Details for Patent: 11,000,508

Which drugs does patent 11,000,508 protect, and when does it expire?

Patent 11,000,508 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 11,000,508

Title:	Secnidazole for use in the treatment of trichomoniasis
Abstract:	Method of treating trichomoniasis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) at least 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; or (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; or (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
Inventor(s):	Pentikis; Helen S. (Timonium, MD), Palling; David (Glen Ridge, NJ), Braun; Carol J. (Ellicott City, MD), Holl; Richard (Somerset, NJ)
Assignee:	LUPIN INC. (Baltimore, MD)
Application Number:	16/901,739
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

Analyzing the Scope and Claims of United States Patent 11,000,508

Introduction

Understanding the scope and claims of a patent is crucial for inventors, businesses, and legal professionals. This analysis will delve into the specifics of United States Patent 11,000,508, focusing on its claims, patent landscape, and relevant context.

Patent Overview

United States Patent 11,000,508 protects the drug SOLOSEC, which is included in one New Drug Application (NDA)[5].

Claims Analysis

Number and Scope of Claims

Patent 11,000,508 includes a specific number of claims that define the scope of the invention. Typically, patents have multiple claims, each serving to delineate different aspects of the invention. For SOLOSEC, the patent has a defined set of claims that cover the drug's composition, method of use, and any specific formulations or dosages.

Claim Types

Patents often include various types of claims:

• Independent Claims: These stand alone and do not refer to any other claims. They broadly define the invention.
• Dependent Claims: These refer back to an independent claim and narrow down the scope further.
• Method Claims: These describe the process or method of using the invention.
• Composition Claims: These describe the chemical or physical composition of the invention.

For SOLOSEC, the claims would likely include a mix of these types, ensuring comprehensive protection of the drug.

Patent Landscape

Patent Family

The patent has sixteen patent family members in five countries, indicating a global strategy for intellectual property protection. This spread across multiple jurisdictions helps in safeguarding the invention against infringement in different markets[5].

International Protection

The presence of patent family members in multiple countries highlights the importance of international patent protection. This ensures that the inventor or assignee has legal recourse in various regions, protecting their intellectual property from unauthorized use.

Related Applications and Citations

Using tools like the Common Citation Document (CCD), one can consolidate prior art citations from multiple patent offices. This helps in understanding how different offices have treated similar inventions and can provide insights into potential challenges or strengths of the patent[1].

Search and Analysis Tools

To conduct a thorough analysis of the patent landscape, several tools are available:

Patent Public Search

The USPTO's Patent Public Search tool provides enhanced access to prior art and allows for a detailed search of patent documents, including those related to SOLOSEC[1].

Global Dossier

The Global Dossier service offers access to the file histories of related applications from participating IP Offices, which can be crucial for understanding the global patent family and any office actions related to the patent[1].

Public Search Facility and PTRCs

The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) provide additional resources for conducting thorough patent searches and analyses[1].

Economic and Practical Considerations

Cost and Time

The process of obtaining and maintaining a patent is costly and time-consuming. For utility patents like the one protecting SOLOSEC, costs can range from $5,000 to $15,000, depending on the complexity of the technology and the size of the entity filing the patent[4].

Expedited Examination

For inventions in rapidly evolving fields, expedited examination options such as the Track One Prioritized Examination can reduce the examination time to 12 months, which may be beneficial for drugs like SOLOSEC where market timing is critical[4].

Legal and Policy Context

Small Claims Patent Court

While not directly related to the specific patent, the discussion around a potential small claims patent court highlights ongoing efforts to streamline and make patent litigation more accessible and efficient. This could have future implications for how patent disputes related to SOLOSEC or similar drugs are handled[2].

Key Takeaways

• Patent Claims: Understanding the number, type, and scope of claims is essential for defining the invention's boundaries.
• Patent Family: The presence of multiple patent family members in different countries ensures broad protection.
• Search Tools: Utilizing tools like Patent Public Search, Global Dossier, and CCD is crucial for a comprehensive analysis.
• Economic Considerations: The cost and time involved in patent prosecution can be significant, and expedited options may be necessary.
• Legal Context: Ongoing legal and policy developments can impact how patent disputes are handled.

FAQs

Q1: What is the significance of having multiple patent family members in different countries? Having multiple patent family members in different countries ensures that the invention is protected against infringement in various markets, providing broader legal recourse.

Q2: How can one conduct a thorough search of prior art related to a patent? One can use tools like the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) to conduct a thorough search of prior art.

Q3: What are the typical costs associated with filing a utility patent application? The costs can range from $5,000 to $15,000, depending on the complexity of the technology and the size of the entity filing the patent.

Q4: What is the purpose of expedited examination options like Track One Prioritized Examination? These options aim to reduce the examination time to 12 months, which is particularly beneficial for inventions in rapidly evolving fields.

Q5: How does the discussion around a small claims patent court impact patent holders? It could make patent litigation more accessible and efficient, potentially reducing costs and time associated with resolving patent disputes.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. SBIR - Timeline and Costs for Patent Filings: https://www.sbir.gov/sites/all/themes/sbir/dawnbreaker/img/documents/Course16-Tutorial2.pdf
5. DrugPatentWatch - Patent 11,000,508: https://www.drugpatentwatch.com/p/patent/11000508

Drugs Protected by US Patent 11,000,508

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF TRICHOMONIASIS IN ADULTS
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

International Family Members for US Patent 11,000,508

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015311674
Australia	2018203882
Australia	2018217262
Canada	2959414
Canada	3046521