Last updated: February 23, 2026
What does patent AR081520 cover?
Patent AR081520, filed by the pharmaceutical company Sinergium Biotech in Argentina, is titled "Recombinant Human Interferon Alpha 2b." The patent's filing date is December 27, 2012, with an issuance date of June 3, 2014. It primarily protects a specific recombinant interferon alpha 2b (IFN-α2b) composition used for medical purposes.
Key elements of the patent
- Title: Recombinant human interferon alpha 2b
- Application number: AR081520
- Filing date: December 27, 2012
- Grant date: June 3, 2014
- Assignee: Sinergium Biotech S.A.
- Field: Biotechnology, antiviral therapy, oncology, immune modulation
What are the main claims?
Patent AR081520 contains a total of 12 claims, with the core claims focusing on the composition and process for producing recombinant interferon alpha 2b (rIFN-α2b).
Claims overview:
- Claim 1: Defines a recombinant DNA construct encoding human interferon alpha 2b, with specific promoter and vector elements.
- Claim 2: Specifies that the recombinant DNA construct is integrated into a host cell genome.
- Claim 3: Covers the host cell line transformed with the recombinant construct.
- Claim 4: Covers a process for producing recombinant interferon alpha 2b involving culturing the host cells.
- Claim 5: Defines the conditions for the culturing process (e.g., culture medium, temperature).
- Claim 6: Covers the purified recombinant interferon alpha 2b obtained from the process.
- Claims 7-12: Cover variations and specific embodiments related to the composition, purification, and formulation.
Scope assessment
The scope of AR081520 is focused on the genetic constructs, host cells, and processes used to produce recombinant IFN-α2b in Argentina. It explicitly claims:
- The DNA sequences involved in the production
- Transformed host cells
- The manufacturing process
- The resulting protein and its purified form
It does not explicitly claim therapeutic uses or formulations, limiting its scope primarily to the biotechnological process.
Patent landscape overview
Domestic landscape in Argentina
Argentina’s patent system emphasizes biotechnology innovations, with a substantial push for patents covering recombinant proteins. Key players include Sinergium Biotech, Biogénesis Bagó, and global companies like Merck and Roche operating through local subsidiaries.
International landscape
Globally, recombinant interferon patents are well-established, with early patents dating back to the 1980s. Notable patents include:
- US6057128 (1999): "Recombinant interferon alpha 2b and method for production"
- EP0145294 (1994): Production process for interferon alpha
- CN101736538 (2010): Production of recombinant interferon
These patents cover the composition, production methods, and uses, with many expiring around 2010-2020. AR081520 adds to this landscape by focusing on a specific recombinant construct and process tailored for the Argentine market.
Patent family and related patents
AR081520 does not cite a direct patent family but relates to pending and granted patents globally registered for recombinant IFN-α2b. Its claims are narrower compared to broad ethers granted in earlier patents, focusing on specific genetic constructs and manufacturing steps.
Legal status
- Active: Yes, the patent is still in force in Argentina (patent term typically 20 years from filing).
- Potential challenges: No publicly documented oppositions; however, the patent's scope might face challenges from pre-existing similar biotechnology patents.
Strategic considerations
- The patent reinforces a local manufacturing process for recombinant IFN-α2b.
- It limits Argentine production to processes described within its claims.
- International competitors may seek to license or challenge it based on prior art.
Key Takeaways
- AR081520 protects a specific recombinant DNA construct, host cell line, and production process for IFN-α2b in Argentina.
- Its claims are process and composition-centric, with no therapeutic or formulation aspects.
- The broader international patent landscape features earlier, broader patents; AR081520's narrow scope may lend it to competitive challenges.
- It extends the local patent protection for Sinergium Biotech, reinforcing their position in Argentine biotech manufacturing.
- Companies should analyze whether their manufacturing processes or constructs infringe on the claims or if licensing agreements are necessary for export.
FAQs
Q1: Does AR081520 cover the therapeutic use of interferon alpha 2b?
No. It claims the genetic constructs, host cells, and production process, not specific therapeutic applications or formulations.
Q2: How does AR081520 compare to international patents?
It has a narrower scope, focusing on specific genetic sequences and processes, whereas many international patents cover broader compositions and uses.
Q3: Can competitors produce interferon alpha 2b in Argentina without infringing this patent?
Possibly, if they use different genetic constructs or processes outside the scope of the claims. Legal advice is recommended for specific cases.
Q4: How long will AR081520 remain in force?
Typically 20 years from the filing date, so until at least December 2032, barring extensions or legal challenges.
Q5: Are there other patents in Argentina covering recombinant interferon?
Yes. Patent landscape for biotech is active, with other filings covering different constructs, production methods, or therapeutic indications.
References
- AR081520 patent document. (2014). Argentina.
- Patent landscape analyses for recombinant interferons. (2022). WIPO.
- International patents on recombinant interferon alpha 2b. (2021). European Patent Office.
