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Last Updated: December 25, 2024

Patent: 10,105,356


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Summary for Patent: 10,105,356
Title:Aerosol pirfenidone and pyridone analog compounds and uses thereof
Abstract: Disclosed herein are formulations of pirfenidone or pyridone analog compounds for aerosolization and use of such formulations for aerosol administration of pirfenidone or pyridone analog compounds for the prevention or treatment of various fibrotic and inflammatory diseases, including disease associated with the lung, heart, kidney, liver, eye and central nervous system. In some embodiments, pirfenidone or pyridone analog compound formulations and delivery options described herein allow for efficacious local delivery of pirfenidone or pyridone analog compound. Compositions include all formulations, kits, and device combinations described herein. Methods include inhalation procedures, indications and manufacturing processes for production and use of the compositions described.
Inventor(s): Surber; Mark William (San Diego, CA)
Assignee: Avalyn Pharma Inc. (Seattle, WA)
Application Number:13/950,110
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the U.S. Patent Landscape and the Significance of Patent Claims: A Comprehensive Analysis

Introduction

The U.S. patent system is a cornerstone of innovation policy, designed to promote scientific and technological advancements by granting inventors exclusive rights to their inventions for a limited time. This article delves into the intricacies of the U.S. patent landscape, focusing on the critical aspects of patent claims and their impact on the broader patent ecosystem.

The Statutory Basis of U.S. Patent Law

The authority for the U.S. patent system is rooted in the U.S. Constitution, which empowers Congress to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries"[1].

Types of Patents

The U.S. Patent and Trademark Office (USPTO) grants three primary types of patents:

  • Utility Patents: For new and useful processes, machines, articles of manufacture, or compositions of matter, or any new and useful improvement thereof.
  • Design Patents: For new, original, and ornamental designs for articles of manufacture.
  • Plant Patents: For new and distinct varieties of plants[1].

Patentability Requirements

For an invention to be patentable, it must meet several criteria:

  • Usefulness: The invention must be operable and provide some tangible benefit.
  • Novelty: The invention must not be fully anticipated by prior art.
  • Nonobviousness: The invention must not have been readily within the ordinary skills of a competent artisan at the time it was made[1].

The Role of Patent Claims

Patent claims are the heart of a patent application, defining the scope of the invention and the rights granted to the patent holder. Here are some key aspects of patent claims:

Importance of Claims

The business and legal value of a patent resides in its claims. With the increasing number of patent applications and claims, the ability to rapidly and consistently review claims is essential[2].

Structure and Hierarchy

Claims are typically arranged in a hierarchy, with independent claims being the broadest and dependent claims narrowing down the scope. Advanced software tools, such as the Patent Matrix, help in parsing and compressing these claims for easier review[2].

Challenges in Claims Interpretation

The interpretation of patent claims can be complex, especially with legal precedents like the Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd. case, which can limit the scope of claims through prosecution history estoppel and the doctrine of equivalents[2].

The Patent Trial and Appeal Board (PTAB)

Creation and Purpose

The PTAB was established by the 2011 Leahy-Smith America Invents Act (AIA) to improve patent quality and provide a more efficient system for challenging patents that should not have been issued. PTAB hears administrative challenges to the validity of patents, such as Inter Partes Review (IPR) and Post-Grant Review (PGR)[3].

Impact on Patent Litigation

PTAB processes are generally faster and less expensive than judicial proceedings, with a lower burden of proof to invalidate patents. This has made PTAB a preferred route for entities facing patent infringement claims, although critics argue it has created uncertainty in patent rights and stifled innovation[3].

Patent Assertion Entities (PAEs)

Business Models

PAEs, often referred to as "patent trolls," operate under two main business models:

  • Litigation PAEs: These entities primarily generate revenue through patent infringement lawsuits.
  • Portfolio PAEs: These entities negotiate licenses covering large portfolios of patents without necessarily resorting to litigation[4].

Impact on the Patent Landscape

PAEs focus heavily on Information and Communication Technology (ICT) and software patents, asserting these patents against a broad range of industries. The FTC has noted that while PAEs can facilitate the transfer of patent rights, their activities can also lead to significant litigation costs and uncertainty in the patent landscape[4].

The Alice/Mayo Framework

Patentable Subject Matter

The Supreme Court's Alice/Mayo framework is a two-step test for determining patentable subject matter. It first assesses whether the patent claims are directed to ineligible subject matter (e.g., laws of nature, natural phenomena, or abstract ideas). If so, the second step determines whether the claims contain an "inventive concept" that transforms the nature of the ineligible subject matter[3].

Case Study: United States Patent 10,105,356

While the specific details of this patent are not provided here, understanding its claims and context within the broader patent landscape is crucial.

Claim Analysis

  • Claim Scope: Analyzing the hierarchy and breadth of the claims to understand the invention's scope and the rights granted.
  • Prior Art: Ensuring the claims are novel and nonobvious by comparing them against prior art.
  • Legal Precedents: Considering how legal precedents like Festo and the Alice/Mayo framework might impact the interpretation and validity of the claims.

PTAB and PAE Considerations

  • Challenging Validity: If the patent is challenged via PTAB, understanding the process and potential outcomes is vital.
  • Assertion by PAEs: If the patent is held by a PAE, the business model and typical assertion behaviors of such entities need to be considered.

Key Takeaways

  • Patent Claims Are Central: The value and scope of a patent are defined by its claims.
  • Complexity in Interpretation: Legal precedents and administrative challenges can significantly impact claim interpretation.
  • PTAB and PAEs: These entities play crucial roles in shaping the patent landscape through challenges and assertions.
  • Innovation Policy: The U.S. patent system aims to balance innovation incentives with the need to maintain patent quality and reduce unwarranted litigation.

FAQs

What are the main types of patents granted by the USPTO?

The USPTO grants utility patents, design patents, and plant patents.

How do patent claims impact the value of a patent?

Patent claims define the scope of the invention and the rights granted to the patent holder, making them the core of a patent's business and legal value.

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

PTAB hears administrative challenges to the validity of patents, aiming to improve patent quality and reduce unwarranted litigation costs.

What are Patent Assertion Entities (PAEs), and how do they operate?

PAEs operate under two main models: Litigation PAEs, which generate revenue through lawsuits, and Portfolio PAEs, which negotiate licenses without litigation.

How does the Alice/Mayo framework affect patentability?

The Alice/Mayo framework is a two-step test to determine if patent claims are directed to ineligible subject matter and whether they contain an "inventive concept" that transforms the ineligible subject matter.

Sources

  1. Congressional Research Service, "Patents and Innovation Policy," June 25, 2022.
  2. Google Patents, "US20110138338A1 - Patent Claims Analysis System and Method."
  3. Congressional Research Service, "The Patent Trial and Appeal Board and Inter Partes Review," May 28, 2024.
  4. Federal Trade Commission, "Patent Assertion Entity Activity: An FTC Study."

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Details for Patent 10,105,356

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biogen Inc. AVONEX interferon beta-1a For Injection 103628 May 17, 1996 10,105,356 2031-01-31
Biogen Inc. AVONEX interferon beta-1a Injection 103628 May 28, 2003 10,105,356 2031-01-31
Biogen Inc. AVONEX interferon beta-1a Injection 103628 February 27, 2012 10,105,356 2031-01-31
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 March 07, 2002 10,105,356 2031-01-31
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 December 17, 2004 10,105,356 2031-01-31
Emd Serono, Inc. REBIF interferon beta-1a Injection 103780 December 21, 2012 10,105,356 2031-01-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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