Freedom-to-operate analysis in biotech and pharma

Patentability and freedom to operate are routinely confused, and the confusion is expensive. Patentability asks whether your invention is new and inventive over everything published before your filing date. Freedom to operate asks whether making, using, selling or importing your product in a given country infringes a patent that is in force there. You can have both, either, or neither.

An FTO analysis therefore looks only at claims, only at patents and pending applications that are alive, and only in the territories where you intend to operate. Expired patents, abandoned applications and academic papers are irrelevant to FTO — however relevant they are to patentability.

A patent claim is a list of features. Under the all-elements rule, a product infringes a claim literally only if it reproduces every feature of that claim; one missing feature and there is no literal infringement. This is why a serious FTO report works claim by claim and element by element rather than by reading abstracts.

For each independent claim of each candidate patent, the analyst — or the software — breaks the claim into its elements, restates each element in the technical vocabulary of your product, and records one of three findings: present, absent, or uncertain. The verdict on the claim follows: an 'absent' on any element means no literal infringement; all 'present' means a hit; any 'uncertain' means the claim needs closer reading, a construction opinion, or a design-around.

Dependent claims narrow the independent claim they refer to. If you do not infringe the independent claim, you do not infringe its dependents. Report time is best spent on independent claims.

A feature that is not literally reproduced may still be caught by the doctrine of equivalents. The United States applies the function-way-result test of Graver Tank and Warner-Jenkinson, limited by prosecution-history estoppel (Festo). The United Kingdom reshaped its test in Actavis v Eli Lilly (2017), asking whether the variant achieves substantially the same result in substantially the same way and whether strict compliance with the literal wording was intended as essential. French courts apply a doctrine of equivalence to means performing the same function for the same result, provided the function itself was not already known.

Practically: when the only 'absent' element in your mapping is a substitution — a different salt, a neighbouring concentration, a homologous linker — the claim goes into the 'uncertain' column until a jurisdiction-specific opinion is obtained.

A claim only matters if the patent is alive where you operate. The FTO report should record, for each family member: the grant status, the renewal-fee position, the expiry date (twenty years from filing, subject to fees), and any supplementary protection certificate. In Europe, an SPC under Regulation (EC) No 469/2009 can extend protection for a medicinal product by up to five years, plus six months for paediatric studies; in the United States, patent term extension under 35 U.S.C. § 156 plays the same role.

Pending applications deserve their own line. Their claims are not yet fixed and often narrow during examination; a pending application is a risk to monitor, not a verdict. The published claims, the search report and the file history tell you which way it is heading.

Several statutory exemptions can neutralise an otherwise blocking claim, and a report that ignores them overstates risk.

• Research and experimental use: Article L613-5(b) CPI exempts acts done experimentally on the subject-matter of the patented invention; most European laws contain the same carve-out, while the US common-law exemption is very narrow (Madey v Duke).
• Bolar exemption: Article L613-5(d) CPI and Article 10(6) of Directive 2001/83/EC exempt the studies and trials needed to obtain a marketing authorisation for a generic or biosimilar; 35 U.S.C. § 271(e)(1) is the US counterpart.
• Private and non-commercial acts, and the preparation of individual medicines in pharmacies on prescription.
• Exhaustion: once a product is put on the market in the EEA by or with the consent of the patentee, its resale is free.
• Compulsory licences and public-health licences exist on paper; they are not a planning tool.

The point of an element-wise mapping is that it tells you exactly which feature to change. If a claim requires a polymer with a molecular weight above 50 kDa and yours can work at 40 kDa, the design-around is concrete and testable. Good FTO work ends with a short list of such levers, ranked by technical cost, and a description of the white space — the combinations no live claim covers — which is also, not coincidentally, where your own filing opportunity lies.

A well-structured report can be triaged quickly. Read the holistic verdict per patent first, then open only the patents marked 'hit' or 'uncertain'. For each, look at the independent claims' element tables, check the legal-status line, and check whether an exemption applies to your intended use. Everything else is supporting material for the day a licensing discussion or a litigation starts.

Whatever tool produced the report, insist on verbatim claim text next to each verdict. A paraphrase is where errors hide, and a claim you cannot quote is a claim you cannot rely on.