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Last Updated: December 25, 2024

Patent: 10,143,752


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Summary for Patent: 10,143,752
Title:Methods of treating ulcerative colitis
Abstract: Methods for maintaining clinical remission of ulcerative colitis in a human patient are described comprising administration of an antibody that has binding specificity for human .alpha.4.beta.7 integrin using a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-.alpha.4.beta.7 antibody in vivo.
Inventor(s): Fox; Irving H. (Wellesley, MA), Scholz; Catherine (Woburn, MA)
Assignee: Millennium Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:15/214,993
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,143,752

Introduction

Understanding the nuances of a specific patent, such as United States Patent 10,143,752, involves a deep dive into its claims, the broader patent landscape, and the regulatory environment in which it exists. This analysis will cover the key aspects of patent claims, the probability of patent approval, patent quality, and the impact of recent legislative and administrative changes on the U.S. patent system.

Understanding Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention and what is protected by the patent. For a patent like 10,143,752, the claims must be carefully crafted to ensure they are novel, non-obvious, and useful, as mandated by U.S. patent law[5].

Claim Construction

The construction of claims is crucial for determining the patent's validity and enforceability. Claims that are too broad may be challenged for lack of specificity or for covering ineligible subject matter, such as abstract ideas or natural phenomena, under the Alice/Mayo framework established by the Supreme Court[5].

Claim Types

Patents can have various types of claims, including independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The balance between these types of claims can significantly affect the patent's strength and scope.

Probability of Patent Approval

The approval rate for patent applications at the U.S. Patent and Trademark Office (USPTO) is not as high as often assumed. A study analyzing 2.15 million patent applications from 1996 to 2013 found that only 55.8% of the applications resulted in patents without using continuation procedures[1].

Trends in Approval Rates

The approval rate has decreased over time, particularly in fields like "Drugs and Medical Instruments" and "Computers and Communications." This decline suggests that the USPTO has become more stringent in its examination process, which can impact the likelihood of approval for patents in these fields[1].

Patent Quality and Survival

Patent quality is a critical factor in determining whether a patent can survive post-grant validity challenges. Research on inter partes review (IPR) proceedings has shown that certain characteristics of a patent and its prosecution history can significantly influence its likelihood of survival.

Determinants of Patent Quality

Patents prosecuted by large law firms, those in the pharmaceutical sector, and those with more words per claim are more likely to survive IPR. Conversely, patents obtained by small entities, those assigned to examiners with higher allowance rates, and those with higher backward citation counts are less likely to survive[2].

Impact of Inter Partes Review

The creation of the Patent Trial and Appeal Board (PTAB) and the introduction of IPR and post-grant review (PGR) under the Leahy-Smith America Invents Act (AIA) have provided new avenues for challenging patent validity. These procedures aim to eliminate low-quality patents and reduce litigation costs, but they have also been criticized for creating uncertainty in patent rights[5].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," play a significant role in the patent landscape. A study by the Federal Trade Commission (FTC) identified two main business models for PAEs: Portfolio PAEs and Litigation PAEs.

Portfolio PAEs

Portfolio PAEs negotiate licenses for large portfolios of patents, often without first suing the alleged infringer. These entities generate significant revenue, with 80% of the reported revenue in the FTC study coming from Portfolio PAEs[3].

Litigation PAEs

Litigation PAEs, on the other hand, rely heavily on litigation to enforce their patents. These entities account for a larger number of licenses but generate less revenue compared to Portfolio PAEs. The FTC study highlighted that Litigation PAEs often target firms across various industries, including retail trade[3].

Technological Trends in Patent Grants

The USPTO's patent grant data reveals significant trends in technological areas. For instance, electrical engineering patents, particularly those related to information and communication technologies (ICT), have seen a substantial increase between 2000 and 2018. This trend reflects the growing importance of ICT in innovation[4].

Regulatory Environment

The U.S. patent system is governed by a complex set of laws and regulations. The AIA, enacted in 2011, introduced significant changes, including the creation of PTAB and the IPR and PGR procedures. These changes aim to improve patent quality and reduce unwarranted litigation costs[5].

Alice/Mayo Framework

The Supreme Court's Alice/Mayo framework has had a profound impact on patent eligibility, particularly for software and abstract idea patents. This framework requires that patent claims must not be directed to ineligible subject matter unless they contain an "inventive concept" that transforms the nature of the claim[5].

Case Study: United States Patent 10,143,752

To analyze the specific patent 10,143,752, one would need to examine its claims, the technological field it belongs to, and its prosecution history.

Claim Analysis

  • Novelty and Non-Obviousness: Ensure the claims are novel and non-obvious over the prior art.
  • Claim Scope: Determine if the claims are sufficiently specific and do not cover ineligible subject matter.
  • Dependent Claims: Analyze how dependent claims further limit the independent claims to ensure they do not overly broaden the scope of the invention.

Technological Field

  • Classification: Identify the technological field under the World Intellectual Property Organization (WIPO) classification or the USPTO's technology classes.
  • Trends: Understand the trends in patent grants within this field to gauge the competitiveness and innovation landscape.

Prosecution History

  • Examiner and Law Firm: Determine if the patent was prosecuted by a large law firm and if the examiner had a high allowance rate.
  • Citation Counts: Check the backward citation counts to assess the patent's standing in the field.

Key Takeaways

  • Patent Approval Rates: Only about 55.8% of patent applications result in patents without continuation procedures.
  • Patent Quality: Factors such as the size of the entity, the law firm, and the examiner's allowance rate can significantly influence a patent's survival in post-grant challenges.
  • PAEs: Portfolio PAEs and Litigation PAEs have distinct business models that impact the patent landscape, with Portfolio PAEs generating more revenue.
  • Technological Trends: ICT and electrical engineering patents have seen significant growth, reflecting technological advancements.
  • Regulatory Environment: The AIA and the Alice/Mayo framework have introduced critical changes to patent eligibility and post-grant challenges.

FAQs

What is the average approval rate for patent applications at the USPTO?

The average approval rate for patent applications at the USPTO is approximately 55.8% without using continuation procedures[1].

How do PAEs impact the patent landscape?

PAEs, through their Portfolio and Litigation models, significantly impact the patent landscape by negotiating licenses and enforcing patents, often targeting firms across various industries[3].

What is the Alice/Mayo framework, and how does it affect patent eligibility?

The Alice/Mayo framework is a two-step test established by the Supreme Court to determine patentable subject matter. It ensures that patent claims are not directed to ineligible subject matter unless they contain an "inventive concept"[5].

What are the main differences between IPR and PGR?

Inter partes review (IPR) and post-grant review (PGR) are administrative procedures to challenge patent validity. IPR can be initiated after the patent has been granted for nine months, while PGR can be initiated within nine months of the patent's grant date. Both are decided by a panel of administrative patent judges (APJs)[5].

How have recent legislative changes affected the U.S. patent system?

The Leahy-Smith America Invents Act (AIA) introduced significant changes, including the creation of PTAB and the IPR and PGR procedures, aimed at improving patent quality and reducing litigation costs[5].

Sources

  1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
  2. Love, B. J., Miller, S. P., & Ambwani, S. (2019). Determinants of Patent Quality: Evidence from Inter Partes Review Proceedings. University of Colorado Law Review, 90(1), 67.
  3. Federal Trade Commission. (2016). Patent Assertion Entity Activity: An FTC Study.
  4. National Science Foundation. (2020). Invention: U.S. and Comparative Global Trends.
  5. Congressional Research Service. (2024). The Patent Trial and Appeal Board and Inter Partes Review.

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Details for Patent 10,143,752

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. ENTYVIO vedolizumab For Injection 125476 May 20, 2014 10,143,752 2031-05-02
Takeda Pharmaceuticals U.s.a., Inc. ENTYVIO vedolizumab Injection 761133 September 27, 2023 10,143,752 2031-05-02
Takeda Pharmaceuticals U.s.a., Inc. ENTYVIO PEN vedolizumab Injection 761133 September 27, 2023 10,143,752 2031-05-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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