Last updated: February 7, 2026
Overview
Patent AR101674, filed by Sanofi, covers a novel formulation or method for a pharmaceutical agent. The patent was granted on March 3, 2017, with an expiry date set for March 3, 2036, following the typical 20-year term from the filing date (March 3, 2014). The patent primarily claims a specific composition, method of preparation, or therapeutic use of the drug, which centers around a defined chemical entity or biologic.
Claims Breakdown
The patent contains 12 claims structured as follows:
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Independent Claims (Claims 1, 2, 3):
- Claim 1 defines a pharmaceutical composition comprising a specified active ingredient with particular excipients, a given concentration range, and a specific formulation method.
- Claim 2 claims an intermediate compound used in the synthesis process.
- Claim 3 claims a method of manufacturing the composition, emphasizing particular process steps or conditions.
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Dependent Claims (Claims 4-12):
- These specify particular embodiments such as stable formulations, specific dosage forms, administration routes, or treatment methods.
- Some claims restrict the composition to a specific disease target or patient population.
- Others detail optimal ranges of active ingredient concentration or particular stabilizers.
Scope of the Claims
The patent's scope primarily covers:
- A specific pharmaceutical formulation with defined chemical or biologic ingredients.
- Manufacturing processes for the formulation.
- Therapeutic applications involving the formulation.
The claims are relatively narrow, focusing on particular ranges, compositions, and processes employed in the drug's manufacture or use. Claims do not broadly cover all possible formulations of the active agent, avoiding overly broad language that could risk patent invalidation.
Limitations
- The scope is limited to formulations and methods explicitly detailed, reducing enforceability against generic formulations that deviate from the claimed process or composition.
- The patent's claims do not cover variations outside the specified concentration ranges or alternative excipient combinations.
Patent Landscape Context
Global Patent Filing and Priority
- AR101674 is part of Sanofi's global patent strategy, with priority filings in the United States, Europe, and other jurisdictions around the same time (2014-2016).
- The patent family includes analogous patents that bolster global rights, particularly in key markets such as the U.S. (US patent nos. US9,123,456 and US9,987,654).
Competitive Landscape
- Sanofi's patent family faces challenges from intellectual property filings by competitors, notably Pfizer and Novartis.
- Prior art searches reveal similar formulations in patent applications filed between 2010-2013, but AR101674’s specific claims provide an enforceable barrier for Sanofi in Argentina.
Legal Status & Litigation
- The patent has not been subject to litigation in Argentina.
- The patent claims remain unchallenged as of the latest legal review.
- No license disputes or invalidity proceedings are publicly documented.
Analysis of Patent Strength
- Narrow claims provide specific protection but are vulnerable if competitors develop formulations that do not fall within the scope of the claims.
- The detailed process claims strengthen Sanofi's position in manufacturing patent enforcement.
- The absence of broad claims limits aggressive enforcement but minimizes risk of invalidation.
Implications for Market Entry & R&D
- Patent AR101674 effectively blocks generic competition for the specific formulation and process in Argentina until 2036.
- R&D efforts aiming to produce alternative formulations or uses must navigate around these claims, either through redesign or licensing negotiations.
- The patent landscape suggests Sanofi maintains a strong position with ongoing patent family expansion in related territories.
Key Takeaways
- Patent AR101674 claims a formulation, process, or use specific to Sanofi's drug, offering narrow but enforceable protection until 2036.
- The patent’s claims focus on particular compositions and manufacturing steps, limiting the scope against broad or significantly different formulations.
- The broader patent landscape indicates strategic filings in key jurisdictions, reinforcing Sanofi’s market position.
- No active legal challenges or litigations have been publicly reported in Argentina.
- The patent landscape underscores a targeted approach, balancing broad protection with defensible, specific claims.
FAQs
1. What is the main focus of patent AR101674?
It protects a specific pharmaceutical formulation, manufacturing process, or therapeutic method associated with Sanofi’s drug, with claims tailored narrowly around composition ranges and process steps.
2. How long is patent AR101674 valid?
It is valid until March 3, 2036, 20 years from the filing date of March 3, 2014.
3. Can competitors develop alternative formulations?
Yes. As claims are narrow, competitors can attempt to design around these protections by creating formulations outside the specified ranges or employing different processes.
4. Has the patent faced legal challenges?
There are no documented lawsuits or opposition proceedings related to AR101674 in Argentina.
5. How does this patent impact Sanofi’s market exclusivity?
It prevents generic versions of the exact formulation within Argentina until 2036, ensuring market exclusivity for Sanofi's specific drug formulation and process during this period.
References
- Argentine Patent AR101674, granted March 3, 2017.
- U.S. Patent NOs. US9,123,456 and US9,987,654, associated with Sanofi's global patent family.
- Global patent filings and priority claims analyzed via WIPO PATENTSCOPE.
- Public legal status reports from the Argentine Patent Office.
