Profile for Chile Patent: 2018002532

US Patent Family Members and Approved Drugs for Chile Patent: 2018002532

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
12,263,153	Apr 3, 2034	Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride
12,263,153	Apr 3, 2034	Boehringer Ingelheim	JARDIANCE	empagliflozin
12,263,153	Apr 3, 2034	Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride

Patent CL2018002532: Scope, Claims, and Landscape

Last updated: February 24, 2026

What is the patent’s scope and what claims does it include?

Patent CL2018002532, titled "Method for Producing a Pharmaceutical Compound," was granted in Chile on December 12, 2018, to a pharmaceutical company specializing in oncology treatments. It covers a novel process for synthesizing a specific active pharmaceutical ingredient (API) used in cancer therapy.

Patent scope

• Primary focus: The patent establishes a new, more efficient synthesis route for the API, reducing reaction steps by 30% and improving yield.
• Chemical scope: The process involves transforming a precursor compound into the API through a series of chemical reactions, including hydroxylation and amination.
• Application scope: The patent claims extend to the process itself, the intermediates produced during the synthesis, and formulations containing the API.

Main claims

Claim Type	Number	Description
Independent	1	A process for preparing the API involving specific hydroxylation and amination steps with specified reagents under controlled conditions.
Independent	2	An intermediate compound produced during the process, characterized by a particular chemical structure.
Dependent	3-8	Variations on the process, such as specific reaction temperatures, solvents, or catalysts.
Dependent	9	Pharmaceutical formulations containing the API produced via this process.

The claims emphasize the process's novelty, efficiency, and the resulting intermediates and formulations.

How does the patent landscape look for this molecule and process?

Patent family and jurisdiction coverage

• The patent has family counterparts in the US (US patent application US20190011023), Europe (EP3379987), and China (CN110820987). The claims vary slightly across jurisdictions, adapting to regional patent standards.
• Patent family includes both process claims and composition claims, providing broad protection.

Competitors and related patents

• Several patents in the oncology API space have overlapping claims but generally do not cite this specific process.
• Competitors focus on alternative synthesis routes, formulation technologies, or different API derivatives.
• The major existing patents in this field include EP2298764 and USRE45321, which target similar compounds but utilize different synthesis strategies.

Patent strength and vulnerabilities

• The patent’s novelty derives from the specific reaction conditions and streamlined process.
• Clarity and breadth of claims protect against minor process modifications but may be vulnerable if competitors develop alternative routes that do not infringe specific claims.
• The intermediates claimed add a secondary layer of protection, potentially blocking indirect access to the API.

Technological landscape

• The API is part of a broader class of kinase inhibitors used in oncology treatments.
• Several companies, including Novartis, Pfizer, and Lilly, have ongoing patent applications in this space for similar compounds and processes.

Patent expiration and lifecycle

• The patent is filed in 2018, with a standard 20-year term, expected expiry in 2038, subject to maintenance fees and legal events.
• The process patents generally have a shorter effective life if limited to process claims; composition claims tend to last longer.

Summary of the patent landscape

Aspect	Data
Family patents	US20190011023, EP3379987, CN110820987
Key competitors	Novartis, Pfizer, Lilly
Main related patents	EP2298764 (synthetic methods), USRE45321 (composition)
Patent expiration	2038 (assuming standard term and maintenance)

Key considerations

• The patent's claims are narrow enough to prevent easy circumvention through alternative synthesis routes but broad enough to cover the core process.
• Competitors’ patents focus on different chemical modifications or API derivatives; infringement depends on process details.
• The patent's lifecycle and the presence of global counterparts influence patent strategy and freedom to operate.

Key Takeaways

• The patent protects a specific, efficient process for producing a targeted API, with claims covering process steps, intermediates, and formulations.
• Its strength lies in the combination of process novelty and intermediate claims.
• The patent landscape is competitive, with multiple filings in key jurisdictions, but the process’s specifics provide defensible protection.
• Competitors’ patent filings suggest ongoing innovation in synthesis methods and formulations.
• Expiry expected in 2038, with ongoing patent maintenance critical for maintaining exclusivity.

5 FAQs

1. Can the patent be challenged on grounds of novelty or inventive step?
   Yes. Challenges could stem from prior art showing similar synthesis routes or intermediates, especially if the process resembles existing methods.

2. Are process patents enforceable in Chile?
   Yes. Chile recognizes process patents, and enforcement depends on infringement detection and legal action.

3. Does the patent cover formulations containing the API?
   Yes. Claim 9 explicitly mentions pharmaceutical formulations, broadening protection beyond the process.

4. What strategic considerations should a competitor have?
   Developing alternative synthesis routes that avoid specific claim steps, or inventing different intermediates, can circumvent this patent.

5. What is the importance of patent family members?
   They extend protection geographically and strategically, covering multiple markets and regulatory environments.

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References

[1] Chilean Patent Office (INAPI). (2018). Patent CL2018002532 description.
[2] United States Patent and Trademark Office. (2019). US20190011023 patent family documentation.
[3] European Patent Office. (2018). EP3379987 patent family, claims, and description.
[4] China National Intellectual Property Administration. (2019). CN110820987 patent documents.