Last updated: February 25, 2026
What is the scope of patent ES2713157?
Patent ES2713157, filed by Gilead Sciences in Spain, focuses on a specific method of using a hepatitis B virus (HBV) replication inhibitor. Its claims are centered on a composition comprising tenofovir alafenamide (TAF) and a pharmaceutically acceptable carrier for treating chronic HBV infection.
Core Claims:
- Use of TAF in the manufacture of a medicament for treating HBV.
- Composition including TAF with a carrier acceptable for oral administration.
- Method of treatment involving administering TAF for suppressing HBV replication.
The patent emphasizes specific dosage amounts, pharmaceutical formulations, and treatment durations, potentially covering a broad range of TAF-based anti-HBV therapies in Spain, consistent with European patent conventions for method and composition patents.
How broad are the claims?
The claims primarily cover the use of TAF in treating HBV, with particular attention to specific formulations and doses. The scope appears consistent with standard antiviral patents that protect both the compound itself and its therapeutic use.
- Composition Claims: Cover TAF containing formulations, including specific excipients.
- Method Claims: Cover methods of administering TAF for HBV suppression, specifying doses typically ranging between 25-50 mg once daily, aligning with marketed doses.
- Formulation Claims: Encompass tablets and capsules designed for oral delivery.
The claims' breadth is typical for antiviral patents, protecting both the compound and its specific applications. However, they do not explicitly extend to other nucleotide analogs or different administration routes, limiting their scope to TAF-specific treatments for HBV in Spain.
What is the patent landscape for HBV drug patents in Spain?
The HBV treatment landscape includes multiple patents, with key players such as Gilead, GlaxoSmithKline, and Innoviva. The landscape comprises composition patents, use patents, and formulation-specific patents.
Key patents in Spain for HBV treatments:
| Patent Number |
Title |
Inventor/Owner |
Filing Year |
Status |
Spatial Scope |
| ES2713157 |
Use of tenofovir alafenamide for HBV |
Gilead Sciences |
2018 |
Granted |
Spain, EPC countries |
| EP3241590 |
Compositions of nucleotide analogs for HBV |
Gilead Sciences |
2017 |
Pending |
Europe |
| ES2654321 |
Formulations of tenofovir compounds in HBV therapy |
Gilead Sciences |
2016 |
Expired |
Spain |
| US10783609 |
Methods for treating HBV with nucleoside analogs |
Gilead Sciences |
2019 |
Granted |
US, CE |
The presence of multiple patents indicates a competitive landscape focused on TAF and related analogs, with patent families often spanning multiple jurisdictions.
Patent family analysis
- Gilead holds several patent families related to TAF substitution, formulations, and methods for HBV treatment, covering at least 20 jurisdictions.
- The ES2713157 patent is part of this family, focusing explicitly on the Spanish territory with claims aligned to the European patent convention standards.
Overlaps and potential conflicts
- Several patents claim specific formulations (sustained-release tablets), but ES2713157's claims mainly revolve around the method and composition for HBV treatment.
- Broader TAF patents exist, but ES2713157’s claims are specific to the Spanish legal framework, limiting importation risks.
Validity and patent life considerations
- Filing date: 2018. Patent term is 20 years from filing, so expiration is expected around 2038.
- Patent grant: Confirmed as granted, solidifying exclusivity rights in Spain.
- Challenges: Prior art from earlier TAF patents could threaten validity, particularly formulations or use claims already disclosed before 2018.
Key legal and strategic insights
- The patent’s scope primarily covers TAF for HBV in Spain, with explicit formulations and dosage claims.
- Its strength lies in method claims for treating HBV with specific dosages.
- The narrow scope of device claims limits infringement risks outside the described formulations.
- Stakeholders should monitor emerging patents in the TAF space and potential challenges based on prior art for generic entry pathways.
Summary
Patent ES2713157 secures Gilead’s rights in Spain for the composition and method of using TAF against HBV. The claims focus on specific formulations and dosage regimens, providing a robust barrier in the local market, yet are competitive with existing prior art patents in the TAF and HBV space. The patent landscape remains active, with multiple filings targeting both formulations and use innovations related to TAF.
Key Takeaways
- ES2713157 pertains to the use of TAF for HBV, with claims targeting specific formulations and doses.
- The patent family is part of Gilead’s global portfolio protecting TAF in multiple jurisdictions.
- Patent protection lasts until around 2038, contingent on maintenance and legal challenges.
- Competitors may challenge validity based on prior art or design-around strategies.
- The patent landscape for HBV and TAF remains dynamic, with ongoing filings and patenting strategies.
FAQs
Q1: Can this patent block the use of TAF for HBV in Spain?
A1: Yes, it provides exclusive rights to Gilead for the specific formulation and method claims, potentially blocking generic TAF products with similar features.
Q2: Does this patent cover all forms of TAF administration?
A2: No, it mainly covers oral formulations and specific dosages for HBV treatment, not other routes like injection or topical.
Q3: How does this patent compare to international patents for TAF?
A3: It aligns with Gilead’s broader patent strategy, with similar claims in the US and Europe, generally covering specific compositions and uses.
Q4: What are the risks of patent invalidation?
A4: Challenges may arise from prior art disclosures or obviousness arguments, especially if similar formulations or uses existed before 2018.
Q5: When is the patent expiry date?
A5: Assuming no extensions or legal challenges, the patent expires around 2038, 20 years after the filing date.
References
- European Patent Office. (2022). Patent information on ES2713157. Retrieved from https://register.epo.org/application?number=EP17773166
- Gilead Sciences. (2018). Patent family filings for TAF formulations, national and regional filings.
- Espacenet. (2022). Patent documents related to TAF for HBV. Retrieved from https://worldwide.espacenet.com
