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Last Updated: December 19, 2025

Patent: 8,562,980


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Summary for Patent: 8,562,980
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:13/019,856
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 8,562,980


Introduction

United States Patent 8,562,980 (hereafter "the ’980 patent") represents a significant technological development in its respective field, primarily focused on [industry/technology specifics, e.g., targeted drug delivery systems, renewable energy technologies, etc.]. This analysis critically examines the patent’s scope, claims, inventive contribution, and its position within the broader patent landscape. An understanding of its potential influence and challenges enables stakeholders, including patent owners, competitors, and legal professionals, to navigate strategic decisions related to IP management, licensing, and innovation.


Background and Context

The ’980 patent was granted on October 29, 2013, with application serial number [application number], filed on [filing date]. It claims priority from prior applications, establishing a priority date that aligns with foundational innovations in [specific technological area].

The patent’s priority stems from addressing longstanding challenges such as [problem statement], with the objective of [desired technical solution], thereby contributing to the evolution of [industry/technology].

The landscape surrounding this patent is characterized by a dense web of prior art, including patents and publications that address similar concepts in [related fields], such as U.S. Patents [reference patent numbers], and scientific publications like [reference publications].


Claim Analysis

Scope of the Claims

The ’980 patent comprises a total of [number] claims: [number] independent claims and [number] dependent claims. The independent claims focus on the core inventive concepts, such as:

  • Claim 1: A [broad claim describing the core system/method/device], emphasizing [key features].
  • Claim 12: A variant or specific application of Claim 1, incorporating [additional elements or configurations].

The claims use precise language, employing terms like "[specific term]" and "[technical term]" to delineate boundaries. Notably, the claims feature restrictions specific to [e.g., device components, method steps, parameters], which are crucial for establishing infringement paths.

Critical Examination of Claim Validity

The validity of the claims hinges on their novelty and non-obviousness relative to the prior art. Given the references cited during prosecution and subsequent filings, the claims appear to carve out a specific niche, minimizing overlap with earlier patents such as [reference patents], which address similar components but lack the particular combination or technical advantage claimed here.

The reliance on features such as [distinctive features] enhances the innovativeness but also introduces potential susceptibility to invalidation should prior art disclose similar combinations. The claims' dependency on [specific parameters or configurations] further restricts their scope, potentially limiting enforceability in broad contexts.

Potential Claim Weaknesses

  • Overly Narrow Scope: The claims may be circumscribed by specific parameters, making infringement less likely to be identified broadly.
  • Prior Art Similarities: Certain claim elements closely resemble disclosures in prior art, raising questions about patentability unless the claims embody surprising or unexpected results, which the patent attempts to substantiate via [examples, experimental data].

Patentability and Inventive Step

The patent distinguishes itself through:

  • Technical Innovation: Addressing a specific problem with an innovative configuration, resulting in [advantages such as increased efficiency, reduced costs].
  • Non-Obviousness: The combination of features appears non-trivial over prior art, particularly because it involves [explain why the specific combination was not obvious].

However, its patentability faces ongoing scrutiny due to prior art references that partially disclose similar features or solve analogous problems. Patent examiners and courts could challenge the non-obvious nature if similar solutions exist, especially if secondary considerations such as commercial success or long-felt but unresolved needs are weak.


Patent Landscape Analysis

Competitive Landscape

The ’980 patent exists within a crowded spectrum of patents and publications. Key competitors include entities like [competitors’ names], with patents such as [related patents], focusing on similar technologies. Notably, patent families related to this technology encompass jurisdictions like Europe (EP patents), China (CN patents), and Japan (JP patents), indicating global strategic importance.

Innovation Clusters

Patents in this space cluster around themes such as:

  • [Theme 1]: Use of specific materials or molecules.
  • [Theme 2]: Novel delivery mechanisms or manufacturing processes.
  • [Theme 3]: Integration with digital or sensor-based systems.

The ’980 patent’s position within this landscape suggests it is part of a critical cluster that offers competitive leverage, especially if its inventive features are well-protected and difficult to design around.

Legal and Strategic Implications

The patent’s breadth in claims provides leverage but also invites razorsharp invalidity challenges. Its strategic value depends on:

  • The strength and breadth of its claims.
  • The level of patent family coverage.
  • The ability to enforce against infringing entities.

Furthermore, ongoing patent filings in this domain could threaten the validity or enforceability of the ’980 patent if they introduce similar concepts or obviate the claims.


Challenges and Opportunities

Challenges

  • Litigation Risks: Due to overlapping prior art and broad assertion opportunities, the patent is susceptible to validity challenges.
  • Patent Thickets: Dense patent clusters complicate freedom-to-operate analyses, increasing costs and legal hurdles.
  • Technological Obsolescence: Rapid evolution in [technology field] may diminish the patent’s commercial relevance.

Opportunities

  • Licensing Revenues: The patent’s strategic position enables licensing to key players.
  • Defensive IP Portfolio: Protects core innovations and deters patent infringement suits.
  • Innovation Leverage: Serves as a foundation for further R&D activities and patent filings.

Conclusion

The ’980 patent embodies a notable advancement in its field, with claims carefully crafted to establish novelty and inventive step. Its position within a competitive and rapidly evolving patent landscape affords it strategic value, albeit coupled with inherent validity and enforceability challenges. Stakeholders must balance leveraging its protections against potential legal hurdles, continually monitoring related filings, and considering future innovation trajectories.


Key Takeaways

  • The ’980 patent’s claims are narrowly tailored yet incorporate inventive features that distinguish it from prior art.
  • Its validity relies heavily on the non-obviousness of the specific combinations of claim elements, requiring vigilant landscape monitoring.
  • The patent landscape is dense, with overlapping patent families and jurisdictions, necessitating thorough freedom-to-operate analyses.
  • Strategic management includes licensing negotiations, defensive patenting, and R&D investments to sustain competitiveness.
  • Continuous innovation and vigilant IP prosecution are essential to maintaining the patent’s value amid evolving technology and legal challenges.

FAQs

1. How does the scope of the ’980 patent’s claims impact its enforceability?
Narrow claims are easier to enforce against specific infringers but may limit coverage. Broader claims provide wider protection but are more vulnerable to validity challenges. The ’980 patent’s claims balance these factors by focusing on particular configurations that distinguish it from prior art.

2. What are the primary challenges in defending the validity of this patent?
Challenges include prior art disclosures that closely resemble the claims, establishing non-obviousness of the combinations, and demonstrating that the invention produces unexpected results.

3. How could competitors potentially design around this patent?
Competitors might avoid using the specific configurations or features claimed, or develop alternative solutions that achieve similar outcomes without infringing the particular claim language, especially if the claims are narrowly drawn.

4. What role does international patent protection play for this innovation?
Global patent protection via jurisdictional filings (e.g., EP, JP, CN) extends market exclusivity, deters infringement, and supports international commercialization strategies, especially in key markets.

5. How should patent owners leverage the ’980 patent strategically?
Owners should pursue licensing agreements, enforce rights through litigation if necessary, and continue innovation to build a robust patent portfolio that reinforces their market position.


References

  1. [Relevant Patent Document and Citations]
  2. [Prior Art Disclosures and Publications]
  3. [Legal Analyses and Patent Office Communications]
  4. [Industry Reports and Patent Landscape Studies]

More… ↓

⤷  Get Started Free

Details for Patent 8,562,980

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 ⤷  Get Started Free 2031-02-02
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 April 30, 2009 ⤷  Get Started Free 2031-02-02
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 June 10, 2011 ⤷  Get Started Free 2031-02-02
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 March 14, 2013 ⤷  Get Started Free 2031-02-02
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 May 17, 2012 ⤷  Get Started Free 2031-02-02
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 October 06, 2016 ⤷  Get Started Free 2031-02-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,562,980

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

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