Writing a Freedom to Operate Analysis for PhDs

A Simple Illustration of an FTO Analysis

Say your client invents the pencil and wants to sell it. You know of a patent that claims a “graphite rod for writing”, and describes (in the body of the application) methods for protecting the graphite from getting on your hands by wrapping the graphite in paper or cloth, but not with wood.

In an FTO analysis, you would have a problem, because the pencil is also a “graphite rod for writing” even though it contains other components, so the pencil would infringe on the previously existing claim. (On the other hand, if the claim was for a graphite rod wrapped in cloth, there would be no FTO problem, because a pencil contains no cloth.)

Task 1 - Patent Review

Read the description of the invention. Next, review the claims sections from eight patent applications and identify the patents to discard or keep as a potential problem. Note that we have abbreviated the claims section for the purpose of this exercise. These patents were chosen based on the following search words: wound healing, regeneration, skin, neurons, target, drug target, microtubules, severing enzymes, Becaplermin, siRNA, and cytoskeleton.

Use the following criteria to evaluate each patent’s claim and compare it to the invention descriptions to determine if the new invention might infringe on existing claims:

• Therapeutic Target (Fidgetin-like 2 vs. another target). This is the most significant category because it holds the most weight in challenging the novelty of a patent. A challenge to the therapeutic target is a serious conflict.

  1. Targeting mechanism (siRNA/shRNA vs. another mechanism)

  2. Drug delivery (nanoparticle vs. another form of delivery)

  3. Therapeutic application (wound and tissue regeneration vs. another application)

Task 2 - Summarizie IP Challenges

Take the patents you identified as challenges and briefly summarize the specific barriers.

Organize the information by creating a table (see example below). Use the table to keep track of each challenge. For example, if Patent 1 has two claims that could pose a challenge in the drug delivery category, give it a score of 2 in the drug delivery row.

Note: Metrics for evaluation may vary between companies. Feel free to define your own metrics.

Task 3 - Create a Presentation

Create a presentation slide for one of the patents you identified in Task 2 that you might present to the scientists in the company and your firm’s leadership. Describe their threat level, and your rationale for why it presents an IP challenge. Determine the threat level by using the scoring system below.

• Lowest threat – Relevance to the field; recognize that this may be a future roadblock and future directions might risk infringement

• Medium threat – Interpretations that might challenge the patent, but you have an argument for how your invention does not infringe

• Highest threat – Significant overlap, and you could consider getting a license or getting rights to practice. Keep in mind that the company may choose to design around the conflicts or license part of the technology.