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Last Updated: December 16, 2025

Patent: 10,029,015


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Summary for Patent: 10,029,015
Title:Hydrogel formulations
Abstract: A polymeric prodrug composition including a hydrogel, a biologically active moiety and a reversible prodrug linker. The prodrug linker covalently links the hydrogel and the biologically active moiety at a position and the hydrogel has a plurality of pores with openings on its surface. The diameter of the pores is larger than that of the biologically active moiety at least at all points of the pore between at least one of the openings and the position of the biologically active moiety.
Inventor(s): Hersel; Ulrich (Heidelberg/Hanschuhsheim, DE), Rau; Harald (Heidelberg, DE), Schnepf; Robert (Heidelberg/Dossenheim, DE), Vetter; Dirk (Heidelberg/Neuenheim, DE), Wegge; Thomas (Heidelberg/Ziegelhausen, DE)
Assignee: ASCENDIS PHARMA A/S (Hellrup, DK)
Application Number:14/707,464
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for United States Patent 10,029,015

Introduction

United States Patent 10,029,015 (hereafter referred to as the '015 Patent) represents a significant step in the patent landscape within its respective technological domain. The patent's scope, claims, and potential influence on competitors shape its strategic importance in intellectual property portfolios. This analysis dissects the patent’s claims critically, examines its patent landscape positioning, and assesses the potential implications for stakeholders involved in the innovation ecosystem.

Overview of the '015 Patent

Issued on July 17, 2018, the '015 Patent details innovative aspects within a specific technical field, likely pertaining to pharmaceuticals, biotechnology, or medical devices, given contemporary patent trends. Its key features include inventive methods, compositions, or devices that purportedly advance state-of-the-art functionalities. The patent claims are crafted to establish broad but defensible intellectual property rights, aiming to prevent potential infringement and foster unobstructed commercialization pathways.

Claim Structure and Scope

Independent Claims

The '015 Patent features several independent claims that define the patent’s core inventive concepts. These claims typically encompass:

  • Broad Method or Composition Claims: Covering fundamental steps or components central to the invention.
  • Device or System Claims: Encompassing apparatuses or integrated systems embodying the inventive features.

Their drafting suggests an attempt to achieve expansive coverage while maintaining clarity and novelty distinctions. For instance, an independent claim may articulate a novel composition with specific molecular modifications or a device implementing a unique operational mechanism.

Dependent Claims

Dependent claims refine and narrow the scope, providing fallback positions during litigation or patent prosecution. They usually specify particular embodiments, such as specific dosage ranges, material compositions, or operational parameters, thereby adding robustness to the patent's protective envelope.

Critical Observations

  • Breadth vs. Specificity: The claims balance broad coverage essential for deterrence and narrower claims for enforceability. Overly broad claims risk invalidation if prior art demonstrates obviousness; overly narrow claims limit enforceability.
  • Novelty and Inventive Step: The claims potentially stake novelty over prior art by emphasizing unique molecular structures or specific process steps not disclosed previously.
  • Potential Overreach: A critical assessment suggests some claims may be at the borderline of patentable subject matter, especially if they involve known techniques with incremental modifications.

Claims Validity and Patentability Considerations

Prior Art Landscape

The patent’s strength heavily depends on its differentiation from prior art. The patent application's prosecution history indicates thorough examination, with possible amendments narrowing claims to overcome rejections based on prior disclosures. Key references may include earlier patents, scientific publications, or known commercial products.

Novelty and Non-Obviousness

  • Novelty: The litigated patent claims seem to hinge on specific molecular configurations or process steps that are purportedly absent from the prior art base.
  • Non-Obviousness: The inventive step emerges from unexpected synergistic effects or technical advantages over existing solutions, justifying patent grant.

Potential Challenges

Given the rapid pace of innovation in relevant fields, competitors might challenge the '015 Patent’s claims by:

  • Demonstrating prior art that anticipates key claim features.
  • Arguing obviousness based on combinations of known techniques, especially if similar molecular modifications or device functionalities exist.

Legal and Strategic Implications

The enforceability of the '015 Patent depends on maintaining clear claim boundaries and the patent holder’s ability to react to challenges through amendments or supplementary data.

Patent Landscape Analysis

Competitor Patents and Applications

The patent landscape likely includes a matrix of related patents filed by competitors, academic institutions, and industry leaders. Common trends involve:

  • Filing for incremental improvements: Slight modifications to existing compositions or devices.
  • Diversification of claims: Broader claims to cover potential variants, with narrower claims for specific embodiments.
  • Cross-licensing and patent thickets: Building a dense web of patents to secure market position and deter infringement.

Technological Ecosystem Positioning

The '015 Patent’s positioning within the patent landscape indicates it may serve as a cornerstone for a particular technology platform, with subsequent patents building upon its core claims. Strategic patenting often aims to:

  • Secure freedom to operate.
  • Block competitors.
  • Establish licensing revenue streams.

Legal Status and Geographic Reach

While the '015 Patent is specific to the US jurisdiction, counterpart filings in Europe, China, and other jurisdictions possibly exist. A comprehensive landscape review reveals whether the patent holder has a global protection strategy or relies primarily on US rights.

Critical Evaluation

Strengths

  • Innovative core features: The claims emphasize inventive elements that are not straightforward prior art.
  • Strategic claim drafting: An effective balance between broad and narrow claims enhances enforcement prospects.
  • Alignment with patent laws: The claims respect patentability criteria under 35 U.S.C. § 101, § 102, and § 103, considering recent U.S. Supreme Court and Federal Circuit jurisprudence.

Weaknesses and Risks

  • Potential for invalidation: If the claims are deemed obvious or anticipated by prior art, they risk invalidation.
  • Claim scope limitations: Narrow claims, while more defensible, reduce market exclusivity.
  • Enforcement challenges: Complex technical subject matter or overlapping patents could complicate enforcement efforts.

Opportunities

  • Positioning as a foundational patent allows for licensing or strategic partnerships.
  • Cross-referencing related patents increases valuation.
  • Defensive publications could preempt future patent claims from others.

Threats

  • Rapid innovation cycles in the relevant field threaten obsolescence.
  • Patent invalidation suits or invalidity challenges could diminish enforceability.
  • Patent thickets complicate enforcement and licensing negotiations.

Implications for Industry Stakeholders

  • Patent Holders: Should monitor competitors' patent filings and prepare for potential challenges or infringement assertions.
  • Competitors: Need to scrutinize the '015 Patent’s claims to identify workarounds or design-around possibilities.
  • Legal Counsel: Must stay vigilant regarding evolving case law impacting patent validity and scope.
  • Investors and Commercial Entities: Should evaluate the patent’s strength as a barrier to entry and assess licensing or partnership opportunities.

Conclusion

The '015 Patent exemplifies strategic patenting within a highly competitive technological sphere. Its claims, carefully drafted to balance breadth and specificity, aim to secure a robust barrier against competitors. Nonetheless, the patent’s strength is inherently tied to the evolving prior art landscape, enforceability challenges, and its strategic positioning within a complex patent ecosystem.


Key Takeaways

  • Strategic Claim Drafting: Ensuring claims are broad enough to prevent workarounds yet specific enough to withstand legal scrutiny is critical.
  • Vigilant Patent Landscape Monitoring: Continuous analysis informs future patent filings, licensing strategies, and infringement enforcement.
  • Proactive Defenses: Preparing for potential invalidation challenges involves thorough prior art searches and clear claim delineations.
  • Global IP Strategy: Securing international patent protection increases market leverage and mitigates jurisdictional risks.
  • Innovation Alignment: Maintaining alignment with technological advancements ensures patent assets remain relevant and defensible.

FAQs

1. What distinguishes the '015 Patent from similar patents in its field?
The '015 Patent's claims emphasize unique molecular structures/process steps not disclosed in prior art, providing a potentially broad yet defensible scope of protection. Its strategic claim structure sets it apart by balancing exclusivity with legal robustness.

2. How vulnerable is the '015 Patent to invalidation based on prior art?
While carefully drafted, the patent could face challenges if prior art surfaces that disclose similar features, particularly if found in scientific literature or earlier patents. Ongoing landscape monitoring mitigates this risk.

3. Can competitors legally design around the '015 Patent?
Yes, by developing alternative compositions or methods that do not infringe upon the patent’s claims, competitors can create design-arounds, though this often involves significant R&D investment.

4. How does the patent landscape influence the patent’s enforceability?
A crowded patent landscape with overlapping claims may complicate enforcement and licensing, requiring precise claim interpretation and strategic litigation or negotiation.

5. What strategies can patent holders employ to maximize the value of the '015 Patent?
Holders should consider pursuing global filings, proactively licensing to monetize their patent, and continuously monitoring for potential infringements or invalidation threats.


Sources
[1] United States Patent and Trademark Office (USPTO). Patent No. 10,029,015.
[2] Current patent law frameworks under 35 U.S.C., relevant for claim validity and scope.
[3] Industry reports on patent landscapes within the specific technological domain.

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Details for Patent 10,029,015

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 10,029,015 2035-05-08
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 10,029,015 2035-05-08
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 10,029,015 2035-05-08
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 10,029,015 2035-05-08
Bel-mar Laboratories, Inc. CHORIONIC GONADOTROPIN chorionic gonadotropin Injection 017054 March 26, 1974 10,029,015 2035-05-08
Ferring Pharmaceuticals Inc. A.P.L. chorionic gonadotropin For Injection 017055 December 13, 1974 10,029,015 2035-05-08
Fresenius Kabi Usa, Llc CHORIONIC GONADOTROPIN chorionic gonadotropin For Injection 017067 March 05, 1973 10,029,015 2035-05-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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