A treatment that works once and keeps working for years is a very different commercial asset from a pill taken every day. The value is created up front. It then has to be defended for decades. That turns the patent vs trade secret question into a horizon question, and it is one every IP strategy should answer before the first filing.

The prompt is a Phase 1 result reported by Cleveland Clinic last month. CTX310, a single-infusion CRISPR therapy developed by CRISPR Therapeutics, switches off the ANGPTL3 gene in the liver. At the highest dose, LDL cholesterol fell 52.5 per cent and triglycerides 47.8 per cent, and the effect held for the full year with no serious treatment-related adverse events. Fifteen patients, early days. But the shape of the asset is already clear.

Durability of effect needs durability of protection

A one-time therapy has no repeat prescription to price. The return has to come from exclusivity over the years in which the market adopts it. The same logic applies outside medicine: a process change, a formulation or an algorithm that permanently lowers a cost base earns over a long horizon, and the protection has to last as long as the earnings do.

The two main forms of protection run on different clocks:

– A patent runs for a fixed term, 20 years from filing, in return for full public disclosure. It does not depend on secrecy surviving, it can be licensed or sold, and it can be enforced against a competitor who develops the same thing independently. But it ends on a known date, and everyone can read it.
– A trade secret has no expiry, but only while the secret holds. It needs constant defending through access controls, contracts and exit procedures, and it gives no remedy against reverse engineering or independent development.

For a therapy that will pass through regulators, clinical publication and contract manufacturers, secrecy for the core invention was never realistic. The gene target, the editing construct and the delivery formulation are patent territory. The manufacturing know-how may be better kept confidential. The decision is rarely one or the other. It is which parts get which form of protection, and how long each will actually hold.

Three questions follow for any board looking at an innovation with a long tail:

– Over what horizon does this earn, and does the protection last that long? The Five-Year IP Roadmap Is Over: How to Build an IP Strategy for a Future You Can’t Predict makes the point that patents outlive most product plans, so the filing has to be written for year 15, not only for today.
– What will the product, the regulator or the customer reveal? Anything they will reveal cannot be a trade secret. What remains genuinely hidden needs the discipline described in When AI is embedded in your Workforce, Trade Secrets Become the Strategy.
– How will exclusivity be extended once the first patent runs down? In pharmaceuticals the answer is layered filings over a public timetable, as The Pharmaceutical Patent Cliff Has a Timetable – And It’s Public shows.

Decide which clock each innovation is running on, then make sure someone is watching it. A result that lasts for decades is only worth what the protection around it lasts.

Read the article: Cleveland Clinic First-In-Human Trial of CRISPR Gene-Editing Therapy Shown to Safely and Continuously Lower Cholesterol and Triglycerides After One Year, Cleveland Clinic Newsroom.