Waylaid in Phase III: What to Do When the FDA Panel Questions Your Foundation

Medical Patents Broker Inc.
By Kenneth Pearce, President

Seems like this is a “Why me?” moment. Fortunately, none of MPB’s clients have had this target on their back. At least, not yet!

First, the curse: Our understanding of medical science is constantly changing. (Yet, we like to think it’s constant.)
Next, the absolute: Humans are as they have always been.
Finally, the axiom: It can always get worse, but it can always get better.

Just because a member of the panel agrees with the latest peer publication only means that the member believes the article is true. How many times have you witnessed a theory or scientific opinion crumble?

Focus on fixing the issue; not people’s opinions. Unless it’s changed, in academia and other institutions there is something about “publish or perish.” There are more articles available than publishers. When reading a medical journal, the acronyms are usually too much to remember. I wonder why it is this way. (And this was the style long before AI.)

1. Isolate the Variable: Separation of Fact from the Unproven Observation

If the data collected coincides with anticipated safe and effective use, then the data is good evidence. The anticipated use has been stressed, poked, prodded, injected, and measured against different body types. If the invention yields the intended results with few side effects, that is great evidence.

Evidence is evidence. The record speaks for itself without pontificating or puffing to the detriment of competitors—which is what the marketeers can do.

2. Run Toward the Critique, Not Away From It

Don’t assume the situation will fix itself. Show the FDA the evidence that proves the technology is safe and effective.

The talking heads can make verbal assertions, but that is just similar to a publication. Long before there was written history, there was group of peers looking on as the first guy placed a round piece of wood with a hole in the center on a stick, spun it round and round, and they looked at him and said, “So what?”

It seems to be human nature for some of us to argue that something is wrong when the evidence indicates just the opposite. It’s difficult to prove the truth wrong.

3. Protect and Expand the Intangible Universe

During Phase I, Phase II, and Phase III, there is a high probability tweaks to the original invention were created. If not already done, you should file additional patent applications.

Whenever possible, increase the scope of the invention’s legal universe from the first wave of the invention. It could be that Phase III revealed a second line of subsequent new inventions that can be the focus of the next surge of patent applications. Science is dynamic rather than static.

4. Transfer to a New Owner

Hands-up-in-the-air and “I’m done!” declaration. If the data supports safe and effective use, there is the possibility of a transfer or license to a third party who is ready to carry the banner over the finish line.

The President’s Viewpoint

In my youth, I could overthink almost anything. At times, still do. Humans are alike while also vastly different. Different personalities generate different perspectives.

We can accomplish more when we are at peace rather than emotionally stressed. And we are blessed when we can be thankful.