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Last Updated: July 7, 2025

Details for Patent: 11,103,495


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Which drugs does patent 11,103,495 protect, and when does it expire?

Patent 11,103,495 protects QUILLICHEW ER and is included in one NDA.

This patent has eight patent family members in eight countries.

Summary for Patent: 11,103,495
Title:Methylphenidate extended release chewable tablet
Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate--ion exchange resin complex, a barrier coated methylphenidate--ion exchange resin complex--matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
Inventor(s): Tu; Yu-Hsing (West Windsor, NJ), Perumal; Ashok (Monmouth Junction, NJ), Kathala; Kalyan (Monmouth Junction, NJ)
Assignee: TRIS PHARMA, INC (Monmouth Junction, NJ)
Application Number:17/213,744
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 11,103,495

Introduction

Understanding the scope and claims of a patent is crucial for determining its validity, enforceability, and potential impact on the market. This analysis focuses on United States Patent 11,103,495, one of the patents involved in a recent intellectual property dispute.

Patent Overview

United States Patent 11,103,495 is part of a series of patents asserted in the case of Tris Pharma, Inc. v. Teva Pharm. U.S., involving allegations of patent infringement related to the drug QuilliChew[2].

Patent Claims

Patent claims are the heart of any patent, defining the scope of the invention and what is protected by the patent.

Claim Structure

The patent claims of U.S. Patent 11,103,495 would typically include independent claims and dependent claims. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and further narrow the scope of the invention.

Claim Analysis

To analyze the claims, one would need to review the claim language, dependencies, and the context in which they are presented. For example, in the case of Tris Pharma, Inc. v. Teva Pharm. U.S., the complaint focused on direct infringement of specific claims, such as claims 22 and 24 of the '399 patent, which are dependent on claim 1 of the same patent. Although the specific claims of the '495 patent are not detailed here, the principle remains that each claim must be carefully examined for its scope and dependencies[2].

Patent Scope

The scope of a patent is determined by the claims and is influenced by various factors, including the specification, drawings, and prior art.

Claim Construction

The process of interpreting patent claims, known as claim construction, is critical. This was evident in the Markman hearing held in the Tris Pharma case, where the court issued a claim construction opinion to clarify the meaning of the claims[2].

Patent Scope Measurements

The USPTO's Patent Claims Research Dataset provides tools to measure patent scope, including claim-level statistics and document-level statistics. These measurements can help in understanding the breadth and depth of the patent's protection[3].

Patent Landscape

The patent landscape includes all relevant patents and patent applications in the same field of technology.

Related Patents

U.S. Patent 11,103,495 is part of a family of patents that include other related patents such as U.S. Patent No. 9,545,399, U.S. Patent No. 9,844,544, U.S. Patent No. 9,844,545, and U.S. Patent No. 11,103,494. Understanding the relationships and overlaps between these patents is essential for a comprehensive analysis[2].

Prior Art

Prior art includes all publicly available information that existed before the patent's priority date. Searching for prior art is a crucial step in determining the novelty and non-obviousness of the invention. Resources such as the USPTO's database, Google Patents, and the European Patent Office's Espacenet can be used for this purpose[4].

Infringement Analysis

Determining whether a product or process infringes a patent involves comparing the claims of the patent with the allegedly infringing product or process.

Direct Infringement

In the case of Tris Pharma, Inc. v. Teva Pharm. U.S., the complaint alleged direct infringement of the asserted patents based on Teva's ANDA filing for a generic version of QuilliChew. The court's decision on direct infringement would hinge on whether Teva's product meets all the limitations of the claims[2].

Induced and Contributory Infringement

While the Tris Pharma case focused on direct infringement, other forms of infringement such as induced and contributory infringement can also be relevant. These involve encouraging or facilitating others to infringe the patent[2].

Legal and Regulatory Context

Patents are subject to various legal and regulatory frameworks that can affect their validity and enforceability.

Doctrine of Obviousness-Type Double Patenting

In another relevant case, Allergan USA, Inc. v. MSN Laboratories Private Ltd., the court dealt with the doctrine of obviousness-type double patenting, which can invalidate claims if they are not patentably distinct from earlier-filed claims. This highlights the importance of ensuring that each patent claim is distinct and not obvious over prior claims[5].

Patent Term Adjustment (PTA)

The patent term can be adjusted based on delays in the prosecution process. For example, in the Allergan case, the patents did not receive any PTA because there were no delays in prosecution, and they will expire twenty years from their priority date[5].

Data and Analytics

Utilizing large datasets and analytics can provide insights into patent trends and the effectiveness of patent strategies.

PatentsView Database

The PatentsView database offers detailed information on patent applications and granted patents, including disambiguated assignee and inventor data. This can help in analyzing the patent landscape and identifying key players and trends[1].

USPTO Datasets

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. This dataset can be used to analyze claim-level statistics and document-level statistics, offering insights into patent scope and trends[3].

Conclusion

Understanding the scope and claims of U.S. Patent 11,103,495 involves a detailed analysis of the claim language, dependencies, and the broader patent landscape. Here are some key takeaways:

  • Claim Analysis: Carefully review the independent and dependent claims to understand the scope of the invention.
  • Claim Construction: Interpret the claims in the context of the specification, drawings, and prior art.
  • Patent Scope: Use tools like the USPTO's Patent Claims Research Dataset to measure the breadth and depth of the patent's protection.
  • Infringement Analysis: Compare the claims with the allegedly infringing product or process to determine direct, induced, or contributory infringement.
  • Legal and Regulatory Context: Ensure compliance with legal doctrines such as obviousness-type double patenting and understand the impact of patent term adjustments.
  • Data and Analytics: Utilize datasets like PatentsView and USPTO datasets to analyze patent trends and strategies.

Key Takeaways

  • Detailed Claim Review: The claims define the invention and must be carefully analyzed.
  • Claim Construction: Court interpretations can significantly impact the scope of the patent.
  • Patent Landscape: Understanding related patents and prior art is crucial.
  • Infringement: Direct, induced, and contributory infringement must be considered.
  • Legal Frameworks: Compliance with legal doctrines and regulations is essential.
  • Data Analytics: Utilizing large datasets can provide valuable insights into patent strategies.

FAQs

Q: What is the significance of claim construction in patent litigation? A: Claim construction is crucial as it determines the meaning and scope of the patent claims, which can significantly impact the outcome of infringement cases.

Q: How do you determine if a product infringes a patent? A: Determining infringement involves comparing the claims of the patent with the allegedly infringing product or process to see if all the limitations of the claims are met.

Q: What is obviousness-type double patenting? A: This doctrine invalidates claims if they are not patentably distinct from earlier-filed claims, ensuring that each patent claim is unique and not obvious over prior claims.

Q: How can datasets like PatentsView be used in patent analysis? A: These datasets provide detailed information on patent applications and granted patents, helping in analyzing the patent landscape, identifying trends, and understanding key players.

Q: What is the importance of patent term adjustment (PTA)? A: PTA adjusts the patent term based on delays in the prosecution process, ensuring that the patent term reflects the actual time spent in review.

Sources

  1. PatentsView: Data Download Tables.
  2. VLEX: Tris Pharma, Inc. v. Teva Pharm. U.S.
  3. USPTO: Patent Claims Research Dataset.
  4. NYPL Libguides: How to Search for an Historical U.S. Patent.
  5. CAFC: ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD.

More… ↓

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Drugs Protected by US Patent 11,103,495

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-001 Dec 4, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED ⤷  Try for Free
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-002 Dec 4, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED ⤷  Try for Free
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-003 Dec 4, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED ⤷  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

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