Details for Patent: 8,283,369

Which drugs does patent 8,283,369 protect, and when does it expire?

Patent 8,283,369 protects DUZALLO and ZURAMPIC and is included in two NDAs.

This patent has ninety-two patent family members in thirty-seven countries.

Summary for Patent: 8,283,369

Title:	Compounds and compositions and methods of use
Abstract:	Described herein are compounds useful in the modulation of blood uric acid levels, formulations containing them and methods of using them. In some embodiments, the compounds described herein are used in the treatment or prevention of disorders related to aberrant levels of uric acid.
Inventor(s):	Quart; Barry D. (Encinitas, CA), Girardet; Jean-Luc (San Diego, CA), Gunic; Esmir (San Diego, CA), Yeh; Li-Tain (Irvine, CA)
Assignee:	Ardea Biosciences. Inc. (San Diego, CA)
Application Number:	13/174,522
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Understanding the Scope and Claims of United States Patent 8,283,369

Introduction to Patents in the United States

In the United States, patents are governed by the Patent Act (35 U.S. Code), which established the United States Patent and Trademark Office (USPTO). Patents grant the patentee the right to exclude others from making, using, or selling the invention for a specified period[1].

Overview of Patent 8,283,369

United States Patent 8,283,369, along with other related patents (8,003,681; 8,084,483; 8,357,713; and 8,546,437), pertains to ZURAMPIC (lesinurad), a human drug product developed by Ardea Biosciences, Inc. These patents were reviewed as part of a new drug application (NDA) 207988[2].

Patent Claims and Scope

What is Protected?

The patent claims in 8,283,369 protect specific aspects of lesinurad, including its composition, method of use, and manufacturing process. These claims are crucial as they define the scope of the invention and what is considered infringing.

Types of Patents

While 8,283,369 is a utility patent, it's important to note that utility patents have a duration of twenty years from the date of filing but are not enforceable until the day of issuance. This distinction is critical for understanding the timeline and enforceability of the patent[1].

Patent Term Extension

The patent term for 8,283,369 and related patents was subject to extension under 35 U.S.C. § 156, which allows for the extension of the patent term to compensate for the time spent in regulatory review. The FDA determined the regulatory review period, and since no due diligence petitions were filed, the regulatory review period determination was considered final[2].

Patent Eligibility and Examination Process

Filing and Examination

To obtain protection, the applicant must submit a patent application to the USPTO, where it is reviewed by an examiner to determine if the invention is patentable. The process involves ensuring the invention is novel, nonobvious, and enabled, meaning it can teach a person with ordinary skill in the art how to make or use the invention[5].

Patent Prosecution

The patent prosecution or examination process can take several years. If the claimed invention is not patentable as submitted, arguments and/or amended claims must be presented. If the patent examiner does not accept these, an appeal to an appeal board or the U.S. court system may be necessary[5].

Economic and Research Implications

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceuticals. This dataset helps in understanding the scope and trends of patent claims, which can be useful for analyzing the patent landscape around 8,283,369[3].

Recent Developments in Patent Law

AI and Patent Eligibility

While 8,283,369 does not pertain to AI, recent updates in USPTO guidance on AI patents highlight the importance of integrating judicial exceptions into practical applications. This guidance, though not directly applicable to 8,283,369, underscores the evolving nature of patent law and the need for clear, practical applications in patent claims[4].

Commercial and Financial Aspects

Costs and Commercialization

The cost of drafting and filing a non-provisional patent application can range from $8,000 to $20,000, with additional costs incurred during the patent prosecution process. For international patents, the costs can be significantly higher. Commercial partners often cover these costs, especially if there is a reasonable likelihood of recovering them[5].

Key Takeaways

• Patent Type and Duration: 8,283,369 is a utility patent with a 20-year duration from the date of filing.
• Patent Term Extension: The patent term was extended under 35 U.S.C. § 156 to compensate for regulatory review time.
• Patent Claims: The patent protects specific aspects of lesinurad, including composition and method of use.
• Examination Process: The patent underwent a rigorous examination process to ensure it met the criteria for novelty, nonobviousness, and enablement.
• Economic Implications: The patent is part of a broader dataset that helps in understanding patent trends and scope.
• Commercial Aspects: The costs associated with patenting and commercialization are significant, often covered by commercial partners.

FAQs

1. What is the duration of a utility patent in the United States?

   • A utility patent in the United States has a duration of twenty years from the date of filing but is not enforceable until the day of issuance[1].

2. What is the purpose of the patent term extension under 35 U.S.C. § 156?

   • The patent term extension under 35 U.S.C. § 156 is to compensate for the time spent in regulatory review, ensuring the patentee has a full term to exploit the invention[2].

3. How does the USPTO determine if an invention is patentable?

   • The USPTO determines if an invention is patentable by ensuring it is novel, nonobvious, and enabled, meaning it can teach a person with ordinary skill in the art how to make or use the invention[5].

4. What are the costs associated with filing and maintaining a patent?

   • The costs can range from $8,000 to $20,000 for drafting and filing a non-provisional patent application, with additional costs during the patent prosecution process. International patents can be significantly more expensive[5].

5. How does recent USPTO guidance on AI patents impact the broader patent landscape?

   • The recent guidance clarifies the process for determining the patent eligibility of AI-related inventions, emphasizing the integration of judicial exceptions into practical applications and ensuring AI-assisted inventions are evaluated on equal footing with other technologies[4].

Sources

1. BitLaw - Patent Law in the United States

   • https://www.bitlaw.com/patent/index.html

2. FDA - U.S. FOOD & DRUG OCT 1 0 MR Re: ZURAMPIC Patent Nos.

   • https://downloads.regulations.gov/FDA-2016-E-2505-0006/attachment_1.pdf

3. USPTO - Patent Claims Research Dataset

   • https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset

4. Mintz - Understanding the 2024 USPTO Guidance Update on AI Patent

   • https://www.mintz.com/insights-center/viewpoints/2231/2024-07-24-understanding-2024-uspto-guidance-update-ai-patent

5. KU Office of Research - Intellectual Property Protection

   • https://research.ku.edu/intellectual-property-protection

Drugs Protected by US Patent 8,283,369

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	8,283,369					TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	8,283,369					TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	8,283,369					ACHIEVING A THERAPEUTIC BENEFIT IN A SUBJECT WITH GOUT
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	8,283,369					TREATMENT OF GOUT

International Family Members for US Patent 8,283,369

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2217577		2016016	Norway
European Patent Office	2217577		CA 2019 00003	Denmark
European Patent Office	2217577		PA2019003	Lithuania
European Patent Office	2217577		300970	Netherlands
European Patent Office	2217577		2019C/502	Belgium
European Patent Office	2217577		122019000008	Germany