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Last Updated: December 22, 2024

Details for Patent: RE45573


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Which drugs does patent RE45573 protect, and when does it expire?

Patent RE45573 protects LATUDA and is included in one NDA.

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

This patent has fourteen patent family members in eleven countries.

Summary for Patent: RE45573
Title:Process for producing imide compound
Abstract: The present invention provides an excellent industrial process for producing an imide compound hydrochloride. The process for producing an imide compound hydrochloride of the formula (2): ##STR00001## or an enantiomer thereof, which comprises treating a compound of the formula (1): ##STR00002## or an enantiomer thereof with an aqueous hydrochloric acid solution in a hydrophilic solvent, followed by crystallizing the resultant.
Inventor(s): Kakiya; Yuzo (Ibaraki, JP), Oda; Mayumi (Osaka, JP)
Assignee: Sumitomo Dainippon Pharma Co., Ltd. (Osaka, JP)
Application Number:14/137,464
Patent Claim Types:
see list of patent claims
Use; Compound; Process;
Patent landscape, scope, and claims:

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

When navigating the complex landscape of U.S. patents, it is crucial to understand the nuances of patent claims, the scope of patent protection, and the legal frameworks that govern them. Here, we will delve into the key aspects of patent claims and the patent landscape, using relevant examples and case studies to illustrate these concepts.

Patent Claims: The Foundation of Patent Protection

What are Patent Claims?

Patent claims are the heart of a patent application, defining the scope of the invention for which protection is sought. These claims must be clear, concise, and definite to ensure that the public understands what is protected and what is not[3].

Types of Patent Claims

  • Independent Claims: These claims stand alone and define the invention without reference to other claims. They are crucial because they set the broadest scope of protection for the invention.
  • Dependent Claims: These claims refer back to and further limit an independent claim. They often provide additional details or narrower aspects of the invention.
  • Product-by-Process Claims: These claims define a product by the process used to make it. However, as seen in the case of the ultrasonic flow meter housings, these claims can be problematic if the product itself does not have distinguishing structural or functional differences from prior art[1].

The Importance of Claim Language

The language used in patent claims is critical. It must be precise to avoid ambiguity and ensure that the invention is clearly defined. For instance, in the case of the ultrasonic flow meter housings, the claim language "cast in one piece" was interpreted as a product-by-process claim, which ultimately led to the patent being invalidated due to a lack of distinguishing structural or functional differences[1].

Patent Scope and Its Metrics

Measuring Patent Scope

Patent scope can be measured using several metrics, including independent claim length, claim count, and the breadth of patent classes. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Impact of Examination Process

The patent examination process often narrows the scope of patent claims. Studies indicate that the duration of the examination process can significantly impact the final scope of the claims, with longer examinations leading to more substantial reductions in claim breadth and length[3].

Patent Landscape: Challenges and Litigation

Patent Litigation and Infringement

Patent litigation is a common occurrence, especially in highly competitive industries such as pharmaceuticals. For example, the litigation surrounding the drug Latuda® involved multiple parties and complex legal battles over patent infringement and the filing of Abbreviated New Drug Applications (ANDAs)[2].

ANDA Filings and Generic Competition

The filing of an ANDA by a generic drug manufacturer can be considered a technical act of infringement, leading to legal disputes. These disputes often result in settlements or court decisions that determine the validity and enforceability of the patents in question[5].

Product-by-Process Claims: A Case Study

Ultrasonic Flow Meter Housings

The case of the ultrasonic flow meter housings highlights the challenges with product-by-process claims. Here, the patentee claimed a housing "cast in one piece," which was deemed a product-by-process claim. The court found that the process did not result in any functional or structural differences that would distinguish the product from prior art, leading to the patent's invalidation[1].

Best Practices for Drafting Patent Claims

Clarity and Precision

Claims must be drafted with clarity and precision to avoid ambiguity. This includes avoiding vague terms and ensuring that each claim is supported by the patent's disclosure.

Support from Disclosure

The patent disclosure must provide sufficient support for the claims. This means that the description and drawings should clearly enable one skilled in the art to make and use the invention.

The Role of the USPTO and Courts

USPTO Examination Process

The United States Patent and Trademark Office (USPTO) plays a crucial role in examining patent applications. The examination process can significantly narrow the scope of claims, and applicants must be prepared to address any issues raised during this process[3].

Court Decisions and Appeals

Courts, particularly the Federal Circuit, have the final say in interpreting patent claims and determining their validity. The decision in the ultrasonic flow meter housings case illustrates how courts scrutinize product-by-process claims and the importance of distinguishing features[1].

Impact on Business and Innovation

Protecting Intellectual Property

Patent protection is vital for businesses to safeguard their innovations and prevent unauthorized use. However, the complexity of patent claims and the legal landscape can pose significant challenges.

Navigating Litigation

Companies must be prepared to navigate the complexities of patent litigation, which can be costly and time-consuming. Understanding the nuances of patent claims and the legal framework can help in making informed decisions.

Key Takeaways

  • Clear and Precise Claims: Patent claims must be clear, concise, and definite to ensure effective protection.
  • Product-by-Process Claims: These claims can be problematic if the product does not have distinguishing structural or functional differences from prior art.
  • Patent Scope Metrics: Narrower claims at publication are associated with a higher probability of grant and a shorter examination process.
  • Litigation and ANDA Filings: Patent litigation, especially in the pharmaceutical sector, can be complex and involves technical acts of infringement.
  • USPTO and Court Roles: The USPTO and courts play critical roles in examining and interpreting patent claims.

Frequently Asked Questions (FAQs)

What is the difference between independent and dependent claims?

Independent claims stand alone and define the invention broadly, while dependent claims refer back to and further limit an independent claim.

Why are product-by-process claims often problematic?

Product-by-process claims are often problematic because courts focus on the product rather than the process, and the product must have distinguishing structural or functional differences from prior art to be patentable.

How does the USPTO examination process affect patent claims?

The USPTO examination process tends to narrow the scope of patent claims, with longer examinations leading to more significant reductions in claim breadth and length.

What is an ANDA filing, and how does it relate to patent litigation?

An ANDA (Abbreviated New Drug Application) filing by a generic drug manufacturer can be considered a technical act of infringement, leading to patent litigation over the validity and enforceability of the patents in question.

Why is clarity and precision important in drafting patent claims?

Clarity and precision are crucial in drafting patent claims to avoid ambiguity and ensure that the public understands what is protected and what is not.

Cited Sources:

  1. Cantor Colburn, "Product-by-process analysis dooms challenged patent," Cantor Colburn.
  2. RPX Insight, "in the united states district court," RPX Insight.
  3. Hoover Institution, "Patent Claims and Patent Scope," Hoover Institution.
  4. OSTI.GOV, "Methods and systems for analysis (Patent)," OSTI.GOV.
  5. Robins Kaplan LLP, "ANDA Litigation Settlements," Robins Kaplan LLP.

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Drugs Protected by US Patent RE45573

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No ⤷  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

Foreign Priority and PCT Information for Patent: RE45573

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2003-281860Jul 29, 2003
PCT Information
PCT FiledJuly 27, 2004PCT Application Number:PCT/JP2004/011035
PCT Publication Date:February 03, 2005PCT Publication Number: WO2005/009999

International Family Members for US Patent RE45573

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 543817 ⤷  Subscribe
Australia 2004259305 ⤷  Subscribe
Brazil PI0413081 ⤷  Subscribe
Canada 2538265 ⤷  Subscribe
China 100422178 ⤷  Subscribe
China 1832946 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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