Who needs this? Any company about to launch a new drug product, formulation, chemical, process or device — or entering a new country. When? Start during development, not the month before launch; the earlier you identify blocking patents, the cheaper the fix.
The checklist
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01
Define the product precisely. Document composition, process steps, specifications, uses and labeling — FTO is only as good as the product description.
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02
Identify every launch market. Patents are territorial; list each country where you will make, use, sell, import or offer to sell.
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03
Search issued patents and pending applications. Published applications can issue with claims aimed at your product.
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04
Check regulatory listings. For drugs, review the Orange Book; for biologics, the Purple Book and any patent lists exchanged under the BPCIA.
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05
Confirm status and expiration. Verify maintenance fees, terminal disclaimers, patent term adjustment and any patent term extension.
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06
Map claims to your product element by element. Flag claims that literally read on the product and those that may reach it by equivalents.
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07
Review file histories of high‑risk patents. Narrowing amendments and arguments can limit claim scope and block equivalents.
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08
Assess validity of blocking claims. Prior art, enablement and written description weaknesses can reduce risk.
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09
Consider design‑arounds and licenses early. A small change in process parameters or formulation, or a license, may remove the problem.
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10
Obtain a written opinion of counsel for key risks. A competent, timely opinion can be important evidence on willfulness and inducement.
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11
Monitor continuously. Set watches on competitor portfolios and pending applications through launch and beyond.
Common mistakes
- Treating a patentability search as an FTO clearance.
- Ignoring process patents for API or intermediate manufacturing by suppliers.
- Waiting until launch, when design changes require new regulatory work.
Frequently Asked Questions
Q: When should a company start a freedom-to-operate analysis?
A: Ideally during development — before the formulation, process or supply chain is locked in — so design‑arounds are still practical and inexpensive.
Q: Is an FTO search the same as a patentability search?
A: No. A patentability search asks whether your invention is new; an FTO analysis asks whether your product would infringe someone else's in‑force claims.
Planning a launch?
Contact Green, Griffith & Associates for freedom‑to‑operate analysis and opinions.
This post is for general informational purposes only and is not legal advice. Reading it does not create an attorney-client relationship.
Tags:
freedom to operate
FTO
opinions of counsel
product launch
patent risk