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Last Updated: April 24, 2025

Patent: 10,925,876


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Summary for Patent: 10,925,876
Title:Methods for using triazolo-pyrazinyl soluble guanylate cyclase activators in fibrotic disorders
Abstract:Provided are methods for treating or preventing a fibrotic disease selected from systemic sclerosis, cystic fibrosis, non-alcoholic steatohepatitis, Peyronie's disease, or interstitial lung disease; the method comprising administering a therapeutically effective amount of a compound of Formula (I) (wherein R, R, R, R, and Rare as herein described) or a pharmaceutically acceptable salt thereof, to a patient in need of such therapy.
Inventor(s):Berger Raphaelle, Dong Guizhen, Raghavan Subharekha, Yang Zhiqiang
Assignee:Merck Sharp & Dohme Corp.
Application Number:US16301936
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,925,876

Introduction

Understanding the intricacies of a patent, particularly one like United States Patent 10,925,876, involves a deep dive into its claims, the patent landscape, and the legal frameworks that govern it. This analysis will cover the key aspects of the patent, including its claims, the novelty and nonobviousness requirements, the role of the Patent Trial and Appeal Board (PTAB), and the implications of recent legal and procedural changes.

Understanding the Patent Claims

Claim Structure and Scope

Patent claims are the heart of any patent, defining the scope of the invention and what is protected. For a patent like 10,925,876, the claims must be carefully crafted to ensure they meet the novelty and nonobviousness requirements under U.S. patent law[2].

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. This requirement ensures that the inventor has added something new to the existing body of knowledge[2].

Nonobviousness Requirement

Even if a claimed invention is novel, it must also be nonobvious. This means that the invention must not be an obvious variation of what was already known in the prior art. The nonobviousness test is crucial in determining whether the invention is worthy of patent protection[2].

The Role of the Patent Trial and Appeal Board (PTAB)

Inter Partes Review (IPR) and Post-Grant Review (PGR)

The PTAB, established by the Leahy-Smith America Invents Act (AIA), plays a significant role in challenging the validity of patents. Through IPR and PGR, entities can challenge patents before the USPTO, which is often faster and less expensive than federal court litigation. These procedures use a lower standard of proof (preponderance of the evidence) compared to federal court (clear and convincing evidence)[2].

PTAB Procedures and Benefits

PTAB procedures are designed to improve patent quality and provide a more efficient system for challenging patents that should not have issued. These procedures are particularly beneficial for entities accused of patent infringement, as they offer a quicker and more cost-effective way to resolve patent validity issues compared to traditional court litigation[2].

Legal Frameworks and Recent Changes

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA). Recent cases, such as In re Cellect, highlight the importance of performing ODP analysis based on the adjusted expiration date of the patent, including any duly granted PTA[1].

Director Review

The USPTO has introduced changes in the Director Review process, allowing for a more thorough review of PTAB decisions. This process involves an independent Delegated Review Panel (DRP) that can review fact-intensive issues and determine whether to grant rehearing or remand the case for further proceedings. This change aims to ensure that PTAB decisions are more accurately and fairly reviewed[3].

Advanced Patent Searching Techniques

Claims Variation

During the prosecution process, patent claims may be amended or narrowed to overcome prior art or objections from the examiner. This can result in variations of claims across related patents within the same patent family. Advanced patent searching techniques are essential to navigate these complexities and ensure comprehensive searches[4].

Critical Analysis of the Patent Landscape

Patent Quality and Litigation

The quality of patents is a critical issue, as poor-quality patents can fuel litigation by "patent trolls." The AIA and subsequent procedures like IPR and PGR aim to improve patent quality by providing mechanisms to challenge and potentially invalidate patents that should not have been granted. This helps in reducing unnecessary litigation and promoting innovation[2].

Impact of Recent Legal Decisions

Recent legal decisions, such as those related to ODP and Director Review, have significant implications for patent holders and challengers. These decisions clarify the application of legal doctrines and procedural rules, ensuring that patents are granted and maintained in accordance with the law.

Case Studies and Examples

In re Cellect

The In re Cellect case illustrates the complexities of ODP and the importance of considering PTA in determining patent validity. The case highlights how the Board's analysis of ODP must be based on the adjusted expiration date of the patent, including any granted PTA. This has far-reaching implications for patent strategy and litigation[1].

Key Takeaways

  • Patent Claims: The claims of a patent define its scope and must meet novelty and nonobviousness requirements.
  • PTAB: The PTAB provides efficient mechanisms for challenging patent validity through IPR and PGR.
  • ODP: ODP analysis is crucial and must consider the adjusted expiration date of the patent, including PTA.
  • Director Review: Recent changes in Director Review enhance the fairness and accuracy of PTAB decisions.
  • Advanced Searching: Advanced patent searching techniques are necessary to navigate claim variations and ensure comprehensive searches.

FAQs

What is the role of the Patent Trial and Appeal Board (PTAB) in patent litigation?

The PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, including Inter Partes Review (IPR) and Post-Grant Review (PGR). These procedures are faster and less expensive than federal court litigation and use a lower standard of proof.

How does Obviousness-Type Double Patenting (ODP) affect patent validity?

ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of PTA. ODP analysis must be based on the adjusted expiration date of the patent.

What are the benefits of using advanced patent searching techniques?

Advanced patent searching techniques help navigate the complexities of claim variations during the prosecution process, ensuring comprehensive searches and better patent insights.

How do recent changes in Director Review impact PTAB decisions?

Recent changes in Director Review allow for an independent Delegated Review Panel (DRP) to review fact-intensive issues, ensuring that PTAB decisions are more accurately and fairly reviewed.

Why is patent quality important, and how do IPR and PGR help?

Patent quality is crucial as poor-quality patents can fuel litigation. IPR and PGR help improve patent quality by providing mechanisms to challenge and potentially invalidate patents that should not have been granted, reducing unnecessary litigation and promoting innovation.

Sources

  1. In re Cellect, United States Court of Appeals for the Federal Circuit, Case: 22-1293, Document: 91, Filed: 08/28/2023.
  2. The Patent Trial and Appeal Board and Inter Partes Review, Congressional Research Service, Updated May 28, 2024.
  3. 2023 Changes in Director Review, Sterne Kessler, February 8, 2024.
  4. Advanced patent searching techniques, CAS.org, July 24, 2023.

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Details for Patent 10,925,876

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Genentech, Inc. PULMOZYME dornase alfa Solution 103532 December 30, 1993 10,925,876 2037-05-12
Genentech, Inc. ACTEMRA tocilizumab Injection 125276 January 08, 2010 10,925,876 2037-05-12
Genentech, Inc. ACTEMRA tocilizumab Injection 125472 October 21, 2013 10,925,876 2037-05-12
Genentech, Inc. ACTEMRA tocilizumab Injection 125472 November 19, 2018 10,925,876 2037-05-12
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 4 of 4 entries

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