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Last Updated: January 5, 2025

Details for Patent: RE43797


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Which drugs does patent RE43797 protect, and when does it expire?

Patent RE43797 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: 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): Oppenheimer; Daniel I. (Castro Valley, CA), Dorenbaum; Alejandro (Mill Valley, CA), Okhamafe; Augustus O. (Concord, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:13/299,499
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:

Understanding the Scope and Claims of United States Patents: A Detailed Analysis

Introduction

Patents are a crucial component of intellectual property law, providing inventors and innovators with exclusive rights to their creations. The scope and claims of a patent are essential in defining the boundaries of this protection. This article delves into the intricacies of patent scope, claims, and the broader patent landscape in the United States.

What are Patent Claims?

Patent claims are the heart of a patent application, as they define the scope of the patent's protection. These claims must be clear, concise, and supported by the original description provided in the patent application[4].

Types of Claims

  • Independent Claims: These claims stand alone and do not rely on other claims. They define the broadest scope of the invention.
  • Dependent Claims: These claims build upon independent claims and narrow down the scope of the invention[4].

Importance of Patent Claims

Patent claims are vital because they determine what is protected under the patent. Here are a few key points:

  • Scope of Protection: The claims outline what the inventor can prevent others from making, using, or selling. Broader claims offer more extensive protection, while narrower claims are more specific[5].
  • Patentability: Claims must be novel, non-obvious, and useful to be considered patentable. The patent office examines these claims to ensure they meet these criteria[4].

Measuring Patent Scope

The scope of a patent can be measured using several metrics:

  • Independent Claim Length: Longer independent claims often indicate a broader scope of protection. However, this can also lead to increased complexity and potential litigation issues[5].
  • Independent Claim Count: The number of independent claims can also indicate the breadth of the patent. More claims may suggest a wider scope, but this can also complicate the patent's enforceability[5].

Impact on Patent Quality

The quality of patents is often debated, with concerns about overly broad patents leading to increased licensing and litigation costs. Narrower claims, which are often the result of a longer examination process, are associated with a higher probability of grant and shorter examination times[5].

The Patent Examination Process

The patent examination process is critical in refining the scope of patent claims.

  • Office Actions: During the examination, the patent office may issue Office Actions, which include rejections or objections to the claims. Applicants must respond to these actions by addressing each rejection or objection specifically and making necessary amendments to the claims[4].
  • Claim Amendments: Amendments must be supported by the original description and cannot introduce new matter. This ensures that the claims remain consistent with the initial invention described[4].

Case Study: Allergan USA, Inc. v. MSN Laboratories Private Ltd.

A recent case illustrates the importance of patent claims and their validity. In Allergan USA, Inc. v. MSN Laboratories Private Ltd., the court addressed issues of obviousness-type double patenting and lack of written description for several patents related to eluxadoline, a drug used to treat irritable bowel syndrome. The case highlights the complexities of patent claims and the rigorous standards they must meet to be considered valid[2].

Impact of Patent Protection on Global Operations

Local patent protection can significantly influence a firm's global operations. Research indicates that firms with stronger local patent protection tend to have higher local and foreign sales. However, the decision on where to locate production is influenced by factors such as marginal production costs, transport costs, and imitation threats in different markets[1].

Data and Analytics in Patent Research

The USPTO provides extensive datasets for patent research, including the Patent Claims Research Dataset. This dataset contains detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014. It helps in analyzing patent scope and other metrics related to patent claims[3].

Key Considerations for Patent Applicants

When applying for a patent, several key considerations must be kept in mind:

  • Clarity and Specificity: Claims must be clear and specific to avoid ambiguity and potential litigation.
  • Support from Description: Claims must be supported by the original description provided in the patent application.
  • Novelty and Non-Obviousness: Claims must meet the criteria of novelty and non-obviousness to be considered patentable[4].

The Role of Judicial Independence and Property Rights

The effectiveness of patent protection is also influenced by the quality of property rights protection, judicial independence, and political transparency in different countries. Firms tend to have higher subsidiary sales in countries with stronger IPR protections and more transparent judicial systems[1].

Conclusion

The scope and claims of a patent are fundamental to its validity and enforceability. Understanding these elements is crucial for inventors, businesses, and legal professionals. By analyzing the metrics of patent scope, the complexities of the examination process, and the broader impact on global operations, one can better navigate the intricate landscape of patent law.

Key Takeaways

  • Patent Claims Define Protection: Claims are essential in defining the scope of a patent's protection.
  • Metrics for Patent Scope: Independent claim length and count are simple yet effective metrics for measuring patent scope.
  • Examination Process: The patent examination process refines claims to ensure they meet the criteria of novelty, non-obviousness, and usefulness.
  • Global Operations: Local patent protection influences a firm's global sales and production location decisions.
  • Judicial and Property Rights: Stronger IPR protections and judicial independence enhance the effectiveness of patent protection.

FAQs

What is the purpose of patent claims in a patent application?

Patent claims define the scope of the patent's protection, outlining what the inventor can prevent others from making, using, or selling.

How are patent claims measured in terms of scope?

Patent scope can be measured using metrics such as independent claim length and independent claim count.

What is the significance of the patent examination process?

The patent examination process ensures that claims meet the criteria of novelty, non-obviousness, and usefulness, and it refines claims to avoid ambiguity and potential litigation.

How does local patent protection affect a firm's global operations?

Local patent protection can increase a firm's local and foreign sales but has an ambiguous impact on production location decisions, which depend on factors like marginal production costs and imitation threats.

What role do judicial independence and property rights play in patent protection?

Judicial independence and strong property rights protection enhance the effectiveness of patent protection, leading to higher subsidiary sales in countries with these attributes.

Sources

  1. Analyzing the Impact of Local Patent Protection on Firms' Global Operations - Harvard Kennedy School[1].
  2. Allergan USA, Inc. v. MSN Laboratories Private Ltd. - United States Court of Appeals for the Federal Circuit[2].
  3. Patent Claims Research Dataset - USPTO[3].
  4. Patents - The Maryland People's Law Library[4].
  5. Patent Claims and Patent Scope - SSRN[5].

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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
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>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 ⤷  Subscribe
Australia 2008347005 ⤷  Subscribe
Brazil PI0809470 ⤷  Subscribe
Brazil PI0821970 ⤷  Subscribe
Canada 2682598 ⤷  Subscribe
Canada 2711160 ⤷  Subscribe
China 101678025 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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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. 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.