Patent: 10,035,766

Summary for Patent: 10,035,766

Title:	Compositions for preventing and/or treating lysosomal storage disorders
Abstract:	The present invention provides novel compositions as well as methods for preventing and/or treating lysosomal storage disorders. In particular, the present invention provides methods for preventing and/or treating Gaucher\'s disease.
Inventor(s):	Boyd; Robert (Horsham, PA), Lee; Gary (West Windsor, NJ), Rybczynski; Philip (Branchburg, NJ)
Assignee:	Amicus Therapeutics, Inc. (Cranbury, NJ)
Application Number:	14/083,634
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,035,766

Introduction

Patents are a cornerstone of innovation, providing inventors and companies with the exclusive rights to their inventions. Understanding the claims and the broader patent landscape is crucial for navigating the complex world of intellectual property. This article will delve into the specifics of United States Patent 10,035,766, examining its claims, the patent landscape, and the broader implications for innovation and business strategy.

Understanding Patent Claims

Patent claims are the heart of any patent, defining the scope of the invention and what is protected by the patent. These claims must be carefully crafted to ensure they are novel, nonobvious, and directed to patent-eligible subject matter[3].

Novelty Requirement

For a patent to be granted, 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[3].

Nonobviousness Requirement

In addition to novelty, the claimed invention must also be nonobvious. This means that the invention must be significantly different from existing knowledge and not an obvious combination of prior art elements[3].

Patent-Eligible Subject Matter

The claims must also be directed to patent-eligible subject matter. This involves ensuring that the invention is not a law of nature, natural phenomenon, or abstract idea, unless it contains an inventive concept that transforms the nature of the claim[3].

The Patent 10,035,766: A Case Study

To analyze the claims of United States Patent 10,035,766, we need to consider the specific details of the patent.

Claim Structure

The patent claims are typically structured in a hierarchical manner, with independent claims and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations[2].

Claims Analysis System

Advanced systems, such as the Patent Claims Analysis System, can help in parsing and displaying these claims in a hierarchical and interactive format. This system allows users to input a unique identifier, import the patent from a database, parse the claims, and display them in a compressed format that can be expanded as needed[2].

Patent Landscape and Trends

Understanding the broader patent landscape is essential for contextualizing any specific patent.

Increasing Patent Applications

The number of patent applications has been increasing steadily over the years, driven by technological innovation and facilitated by advancements in technology such as word processing and remote electronic database searching[2].

Geographical Distribution

Patent data can be analyzed geographically, with tools like the USPTO's Patent Technology Monitoring Team providing state, county, and metropolitan regional patent data. This helps in identifying hotspots of innovation and trends in patenting activity[1].

Patent Families

Patent families, which include all related patents filed in different jurisdictions, provide a broad measure of global invention. However, variations in claims across different patents within the same family can complicate analysis, especially after amendments during the prosecution process[4].

Valuation of Patents

The value of a patent can be significant, and understanding this value is crucial for business strategy.

Valuation Methods

There are three primary methods for valuing patents: the cost approach, the income approach, and the market approach. The cost approach considers the replacement cost or the cost of developing the patent. The income approach looks at the future benefits provided by the patent, while the market approach determines the value based on what a willing buyer would pay[5].

Financial Implications

The financial implications of holding a patent can be substantial. For example, the median asking price for a patent can range from $108,000 to $250,000 per family, with some patents selling for as much as $1 million[5].

Challenges in Patent Analysis

Analyzing patents, especially in a rapidly evolving landscape, comes with several challenges.

Data Accuracy

One of the challenges is ensuring data accuracy, particularly with the presence of artificial priority patents that may lack critical information. Addressing this involves selecting the first utility patent in the family as a replacement for the artificial priority patent to obtain relevant information[1].

Claims Variation

Claims can vary significantly across different patents within the same family due to amendments during the prosecution process. This variation complicates comprehensive searches and requires advanced searching techniques to navigate[4].

Legal and Regulatory Framework

The legal and regulatory framework governing patents is complex and evolving.

Patent Trial and Appeal Board (PTAB)

The PTAB plays a crucial role in reviewing patent validity through inter partes review. This process involves determining whether the patent claims are directed to ineligible subject matter and whether they meet the novelty and nonobviousness requirements[3].

Proposed Reforms

There are ongoing debates and proposed reforms regarding the PTAB, including issues of standing, burdens of proof, and discretionary institution of reviews. These reforms aim to improve the efficiency and fairness of the patent review process[3].

Industry Insights and Expert Opinions

Industry experts and practitioners offer valuable insights into the patent landscape.

"The ability to understand and communicate one's patent property and competitive position with respect to a large field of other patent property is a difficult task, and is only becoming more difficult with time."[2]

This quote highlights the increasing complexity of managing patent portfolios and the need for sophisticated tools and strategies to navigate this landscape.

Statistics and Trends

Several statistics underscore the significance and trends in patenting activity:

"From 1963 through 1983, approximately 100,000 patent applications per year were filed at the United States Patent & Trademark Office (USPTO), whereas in 2001 alone, 326,508 patent applications were filed."[2]

This trend indicates a substantial increase in patent applications, driven by technological advancements and the need for intellectual property protection.

Key Takeaways

• Patent Claims: Carefully crafted claims are essential for defining the scope of the invention and ensuring patent protection.
• Patent Landscape: The number of patent applications is increasing, driven by technological innovation, and geographical distribution of patents can reveal trends in innovation.
• Valuation: Patents can be highly valuable, with various methods for valuation including cost, income, and market approaches.
• Challenges: Data accuracy and claims variation are significant challenges in patent analysis.
• Legal Framework: The PTAB and ongoing reforms play a critical role in shaping the patent landscape.

FAQs

Q: What is the primary purpose of patent claims?

A: The primary purpose of patent claims is to define the scope of the invention and what is protected by the patent.

Q: How has the number of patent applications changed over the years?

A: The number of patent applications has significantly increased over the years, from approximately 100,000 per year in the 1960s and 1980s to over 326,000 in 2001.

Q: What are the main methods for valuing patents?

A: The main methods for valuing patents include the cost approach, the income approach, and the market approach.

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

A: The PTAB reviews patent validity through inter partes review, determining whether patent claims are directed to ineligible subject matter and meet novelty and nonobviousness requirements.

Q: How do artificial priority patents affect patent data analysis?

A: Artificial priority patents can lead to missing information, but selecting the first utility patent in the family as a replacement can help obtain relevant information and improve data accuracy.

Sources

1. National Science Foundation. Invention, Knowledge Transfer, and Innovation. 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. 2023.
4. CAS.org. Advanced patent searching techniques - CAS.org. 2023.
5. Perpetual Motion Patents. The value of a patent.

Details for Patent 10,035,766

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	May 23, 1994		2029-10-19
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	September 22, 1999		2029-10-19