You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 21, 2024

Patent: 10,888,611


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,888,611
Title:Neisseria meningitidis
Abstract:In one aspect, the invention relates to a composition including a first polypeptide having the sequence set forth in SEQ ID NO: 1 and a second polypeptide having the sequence set forth in SEQ ID NO: 2. In one embodiment, the composition includes about 120 μg/ml of a first polypeptide including the amino acid sequence set forth in SEQ ID NO: 1, 120 μg/ml of a second polypeptide including the amino acid sequence set forth in SEQ ID NO: 2, about 2.8 molar ratio polysorbate-80 to the first polypeptide, about 2.8 molar ratio polysorbate-80 to the second polypeptide, about 0.5 mg/ml aluminum, about 10 mM histidine, and about 150 mM sodium chloride. In one embodiment, a dose of the composition is about 0.5 ml in total volume. In one embodiment, two-doses of the composition induce a bactericidal titer against diverse heterologous subfamily A and subfamily B strains in a human.
Inventor(s):Jansen Kathrin Ute, Anderson Annaliesa Sybil, Arumugham Rasappa Gounder, Farley John Erwin, Fletcher Leah Diane, Harris Shannon Lea, Jones Thomas Richard, Khandke Lakshmi, Loun Bounthon, Perez John Lance, Zlotnick Gary Warren
Assignee:PFIZER INC.
Application Number:US15543232
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,888,611

Introduction

The United States patent system is a complex and dynamic environment, influenced by various legislative, judicial, and administrative factors. This analysis will delve into the specifics of United States Patent 10,888,611, examining its claims, the broader patent landscape, and the implications of recent changes in patent law and practice.

Understanding the Patent

To analyze the claims of United States Patent 10,888,611, it is crucial to understand the patent's subject matter, its novelty, nonobviousness, and the eligibility of the subject matter for patent protection.

Subject Matter Eligibility

The patentability of an invention is governed by the eligibility requirements set forth in the Patent Act. The invention must be a new and useful "process, machine, manufacture, or composition of matter, or any improvement thereof"[1].

  • Eligible Subject Matter: The patent claims must not be directed to "laws of nature, natural phenomena, or abstract ideas" unless they contain an "inventive concept" that transforms the nature of the claim into a patent-eligible application[1].

Novelty Requirement

The claimed invention must be novel, meaning it must not have been patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[1].

Nonobviousness Requirement

Even if the invention is novel, it must also be nonobvious. This means that the invention must not be obvious to a person having ordinary skill in the relevant field at the time of the invention[1].

Drafting Patent Claims

The drafting of patent claims is a critical aspect of patent practice. Here are some key considerations:

Precision in Claim Drafting

Claims must be drafted with precision to avoid ambiguities and unintended limitations. For example, the use of "or" instead of "and/or" can significantly impact the scope of the claim, as seen in the Kustom Signals, Inc. v. Applied Concepts, Inc. case[2].

Role of Specification

The entire specification, including the "Summary of the Invention" and "Abstract," can be used in claim construction. Statements in these sections can inadvertently limit the scope of the claims, as illustrated in C.R. Bard, Inc. v. U.S. Surgical Corp[2].

Patent Trial and Appeal Board (PTAB) and Inter Partes Review (IPR)

The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the PTAB and the IPR process.

PTAB and IPR

  • Purpose: The PTAB was established to improve patent quality and provide a more efficient system for challenging patents that should not have issued[1].
  • Process: IPRs and post-grant reviews (PGRs) are administrative challenges to the validity of patents. These proceedings are typically faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents[1].

Strategic Use of IPR

Entities accused of patent infringement often use IPR to challenge the validity of patents asserted against them. This approach can be more advantageous due to the faster and less costly nature of PTAB proceedings compared to federal court litigation[1].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," play a significant role in the patent landscape.

Business Models

  • Portfolio PAEs: These entities negotiate licenses covering large portfolios of patents without necessarily suing the alleged infringer. They generate significant revenue, often in the millions of dollars[4].
  • Litigation PAEs: These entities focus on litigation, with a high percentage of their licenses following patent infringement suits. They are more prevalent and account for a larger number of licenses but less revenue compared to Portfolio PAEs[4].

Impact on Industries

PAEs assert patents across various industries, including retail trade, and their activities can have significant economic implications. The FTC study highlighted that PAEs generate substantial revenue through patent assertion, with a focus on ICT and software patents[4].

European Commission's SEP Regulation Proposal

While not directly related to U.S. patents, the European Commission's proposal for the regulation of Standard Essential Patents (SEPs) provides insights into global patent landscape challenges.

FRAND Determination

The proposal includes a non-binding FRAND (Fair, Reasonable, and Non-Discriminatory) determination process, which can be initiated by either the SEP holder or the implementer. However, this process has been criticized for potentially delaying court actions and unfairly benefiting implementers[3].

Critical Analysis of Patent 10,888,611

Claim Construction

To critically analyze the claims of Patent 10,888,611, one must carefully examine the language and scope of each claim. This includes ensuring that the claims are precise and do not inadvertently include limitations from the specification.

Patentability Requirements

The patent must meet the novelty, nonobviousness, and subject matter eligibility requirements. Any failure to meet these criteria could result in the patent being invalidated through IPR or PGR proceedings.

Strategic Considerations

Given the PTAB's role in challenging patent validity, it is crucial to consider the potential for IPR or PGR challenges when drafting and enforcing patent claims. The strategic use of these administrative proceedings can significantly impact the patent's validity and enforcement.

Key Takeaways

  • Precision in Claim Drafting: Ensure that patent claims are drafted with precision to avoid unintended limitations.
  • PTAB and IPR: Understand the role of PTAB and IPR in challenging patent validity and the strategic advantages of these proceedings.
  • PAEs: Be aware of the activities and impact of PAEs on patent enforcement and licensing.
  • Global Patent Landscape: Consider global developments, such as the European Commission's SEP regulation proposal, which can influence patent strategies.

FAQs

  1. What is the significance of the Leahy-Smith America Invents Act (AIA) in U.S. patent law?

    • The AIA is the most significant patent statute enacted by Congress in over 50 years, introducing the PTAB and IPR/PGR proceedings to improve patent quality and efficiency[1].
  2. How do Patent Assertion Entities (PAEs) impact the patent landscape?

    • PAEs assert patents across various industries, generating revenue through licensing and litigation, with significant economic implications[4].
  3. What are the key differences between Portfolio PAEs and Litigation PAEs?

    • Portfolio PAEs negotiate licenses for large patent portfolios without suing, while Litigation PAEs focus on litigation to enforce their patents[4].
  4. Why is precision important in drafting patent claims?

    • Precision avoids ambiguities and unintended limitations, ensuring the claims accurately reflect the invention and its scope[2].
  5. How do IPR and PGR proceedings differ from federal court litigation?

    • IPR and PGR proceedings are generally faster, less expensive, and require a lower burden of proof to invalidate patents compared to federal court litigation[1].

Sources

  1. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024.
  2. Finnegan. Practical Considerations and Strategies in Drafting U.S. Patent Applications.
  3. Kluwer IP Law. A Critical Analysis of the EC Proposal for SEP Regulation. February 27, 2024.
  4. Federal Trade Commission. Patent Assertion Entity Activity: An FTC Study. 2024.

More… ↓

⤷  Subscribe

Details for Patent 10,888,611

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc GARDASIL human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant Injection 125126 June 08, 2006 ⤷  Subscribe 2036-02-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.