Patent: 11,016,099

Summary for Patent: 11,016,099

Patent Claims:

see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 11,016,099

Introduction

United States Patent 11,016,099, which covers a process for manufacturing a sustained-release mefloquine composition, is a significant patent in the pharmaceutical sector. This analysis will delve into the claims of the patent, the broader patent landscape, and the implications for both the patent holder and the industry.

Understanding the Patent Claims

The patent in question involves a specific process for manufacturing a sustained-release mefloquine composition. Here are some key aspects of the claims:

Claim Scope

The claims define the specific steps and components involved in the manufacturing process. This includes the ratio of the drug to lipophilic excipients, which is crucial for achieving the sustained-release profile. The precision in these claims is essential to ensure that the patent covers the unique aspects of the invention while avoiding overly broad or vague language that could lead to invalidation or infringement issues[2].

Claim Construction

The language used in the claims must be carefully drafted to avoid ambiguities. For instance, using specific terms like "selecting at least one of a greatest magnitude search and a highest frequency search" instead of "selecting either a greatest magnitude or highest frequency search" can prevent misinterpretation, as seen in the Kustom Signals, Inc. v. Applied Concepts, Inc. case[2].

Specification and Abstract

The specification and abstract of the patent application are critical. Any statements made in these sections can be used in claim construction, as illustrated by the C.R. Bard, Inc. v. U.S. Surgical Corp. case. Therefore, the drafters must ensure that these sections accurately describe the invention without introducing unnecessary limitations[2].

Patent Landscape and Competition

Biologic and Pharmaceutical Patents

The patent landscape for biologic and pharmaceutical patents is complex and highly competitive. Patents like 11,016,099 must navigate through a crowded field where small variations in manufacturing processes can lead to distinct patentable inventions. The expiration dates of such patents, particularly for biologics, are crucial as they determine when biosimilars can enter the market[5].

Continuation Procedures and Family Allowance Rates

The strategy of using continuation procedures can significantly impact the patent landscape. Continuation applications, including Requests for Continued Examination (RCEs) and continuation-in-part (CIP) applications, can extend the life of a patent family and allow for additional claims to be pursued. This is relevant as 31% of progenitor applications utilize at least one continuation procedure, and 15.8% result in at least one serialized continuation[1].

Economic and Technological Impact

The economic value of patents like 11,016,099 can be substantial. Research by the USPTO indicates that patent values are influenced by factors such as renewal choices and citation dynamics. Patents with high forward citation counts and timely citations tend to have higher economic values, suggesting that 11,016,099 could be valuable if it is frequently cited in subsequent patents[4].

Use of AI Tools in Patent Drafting

Disclosure Requirements

With the increasing use of AI tools in patent drafting, it is essential to disclose any material contributions made by AI systems. If an AI tool assists in drafting portions of the specification or claims, this must be disclosed to the USPTO to ensure compliance with patentability requirements[3].

Accuracy and Verification

Practitioners must verify the accuracy of all documents prepared with AI assistance. This includes ensuring that no inaccurate statements or evidence are introduced into the record and that all material information is disclosed. This is crucial to maintain the integrity of the patent application process[3].

Litigation and Enforcement

Patent Litigation Data

The USPTO's Patent Litigation Docket Report Data provides comprehensive insights into patent litigation trends. For patents like 11,016,099, understanding these trends can help in anticipating and preparing for potential litigation. The data includes information on litigating parties, court locations, and case types, which can be invaluable in strategic planning[4].

Gender and Technological Impacts

Research has shown that additional assistance during patent examination can significantly impact the probability of obtaining a patent, particularly for women and new inventors. This highlights the importance of equitable access to resources and support in the patent process, which can influence the overall patent landscape[4].

Key Takeaways

• Precise Claim Drafting: The claims of a patent must be carefully drafted to avoid ambiguities and ensure broad yet valid protection.
• Continuation Procedures: Utilizing continuation procedures can extend the life and scope of a patent family.
• AI Tool Disclosure: Any contributions made by AI tools in patent drafting must be disclosed to the USPTO.
• Economic Value: The economic value of a patent is influenced by factors such as renewal choices and citation dynamics.
• Litigation Preparedness: Understanding patent litigation trends and having access to comprehensive data can aid in strategic planning.

FAQs

1. What is the significance of the ratio of drug to lipophilic excipients in the patent claims?

   • The ratio is crucial for achieving the sustained-release profile of the mefloquine composition, making it a key aspect of the invention.

2. How can continuation procedures impact the patent landscape?

   • Continuation procedures can extend the life of a patent family and allow for additional claims to be pursued, potentially leading to multiple patents from a single progenitor application.

3. What are the disclosure requirements when using AI tools in patent drafting?

   • Any material contributions made by AI systems must be disclosed to the USPTO to ensure compliance with patentability requirements.

4. How does the USPTO's Patent Litigation Docket Report Data help in patent strategy?

   • The data provides comprehensive insights into patent litigation trends, helping in anticipating and preparing for potential litigation.

5. What is the impact of additional assistance during patent examination on the probability of obtaining a patent?

   • Additional assistance can significantly increase the probability of obtaining a patent, particularly for women and new inventors, helping to bridge the gender gap in patenting.

Sources

1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent? The Yale Journal of Law & Technology.
2. Finnegan. (n.d.). Practical Considerations and Strategies in Drafting U.S. Patent Applications.
3. BIPC. (2024, April 15). U.S. Patent Office Issues Additional Guidance on Use of AI Tools.
4. USPTO. (2024). Working papers and book chapters - USPTO.
5. DrugPatentWatch. (2024, December 17). When do biologic drug patents expire and when will biosimilars enter the market?

Details for Patent 11,016,099

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	September 25, 2009
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	December 30, 2009
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	761044	September 23, 2016
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	July 13, 2017
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	January 29, 2019