A pharma FTO search is a freedom to operate (FTO) search for a drug or a biologic. It identifies patents in force, or still pending, whose claims could cover the product, its manufacture or its use in each country of launch. It differs from other FTO work because a medicine is usually protected by several layers of patents with extendable terms.
The general method of an FTO search is set out in the freedom to operate search guide.
What a pharma FTO search covers
The compound patent is usually followed by later filings, and each of them can block a generic or biosimilar on its own. The search covers:
- the compound, including Markush claims to a group of compounds;
- salts, polymorphs, crystalline forms and enantiomers;
- formulations, dosage forms and particle size;
- manufacturing processes and intermediates;
- medical uses, dosage regimens and combinations;
- for biologics, sequences, targets, cell lines and purification steps.
Small molecules: structure searching and the Orange Book
A compound is often claimed by a generic formula that covers thousands of molecules, so keyword searching misses it. A pharma FTO search for a small molecule runs exact, substructure and Markush structure searches in chemical databases, while keyword and classification searches cover formulations, processes and uses.
In the US, the Orange Book of the Food and Drug Administration (FDA) lists the patents declared for each approved drug. Under 21 CFR 314.53, the applicant submits drug substance, drug product and method-of-use patents, and must not submit process, packaging, metabolite or intermediate patents.
Biologics: sequence searching and the Purple Book
Biologics are claimed by sequence, by function or by target. The search uses a biological sequence search against patent sequence databases, with an identity threshold set for each sequence. An antibody may also be claimed by its complementarity-determining regions (CDRs), its epitope or its function, so keyword searching runs alongside.
The FDA Purple Book publishes patent lists for some licensed biologics. Under 42 U.S.C. 262(k)(9), a reference product sponsor sends FDA the list it gave a biosimilar applicant within 30 days. Where no such exchange has taken place, there is no list.
Expiry dates and extensions in a pharma FTO search
Each relevant patent needs an expected expiry date in each country. The 20-year term is only the starting point, and in the US, patent term adjustment adds days for delay at the patent office.
| Mechanism | Where | Effect (checked October 2026) |
|---|---|---|
| Patent term extension (PTE) | US | Up to 5 years; total term after approval capped at 14 years; 1 patent per review period (35 U.S.C. 156) |
| Supplementary protection certificate (SPC) | EU | Up to 5 years after patent expiry, granted country by country (Regulation 469/2009) |
| Paediatric extension | EU | 6 months added to an SPC |
| Regulatory exclusivity | US and EU | Not a patent; it delays approval or marketing, for example 12 years from first licensure of a US reference biologic |
Regulatory exclusivity is outside a patent search, but the later of the approval date and the patent dates sets the earliest launch.
Development, manufacture and the safe harbour
Some development work needs no clearance. In the US, using a patented invention solely for uses reasonably related to submitting information to FDA is not infringement (35 U.S.C. 271(e)(1)). However, filing a generic or biosimilar application to market a product before a relevant patent expires can itself be an act of infringement under section 271(e)(2).
Europe has a narrower exemption for the studies and trials needed for a generic or biosimilar approval (Directive 2001/83/EC, Article 10(6)). Under the SPC manufacturing waiver in Regulation 2019/933, in force since July 2019 (July 2022 for older SPCs), an SPC-protected product may be made for export outside the EU. Stockpiling for EU launch is allowed only in the last 6 months of the SPC, after at least 3 months’ notice to the granting office and the SPC holder. The search therefore looks at where and when the product is made, as well as where it is sold.
Report contents and cost
A pharma FTO search report usually contains:
- the relevant patents, grouped by layer and ranked by risk;
- legal status and expected expiry in each country, including PTE and SPC;
- claim charts for the high-risk claims;
- the search record of structure queries, sequence queries and strings.
Cost depends on the number of layers, countries and sequences. As a reference, FTO searches at Synoptic IP cost USD 800–4,000 (October 2026). The legal view on infringement comes from an attorney, as explained in FTO search vs FTO opinion.
Commission a pharma FTO search
We run pharma FTO searches for drugs and biologics, including structure and sequence searches. Send the product profile and launch countries through our FTO search service page to receive a proposal.
This guide is general information and is not legal advice.
Frequently Asked Questions
Is the Orange Book enough for a pharma FTO search?
No. The Orange Book lists only the patents an applicant has declared for an approved drug, and the rules exclude process, packaging, metabolite and intermediate patents. Patents the applicant does not list, such as many competitors’ formulation patents, are also missing, so a full database search is needed.
How far back should a pharma FTO search go?
Usually at least 25 years back from the search date. A patent normally lasts 20 years from filing. A US patent term extension or an SPC in Europe can add up to 5 years, and a paediatric extension or patent term adjustment can add more.
Can a generic launch once the compound patent expires?
Not always. Later patents on salts, crystalline forms, formulations, processes and medical uses can stay in force for years after the compound patent expires. An SPC can also extend the compound protection itself. Each layer therefore needs its own expiry date in each country of launch.
Can clinical trials infringe a patent?
Usually not, if they are done solely to obtain approval. In the US, such work falls within the safe harbour of 35 U.S.C. 271(e)(1). Europe has a narrower exemption whose scope differs between countries, while commercial manufacture and sale fall outside both.
Do pending applications matter in a pharma FTO search?
Yes. A pending application can be granted with claims that cover the product, and divisional or continuation filings can add new claims. The report lists relevant applications separately, and their claims are checked again shortly before launch, because they can still change.