Patent: 8,236,750

Summary for Patent: 8,236,750

Title:	Composition comprising a pulmonary surfactant and a TNF-derived peptide
Abstract:	The invention relates to the combination of a pulmonary surfactant and a TNF-derived peptide and its use for the treatment of respiratory disease.
Inventor(s):	Schaefer Klaus P., Wollin Stefan-Lutz, Muehldorfer Ingeborg
Assignee:	Nycomed GmbH
Application Number:	US11658727
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 8,236,750

Introduction

United States Patent 8,236,750, like any other patent, is a complex document that grants exclusive rights to its holder for a specific invention. To understand its implications and the broader patent landscape, it is crucial to delve into the details of the patent claims, the legal framework governing patents, and the potential challenges and controversies surrounding such patents.

Understanding Patent Claims

Patent claims are the heart of any patent, defining the scope of the invention and the rights granted to the patent holder. These claims must be clear, concise, and technically detailed to inform the public about what the patented invention is[5].

Eligible Subject Matter Requirement

For a patent to be valid, it must satisfy the eligible subject matter requirement. This means the invention must be a new and useful "process, machine, manufacture, or composition of matter, or improvement thereof"[1]. The Supreme Court has clarified that laws of nature, natural phenomena, and abstract ideas are not patentable, as they are considered the "basic tools of scientific and technological work"[1].

Novelty and Nonobviousness Requirements

The claimed invention must also be novel, meaning it was not previously 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]. Additionally, the invention must be nonobvious, meaning it must be significantly different from existing knowledge and not obvious to a person of ordinary skill in the relevant field[1].

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

The PTAB, established by the Leahy-Smith America Invents Act (AIA) in 2011, plays a critical role in challenging the validity of patents. PTAB administers Inter Partes Review (IPR) and Post-Grant Review (PGR) proceedings, which allow third parties to challenge patents on grounds such as lack of novelty, nonobviousness, or failure to satisfy the eligible subject matter requirement[1][4].

Inter Partes Review (IPR)

IPR is a faster and less expensive alternative to judicial proceedings for challenging patent validity. The standard for invalidity in IPR is "preponderance of the evidence," which is lower than the "clear and convincing" standard used in district courts. This process is often favored by accused patent infringers due to its efficiency and lower burden of proof[1][4].

Estoppel and Its Implications

Following an IPR, estoppel may attach to the patent owner and the petitioner, preventing them from asserting or challenging the same claims in other forums. This includes district courts and the International Trade Commission (ITC). The scope of estoppel, however, remains a subject of ongoing legal debate[4].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," play a significant role in the patent landscape. They can be categorized into two main types: Litigation PAEs and Portfolio PAEs. Litigation PAEs primarily generate revenue through litigation, while Portfolio PAEs negotiate licenses for large portfolios of patents. PAEs often target a wide range of industries, including retail and technology sectors[3].

Freedom to Operate (FTO)

When analyzing a patent like 8,236,750, it is essential to conduct a Freedom to Operate (FTO) search. This involves identifying all relevant patents that may cover different features or subsystems of the invention. An FTO search helps determine whether the product or service infringes on any enforceable patents, ensuring that the invention is not covered by existing patent claims[5].

Critical Analysis of Patent 8,236,750

Claims Analysis

To critically analyze the claims of Patent 8,236,750, one must examine each claim for clarity, specificity, and compliance with the eligible subject matter, novelty, and nonobviousness requirements. Any ambiguity or lack of detail in the claims could lead to challenges during IPR or PGR proceedings.

Potential Challenges

Given the lower burden of proof in IPR proceedings, Patent 8,236,750 could be vulnerable to challenges if the claims are not robustly supported by prior art or if there are significant doubts about their novelty or nonobviousness. The PTAB's broadest reasonable construction of claims could also impact the patent's validity.

Impact on Industry

The patent's impact on the industry depends on its scope and the sectors it affects. If the patent is asserted aggressively by a PAE, it could lead to significant litigation costs and disruptions for companies operating in those sectors. Conversely, if the patent is held by an operating company, it might be used to protect innovation and prevent unauthorized use.

Case Studies and Industry Trends

Litigation Trends

Recent trends show an upswing in US patent litigation, with Non-Practicing Entities (NPEs) continuing to play a significant role. This environment makes it crucial for patent holders to ensure their patents are robust and for potential infringers to be aware of the patent landscape[2].

PAE Activities

The FTC study on PAEs highlights the different business models and their revenue generation strategies. Understanding these models can help companies anticipate and prepare for potential patent assertion activities[3].

Key Takeaways

• Clear and Specific Claims: Patent claims must be clear, concise, and technically detailed to define the scope of the invention.
• Legal Framework: Patents must comply with eligibility, novelty, and nonobviousness requirements.
• PTAB and IPR: The PTAB and IPR proceedings provide a faster and less expensive way to challenge patent validity.
• PAEs and Litigation: PAEs can significantly impact the patent landscape through litigation and licensing activities.
• Freedom to Operate: Conducting an FTO search is essential to ensure that a product or service does not infringe on existing patents.

FAQs

1. What is the role of the PTAB in patent challenges? The PTAB administers IPR and PGR proceedings, allowing third parties to challenge the validity of patents on various grounds.

2. How does IPR differ from district court litigation? IPR has a lower burden of proof ("preponderance of the evidence") and is generally faster and less expensive than district court litigation.

3. What are the two main types of PAEs? The two main types are Litigation PAEs, which generate revenue primarily through litigation, and Portfolio PAEs, which negotiate licenses for large portfolios of patents.

4. Why is an FTO search important? An FTO search helps determine whether a product or service infringes on any enforceable patents, ensuring that the invention is not covered by existing patent claims.

5. What are the implications of estoppel in IPR proceedings? Estoppel prevents the patent owner and the petitioner from asserting or challenging the same claims in other forums, such as district courts and the ITC.

Sources

1. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review, Updated May 28, 2024.
2. RPX Corporation. Q3 in Review: US NPE Upswing Continues as UPC Comes Further into Focus, October 8, 2024.
3. Federal Trade Commission. Patent Assertion Entity Activity: An FTC Study, 2023.
4. Maier & Maier. Inter Partes Review (IPR), 2024.
5. World Intellectual Property Organization. Tool 5 Freedom to Operate, 2022.

Details for Patent 8,236,750

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	SURVANTA	beractant	Suspension	020032	July 01, 1991	8,236,750	2025-07-27
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	July 01, 1998	8,236,750	2025-07-27
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	December 12, 2002	8,236,750	2025-07-27