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Last Updated: March 28, 2025

Details for Patent: RE37516


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Summary for Patent: RE37516
Title: Acetamide derivative having defined particle size
Abstract:Pharmaceutical compositions comprising modafinil in the form of particles of defined size. The particle size of modafinil can have a significant effect on the potency and safety profile of the drug.
Inventor(s): Grebow; Peter E. (Penllyn, PA), Corvari; Vincent (Nahua, NH), Stong; David (Coatesville, PA)
Assignee: Cephalon, Inc. (West Chester, PA)
Application Number:09/285,166
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE37516
Patent Claim Types:
see list of patent claims
Composition; Use; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of U.S. Patents: A Detailed Analysis

Introduction to U.S. Patents

Patents in the United States are granted by the U.S. Patent and Trademark Office (USPTO) and provide the patent holder with the exclusive right to make, use, sell, or import the invention in the United States until the patent expires. This exclusive right is a quid pro quo for the inventor's disclosure of the invention in sufficient detail to enable others to make and use it[1].

The Leahy-Smith America Invents Act (AIA) and PTAB

The 2011 Leahy-Smith America Invents Act (AIA) is a landmark legislation that significantly altered U.S. patent law. One of its most impactful provisions was the creation of the Patent Trial and Appeal Board (PTAB), a tribunal within the USPTO. PTAB is authorized to hear administrative challenges to the validity of patents, including Inter Partes Review (IPR) and Post-Grant Review (PGR). These proceedings allow anyone to challenge patents before the USPTO, potentially leading to the cancellation of patent claims if PTAB determines they should not have been issued[1].

Patentability Requirements

For a patent to be granted, the invention must meet several key requirements:

Eligible Subject Matter

The invention must fall within the categories of "process, machine, manufacture, or composition of matter, or any improvement thereof." However, laws of nature, natural phenomena, and abstract ideas are not patentable. The USPTO has guidelines to determine if a patent application seeks to claim ineligible subject matter, using the Alice/Mayo test to ensure the claims have an "inventive concept" that transforms the nature of the claim[1].

Novelty

The claimed invention must be new and not previously disclosed in the prior art. If every element of the claimed invention is already known to the public, no valid patent can be issued[1].

Nonobviousness

The invention must be nonobvious, meaning it must be significantly different from existing knowledge. This requirement ensures that the invention is not merely a combination of existing elements in an obvious way[1].

Enablement Requirement

The patent application must describe the invention in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the invention. This requirement is crucial for ensuring that the patent disclosure is sufficient for others to replicate the invention. For example, in the case of Amgen Inc. v. Sanofi, the Supreme Court emphasized that the enablement requirement must be met to avoid claiming inventions through a trial-and-error process rather than clear and exact descriptions[5].

Patent Claims and Scope

Patent claims define the scope of the invention and are critical in determining what is protected by the patent. The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014 and patent applications published between 2001 and 2014. This dataset helps in analyzing the scope and complexity of patent claims, including dependency relationships between claims and newly-developed measures of patent scope[3].

Administrative Challenges: IPR and PGR

IPR and PGR proceedings before PTAB offer a faster and less expensive alternative to judicial proceedings for challenging patent validity. These processes require a lower burden of proof to invalidate patents, making them attractive for entities facing patent infringement claims. The purpose of these proceedings is to improve patent quality and provide a more efficient system for challenging patents that should not have been issued[1].

Case Studies: Patent Litigation and Challenges

Lite-Netics LLC v. Nu Tsai Capital LLC

In this case, Lite-Netics LLC sued Nu Tsai Capital LLC (DBA Holiday Bright Lights) for patent infringement related to a magnetic cord invention. The dispute centered on the interpretation of patent claims and whether the accused product infringed the patent. The court's decision highlighted the importance of claim construction and the reasonableness of patent infringement allegations[2].

Amgen Inc. v. Sanofi

This case involved Amgen's patents for antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding to LDL receptors. The Supreme Court focused on the enablement requirement, emphasizing that Amgen's claims were too broad and did not provide sufficient guidance for making and using the claimed antibodies. This case underscores the importance of detailed and specific descriptions in patent applications[5].

Patent Quality and Compliance

The USPTO has been working to improve patent quality through various measures. The Government Accountability Office (GAO) recommended that the USPTO define patent quality more consistently and articulate this definition in agency documents and guidance. The USPTO has developed correctness measures and compliance targets to ensure statutory compliance with patentability requirements[4].

Key Takeaways

  • Patentability Requirements: Inventions must meet eligibility, novelty, and nonobviousness requirements.
  • Enablement: Patent applications must describe the invention in sufficient detail to enable others to make and use it.
  • Administrative Challenges: IPR and PGR proceedings offer efficient ways to challenge patent validity.
  • Patent Claims: Claims define the scope of the invention and are crucial in patent litigation.
  • Patent Quality: The USPTO is working to improve patent quality through consistent definitions and compliance measures.

Frequently Asked Questions (FAQs)

What is the purpose of the Patent Trial and Appeal Board (PTAB)?

PTAB was created to improve patent quality and provide a more efficient system for challenging patents that should not have been issued.

What are the key requirements for a patent to be granted?

A patent must meet the requirements of eligible subject matter, novelty, and nonobviousness, and the application must enable others to make and use the invention.

How do IPR and PGR proceedings differ from judicial proceedings?

IPR and PGR proceedings are typically faster and less expensive, with a lower burden of proof to invalidate patents.

What is the significance of the enablement requirement in patent law?

The enablement requirement ensures that the patent application provides sufficient detail for others to make and use the invention, preventing overly broad claims.

How does the USPTO measure patent quality?

The USPTO uses correctness measures and compliance targets to ensure statutory compliance with patentability requirements, such as those under 35 U.S.C. 101, 112, 102, and 103[4].

Cited Sources

  1. Congressional Research Service, "The Patent Trial and Appeal Board and Inter Partes Review," Updated May 28, 2024.
  2. Lite-Netics LLC v. Nu Tsai Capital LLC, Case: 23-1146, Document: 37, Filed: 02/17/2023.
  3. USPTO, "Patent Claims Research Dataset," August 28, 2017.
  4. Government Accountability Office, "Intellectual Property: Patent Office Should Define Quality, Reassess Compliance," June 30, 2016.
  5. Supreme Court of the United States, "Amgen Inc. v. Sanofi," May 18, 2023.

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Drugs Protected by US Patent RE37516

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
No data available in table
>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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International Family Members for US Patent RE37516

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Austria 188607 ⤷  Try for Free
Austria 199216 ⤷  Try for Free
Austria 400260 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 3 of 3 entries

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