Comment Submission on the Consideration of Exercising March-In Rights

February 6, 2024

Under Secretary Dr. Laurie Locascio

The National Institute of Standards and Technology (NIST)

Bureau Drive

Gaithersburg, MD 20899

Re: Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

Dear Under Secretary Locascio,

First, let me begin by stating I am not a physician, medical researcher, or a patent lawyer. I am a 30-year survivor of the progressive neurological disease known as multiple sclerosis (MS). MS has no cure and had no FDA-approved treatment to slow its cruel and unpredictable attack on the nervous system until 1993, which coincidentally was the same year of my diagnosis. I am writing today to offer the point-of-view of a sick patient and ask you to examine the legislative intent, the results produced by the current treatment, and the hope of future patients.

The bipartisan legislation that is being discussed was crafted in order to create untapped value for taxpayer-funded research. Up until then, important and potentially valuable research was being done in government labs. This research was unable to inform advances in patient health because the government had neither the expertise nor the motive to create the medicine or treatment or license it to private companies for further development. Instead, billions of taxpayer dollars filled three-ring binders and gathered dust. The Bayh-Dole Act, however, unlocked those patents so that basic research could inspire work to improve the health of actual people. The intent was never meant to be used as a blunt instrument or for the government to say that because they were involved in some of the basic research, it could now set the prices. Congress passed a bipartisan bill to ensure that taxpayer-funded research was not wasted but instead allowed to advance science. Legislators wanted to be sure that the research was handed off to the innovators who had the best chance to help the most people.

The second consideration I would ask for is to look at the results. Think for a moment what getting this research into the hands of people with the best chance of delivering better health outcomes has done.

By almost any measure, the law was a tremendous success. But as a patient, the result was life-changing.

This policy and legislation, such as the bipartisan Hatch-Waxman law that passed a few years later, combined to unleash innovations that propelled the US from a laggard in the creation of breakthrough medicine to its undisputed leader. There’s no doubt that without this one-two public policy push, I would not have had the medicine that allowed me to escape from permanent residency in a nursing home. Luckily, there were four different drugs that I used in my battle with MS – zero of which existed when I was first diagnosed. Today, there are more than a dozen, and that’s what happens when public policy encourages innovation. Lives are changed.

Lastly, I would appeal to the proud history of the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) in assessing real results to craft standards that make the future better. As I described above, the legacy of keeping innovation going means lives are saved. The last thing we need is myopic and twisted theories that jeopardize future generations of patients. The proposed framework would transform so-called “march-in” rights into a negligent scheme to confiscate the fruits of a well-balanced team effort that has put America first in saving lives. NIST should not adopt a new framework that can only endanger the miracles we have come to expect.

As you consider implementing “march-in” rights, I urge you to remember my story and the ones put forth by my fellow patients. If you have any questions about my comment, please contact me at cz@survivorsforsolutions.com.

Sincerely,

John “CZ” Czwartacki

Founder & Chairman, Survivors For Solutions