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In this second article of a three-part series, Andrea Walsh and Cris Flagg of Express Search focus on the value of preliminary freedom-to-operate research throughout the product development cycle.
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.
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.
"Cost savings are realised by eliminating wasted R&D efforts that duplicate already available technology."
Stage two investigates source materials, such as cell lines, viruses, bacteria, biopolymer sequences, bioinformatics, and molecular biology and protein expression tools that may have been used to create the product candidate but will not be actively used during development or commercialisation.
Stage three includes suitable formulations for delivering the biological agent and is conducted only when the top three candidates have been selected.
Stage four covers all manufacturing steps required to manufacture the commercial product, including host cells, cell cultures, and downstream purification techniques.
A well-conducted investigative FTO search programme will (1) reduce developing product clearance risks; (2) identify valuable patent information for ongoing R&D activities; (3) manage predictive patent filings; and (4) monitor competitor activities in your technology area.
To comprehend our model, you will realise that this search does not analyse claims, since claims are written only when the product is finalised (in contrast to a product clearance, which focuses on the granted claims of the product to be commercialised and seeks to determine whether the proposed product infringes any third party patent claims that are in force).
Cost savings are realised by eliminating wasted R&D efforts that duplicate already available technology, avoiding the cost of pulling back a new product from commercialisation due to infringement issues; success in returning the cost of capital in the investment; and minimising litigation and licensing demands.
Andrea Walsh is a senior patent analyst at Express Search. She has expertise in dynamic patent research and analysis in multiple chemical and biotechnology areas. Walsh provides innovative research solutions in molecular/cell biology, immunology, gene editing and biosequence analysis. She can be contacted at: email@example.com
Cris Flagg is president of Express Search. He has a Master’s degree in computer science, focusing on machine learning/artificial intelligence. With 25 years’ experience in patent research, Flagg has developed landscaping analytics and software research tools that his company uses to provide research. He can be contacted at: firstname.lastname@example.org
FTO, patent, patent intelligence, Andrea Walsh, Chris Flagg, Express Search Focus, IP strategy, Titanic, freedom to operate