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Last Updated: December 22, 2024

Details for Patent: 8,772,306


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Which drugs does patent 8,772,306 protect, and when does it expire?

Patent 8,772,306 protects XYREM and XYWAV and is included in two NDAs.

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

This patent has thirty-three patent family members in twenty-one countries.

Summary for Patent: 8,772,306
Title:Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Abstract: One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Inventor(s): Eller; Mark (Redwood City, CA)
Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)
Application Number:13/872,997
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,772,306
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery;
Patent landscape, scope, and claims:

United States Patent 8,772,306: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,772,306, assigned to Jazz Pharmaceuticals Ireland Limited, is part of a broader patent family related to pharmaceutical compositions and methods, particularly focusing on gamma-hydroxybutyrate (GHB). This patent is crucial in the context of treating certain sleep disorders and other medical conditions. Here, we will delve into the scope, claims, and the surrounding patent landscape.

Patent Overview

Patent Number and Title

The patent in question is U.S. Patent No. 8,772,306, titled "Method of Administration of Gamma Hydroxybutyrate with a Monocarboxylate Transporter."

Assignee and Inventor

The assignee of this patent is Jazz Pharmaceuticals Ireland Limited, and the inventor is Mark Eller, based in Redwood City, California[4].

Scope of the Patent

Subject Matter

The patent covers methods of administering GHB, a medication used to treat conditions such as narcolepsy and certain sleep disorders. The method involves the use of a monocarboxylate transporter to enhance the delivery and efficacy of GHB[4].

Claim Construction

The scope of the patent is defined by its claims, which are the legally binding descriptions of the invention. Claim construction is a critical process that involves interpreting the meaning of claim terms to determine the patent's boundaries. Intrinsic evidence, such as the patent specification and prosecution history, and extrinsic evidence, like expert testimony, are used to guide this interpretation[1].

Claims Analysis

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. For example, the patent might include claims related to the specific method of administration, the dosage regimen, and the use of monocarboxylate transporters[4].

Claim 1: Method of Administration

A key claim might describe a method of administering GHB to a patient, including the steps of preparing the pharmaceutical composition and using a monocarboxylate transporter to facilitate its absorption. This claim sets the foundation for the invention's scope[4].

Patent Landscape

Related Patents

The '431 patent family, which includes U.S. Patent No. 8,772,306, comprises several other patents related to GHB pharmaceutical compositions and methods. These include U.S. Patent Nos. 6,472,431, 6,780,889, 7,262,219, and others. These patents collectively cover various aspects of GHB formulations, delivery systems, and treatment methods[1].

Competitors and Litigation

In the pharmaceutical industry, patents like U.S. Patent No. 8,772,306 are often subject to challenges and litigation. For instance, Amneal Pharmaceuticals has filed notices of Paragraph IV certification against Jazz Pharmaceuticals, challenging the validity of patents in the '431 family, including the '306 patent family which includes the '306 and '302 patents[4].

Post-Grant Proceedings

Inter Partes Review (IPR)

Patents can be challenged through post-grant proceedings such as Inter Partes Review (IPR) before the Patent Trial and Appeal Board (PTAB). These proceedings can significantly impact the patent's validity and scope. For example, Quinn Emanuel Urquhart & Sullivan, LLP has successfully defended several patents against IPR challenges, demonstrating the importance of robust defense strategies in maintaining patent validity[2].

Metrics for Measuring Patent Scope

Claim Length and Count

Research has shown that metrics such as independent claim length and count can be useful in measuring patent scope. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and shorter examination processes. This suggests that the scope of U.S. Patent No. 8,772,306, as defined by its claims, would be subject to similar scrutiny and potential narrowing during the examination process[3].

Practical Implications

Innovation and Licensing

The scope and validity of patents like U.S. Patent No. 8,772,306 have significant implications for innovation and licensing in the pharmaceutical industry. Broad or overly broad patents can lead to increased licensing and litigation costs, potentially stifling innovation. Therefore, the precise definition and enforcement of patent claims are crucial[3].

Key Takeaways

  • Patent Scope: The scope of U.S. Patent No. 8,772,306 is defined by its claims, which cover methods of administering GHB using a monocarboxylate transporter.
  • Claim Construction: Claim construction involves interpreting claim terms using intrinsic and extrinsic evidence.
  • Related Patents: The patent is part of the '431 patent family and the '306 patent family, covering various aspects of GHB formulations and methods.
  • Post-Grant Proceedings: The patent could be subject to IPR challenges, which can impact its validity.
  • Metrics for Scope: Metrics like claim length and count can help measure the patent's scope and predict its examination outcomes.

FAQs

Q: What is the main subject matter of U.S. Patent No. 8,772,306?

A: The main subject matter is the method of administering gamma-hydroxybutyrate (GHB) using a monocarboxylate transporter.

Q: Who is the assignee of U.S. Patent No. 8,772,306?

A: The assignee is Jazz Pharmaceuticals Ireland Limited.

Q: What is the significance of claim construction in patent law?

A: Claim construction is crucial as it determines the legal boundaries of the invention, using both intrinsic and extrinsic evidence.

Q: How can the scope of a patent be measured?

A: Metrics such as independent claim length and count can be used to measure the scope of a patent.

Q: What are the potential challenges to the validity of U.S. Patent No. 8,772,306?

A: The patent could face challenges through Inter Partes Review (IPR) proceedings before the PTAB.

Sources

  1. Jazz Pharms., Inc. v. Amneal Pharms., LLC - Casetext
  2. Post-Grant Practice | Quinn Emanuel Urquhart & Sullivan, LLP
  3. Patent Claims and Patent Scope - SSRN
  4. U.S. Patent No. 9,050,302 B2 - Patent Images Storage Google Cloud

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Drugs Protected by US Patent 8,772,306

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 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 8,772,306

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014223373 ⤷  Subscribe
Brazil 112015021012 ⤷  Subscribe
Canada 2902948 ⤷  Subscribe
China 105073106 ⤷  Subscribe
China 111317730 ⤷  Subscribe
Cyprus 1120086 ⤷  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.