A freedom-to-operate checklist before a product launch

A freedom-to-operate (FTO) review asks whether a product can be made and sold in its target markets without infringing anyone else's in-force patent claims. Done properly it is a sequence: define the product, fix the markets and dates, search granted patents and pending applications, read the claims against each feature, and record a decision for every patent that survives triage. The checklist below follows that order.

An FTO search is a different exercise from a patentability or validity search, with different sources and a different question. If the distinction is new to your team, read FTO, patentability and validity searches compared first.

1. Define the product and its features

The review can only clear what it describes, so work from the specification, the architecture documents or the bill of materials, not the marketing copy. Write down what the product does at the level a claim would describe it: components, method steps, data flows, materials and operating parameters.

Mark which features are new and which come from suppliers. A supplier's component may already be licensed or covered by an indemnity, which changes who carries the risk. Then freeze a version. If engineering changes the design next quarter, you need to know which version the review cleared.

2. List the markets

Patents are territorial. Under 35 U.S.C. § 271(a), a US patent is infringed by making, using, offering to sell or selling the patented invention within the United States, or importing it into the United States, during the patent's term. A US patent does not reach sales in Germany, and a German patent does not reach sales in Texas.

List every country where the product will be made, used, sold or imported, including manufacturing sites and contract manufacturers. Each country is its own search. Outside the US, note that Europe's Unified Patent Court began operating on June 1, 2023, so some European patents can now be enforced in a single action across participating states.

3. Decide the time window

Fix the launch date and the expected commercial life of the product. A patent that expires before launch is a minor concern. One that runs ten years past launch is a central one.

The window also sets how far back the search must reach. A US utility patent generally expires 20 years from the filing date of the earliest US non-provisional application it claims benefit from, plus any patent term adjustment, under 35 U.S.C. § 154. Documents filed well before that cutoff matter mainly as prior art, not as blocking patents.

4. Search in-force patents and published applications

Search granted patents still in force and published applications that could still mature into patents. Use more than one route: concept and keyword searches built from the feature list, classification searches around the relevant codes, citation searches outward from the strongest hits, and assignee searches on known competitors and suppliers.

Expect a blind spot at the recent end. Under 35 U.S.C. § 122(b), applications generally publish about 18 months after the earliest priority date, so the newest filings cannot be found on the day you search. A clean result is a result as of a date, and the report should say which date.

5. Filter by status and expiry

Remove what cannot block you, and record why each item was removed.

• Expired by term. Calculate the expiry date from the filing history rather than relying on a database field, which may omit adjustments or disclaimers.
• Lapsed for unpaid fees. Under 35 U.S.C. § 41(b), utility maintenance fees fall due 3.5, 7.5 and 11.5 years after grant, with a six-month grace period on payment of a surcharge. If the fee is not paid, the patent expires.
• Lapsed, but possibly not for good. Under 37 C.F.R. § 1.378, the owner can petition to reinstate a patent that lapsed for non-payment if the delay was unintentional. Put recent lapses on a watch list instead of closing them.
• Abandoned applications. These do not block, but check whether a continuation in the same family is still pending.

6. Read the claims, not the abstract

Infringement turns on the claims. The title and abstract describe the disclosure, which can be much broader or narrower than what was actually claimed.

Start with the independent claims. Break each one into limitations and compare them, one at a time, with the feature list. Literal infringement generally requires every limitation to be present, so a limitation the product clearly lacks usually takes that claim off the critical list. Review dependent claims only where the independent claim reads on the product, because a dependent claim cannot be infringed unless the claim it depends on is.

7. Triage by feature overlap

Rank candidates by how many limitations the product actually meets, not by how similar the patent sounds. Three tiers are usually enough:

Medium-tier patents need a second look under the doctrine of equivalents. A limitation that is not met literally may still be met by an equivalent, unless prosecution history or another limit rules that out.

8. Check pending applications and continuations

Pending applications are the moving part of any FTO review. Their claims can be amended before grant, and an open family can file continuations with new claims drafted after the applicant has seen your product. List every family that is still pending and check its status again before launch.

Published applications can also create exposure before grant. Under 35 U.S.C. § 154(d), a patent owner can recover a reasonable royalty from the date the application was published, if the issued claims are substantially identical to the published claims and the infringer had actual notice of the published application. A published claim that closely matches your product is a current risk, not a future one.

9. Decide per patent: license, design around, challenge or monitor

Every patent left on the list needs a decision, written down with the reason for it.

1. License when a claim clearly reads on the product, the patent looks valid and the owner is likely to deal.
2. Design around when a feature can change so that a limitation is no longer met. Re-check the new design against the same claim, including equivalents.
3. Challenge when strong prior art suggests the claim is invalid. This needs a prior-art search and, in most cases, counsel.
4. Monitor pending applications, recently lapsed patents and low-tier hits that could change. Set a date for the next review.

10. Document the analysis

Record what was searched, in which sources, on what date and with which terms and classifications. List the patents reviewed and the reason each one was closed or escalated. Keep the claim charts together with the product version they were made against.

A documented review can be repeated when the design changes, and it shows how decisions were reached if they are questioned later.

11. Know when to get an opinion of counsel

For high-tier patents, many companies ask outside counsel for a written non-infringement or invalidity opinion. Two legal points shape that decision.

In Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016), the Supreme Court held that enhanced damages under 35 U.S.C. § 284 are within the district court's discretion and are generally reserved for egregious infringement behavior. It rejected the rigid two-part Seagate test. Separately, under 35 U.S.C. § 298, the failure to obtain or present advice of counsel may not be used to prove willful infringement or intent to induce infringement.

So an opinion is not mandatory. Companies still commission them for the patents that matter most, because a reasoned opinion records why the business decided to proceed.

Where One Transform fits

One Transform's Freedom to Operate search handles the first pass of steps 1, 4 and 7. It decomposes the product into features, looks for in-force patents that could read on them, and scores each blocking candidate for risk with a feature-by-feature overlap analysis and the blocking claims quoted in full. Each candidate comes with a recommended next step: license, design around, challenge or monitor.

Scores are computed from claim-element coverage, and every finding links to its sources, so your team can check the triage before acting on it. Steps 8 to 11 stay with your team and counsel.

Next step

Describe your next launch candidate in a Freedom to Operate search at onetransform.ai, then take the high-tier results through steps 8 to 11.

This article is general information about patent practice, not legal advice. For advice on a specific matter, consult a registered patent attorney or agent.