IP Protections for Scientific Discoveries and Innovations Critical for America’s Economic Success

Tue, 29 Sept 2026

Coke Morgan Stewart, President and CEO of the Council for Innovation Promotion (C4IP), and a Former Deputy Undersecretary of Commerce for Intellectual Property and Deputy Director of the U.S. Patent and Trademark Office (USPTO), discusses the Constitutional foundations of intellectual property protection and the resulting democratization of innovation, patent eligibility, false narratives about the U.S. patent system, and the need to stabilize and strengthen our IP system to outcompete China.

Transcription

Giachino (00:04.0980 - 00:38.0959)

Welcome to IP Protection Matters. I'm your host, Renee Giachino. Today, we are joined by Coke Morgan Stewart, President and CEO of the Council for Innovation Promotion and a Former Deputy Undersecretary of Commerce for Intellectual Property and Deputy Director of the U.S. Patent and Trademark Office (USPTO).

Coke joins us today to discuss intellectual property litigation and efforts to improve certainty in patent rights. Coke, welcome to IP Protection Matters. It's a pleasure to have you join me.

Stewart (00:39.0139 - 00:40.0880)

Thanks so much for having me, Renee.

Giachino (00:41.0439 - 01:11.0660)

So you have had a long and incredibly impressive career from government service to private practice, academia and now working with C4IP, all roles that involve a wide array of legal and policy matters that relate to intellectual property and our discussion today, the need for strong IP rights.

Throughout your distinguished career, what do you think the biggest changes are that you have seen, and I guess tied into that, maybe what are some of the biggest disappointments?

Stewart (01:12.0150 - 02:17.0690)

When I joined the USPTO in 2011 for my first tour of duty, the big change that was happening was the America Invents Act (AIA). I had been working in private practice for some time on patent litigation issues, and I think there was a genuine concern about mom-and-pop businesses dealing with patent enforcement strategies and what was the best way to address this.

What started from perhaps a focused concern on the impact of small businesses morphed into a larger patent reform effort that fundamentally changed the operation of the USPTO and the patent system. When I think about big changes, I really think about that inflection point for me and for the system that happened in 2011.

Giachino (02:18.0300 - 02:26.0639)

And what about any disappointments over the years? Anything that immediately comes to mind that you're like, boy, that could have been done better or should be done better?

Stewart (02:27.0029 - 04:24.0739)

I would say there are two things that come to mind. One really is the creation and implementation of the AIA. Again, I think there are some legitimate issues there. I think by many people who were involved in that process, it was a very well-intended effort. But the actual outcome of that legislative effort and the implementation has really been devastating to the patent system in a negative way. We can talk more about that.

Another issue that I think has been, I would say, a disappointment is on the Court's interpretation of Section 101 and patent eligibility. Again, I think there's legitimate curiosity and concern about how patent eligibility works, but there's a lack of understanding on all of the different gates that a particular claim has to go through from [Sections] 101, 102, 103, 112, a lot of other gatekeeping functions, printed matter, [and] other forms of intellectual property.

I think that we in the IP community and we IP attorneys did a really poor job communicating to the Supreme Court on how [Section] 101 fits into the larger patent granting and patent evaluation process. As a result, I think the Court and other courts have felt a lot of pressure to really make [Section] 101 the one gating event for determining what kinds of inventions should be eligible for patent protection. Certainly if we could go back in time, I think we could do a better job of explaining those issues to the Court.

Giachino (04:25.0089 - 04:43.0290)

So you worked on and off for over a decade at the USPTO. Going back to your time there, what do you hope people remember you most by from all those years of service and in the many different roles that you held? In other words, what do you hope your legacy is?

Stewart (04:43.0459 - 06:32.0640)

That's a good question. In my first 10 years at the USPTO, about half that time was spent working on appeals to the Federal Circuit, working on administrative appeals in the district courts, and assisting the Department of Justice at the Supreme Court. That's just the bread and butter of the Solicitor's Office. So certainly I remember fondly, and I think it's essential, that the IP community appreciates the incredible work that is done by the Solicitor's Office at the USPTO. So that was kind of phase one.

Phase two was really my work in the front office initially for Michelle Lee during her transition, but ultimately for a long period of service for Andrei Iancu. There it was really supporting Andrei's efforts to start to make some reforms, particularly with respect to [Section] 101 and the AIA.

Then the third phase was this recent service that I've had in the Trump Administration. I hope to be remembered, and I think I will be remembered, for operational changes that helped turn around the unprecedented backlog of unexamined applications we had and bringing more attention to reforms needed with respect to PTAB so that we can have the government really standing behind the patent rights that they issue and giving patent holders a sense of certainty so that they can get the investment they need in their patent rights. Not to say that there shouldn't be forms of challenge and we shouldn't be taking that up, but really trying to bring stability to that patent challenge landscape.

Giachino (06:33.0230 - 07:15.0980)

I want to talk about that a little more in just a moment, but before we do, there's an interesting quote from you recently where you said, “My time at the USPTO reinforced for me that IP policy isn't abstract.”

So when we're talking about Section 101 and using a lot of the different terminology, a lot of people probably think, oh, this IP stuff, it's just for lawyers, not necessarily understanding why strong intellectual property rights are essential to American innovation and economic growth.

Can you touch a little bit on what you meant by the fact that IP policy isn't abstract?

Stewart (07:16.0130 - 09:51.0569)

I think a great place to start and an appropriate topic given this year's celebration of the 250th anniversary of our country is really going back to what the Founders were thinking about intellectual property policy and why they decided to put it in the Constitution. It's easy to get caught up in the weeds of IP policy.

IP lawyers and policymakers kind of lose the greater plot, which is why were IP rights incorporated into the Constitution? Why did George Washington talk about the importance of intellectual property protection in his first State of the Union? Why was it very soon after codified in the first Patent Act in April of 1790? That's because the Founders, in creating our country and looking at the model of what was working and not working in England, saw that economic protection for scientific discoveries and innovations was critical to grow, support and nurture the economic success of a new country.

Maybe reasonable people can disagree on the importance of IP policy. But going back to the Constitution really is the tiebreaker, right? The Founders had the wisdom to embed that into the fabric of our founding and what happened after that? IP helped democratize innovation. So it wasn't like the crown giving monopoly rights to favored persons as part of a class entitlement issue. This was about motivating individual inventors and entrepreneurs and giving people a seat at the table.

I think you make an excellent point, which is why does this matter? Let's not get too caught in the weeds of the patent laws and parsing Supreme Court cases. Let's really talk about why this matters. It matters for investment. It matters for giving individual inventors and entrepreneurs and small- and medium-sized businesses the tools to compete with established firms.

Giachino (09:52.0170 - 11:29.0290)

I love hearing about the history and hearing about the importance to the Founders of our country. As you mentioned, America just celebrated its 250th anniversary. Then a month later, the USPTO held a virtual program commemorating the 236th anniversary of the first U.S. patent, which was actually signed by George Washington. As you said, he was major in pushing for this in his first speech. That [patent] was granted to Samuel Hopkins, I understand, on July 31, 1790. As you said, that system has empowered centuries of inventors, entrepreneurs and small businesses to drive America forward.

I understand that while you were in private practice you represented both patent holders and patent infringers, which gives you a very unique perspective, I would think, on the importance of people seeing both sides of this coin and taking that one step further with bipartisan support for these enhanced strong IP rights.

We've got Democratic and Republican lawmakers continuing to weigh in currently on legislation that's going to prioritize strengthening IP protections, including, for example, the reintroduction of several significant bills, which we don't have time today to get into, but I'd like to touch on briefly.

Coke, do you see a world where bipartisan support for patent reform legislation - let's just start with the PREVAIL Act - where that could be accomplished? What do you think that's going to take?

Stewart (11:30.0230 - 14:15.0610)

I do see a world where that can be accomplished. I think going back to the original foundation of your question and my representation of both patent holders and those that have been accused of infringement allows me to bring a very honest perspective to this conversation, which is, of course, the [Patent] Office can make mistakes. Of course there's abuse on all sides. We need avenues to correct mistakes and address in an efficient way the mistakes that occur.

Sometimes it's not a mistake. Sometimes it's a change in the law that impacts a group of patents. We don't want people asserting patents that should not be enforced. But that's a narrow question. What's happening right now is that in the absence of some of the adjustments to legislation that can be made in the PREVAIL Act, it's very broad and it's like a sledgehammer working when you need a scalpel. It's really destroying the ability for businesses to invest in their IP rights and to obtain investment in their businesses because nobody can rely very well on the patent rights that they have.

That is why I have optimism about what can happen with respect to PREVAIL or something like PREVAIL, because I think reasonable people can really agree that we need reform. There are some people who would prefer that there not be any challenges brought at the USPTO and they all be handled in court. There are others that think that bringing back every patent that the Office has issued is an appropriate use of Office resources, but there's definitely middle ground here.

I think if we can raise the burden of proof to match what's happening at the district court, so we're not just bringing back patents that I would describe as like close calls and we're focusing on real problems, then we can get behind that. If legislators understand what's happening and they hear that, I think they can get behind it. But they really need to hear from businesses and people in their districts. I don't think that they are really being moved by the inside-the-beltway conversation right now. I think we need to really make it real by bringing in small- and medium-sized businesses that need this reform.

Giachino (14:16.0509 - 15:27.0190)

I love that idea because as we touched on briefly a couple of minutes ago, for many Americans, these pieces of legislation - the PREVAIL Act, Restore Act, PERA, No Fakes, a lot of things that are being considered on Capitol Hill - and those acronyms don't mean much to people. At least not that they can relate to until they understand the importance in their everyday lives, whether that's technological advancements, biotechnology, AI or anything else coming down the pipeline.

I also think that numbers can help confirm why it is so important for us and for our legislators to get behind strong IP protections. I love that you're optimistic about that. When we talk about numbers, I was very impressed by the fact that, for example, it can take more than a decade and over $2 billion to develop a new medicine. Roughly 90% of experimental drugs fail in clinical trials.

Coke, in your opinion, without these strong IP protections, what do you think is going to happen in terms of research spending and medical progress?

Stewart (15:27.0649 - 17:15.0789)

I think there's a lot of misunderstanding about what's happening right now with respect to medicine and development of new drugs and treatments. It's really a success story in the United States. Our biopharma industry is probably one of our most successful industries, and that's a direct result of the strength of our patent system and protecting those innovations.

I, like everyone, get very frustrated at times with the cost of health insurance and medical care, but it has nothing to do with the patent system. The patent system is why we have the innovations that Americans want and why we have such incredible life-saving health care treatments and devices in the United States.

The question is how do we motivate companies to take the risks that you articulated if it takes 10 years, if it takes billions of dollars and if 90% of their efforts fail? The only way industry is going to make those kinds of investments is when they do have that winning formula that it can be protected. Then in turn generic companies benefit from those innovations. If it weren't for the drug innovations, we wouldn't have a generic drug industry at all.

So I think the answer to me here is working on other inefficiencies in the healthcare system and making sure that other countries are paying their fair share for the innovations that are happening in the United States.

Giachino (17:16.0480 - 18:15.0142)

There's a recent one-pager that I saw that your organization, C4IP, put out. Folks who want to go to the organization's website, it's C4IP.org. That's the Council for Innovation Promotion. It was a fabulous one-pager called, “Life Sciences, Patent Myths and Facts.”

This is something I think that needs to land on every Member of Congress's desk because, as you said, it's up to the businesses, it's up to the general public to make sure these issues stay in front of our Members of Congress and that they are familiar with some of the myths about drug patents and their alleged role in preventing generic competition.

What do you believe are some of the biggest myths regarding drug patents? Maybe just touch on one of them perhaps. And again, folks can look for the one pager and read through it, but what would you say one of the biggest myths would be regarding drug patents?

Stewart (18:16.0042 - 19:52.0640)

We all know the taglines about evergreening, product hopping and patent thickets. Those are all truly false narratives. I’m very happy to discuss them because I think they're very easily debunked. But the one I think would be most interesting to talk about is the concept of patent thickets.

I think it's good to use analogies here. Americans love choice. Americans love their cars. They love SUVs. So as the market changes and commercial interest grows in a certain area, you're going to have a proliferation of new products and innovations in that area. When you walk down the aisle in the grocery store, think about all of the choices you see from laundry detergent to desserts and ice cream. Anytime there's concentrated interest in a particular product, you're going to have a lot of innovation around that product.

So no one would ever look at the choices that we have in our grocery stores or with respect to car manufacturers and say we have a thicket of innovation. Those are considered part of the choices that we demand and want in the United States and elsewhere. So yes, there are going to be a lot of patents in areas where there's a lot of investment and interest. That's a good thing, not a bad thing.

Giachino (19:53.0350 - 20:18.0679)

We are rapidly approaching October, which is our National Intellectual Property Month. A very exciting time. Coinciding with that, I understand that you're going to be speaking on a very interesting panel that's hosted by the Congressional Inventions Project.

The question that's being asked: Is America or China winning the innovation race? Can we have a sneak peek? How would you answer that question?

Stewart (20:19.0339 - 21:36.0130)

Unfortunately, I think there's a lot of fear mongering about what's happening with China right now. Obviously, China is a very important competitor to the United States. They take a very long view of innovation. They just announced a five-year program to support basically what we would refer to as little tech. So they have a long-term view.

The midterms are happening, then there's going to be people ramping up for another presidential election and appointments. We need to take a longer view if we want to compete with China. We can't say, well, China's engaging, their companies are filing a lot of patents in the U.S. and therefore, we should weaken patent rights.

What we should be saying is they're investing in innovation, they're investing in their IP system. If we want to outcompete them, we need to strengthen and stabilize our IP system and not worry that China and other foreign countries want to file patents in the U.S. They want to file for patents here because they want to be part of the U.S. market. And that's a good thing.

Giachino (21:36.0780 - 21:52.0100)

You've been listening to IP Protection Matters. Our guest has been Coke Morgan Stewart, President and CEO of the Council for Innovation Promotion.

Coke, one last question I like to end with - any parting thoughts on why IP protection matters?

Stewart (21:52.0100 - 22:54.0640)

I think we've covered so much of that today. I'd like to bring it back to where we started with the founding of the country. Our country was founded on economic freedom and the ability to protect people's ideas, inventions and democracy. I think following that thread through present day, we're in a knowledge economy now. We're not talking about machines, manufacturing and inventions as much as we were in the 1700 and 1800s.

We're talking about our knowledge economy. Those kinds of IP rights are going to be the rights that bring us into the next century and ensure that we can compete with other countries. So what I'm passionate about is carrying that message to Congress, to Capitol Hill and to the business community so that we can broaden our support for strong IP rights.

Giachino (22:54.0959 - 23:12.0100)

I'm really excited to see the wonderful work that I know you're going to accomplish in your new role. Coke, we thank you so much for your time today and for all of your hard work and efforts over the years. You've been really a champion of IP protection. Thank you for your time today. We appreciate it.

Stewart (23:12.0150 - 23:14.0069)

Thank you so much, Renee.

Giachino (23:14.0650 - 23:21.0160)

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