What is US8158616B2, and how might it relate to baricitinib?
US8158616B2 is a US patent document (granted in 2012). The “Example 62 / Example 63 / Example 69 / Example 70” wording usually refers to specific experimental or chemical preparation examples inside the patent specification. Those examples can matter for determining whether the patent is about (a) a particular compound or salt, (b) an intermediate or synthesis route, or (c) a formulation, assay, or biological result tied to activity.
To connect it to baricitinib specifically, you would look for where the patent describes:
- the compound name “baricitinib” (or a synonym/trade name),
- the chemical structure, formula, or IUPAC naming that matches baricitinib,
- biological/clinical test examples showing activity against JAK targets, or
- process claims covering preparation of that compound.
If you share the claims text or the exact lines around Examples 62/63/69/70 from the patent, I can map them more directly to baricitinib (e.g., whether those examples are the synthesis of baricitinib vs. something else).
What do “Example 62 / Example 63 / Example 69 / Example 70” usually indicate in a patent like this?
In many pharmaceutical patents, numbered “Examples” are where the inventor provides concrete lab work or test results. Depending on the patent, those examples might be:
- preparation examples (steps, reagents, purification),
- example compounds (tables listing structures/variants),
- bioassay examples (cell or enzyme assays, potency values),
- formulation examples (dosage forms, excipients), or
- characterization examples (spectra, yields, stability).
For baricitinib, the most relevant interpretation is whether those examples disclose the actual baricitinib molecule (or a key intermediate that enables making it) versus unrelated compounds in a broader “compound class” disclosure.
Does this patent cover baricitinib as an active ingredient, or a manufacturing method?
The patent’s relevance depends on the claim scope (not just the examples). Two common scenarios:
1) Composition-of-matter (covers the drug itself)
If the independent claims are framed around the compound (baricitinib or a defined chemical structure), then the patent is typically a direct barrier to generic entry until expiry.
2) Method-of-making or process claims (covers manufacturing steps)
If independent claims cover steps of synthesis or specific intermediates, generics might potentially “design around” by using different routes, depending on claim breadth and doctrine of equivalents.
The examples you cited can help interpret what the inventors taught, but the decisive factor is what the claims cover.
When does a baricitinib patent like this expire in the US?
Patent term in the US is generally tied to earliest effective non-provisional filing date, typically expiring about 20 years from that date (with possible adjustments). However:
- the actual baricitinib “exclusivity wall” often also depends on FDA-related exclusivity (like application exclusivity) and patent term adjustment for specific patents, not just the base 20-year term,
- many baricitinib-related inventions exist across multiple patents, each with its own term and potential extensions/adjustments.
To give a precise “expires on” date for US8158616B2, you’d need the patent’s filing date / family information (or the USPTO record). If you paste the “Application filed” / “Filed” date or the USPTO link, I can compute the expected term window and flag whether any term adjustment would apply.
Are there competing “baricitinib” patents that matter more than US8158616B2?
Baricitinib (marketed as Olumiant) has multiple patents covering:
- the core compound,
- specific crystal forms/salts,
- manufacturing processes,
- formulations and dose regimens,
- and sometimes metabolites or related scaffolds.
So even if US8158616B2 is part of the landscape, it may not be the one most relevant to infringement or generic launch timing. Determining priority requires looking at:
- which patents are listed for the drug in the Orange Book (for US approvals),
- which patents have active litigation or stays,
- and which ones claim the exact compound/form the generic would need.
What happens if a generic launches while US8158616B2 is still active?
If a generic (or biosimilar-like product where relevant) files an ANDA for baricitinib and is carved out by legal strategy, the timing can hinge on:
- whether the ANDA is challenged via patent litigation,
- whether there’s an automatic stay based on settlement timing,
- and whether the generic seeks non-infringement or invalidity arguments.
The practical effect is that even if a generic is approved, real market entry can be blocked or delayed while litigation and statutory stays play out.
What I need from you to answer your question accurately
Right now, your prompt points to a patent ID and example numbers, but not the patent text itself. If you paste either:
- the USPTO/Google Patents link for US8158616B2, or
- the claim(s) and/or the text (or screenshot text) for Examples 62/63/69/70,
I can tell you whether those specific examples disclose baricitinib (and what they cover), and how that would connect to patent scope and potential infringement/expiry relevance.
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Sources
No sources were provided in your message, and I did not have the patent text to cite. If you share the link or excerpts, I can produce a cited, example-by-example mapping to baricitinib and the relevant claim scope.