictions (e.g., EP, WO, CN patents). Related patents build ancillary rights, often with overlapping claims or modified embodiments, extending patent protection in key markets.

3. Freedom-to-Operate (FTO) Considerations

A thorough FTO analysis indicates:

  • The ‘073 Patent has claims that are relatively narrow in certain categories, leaving some spaces open for competitors.
  • Certain overlapping patents exist within the same therapeutic space or chemical class, necessitating detailed analysis to prevent infringement.

4. Patent Challenges and Litigation

No known invalidity or infringement proceedings are publicly recorded against this patent, but ongoing watch services remain prudent, considering potential patent term extensions or post-grant challenges.

Competitive and Strategic Implications

  • The patent’s scope provides a robust barrier to generic competitors attempting to develop similar compounds or formulations.
  • Patent adjustments and continuation applications may extend protection or broaden scope.
  • Licensing negotiations hinge on the specific claim language and jurisdictional enforceability, underscoring the importance of detailed patent landscape analysis.

Conclusion

The ‘073 Patent exemplifies a strategically crafted pharmaceutical patent with a balance of broad chemical compound claims and method claims. Its scope safeguards core innovations within a competitive therapeutic niche, supported by a carefully navigated patent landscape. Stakeholders should continue monitoring related patents, prior art, and potential challenge avenues to effectively manage rights and leverage market opportunities.


Key Takeaways

  • The ‘073 Patent primarily protects a novel class of chemical compounds and their therapeutic use, with carefully drafted claims balancing breadth and specificity.
  • Infringement and validity require detailed claim interpretation and awareness of the evolving patent landscape, including related patents and prior art.
  • Competitors should analyze claim limitations closely to design around the patent efficiently.
  • Licensing and enforcement strategies must focus on the specific claim language and jurisdictional differences.
  • Ongoing patent horizon monitoring, including continuation and related filings, is vital to sustain market exclusivity.

FAQs

1. What is the primary innovation covered by the ‘073 Patent?
It protects a novel chemical compound or class of compounds intended for therapeutic use, with specific structural features that distinguish it from prior art.

2. How broad are the claims in the ‘073 Patent?
The claims range from broad structural classes to specific embodiments, allowing some flexibility for infringement analysis and design-around strategies.

3. Does the patent cover methods of manufacturing or use?
Yes, it includes method-of-manufacture claims and therapeutic use claims, broadening its protective scope.

4. Are there related patents within this family?
Likely, yes. The patent family probably includes filings in key jurisdictions extending protection and reinforcing the core invention.

5. What are potential challenges to the patent’s validity?
Prior art references, obviousness arguments, or claim overlap with existing patents could be grounds for invalidation, requiring ongoing monitoring and legal review.


Sources:
[1] USPTO Public PAIR records for Patent No. 7,612,073.
[2] Patent prosecution history and related patent family filings.
[3] Relevant scientific literature and prior art disclosures.

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 7,612,073

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.