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Last Updated: January 9, 2025

Details for Patent: 10,457,666


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Which drugs does patent 10,457,666 protect, and when does it expire?

Patent 10,457,666 protects LONSURF and is included in one NDA.

This patent has forty-seven patent family members in twenty-nine countries.

Summary for Patent: 10,457,666
Title:Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Abstract: Crystal Form I of 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidinedione hydrochloride exhibiting powder X-ray peaks at two or more angles selected from the group consisting of 11.6.degree., 17.2.degree., 17.8.degree., 23.3.degree., 27.1.degree., and 29.3.degree. as a diffraction angle (2.theta..+-.0.2.degree.).
Inventor(s): Kazuno; Hideki (Tsukuba, JP), Mutsumi; Tomonobu (Kodama-gun, JP)
Assignee: TAIHO PHARMACEUTICAL CO., LTD. (Chiyoda-ku, JP)
Application Number:15/969,434
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,457,666
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,457,666

Introduction

Patent litigation and the intricacies of patent claims are crucial in the pharmaceutical and biotechnology industries. The United States Patent 10,457,666, though not directly detailed in the provided sources, can be analyzed through the lens of general patent law principles, the structure of similar patents, and the broader patent landscape.

Patent Scope and Claims

Definition and Importance

Patent scope refers to the breadth and specificity of what is protected by a patent. It is defined by the claims section of the patent, which outlines the exact boundaries of the invention[3].

Metrics for Measuring Patent Scope

Research suggests that patent scope can be measured using simple metrics such as independent claim length and independent claim count. These metrics have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3].

Structure of Patent Claims

Independent and Dependent Claims

Patents typically include 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, in the case of the #284 patent, independent claim 1 outlines the method for treating digestive and breast cancers, while dependent claims like claim 13 further specify the administration schedule[1][4].

Claim Language and Specificity

The language used in claims is critical. It must be clear and specific enough to define the invention but broad enough to cover variations that might be developed later. The #284 patent, for instance, specifies the molar ratio and dose of the composition administered, as well as the administration schedule, to ensure clarity and specificity[1][4].

Patent Landscape and Litigation

ANDA Litigation

In the pharmaceutical industry, Abbreviated New Drug Applications (ANDAs) often lead to patent litigation. Generic manufacturers may challenge the validity of patents or seek to prove non-infringement. Settlements in ANDA litigation can involve dismissal of claims, injunctions against infringement, and agreements on the timing of generic drug approvals[2].

Reissue Proceedings

Patents can be reissued to correct errors or to broaden or narrow the scope of the original patent. The #284 patent, for example, was a reissue of U.S. Patent No. 7,799,783, with changes made to the claims during the reissue proceedings[1][4].

Nonobviousness and Written Description Requirements

Nonobviousness

To be patentable, an invention must be nonobvious to a person of ordinary skill in the relevant field. This is often a point of contention in litigation. For instance, in the case involving the #284 patent, the defendants argued that the administration schedule was obvious based on prior art, while the plaintiff argued that it was not[1][4].

Written Description Requirement

The written description requirement mandates that the patent specification must show that the inventors were in possession of the claimed subject matter at the time of filing. Disputes often arise over whether the specification adequately describes the inventive aspects claimed[1][4].

Objective Indicia of Nonobviousness

Unexpected Results, Long-Felt Need, Industry Praise, and Commercial Success

Objective indicia can support the nonobviousness of an invention. These include unexpected results, a long-felt but unsolved need, industry praise, and commercial success. These indicia can be crucial in defending a patent against invalidity challenges[1][4].

Settlements and Injunctions

Dismissal of Claims and Injunctions

Settlements in patent litigation can result in the dismissal of claims, either with or without prejudice, and may include injunctions against the defendant from infringing the patent until its expiration. For example, in the case of Veloxis Pharmaceuticals, Inc. v. Accord Healthcare, Inc., Accord was enjoined from infringing the patents-in-suit unless specifically authorized by Veloxis[2].

Key Takeaways

  • Patent Scope: Defined by the claims section, it is crucial for determining the breadth and specificity of the invention.
  • Claim Structure: Includes independent and dependent claims, with clear and specific language.
  • ANDA Litigation: Common in the pharmaceutical industry, often involving challenges to patent validity or non-infringement.
  • Reissue Proceedings: Allow for corrections or changes to the original patent claims.
  • Nonobviousness and Written Description: Critical requirements for patentability, frequently contested in litigation.
  • Objective Indicia: Support the nonobviousness of an invention through evidence of unexpected results, long-felt need, industry praise, and commercial success.

FAQs

Q1: What is the significance of independent and dependent claims in a patent? Independent claims define the invention, while dependent claims further limit the independent claims, providing additional specificity.

Q2: How is patent scope measured? Patent scope can be measured using metrics such as independent claim length and independent claim count, which have explanatory power for various correlates of patent scope[3].

Q3: What is the purpose of reissue proceedings in patent law? Reissue proceedings allow for the correction of errors or the broadening or narrowing of the original patent claims.

Q4: What are the key requirements for a patent to be considered nonobvious? A patent must be nonobvious to a person of ordinary skill in the relevant field, and this can be supported by objective indicia such as unexpected results, long-felt need, industry praise, and commercial success.

Q5: How do settlements in ANDA litigation typically resolve? Settlements often involve the dismissal of claims, either with or without prejudice, and may include injunctions against the defendant from infringing the patent until its expiration[2].

Sources

  1. District of Delaware: 19-2309.pdf - District of Delaware[1]
  2. Robins Kaplan: ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan[2]
  3. SSRN: Patent Claims and Patent Scope[3]
  4. GovInfo: Case 1:19-cv-02321-CFC Document 149 Filed 08/15/23[4]

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Drugs Protected by US Patent 10,457,666

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB RX Yes No 10,457,666 ⤷  Subscribe Y Y ⤷  Subscribe
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes 10,457,666 ⤷  Subscribe Y 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
Showing 1 to 2 of 2 entries

Foreign Priority and PCT Information for Patent: 10,457,666

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2013-126567Jun 17, 2013

International Family Members for US Patent 10,457,666

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2014282281 ⤷  Subscribe
Australia 2017208215 ⤷  Subscribe
Australia 2018219967 ⤷  Subscribe
Brazil 112015031619 ⤷  Subscribe
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 4 of 4 entries

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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.