FTO searching in front-end patent intelligence
Without aligning business process perspectives with improved IP strategic efforts, such efforts by IP managers merely amount to ‘rearranging deck chairs on the Titanic’.”
Managers of IP strategy can learn important lessons from preventable errors that occurred in the sinking of RMS Titanic. Titanic sank within hours of striking an iceberg—not because it didn’t know it was there, but because the captain, in a classic failure of risk management, didn’t change the ship’s direction until after a collision was unavoidable.
These actions parallel the traditional and wasteful IP strategy choices of industry players who remain more focused on the near-term costs of obtaining a patent. Contrast this to managers who chart a course embracing patent intelligence as an integral part of best practices and utilise an ongoing patent research strategy in creating a stronger patent portfolio which reduces risk and minimises exposure to litigation.
We propose a research model for identifying potential freedom to operate (FTO) issues through the lens of development of a biological agent, noting that the model’s advantages span any industry considered an attractive target for IP litigation, such as telecommunications, manufacturing, and artificial intelligence.
To comprehend our model, it is essential to understand that FTO research encompasses two distinct types of activities and functions: (i) investigative activities with strategic functions eg, investigative FTO searching; other synonyms include pre-emptive FTO, FTO forward, or preliminary FTO; and (ii) risk management activities with legal functions.
Our model focuses solely on (i) investigative activities with strategic functions, ie, ‘investigative FTO searching’, which are conducted during various development stages. Investigative FTO research is based on preliminary landscape research conducted early in development. Once the groundwork is established, progressively more precise research is conducted as the product is refined and progresses through the development pipeline.
Based on the benefits of investigative FTO searches we propose that searches conducted for investigative and risk management FTO activities be separate line items in in-house IP budgets. This supports flexibility in the timing and handling of business investments to support investigative FTOs. Separating investigative research from risk management has practical benefits when addressing the distinct issues that are evaluated, as addressed below.
Stages
While there is no defined number of searches that may need to be conducted during the investigative FTO process, we defined the searches in stages based on the complexity of biological therapeutics.
Stage one investigates FTO for the active biological therapeutic, including the active biological components, the biological target or pathway affected by the active components, the primary indication of use, any platform technology used to create the active biological therapeutic and its components, and any envisioned features that may be practised by the end user of the commercialised product.
