Last Updated: July 27, 2026

Patent: 8,247,536


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Summary for Patent: 8,247,536
Title:Factor VIII compositions
Abstract:Conjugates of a Factor VIII moiety and one or more water-soluble polymers are provided. Typically, the water-soluble polymer is poly(ethylene glycol) or a derivative thereof. Also provided are compositions comprising the conjugates, methods of making the conjugates, and methods of administering compositions comprising the conjugates to a patient.
Inventor(s):Bossard Mary J., Bentley Michael D., Zhang Ping
Assignee:Nektar Therapeutics
Application Number:US12636594
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 8,247,536: Claim Scope and US Patent Landscape for the Invention’s Core Coverage

Executive summary

United States Patent 8,247,536 (US 8,247,536) is a utility patent with a claim set that defines the invention’s operative coverage and the boundaries of potential design-around strategies. A comprehensive, litigation-grade analysis requires the full claim text (independent and dependent claims) and the patent’s bibliographic data (assignee, filing date, priority, prosecution history, and cited art). The requested prompt does not include the “claims are:” content, so a complete and accurate claim-by-claim landscape cannot be produced.

What are the claims of US Patent 8,247,536, and what do they cover?

Answer: Claim coverage cannot be mapped without the missing claim text.

Which claim types typically drive enforceability for US 8,247,536?

  • Independent claims define the enforceable boundaries (product, method, composition, or use).
  • Dependent claims narrow the scope to specific embodiments that can support fallback positions in litigation.

How claim structure affects infringement theory?

  • Product claims require identity of claimed structural or compositional elements.
  • Method claims turn on performance of steps, including where and by whom steps occur (inducement and attribution issues).
  • Use claims may align with prescribing, labeling, and patient administration evidence.

How strong is the patent estate around US 8,247,536?

Answer: Patent strength and adjacency coverage cannot be assessed without the invention’s technical subject matter from the claims.

What to measure to assess strength

  • Claim breadth vs. prior art overlap
  • Whether key claim elements appear in the specification only or also in the claims
  • Family size and geographic continuation strategy
  • Citation network density (how often the same prior art appears in later filings)

What to look for in prosecution history

  • Claim amendments that narrow scope
  • Examiner arguments that may create estoppel-like risk in later interpretation
  • Any terminal disclaimer, restriction findings, or election results

What prior art likely limits US 8,247,536’s claim scope in the US?

Answer: A prior-art validity map cannot be compiled without the claim elements.

How prior art analysis is typically structured

  • Element-by-element mapping of each independent claim limitation
  • Identification of closest prior art references in the cited and uncited corpus
  • Assessment of obviousness combinations (KSR rationale) vs. anticipation risk

Which later US patents cite or improve upon the invention in US 8,247,536?

Answer: Citation-based landscape cannot be completed without the invention’s technical keywords derived from the claims.

What constitutes “adjacent” for landscape purposes

  • Continuations and divisionals in the same family
  • Improvement patents from competitors that retain the commercial target but alter key elements
  • Formulation, device, process, or method-of-treatment workarounds

What patent expiration and exclusivity timelines apply to US 8,247,536?

Answer: Expiration and any term adjustment calculations require the patent’s filing date and PTA status, which are not provided.

How US patent term is calculated for enforceability planning

  • Base term from earliest effective non-provisional filing date
  • Adjusted term including any Patent Term Adjustment (PTA)
  • Statutory disclaimers, terminal disclaimers, and maintenance status impacts

Does US 8,247,536 face PTAB challenges or reexamination risk?

Answer: PTAB risk cannot be assessed without the patent’s prosecution and claims’ vulnerability profile.

How claim vulnerability is evaluated

  • Whether claim elements are well supported but still broad enough to read on prior art
  • Whether dependent claims contain narrower alternatives that survive attempted cancellation
  • Whether the patent is asserted in litigation, which often increases challenge probability

What generic or biosimilar entry risks exist if US 8,247,536 is asserted?

Answer: Entry risk depends on the drug product type (small molecule vs biologic), the FDA regulatory classification, and whether the claims read on composition, method-of-use, or manufacturing.

If the patent claims a product or composition

  • Generic risk hinges on the ability of a substitute to avoid each structural/compositional limitation.

If the patent claims a method of treatment

  • Risk shifts to labeling and prescribing practices, and whether the generic can offer a non-infringing regimen.

If the patent claims manufacturing methods

  • Risk shifts to process similarity and evidence availability in discovery.

What FDA and Orange Book status would be relevant to US 8,247,536?

Answer: FDA regulatory status and Orange Book listings depend on the associated active ingredient and NDA/ANDA linkages, which are not provided.

How to tie patent to FDA listings in US practice

  • Orange Book “patent numbers” mapping to NDA/ANDA
  • Determination whether the listed claims are product, method-of-use, or both
  • Whether any Paragraph IV certifications were made and what triggered litigation

How do you design around US 8,247,536 without triggering infringement?

Answer: Design-around cannot be evaluated without the claim elements.

Common design-around vectors

  • Substituting non-equivalent alternatives for each limitation
  • Reconfiguring process steps to avoid method-claim “performance”
  • Altering formulation attributes or process conditions that are claimed

Claim construction risk

  • Means-plus-function or “comprising” vs “consisting” language can dramatically change analysis
  • Dependent claim narrowing can still allow literal infringement if the accused product matches the narrowed embodiment

What patent litigation affects US 8,247,536?

Answer: Litigation cannot be identified without the patent’s asserted parties, docket numbers, or at least the title/subject matter.

Litigation artifacts that matter

  • Alleged infringing products and asserted claims
  • Court constructions of claim terms
  • Settlement terms including license scope and launch dates

Key Takeaways

  • A claim-by-claim critical analysis of US 8,247,536 and the surrounding US patent landscape cannot be completed without the missing “claims are:” text.
  • Enforceability, invalidity risk, expiration planning, and generic or biosimilar entry analysis all depend on the specific claim limitations that are not included in the prompt.

FAQs

  1. What is the earliest effective filing date of US 8,247,536 and how does it affect expiration?
  2. Which specific claim limitations in US 8,247,536 most likely drive infringement findings?
  3. How do means-plus-function claim elements in US patents typically limit enforceability?
  4. How would a Paragraph IV certification strategy evaluate exposure to US 8,247,536 if it is listed in the Orange Book?
  5. What citation patterns most reliably identify improvement patents around a core US patent?

References

  1. (No sources were cited because US 8,247,536 claim text and bibliographic details were not provided.)

More… ↓

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Details for Patent 8,247,536

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Wyeth Pharmaceuticals Llc REFACTO antihemophilic factor (recombinant) For Injection 103779 June 27, 2001 ⤷  Start Trial 2029-12-11
Wyeth Pharmaceuticals Llc REFACTO antihemophilic factor (recombinant) For Injection 103779 July 06, 2001 ⤷  Start Trial 2029-12-11
Takeda Pharmaceuticals U.s.a., Inc. ADYNOVATE antihemophilic factor (recombinant), pegylated For Injection 125566 November 13, 2015 ⤷  Start Trial 2029-12-11
Takeda Pharmaceuticals U.s.a., Inc. ADYNOVATE antihemophilic factor (recombinant), pegylated For Injection 125566 October 25, 2016 ⤷  Start Trial 2029-12-11
Takeda Pharmaceuticals U.s.a., Inc. ADYNOVATE antihemophilic factor (recombinant), pegylated For Injection 125566 March 13, 2017 ⤷  Start Trial 2029-12-11
Novo Nordisk Inc. ESPEROCT antihemophilic factor (recombinant), glycopegylated-exei For Injection 125671 February 19, 2019 ⤷  Start Trial 2029-12-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,247,536

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2004075923 ⤷  Start Trial
United States of America 11141465 ⤷  Start Trial
United States of America 2004235734 ⤷  Start Trial
United States of America 2008058504 ⤷  Start Trial
United States of America 2009041714 ⤷  Start Trial
United States of America 2010120689 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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