Last Updated: August 4, 2026

Patent: 10,098,930


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Summary for Patent: 10,098,930
Title:PEGylated Recombinant Human Growth Hormone Compounds
Abstract:A chemically modified human Growth Hormone (rhGH) prepared by attaching a transient linker which comprises a polyethylene glycol. The chemically modified protein may have a much longer lasting rhGH activity than that of the unmodified rhGH, enabling reduced dose and scheduling opportunities and the modified rhGH may not cause lipoatrophy. Also includes methods of use for the treatment and/or prevention of diseases or disorders in which use of growth hormone is beneficial.
Inventor(s):Rau Harald, Kindermann Susanne, Lebmann Torben, Norskov Rasmussen Grethe, Hersel Ulrich, Wegge Thomas, Sprogoe Kennett
Assignee:Ascendis Pharma Endocrinology Division A/S
Application Number:US15000242
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 10,098,930 Claims and US Patent Landscape Analysis

Executive summary: US Patent 10,098,930 is a US grant that, based on the information provided, cannot be analyzed for claim scope, enforceable subject matter, or landscape coverage without the actual claim text (claims are referenced but not supplied). No patent-claim-level conclusions, litigation impact, Orange Book relevance, or competitor/entry risk mapping can be produced accurately from the patent number alone.

What exactly are the claims in US Patent 10,098,930 and what do they cover?

US Patent 10,098,930 claim analysis requires the full claim set (independent claim(s) and all dependent claims), including:

  • Claim preamble and any intended use limitations
  • Active ingredient and any compositional scope (defined ranges, optional components, purity, particle size, polymorph/form, stereochemistry)
  • Process steps and process constraints (order, temperatures, times, catalysts, conditions)
  • Structural limitations (substituents, linkers, scaffold definitions, sequence motifs if biologic)
  • Functional limitations (parameters with thresholds, yields, stability, receptor binding, potency, release profiles)
  • “Consisting of” vs “comprising” style transitions
  • Jeopardizing ambiguities (open-ended functional language, lack of antecedent basis, inconsistent definitions)

Without the claim text, no defensible determination can be made on:

  • What the patent protects at a technical level
  • How broadly the claims read on commercial products or generic candidates
  • Which dependent claims create narrowing funnels and which expand coverage

How strong is US Patent 10,098,930’s enforceability based on claim breadth and likely invalidity vectors?

Enforceability strength typically hinges on claim construction risk and invalidity exposure. For a claim set, a critical analysis normally addresses:

What obviousness combinations are likely to attack the independent claims?

Key factors depend on:

  • Whether the invention is a new composition versus a selection of known ranges
  • Whether it is a formulation change versus a novel manufacturing method
  • Whether functional results are supported by experimental data in the specification

Are there written description and enablement vulnerabilities?

These arise when:

  • Claims include broad ranges not supported by examples
  • Claims cover variants not enabled across the full scope
  • Functional outcomes are claimed without commensurate disclosure

What claim terms are most likely to be construed narrowly?

Common risk terms:

  • “Suitable for,” “effective amount,” “comprising,” “substantially,” “about”
  • Parameter-based limitations with unclear measurement methods

No claim text was provided, so no such evaluation can be completed.

What patents are likely in the same family as US 10,098,930 (US continuations, divisionals, and foreign equivalents)?

Landscape mapping requires:

  • The priority application(s)
  • Publication numbers (WO/US)
  • Continuation/divisional relationships
  • Foreign patent coverage

With only the grant number and without family data, no accurate family chart or overlap assessment can be produced.

How does US Patent 10,098,930 relate to Orange Book listings and FDA-approved products?

Orange Book relevance depends on:

  • Whether the patent lists in the Orange Book for an approved drug product
  • Whether the patent is listed for use code(s), dosage form, or drug substance
  • Whether it is a method-of-use patent eligible for listing

No Orange Book listing details were provided, and the claim content was not supplied, so Orange Book status cannot be analyzed.

What generic entry risks exist if a competitor launches a “nearby” product?

Generic entry risk analysis requires:

  • A claim chart comparing each limitation to generic design-arounds
  • Whether the patent covers the same active ingredient, same salt/polymorph, same formulation architecture, or same method-of-use
  • Whether the patent is a strong composition claim or a narrower process claim
  • Whether design-arounds avoid essential limitations or substitute equivalent features

Without claim text and without product mapping, no valid risk conclusions can be made.

Can US Patent 10,098,930 be challenged via inter partes review (IPR) and what would an IPR attack target?

IPR invalidity strategies depend on claim construction and prior art selection, typically focusing on:

  • Primary obviousness grounds for independent claims
  • Secondary obviousness grounds for dependent claims
  • Anticipation (35 USC 102) for single-reference coverage
  • Combination of disclosures for 103

No claim set was provided, so attack targets cannot be identified.

What patent litigation could be tied to US 10,098,930 (and which parties are commonly involved)?

A litigation landscape requires:

  • Docket-level matches to the patent number
  • Parties and asserted claims
  • Claim-specific theories and claim construction outcomes

No litigation data was provided, so no linkage can be stated.

How many patents cover the same drug product, formulation, or method-of-use (and where do they overlap)?

A meaningful “how many patents” answer requires:

  • Identification of the drug and regimen implicated by the claims
  • A family and continuation tree
  • Orange Book listing count and composition/formulation method-of-use distribution

None of that can be derived from the grant number alone in the absence of claim text or product identifiers.

What is the key claim-by-claim map needed for a competitor to assess infringement?

A complete infringement readiness package normally includes a limitation-by-limitation chart for:

  • Independent claims with all required structural, compositional, and functional elements
  • Each dependent claim’s added limitations
  • Measurement or test method definitions used in the claims
  • “Substantially”/“about” tolerance effects
  • Whether the competitor’s product/process performs each step or achieves each parameter

Because the claim text was not provided, this map cannot be built.


Key Takeaways

  • No claim scope, enforceability, design-around, or litigation risk analysis can be completed for US Patent 10,098,930 without the actual claim text.
  • Landscape work (family mapping, Orange Book status, competitor overlap, IPR attack planning, and infringement claim charts) cannot be produced accurately from the patent number alone given the constraints.
  • The next analysis step must be claim-level extraction, then mapping to prior art, product facts, and regulatory listings.

FAQs

  1. What information is required to perform a claim-construction risk assessment for a US patent like 10,098,930?
  2. How do composition versus method-of-use claims change generic design-around strategies?
  3. What claim terms most commonly drive narrow constructions in district court for pharmaceutical patents?
  4. How is a patent’s Orange Book eligibility determined for formulation and method-of-use listings?
  5. What factors decide whether a pharmaceutical patent is a good IPR target (institution likelihood and claim selection)?

References (APA)

  1. US Patent 10,098,930.

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Details for Patent 10,098,930

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ascendis Pharma Endocrinology Division A/s SKYTROFA lonapegsomatropin-tcgd For Injection 761177 August 25, 2021 10,098,930 2036-01-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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