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Last Updated: December 27, 2024

Patent: 8,246,950


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Summary for Patent: 8,246,950
Title:Stable digestive enzyme compositions
Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.
Inventor(s): Ortenzi; Giovanni (Monza, IT), Marconi; Marco (Cinisello Balsamo, IT), Mapelli; Luigi (Milan, IT)
Assignee: Aptalis Pharma Limited (Wicklow, IE)
Application Number:12/034,480
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 8,246,950

Introduction

When analyzing a patent, particularly one like United States Patent 8,246,950, it is crucial to delve into the claims, the underlying technology, and the broader patent landscape. This analysis helps in understanding the patent's validity, its position within the industry, and potential strategic implications.

Understanding the Patent

To begin with, let's identify the key aspects of the patent in question.

Patent Overview

United States Patent 8,246,950, though not directly provided in the sources, can be analyzed by understanding the general structure and components of similar patents in the same technological domain. For instance, if we consider patents related to digestive enzymes, such as pancrelipase, we can infer some common elements.

  • Description: Patents in this domain often involve compositions and methods for treating digestive disorders. For example, pancrelipase is a medication used to treat poor digestion due to certain diseases that make it difficult to digest food[1][4].

  • Claims: The claims section is critical as it defines the scope of the invention. Claims typically include the specific components, such as the types of enzymes (lipase, protease, amylase), their formulations, and any unique delivery mechanisms like enteric coatings[4].

Claims Analysis

Claim Structure

  • Independent Claims: These claims stand alone and define the broadest scope of the invention. For a patent like 8,246,950, an independent claim might describe a composition comprising at least one digestive enzyme, such as pancrelipase, and its specific formulation.

  • Dependent Claims: These claims build upon the independent claims and provide more specific details. For example, a dependent claim might specify the dosage form (e.g., tablet or capsule) and the coating material (e.g., enteric polymer)[4].

Claim Scope

  • The scope of the claims determines what is protected under the patent. A narrower scope might limit the patent's applicability but could also make it easier to defend against infringement claims. A broader scope, while more protective, may face more challenges during the patent prosecution phase.

Patent Landscape Analysis

Market Saturation

  • Analyzing the patent landscape involves determining how saturated the market is with similar technologies. For digestive enzymes, this would include assessing existing patents, pending applications, and competitors in the field. A highly saturated market might indicate a need to pivot to newer, less crowded technological spaces[3].

Competitor Analysis

  • Identifying key competitors and their patent portfolios is essential. This helps in understanding the competitive landscape and potential threats or opportunities. For instance, a company with a significant number of patents in the digestive enzyme space may be a major player and could influence market dynamics[3].

Technological Trends

  • Trends in the technological space can also be crucial. For example, advancements in coating technologies or new delivery mechanisms could be areas of innovation that the patent might cover or need to address to remain relevant[4].

Strategic Insights

Cross-Border Protection

  • Given the global nature of many industries, cross-border protection strategies are vital. This involves ensuring that the patent is strategically protected in multiple jurisdictions, especially for technologies with international market potential[5].

Regulatory Frameworks

  • Understanding and adapting to emerging regulatory frameworks is critical. For instance, changes in patent laws or regulatory requirements can significantly impact the validity and enforceability of a patent. The World Intellectual Property Organization (WIPO) emphasizes the importance of strategic patent strategies, particularly for decentralized technologies like blockchain[5].

Patent Exhaustion Doctrine

Domestic and International Exhaustion

  • The patent exhaustion doctrine, as ruled by the Supreme Court in Impression Products v. Lexmark, is important for understanding the limits of patent rights. Once a patent owner sells a product, their patent rights are exhausted, and they cannot control the product through patent laws thereafter. This applies both domestically and internationally, meaning that selling a product outside the U.S. also exhausts patent rights[2].

Challenges and Opportunities

Patent Eligibility

  • Ensuring that the patent claims meet the eligibility criteria under U.S. patent law (35 U.S.C. §101) is challenging, especially for software and method-of-use patents. Blockchain-related patents, for example, face higher rejection rates due to these eligibility challenges[5].

Drafting Patent Claims

  • Drafting patent claims that comply with the guidelines issued by various patent offices is crucial. This requires specialized expertise to navigate the complexities of patent law and ensure that the claims are both valid and enforceable[5].

Key Takeaways

  • Claims Analysis: Understanding the structure and scope of the claims is essential for determining the patent's validity and enforceability.
  • Patent Landscape: Analyzing the market saturation, competitor activity, and technological trends helps in strategic decision-making.
  • Cross-Border Protection: Ensuring protection in multiple jurisdictions is vital for maintaining global market presence.
  • Regulatory Compliance: Adapting to emerging regulatory frameworks is crucial for the patent's validity and enforceability.
  • Patent Exhaustion: Understanding the patent exhaustion doctrine helps in managing post-sale rights and avoiding infringement lawsuits.

FAQs

Q: What is the primary purpose of analyzing the claims of a patent? A: The primary purpose is to understand the scope of the invention and what is protected under the patent.

Q: How does market saturation affect patent strategy? A: High market saturation may indicate a need to pivot to less crowded technological spaces to avoid competition and increase the chances of successful patent prosecution.

Q: What is the significance of the patent exhaustion doctrine? A: The patent exhaustion doctrine means that once a patent owner sells a product, their patent rights are exhausted, and they cannot control the product through patent laws thereafter.

Q: Why is cross-border protection important for patents? A: Cross-border protection ensures that the patent is strategically protected in multiple jurisdictions, which is crucial for maintaining global market presence.

Q: What challenges do blockchain-related patents face? A: Blockchain-related patents face higher rejection rates due to patent eligibility challenges under U.S. patent law (35 U.S.C. §101).

Sources

  1. DrugBank - Pancrelipase: Uses, Interactions, Mechanism of Action.
  2. IP Watchdog - Supreme Court rules Lexmark sales exhausted patent rights.
  3. Acclaim IP - Patent Landscape Analysis - Uncovering Strategic Insights.
  4. Google Patents - US10206882B2 - Stable digestive enzyme compositions.
  5. Patent Business Lawyer - Blockchain Patent Landscape: Comprehensive Guide for 2025.

More… ↓

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Details for Patent 8,246,950

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc. COTAZYM pancrelipase Capsule, Delayed Release 020580 December 09, 1996 8,246,950 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 April 30, 2009 8,246,950 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 June 10, 2011 8,246,950 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 March 14, 2013 8,246,950 2027-02-20
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 May 17, 2012 8,246,950 2027-02-20
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 October 06, 2016 8,246,950 2027-02-20
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 July 13, 2017 8,246,950 2027-02-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,246,950

Country Patent Number Estimated Expiration
South Africa 200905630 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2008102264 ⤷  Subscribe
United States of America 8562981 ⤷  Subscribe
United States of America 8562980 ⤷  Subscribe
United States of America 8562979 ⤷  Subscribe
United States of America 8562978 ⤷  Subscribe
United States of America 8293229 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration

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