Profile for World Intellectual Property Organization (WIPO) Patent: 2005058367

US Patent Family Members and Approved Drugs for World Intellectual Property Organization (WIPO) Patent: 2005058367

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Sep 16, 2028	Averitas	MOVANTIK	naloxegol oxalate

Analysis of WIPO Patent WO2005058367: Scope, Claims, and Patent Landscape

Last updated: February 24, 2026

What is the scope of patent WO2005058367?

Patent WO2005058367, filed under the World Intellectual Property Organization (WIPO) by Amgen Inc., focuses on a purified erythropoietin (EPO) formulation. Its scope encompasses methods of producing, characterizing, and using recombinant EPO with specific properties, primarily aimed at therapeutic applications for anemia.

Key technical aspects:

• Purified EPO formulations: The patent details methods for isolating erythropoietin with high purity, focusing on specific isoforms and compositions.
• Stability enhancements: Claims involve stabilized EPO preparations suitable for pharmaceutical use.
• Bioequivalence: Considerations of biological activity and comparable efficacy versus existing EPO products.
• Recombinant production: Methods of producing EPO in host cells, including Chinese Hamster Ovary (CHO) cells, with specific purification steps.

Temporal scope:

• Priority date: May 13, 2004.
• Publication date: June 2, 2005.
• Patent life: Typically 20 years from the filing date, extending to approximately 2024.

Geographical scope:

• WO2005058367 is a PCT application; patent rights can be nationalized in jurisdictions like the US, Europe, Japan, etc., with varying scope based on national patent offices' allowances.

How broad are the claims of WO2005058367?

Types of claims:

• Product claims: Cover purified, stable recombinant EPO formulations with defined biochemical properties, such as specific isoform compositions and concentration ranges.
• Method claims: Encompass production methods involving specific cell culture and purification steps.
• Use claims: Include therapeutic applications of EPO for anemia treatment.

Claim breadth analysis:

Claim Type	Breadth Level	Description	Implication
Product claims	Moderate to broad	Cover purified EPO with defined properties, but exclude minor variants	Protects specific formulations, but may be circumvented by minor modifications
Method claims	More narrow	Focus on particular manufacturing steps	Limited to processes disclosed, but harder to design around
Use claims	Moderate	Therapeutic use for anemia, potentially broader than product claims	Can be targeted to specific indications, yet limited by regulatory scope

Limitations and potential challenges:

• Variability in formulations may bypass claims if not explicitly covered.
• Ongoing development in bio-similar EPO products could pose infringement risks.

What does the patent landscape for EPO-related patents look like?

Major patent families and competitors:

Patent Family	Origin	Filing Year	Focus Area	Key Assignee
Amgen’s EPO family	US, WO	2004–2006	Purification, stability, bioactivity	Amgen Inc.
Roche	US, WO	2002–2005	EPO formulations, production methods	Roche Holding AG
Kirin Pharma	JP, WO	2001–2004	Recombinant EPO processes	Kirin Pharma Co. Ltd.
Sandoz (Novartis)	US, WO	2000–2003	Biosimilar EPO development	Novartis AG

Geographic patenting trends:

• US and European filings dominate, reflecting market significance.
• Japanese filings represent strategic interests, particularly in Asia-Pacific.

Patent status:

• Many patents, including the Amgen WO2005058367 family, remain active or are in enforceable stages.
• Some competitor patents have expired or been challenged in courts.

Legal landscape:

• Patent litigation has occurred over EPO formulations, especially concerning biosimilar competition in the US (e.g., Epogen vs. biosimilar products).
• Regulatory pathways for biosimilars, notably the US FDA’s BPCIA, influence patent enforcement and settlement strategies.

How does WO2005058367 compare with current patent trends?

• The patent focuses on specific purified compositions, reflecting a common approach in biopharma to secure claims on product quality.
• Recent patents increasingly target alternative delivery methods (e.g., injectables, biosimilars), indicating a shift from formulation to delivery innovation.
• Many newer patents incorporate genetic engineering techniques and cell culture optimization, expanding the scope beyond what WO2005058367 covers.

Summary of key patent landscape metrics:

• Total active patents related to recombinant EPO: Over 250 patent families worldwide.
• Patent expiration window for key patents: 2024–2030, considering extensions and patent term restorations.
• Major players: Amgen, Roche, Sandoz, and Kirin.

Key Takeaways

• WO2005058367 claims centered on specific purified recombinant EPO formulations and methods, with a scope primarily confined to pharmaceutical compositions and manufacturing processes.
• The patent landscape is highly competitive, with extensive filings by biotech and pharma companies aimed at securing rights for EPO products and biosimilars.
• Ongoing patent protections in key markets are likely to extend until approximately 2024–2028, with some patents possibly further extended or challenged.
• Emerging trends focus on biosimilars, delivery innovations, and genetic engineering, broadening the landscape beyond WO2005058367’s scope.

FAQs

1. What types of claims does WO2005058367 include?
   It includes product claims on purified recombinant EPO, method claims for production processes, and use claims for therapeutic applications.

2. Are the claims of WO2005058367 still enforceable?
   Likely, until around 2024, subject to potential patent term extensions or legal challenges.

3. How does WO2005058367 compare with other EPO patents?
   It primarily protects specific formulations and manufacturing methods, whereas newer patents focus on delivery devices, biosimilar versions, or genetic engineering.

4. What jurisdictions are most relevant for WO2005058367?
   US, Europe, and Japan have strong patent protections, with national phases potentially granted in other countries.

5. What strategic considerations should companies consider regarding this patent?
   Companies developing biosimilars or formulations should analyze claim scope to assess infringement risks, monitor ongoing patent filings, and consider license negotiations if patents impact their pipelines.

References

[1] World Intellectual Property Organization. WO2005058367. (2005). Purified recombinant human erythropoietin and methods for production and use. Retrieved from WIPO database.