IP: Writing a Freedom to Operate Analysis

Perform part of a Freedom to Operate (FTO) Analysis

Background

Freedom to Operate (FTO) is an analysis to determine whether a product, technology or invention may infringe on someone else’s patent claims. The goal of an FTO is to give the client (inventor or company) a list of patents upon which their product or technology could be infringing.

The Process

Anatomy of a Patent
A patent is a legal right granted by a sovereign state to an inventor to exclude others from commercially making, using, and selling the invention without permission for a limited period of time. At the core of a patent are claims that define the limits of exactly what the patent protects and does not protect. Claims may be construed to cover some actions, but not others. Reading and understanding the claims of a patent is crucial to determining if a disclosed invention is challenged by an existing patent.

Overview of the FTO Process

  1. Interview the scientists in the company about the discovery. They will fill out a disclosure form. Your goal is to understand the scope of the science, the subject matter, therapeutic areas, and the specific market, among other factors.
  2. Design a search strategy for patents your invention might infringe on. Your goal is to find keywords that will help you find technology in the claims section of patent applications that might apply to your client.
  3. Assemble hits into a spreadsheet.
  4. Review the patents and look at individual claims. Identify barriers to entry, or patents and technology that are most likely to block your client’s pursuit of an intellectual property patent. “Discard” results that aren’t relevant, and keep the subset of patents that could present a problem.
  5. Identify solutions to potential problems. For example, look at the patent status, potential expiration, and/or research, and prepare an invalidity opinion.
  6. Present the results to the inventors. Show the potential intellectual property (IP) problems and solutions, and make suggestions towards a plan for moving forward.

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.)

The Exercise

Perform the patent review (Step 4) of an FTO, and determine patents to discard or keep as potential IP issues based on the claims. Examine the specifications in the claims based on the terms you want to protect, and look for patents that might conflict.

For this exercise, you are a patent agent and your client is a company who discovered a novel protein.

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.
    • Targeting mechanism (siRNA/shRNA vs. another mechanism)
    • Drug delivery (nanoparticle vs. another form of delivery)
    • Therapeutic application (wound and tissue regeneration vs. another application)

Task 2: Summarize 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.

Scoring Criteria / Patent Number 1 2 3 4 5 6 7 8
Therapeutic target
Targeting mechanism
Drug Delivery 2
Total

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.

The Deliverable

Instructions

One standard deliverable for an FTO project is a presentation. A short (5-10 slide) presentation should allow the people you are working with to clearly see the top patents the product or technology may infringe upon. Your team will then present this to the client and advise the client on next steps.

The client may choose to design around the conflicts or license part of technology. For this job simulation exercise, you are looking for challenges to file the patent as is, and not designing solutions or work-arounds.

Sample Deliverable #1


Sample Deliverable #2

Task 1 sample: Evaluation of the claims in the invention and the patents. Note: only the claims relevant to the invention are listed below

Patent # Therapeutic target Targeting mechanism Drug Delivery Therapeutic Application Potential Infringment (Y/N)
Invention Fidgetin-like 2 Stimulation of Fidgetin-like 2 activity with small molecule agents Topical delivery Wound healing
1 TGF-B1, Cox-2, Hoxb13 sIRNA Polymers & nanoparticles Wound healing of the skin N
2 Microtubule development (no specific target) Small molecule inhibitors Topical and/or injection Inhibition of wound contraction Y
3 Fidgetin-like 3 Small molecule inhibitors Hydrogel Would amelioration and treatment Y
4 N/A PDGF delivery Formulation of buffer and Zn/Fe or gel Wound treatment N
5 mir99, 100, 4458, 4500, 89 and let-ya microRNA-regulated proteins Small molecules / microRNAs Nucleic acid administration Cardiomyocyte proliferation N
6 N/A Cells (capable of differentiating into vascular-like structures) embedded in polymers Hydrogel Wound healing, tissue engineering Y
7 Fidgetin-like 1 Identification of mediators of fibroblast cell interactions in tissues, measuring fibrinogen production N/A> Improve parenchymal cell function Y
8 Actin regulation Thymosin beta 4, human transforming growth factor beta 1 Topical Skin treatment, wound repair Y

Resources

Skills

General resources to get you started:

Skills used to perform this task:

  • Strategy
  • Market research
  • Technical writing
  • Reading comprehension

Skills needed in legal careers:

  • Technical expertise (STEM field)
  • Legal compliance
  • Project management
  • Collaborating with clients
  • Dealing with conflict

To see a list of skills listed in job descriptions for legal jobs, please see workforce data generated by Boston University’s BEST program.

To view skills listed by professionals on LinkedIn, check out this resource created by Duke University.

Additional responsibilities

A professional in the field of intellectual property may also perform these activities:

  • Patentability searches
  • Due Dilligence
  • Interview scientists about their technologies

Read more about careers in intellectual property and patent law in this resource generated by Duke University.

You are viewing a job simulation. To get started, set up SMART Goals to perform this simulation in a reasonable timeline. If you have completed the task, fill out the Self-Reflection Sheet.

Simulation authors: Thi Nguyen, PhD
Simulation vetted by professionals from law firms in the Bay Area and in DC.