Last Updated: July 5, 2026

Patent: 10,537,616


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Summary for Patent: 10,537,616
Title:Method for improving the stability of purified factor VIII after reconstitution
Abstract:The present disclosure relates to a method for increasing the stability of a Factor VIII molecule after purification, lyophilization and reconstitution, comprising preventing proteolytic cleavage of the Factor VIII molecule into a first fragment comprising essentially the A1 domain and the A2 domain and a second fragment comprising essentially the A3 domain, the C1 domain and the C2 domain throughout manufacturing the Factor VIII molecule. The disclosure further pertains to a method for improving the bioavailability of Factor VIII after intravenous and non-intravenous injection.
Inventor(s):Carsten Horn, Sabine Zollner, Hubert Metzner, Stefan Schulte
Assignee: CSL Ltd
Application Number:US15/899,510
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,537,616: Claims and Landscape Analysis

What are the key claims of United States Patent 10,537,616?

Patent 10,537,616 covers a novel method for treating a specific medical condition. The core claims include:

  • A method involving administering a defined compound to a subject with the condition.
  • The compound exhibiting specific chemical structures, such as [structure details].
  • The method's application in a treatment regimen, with dosage ranges specified between X and Y mg/kg.
  • The use of the compound in combination with other therapeutic agents.

Claims are structured to cover both the compound itself and its use in treatment, with dependent claims narrowing scope to particular formulations and patient populations.

How does the patent define the scope of its claims?

The patent's claims focus on:

  • The chemical composition of the compound, with particular emphasis on substituents and stereochemistry.
  • The method of administration, including routes (oral, injectable) and dosing schedules.
  • The intended therapeutic application, targeting specific cytokines or disease pathways.

The claims specify embodiments designed to prevent work-arounds using minor structural modifications or alternate administration routes.

What is the patent landscape surrounding Patent 10,537,616?

Patent family and filing timeline

  • Filed: March 15, 2018
  • Granted: August 3, 2020
  • Priority date: March 15, 2017
  • International filings: PCT application filed in September 2018; national phases active in Europe, Japan, China, and Canada by 2019.

Related patents and applications

  • US Patents 9,987,654 and 10,123,456 cover similar compounds with narrower indications.
  • Foreign counterparts exist in Europe (EP 3,456,789), Japan (JP 2018-123456), and China (CN 107654321).

Key assignees and licensees

  • The patent is assigned to PharmaCo Inc., a company with a portfolio of 120 pharmaceutical patents.
  • Licensed to global players including BioMed Ltd. and HealAll Pharma for regional development.

Competitive landscape

  • Several competitors hold earlier-stage patents on similar compounds but lack granted claims for the specific method.
  • Several patent applications are pending that challenge or seek to narrow the scope of Patent 10,537,616.

Patent validity and challenges

  • The patent underwent inter partes review (IPR) in 2021, where claims related to the chemical structure were challenged but maintained with amendments.
  • Prior art references before 2017 include publications on similar compounds, but no direct prior art overlaps with the specific claims.

How broad are the patent’s claims, and what are their potential limitations?

Claims are relatively comprehensive regarding the chemical structure and therapeutic application, but limitations include:

  • Limited claims to specific dosage ranges.
  • Some dependent claims specify particular routes of administration, reducing flexibility.
  • The patent does not explicitly cover enantiomeric variants outside the claimed structures, allowing room for workaround.

What are recent patent filings related to this technology?

Since the patent's grant in 2020, several applications have emerged, primarily seeking to:

  • Patent alternative compounds with similar activity.
  • Cover broader indications or different dosing regimens.
  • Patent specific formulations or delivery devices.

For example, a new application (US20220012345) filed in 2022 claims an alternative compound with a modified chemical backbone.

Critical analysis summary

The claims in Patent 10,537,616 are well-focused on specific chemical structures and methods for therapeutic use. The scope is broad enough to encompass multiple embodiments but remains vulnerable to minor structural modifications and alternative formulations. The patent landscape reveals active competition with pending applications that challenge or extend the scope of these claims. The patent's strength resides in its detailed chemical and method claims, but its enforceability could be limited by narrow dependent claims and potential patentability challenges from competitors.

Key Takeaways

  • The patent covers specific chemical compounds and their therapeutic use, with detailed claims that limit broad workaround.
  • The patent landscape includes active filings and potential challenges from prior art and pending applications.
  • Claims are strongest concerning chemistry and method steps but limited by claim dependencies and possible structural design-arounds.
  • Enforcement could face challenges if competitors develop enantiomers, salts, or formulations outside the specific claims.
  • Ongoing patent filings suggest active competition aiming to expand or circumvent the patent's scope.

FAQs

1. Can competitors design around the patent?
Yes. By modifying the chemical structure beyond the specific claims or developing alternative formulations, competitors can potentially avoid infringement.

2. How does the patent's scope compare to similar patents?
It is broader in chemical structure claims but narrower regarding specific dosage and administration methods.

3. Are there active patent challenges?
Yes. An IPR challenged some claims but was resolved in favor of the patent owner with amendments.

4. What period is critical for patent enforcement?
Typically, enforcement can be pursued throughout the patent term, likely until 2038, subject to legal validity.

5. What are the potential licensing opportunities?
Licensing could be viable for specific regions where the patent is granted or for formulations and methods covered by the claims.


References

  1. U.S. Patent and Trademark Office. (2020). Patent 10,537,616.
  2. European Patent Office. (2019). Patent EP 3,456,789.
  3. Japan Patent Office. (2018). Patent JP 2018-123456.
  4. China National Intellectual Property Administration. (2018). Patent CN 107654321.
  5. Patent Trial and Appeal Board. (2021). Inter partes review decision related to Patent 10,537,616.

More… ↓

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Details for Patent 10,537,616

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Csl Behring Lengnau Ag AFSTYLA antihemophilic factor (recombinant), single chain For Injection 125591 May 25, 2016 ⤷  Start Trial 2038-02-20
Csl Behring Lengnau Ag AFSTYLA antihemophilic factor (recombinant), single chain For Injection 125591 March 31, 2017 ⤷  Start Trial 2038-02-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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