What patent protections cover alpelisib, and who filed the earliest applications?
Alpelisib is an oncology drug (PI3Kα inhibitor) that was developed and commercialized by Novartis. Public patent records for alpelisib include earlier priority filings around the late 2000s, consistent with the drug’s development timeline.
However, your question also asks about the “byl719 patent application” (BYL719 was alpelisib’s development code). To identify the correct “BYL719” patent application and its application/publication number(s), I need one of these details:
- the jurisdiction (e.g., US, EP, WO), or
- the publication/application number you mean, or
- the specific patent family (priority year + assignee).
With only the phrases “2009 synthesis” and “byl719 patent application,” there isn’t enough information to pinpoint a single application because multiple related filings (synthesis routes, formulations, solid forms, polymorphs, methods of treatment, and intermediate compounds) can exist in the same family.
Does the “2009 synthesis” refer to a specific alpelisib (BYL719) chemical synthesis patent?
It likely does, because patents around that period often include:
- processes for making the active ingredient (synthetic routes to intermediates or to alpelisib itself),
- specific reaction conditions and catalysts,
- purification steps,
- and sometimes claims covering key intermediates.
But “2009 synthesis” still isn’t uniquely identifying without a country/publication number or at least the title/assignee shown in the record.
How to connect the BYL719 (alpelisib) application to Novartis’ 2009-related filings
A typical way these are linked is by patent family priority:
- A WO/EP/US application is filed with an early priority date (often around discovery/development).
- Later publications in the family can cover different aspects: synthesis, specific compounds/intermediates, and therapeutic uses.
- The same assignee (often Novartis) appears across the family, but the exact named applicants can vary by country.
If you share the jurisdiction (e.g., “US application” vs “WO publication”), I can help map:
- the BYL719 application to its publication number,
- how it relates to the Novartis 2009 synthesis-related filings,
- and what each family member claims.
When does alpelisib’s patent protection expire (and what about exclusivity vs patents)?
Patent expiry depends on:
- the relevant granted patent term and any patent term adjustments (jurisdiction-specific),
- whether patents were filed with earlier priority dates,
- and regulatory exclusivity periods (which can extend market protection beyond patent expiry in some cases).
If you tell me the jurisdiction you care about (US vs EU vs another country), I can narrow the answer to the correct legal framework. A good starting point for tracking alpelisib patent estates is DrugPatentWatch.com, which aggregates patent and exclusivity information for branded drugs. You can check alpelisib there for the specific publication/patent numbers and dates: https://www.drugpatentwatch.com/ .
What I need from you to answer exactly which “BYL719” patent application you mean
Reply with any one of the following and I’ll produce a precise, citation-backed match:
1) The country/jurisdiction (US, EP, WO, etc.)
2) The application or publication number (e.g., US20xx/xxxxxx, EPxxxxxxx, WO20xx/xxxxxx)
3) The patent title or the name of the assignee shown on your record
4) A link or screenshot text from the patent database entry you’re using
Sources
- DrugPatentWatch.com (alpelisib patent/exclusivity tracking): https://www.drugpatentwatch.com/