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Last Updated: May 21, 2025

Details for Patent: 10,646,512


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Which drugs does patent 10,646,512 protect, and when does it expire?

Patent 10,646,512 protects PLENVU and is included in one NDA.

This patent has seventy patent family members in thirty-four countries.

Summary for Patent: 10,646,512
Title:Colonoscopy - preparation
Abstract:The invention provides a colon cleansing solution comprising: a) 300 to 2000 mmol per litre ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods and kits associated with, or making use of the solutions. The invention also provides a method of cleansing the colon of a subject comprising: —administering to the subject an effect amount of a first cleansing solution; and then after a time interval—administering to the subject an effective amount of a second cleansing solution, wherein the two cleansing solutions are as described in the specification.
Inventor(s):Marc Halphen, Hans-Jurgen Gruss, Ian Cox, Alasdair Cockett, Peter Stein, Alex Ungar
Assignee:Norgine BV
Application Number:US15/407,080
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,646,512

Introduction to Patents and the USPTO

Before diving into the specifics of United States Patent 10,646,512, it is essential to understand the broader context of patents and the role of the U.S. Patent and Trademark Office (USPTO). The USPTO is the federal agency responsible for granting U.S. patents and registering trademarks, ensuring that inventors have the exclusive right to their inventions[5].

Overview of Patent 10,646,512

United States Patent 10,646,512, titled "Colonoscopy - preparation," pertains to a colon cleansing solution designed to prepare patients for colonoscopy procedures. Here is a detailed analysis of its scope and claims.

Patentable Subject Matter

To be patentable, an invention must satisfy several criteria: it must be useful, novel, and non-obvious. The invention described in Patent 10,646,512 falls under the category of "useful process, machine, manufacture, or composition of matter, or any improvement thereof," as defined by the Patent Act[2].

Eligible Subject Matter

The patent claims a specific composition for a colon cleansing solution, which includes ascorbic acid or its salts. This composition is within the realm of patentable subject matter, as it is a new and useful improvement in the field of medical preparations. The Supreme Court has established that laws of nature, natural phenomena, and abstract ideas are not patentable, but specific applications of these, such as the composition in this patent, can be[1].

Claims of the Patent

Definition and Importance of Claims

The claims in a patent application are crucial as they define the scope of the patent's protection. For Patent 10,646,512, the claims specify the exact composition and method of preparation for the colon cleansing solution.

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, Claim 1 might describe the basic composition of the solution, while Claim 2 might specify a particular concentration of ascorbic acid within that composition.

Claim Language and Scope

The language used in the claims is precise and technical, ensuring that the scope of the patent is clearly defined. For instance, the patent specifies that the solution includes "300 to 2000 mmol per litre ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a combination thereof"[4].

Patent Scope and Breadth

Metrics for Measuring Patent Scope

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Narrower claims, which are more specific, are generally associated with a higher probability of grant and a shorter examination process compared to broader claims[3].

Specificity of Patent 10,646,512

The claims in Patent 10,646,512 are relatively specific, focusing on a precise composition and concentration of ascorbic acid. This specificity helps in ensuring that the patent is not overly broad and reduces the likelihood of conflicts with other patents or inventions.

Patent Landscape and Competition

Current State of Medical Preparations

The field of medical preparations, particularly those related to colonoscopy, is highly competitive. Patents like 10,646,512 contribute to this landscape by introducing new and improved solutions that enhance patient care and procedural efficiency.

Potential Challenges and Litigation

Given the competitive nature of the medical field, patents are often subject to challenges and litigation. The Patent Trial and Appeal Board (PTAB) provides a mechanism for challenging the validity of patents through Inter Partes Review (IPR) and Post-Grant Review (PGR). These processes allow for faster and less expensive resolution of patent disputes compared to judicial proceedings[1].

Practical Implications

Exclusive Rights and Infringement

The holder of Patent 10,646,512 has the exclusive right to make, use, sell, or import the invention in the United States until the patent expires. Any other person practicing the invention without permission would be infringing the patent and could be liable for monetary damages or subject to injunctive relief[1].

Licensing and Collaboration

The patent holder may choose to license the invention to other companies, allowing them to use the colon cleansing solution in exchange for royalties. This can foster collaboration and innovation within the medical industry.

Key Takeaways

  • Patentable Subject Matter: The invention must be useful, novel, and non-obvious to be patentable.
  • Claims Definition: Claims define the scope of the patent's protection and must be precise and technical.
  • Patent Scope: Narrower claims are generally more favorable in terms of grant probability and examination time.
  • Competitive Landscape: The medical preparations field is competitive, and patents like 10,646,512 must navigate this landscape carefully.
  • Exclusive Rights: The patent holder has exclusive rights to the invention, and infringement can result in significant legal consequences.

FAQs

What is the primary purpose of the USPTO?

The primary purpose of the USPTO is to grant U.S. patents and register trademarks, ensuring that inventors have the exclusive right to their inventions.

What are the key criteria for an invention to be patentable?

An invention must be useful, novel, and non-obvious to be patentable.

What is the significance of claims in a patent application?

Claims define the scope of the patent's protection and are essential for determining what is covered by the patent.

How can the scope of a patent be measured?

The scope of a patent can be measured using metrics such as independent claim length and independent claim count.

What is the role of PTAB in patent disputes?

The PTAB provides a mechanism for challenging the validity of patents through IPR and PGR, offering a faster and less expensive alternative to judicial proceedings.

Can a patent holder license their invention to other companies?

Yes, a patent holder can license their invention to other companies, allowing them to use the invention in exchange for royalties.

Sources

  1. Congressional Research Service, "The Patent Trial and Appeal Board and Inter Partes Review," Updated May 28, 2024.
  2. The Maryland People's Law Library, "Patents," Updated July 9, 2024.
  3. SSRN, "Patent Claims and Patent Scope," September 29, 2016.
  4. Google Patents, "US10646512B2 - Colonoscopy - preparation," Accessed January 13, 2025.
  5. USAGov, "U.S. Patent and Trademark Office (USPTO)," Accessed January 13, 2025.

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Drugs Protected by US Patent 10,646,512

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for 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

International Family Members for US Patent 10,646,512

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3141251 ⤷  Try for Free 122021000018 Germany ⤷  Try for Free
European Patent Office 3141251 ⤷  Try for Free 132021000000044 Italy ⤷  Try for Free
European Patent Office 3141251 ⤷  Try for Free 301099 Netherlands ⤷  Try for Free
European Patent Office 3141251 ⤷  Try for Free C202130017 Spain ⤷  Try for Free
European Patent Office 3141251 ⤷  Try for Free SPC/GB20/075 United Kingdom ⤷  Try for Free
Argentina 085712 ⤷  Try for Free
>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.