Strong IP Protections Critical to Maintaining Robust Innovation Cycle

Mon, 02 Jun 2025

Henry Hadad, Senior Vice President and Deputy General Counsel at Bristol-Myers Squibb, discusses how intellectual property (IP) protection is very much a natural right that encourages - not discourages - innovation, the incremental erosion of IP protections over the last 20 years, how the AI revolution is going to have a significant impact on the biopharmaceutical industry, and the need to restore and maintain the right balance between access and innovation to avoid slowing down biopharma’s robust innovation cycle.

Transcription

Giachino (00:05.0000 - 00:23.0009)

Welcome to IP Protection Matters. I'm your host, Renee Giachino. Today we are joined by Henry Hadad. He's the Senior Vice President and Deputy General Counsel at Bristol-Myers Squibb. We'll be talking today about the latest news and developments surrounding IP litigation and policy. Henry, welcome to the program.

Hadad (00:24.0000 - 00:25.0000)

Thanks, Renee.

Giachino (00:25.0001 - 00:57.0000)

You are very clearly recognized as a leader in the IP community, having previously served as President of the Intellectual Property Owners Association, where you still serve on their board. I also understand that you previously served as Chief IP Counsel at Schering-Plough Corporation and held roles at Johnson & Johnson. In your current role, you're responsible for all aspects of IP procurement and counseling. What do you see as the biggest changes, good or bad, in the IP arena over the last several years?

Hadad (00:57.0669 - 03:06.0570)

Thanks for the opportunity to speak to you today about this really critical topic. I've been practicing since the early 1990s primarily in the life sciences. I've represented the generic industry, the medical device industry and most recently, while I've been in-house, the innovative biopharmaceutical industry. I think you could pretty much draw a line toward a number of developments, probably starting roughly about 20 years ago, where IP protection has effectively been eroded. Not by one big swing, but incrementally, which individually can create issues and collectively makes the [IP] right less predictable and less sound in a manner that makes you question whether we should be investing the billions of dollars and the 12 or so years it takes to develop a drug based on the assumption that you'll have a strong and predictable IP right to protect your innovations.

I would point to various case developments, primarily by the Supreme Court. Some directly impacting our industry. Some just impacting IP rights generally, like the eBay case around injunctions. The KSR case around obviousness. A number of cases around patent eligibility. The passage of the America Invents Act, which created the PTAB and a new venue for challenging patents. The TC Heartland case by the Supreme Court, which opened up multiple venues to litigate biopharmaceutical patent litigation across this country. The Amgen v. Sanofi case coming out of the Supreme Court around the scope of patents that are appropriate. Then maybe I would add in the BPCIA, which created the new biosimilar framework.

I think all of those collectively have made the [IP] right a little less predictable and something that we need to make sure is sufficiently robust to continue innovating.

Giachino (03:06.0006 - 03:32.0000)

Let's go back a little further than 20 years. Your history with an interest in IP, as I understand it, goes way back and is very personal. Can you share with us the story of how the seeds of your passion for IP were sown in your youth. I think it's important for people to understand that IP, when we talk about it, we're not just talking about these big corporations. It very often starts right in someone's home.

Hadad (03:32.0949 - 04:55.0470)

Very much so, Renee. I only look back in retrospect and understand how profound my upbringing had to do with my passion for intellectual property protection. My dad was a very successful songwriter in the late 50s and 60s, writing songs for people like Connie Francis, Frankie Avalon, Anil Sedaka and that whole generation of musicians. My uncle, my mother's brother, was also a stage performer, a movie performer and a song singer-songwriter. He wrote a number of very successful hits for Donna Summer, Barbra Streisand and for The Weather Girls.

So growing up, that was part of the fabric of my existence, and frankly, those songs were the soundtrack of my life. I realized in retrospect how much love and passion my father and my uncle had for what they created and how personal it was to them. And when I went to law school and learned about intellectual property law, it really resonated with me because while I tend to do more on the patent side, I really love working with scientists. You see how personal, how important it is, what they've done and how they really want to leave a legacy of improving patients' lives around the world.

Giachino (04:55.0859 - 05:18.0459)

Let's go back a little further in time if we can. Some deny that IP is a natural right, even though the Founding Fathers very much incorporated the concept of natural rights in drafting and ratifying the Constitution. Can you explain how IP reflects the concept of natural rights and why that's important in the ongoing debate over stronger protections for IP?

Hadad (05:18.0470 - 06:19.0640)

As I've reflected on my career and why this has become not just a profession, but a personal passion of mine, I can't think of anything more profoundly American or just part of your natural rights than if you do something great, if you create or invent something, it shouldn't be stolen from you. It should be something that you can build upon and create a business, employ people, and bring this technology to the world. At the same time teaching the world how to make this technology so they can improve upon it.

This has been the engine which has been driving innovation in our country and frankly across the world since the outset of our country. Since our forefathers implemented this in the Constitution. I think it is very much a natural right. It's very much something which is part of our human nature and something that we should continue to foster because absent this, frankly, I believe the innovation engine will slow to a halt.

Giachino (06:19.0929 - 06:42.0739)

We all understand, I think, that predictable IP systems drive innovation and economic opportunities for everyone. Are there specific reforms that you would recommend to restore the vibrancy of the American patent system? How hopeful are you that in this congressional term we might see finally enacted the PERA and the PREVAIL Acts?

Hadad (06:42.0750 - 08:58.0109)

I think we have to look at what's going on culturally. I think to some degree, the advent of the technology we now live with every day - the internet, social media, our phones - has given sort of a cultural spin that IP is something which is more a barrier to innovation than a driver of innovation. I do feel strongly that we have to remind people that just because innovation has occurred doesn't mean it will continue to occur and that absent adequate and predictable IP protection, it will slow down. It will be reduced or it may even grind to a halt. It's something that needs to be fostered. At the same time, a number of developments have led to certain bills being introduced.

One is the PREVAIL Act. That is an act that is designed to really narrow and more directly address how the PTAB adjudicates IPRs in a manner that's more consistent with the legislative intent back in 2011. That it would be a cost efficient and quicker adjudication of patent rights, not something that would be done serially or in parallel to district court litigation or relitigate things that have already been examined by the office. So I think that's an important development that Senators Coons and Tillis have introduced. I'm hopeful that the Senate and then the House will advance this legislation.

Similarly, the PERA Act, also led by Senators Tillis and Coons, looks to restore patent eligibility to where it was prior to a series of Supreme Court cases starting around 2010. In a world where we want to make sure that things like precision medicine and AI advancements continue to be driven forward, I think we want to be very clear that the patent system does exist for those innovations. We want to encourage them through a robust IP framework.

Giachino (08:58.0109 - 09:07.0979)

We’ve just passed the first 100 days of the president's second term. How clear is your crystal ball in terms of how IP protection will fare under this Administration?

Hadad (09:15.0590 - 10:01.0306)

Certainly there's been a lot of change over the last 100 days. I will say that when it comes to IP protection, I think it is to be determined. I've seen some early encouraging signs. I think the appointment of Acting Director Coke Stewart at the USPTO has led to some important reforms within the PTO. I'm sure there's more to come there. I understand that the nominee for PTO Director John Squires will be considered sometime later this year. We'll see what his agenda is. But so far, so good from the USPTO, at least from someone who would like to see a stronger and more resilient patent right emerge from there.

Giachino (10:01.0776 - 10:20.0035)

Speaking of appointments, you were recently appointed by the US Secretary of Commerce to a nine-person Patent Public Advisory Committee (PPAC), which is charged with reviewing the policies, performance and budget of the USPTO. What do you hope to accomplish during your tenure?

Hadad (10:20.0038 - 11:27.0344)

Yes, my tenure just recently ended actually. The appointment was back in 2022. But that's an important point. I really enjoyed that period, and I learned a lot about USPTO operations. It's not just policy. They have to make the doughnuts, so to speak. They have to be in there examining patent applications, doing the prior art searches, issuing office actions and hopefully issuing robust and strong patents.

The last thing we want is either it grinding to a halt where patents aren't issuing or that patents are issuing quickly and not being robustly examined. Because at the end of the day, a patent is only as good as its ability to stand up in court. So I think finding that right balance is very important, and I learned a lot from that. I very much appreciated the opportunity to participate in public service and serve USPTO.

Giachino (11:27.0354 - 12:02.0369)

It was an exciting time to do that, particularly under the Biden Administration, where we witnessed efforts to unravel some of the longstanding IP protections that have encouraged for years innovation in America. I'll take, for example, the Biden Administration's support for the proposal to waive provisions to the agreement on trade-related aspects of intellectual property rights, known as TRIPS, as it related to the COVID-19 patented innovations. In your opinion and based what you've studied, was the TRIPS waiver necessary?

Hadad (12:02.0570 - 14:24.0719)

No. Not at all because intellectual property was clearly not the barrier here. For example, I think this was largely coming out of the COVID experience and whether somehow IP was a barrier to the uptake of vaccine-related technology. Time and time again it was shown that there were supply chain considerations. There were manufacturing considerations.

But for the most part, and I saw this firsthand, I was so impressed with every company who had either vaccine technology or maybe drug technology that could potentially reduce some of the side effects of COVID. They all got together and offered to share their intellectual property with each other and with public institutions to make sure that the COVID pandemic was addressed as quickly as possible with the minimum amount of people ill and passing away from this disease. That seemed to bear out.

One of the reasons why we were able to so quickly address this and so successfully address this, despite the initial spike in infections, was because we had a robust biopharmaceutical industry in the United States and Europe that had the resilience to spend a fair amount of time and resources to develop vaccines and offer their other products in IP to fighting this pandemic. I think this is actually the poster child for successful public-private partnerships driven by IP rights and not citing them as a barrier. If anything, the idea that you would waive your IP rights by volunteering your technology to fight a pandemic, I think, would have the opposite effect. If anything, it would make folks think twice about being as open about sharing technology if they thought some of their basic technology, which was the premise of their company, could be seized from them.

I think we need to think long and hard about these things. To some degree, some of these decisions, whether it was the Biden Administration's support for a TRIPS waiver or other considerations which would weaken or ameliorate IP, need to be viewed with the lens that we want to encourage more innovation and not discourage it.

Giachino (14:25.0049 - 14:50.0354)

As Senior Vice President and Deputy General Counsel, you have a very focused lens to be able to witness some exciting times involving biopharma companies and their partnerships more and more with third party companies that are providing software, artificial intelligence and big data tools. What does all of this, do you think, mean for IP protection moving forward?

Hadad (14:50.0593 - 16:04.0521)

The AI revolution is going to have a significant impact on our industry. We will continue to discover and develop new medicines. AI can be and has been an important tool in those processes. To this day, based on what I see, AI is a research tool helping to make drug discovery more efficient and clinical trial design more effective. It has a lot of promise. I think there's much more to come there, but I think they're all very important.

I think one thing we have to keep in mind, though, is that AI to date has not been an inventor of any new molecules. When that day comes, and that may come, we should recognize that patent protection, at least currently, is not available for something that is solely invented by AI. It would be a shame if something was discovered that was so effective in treating important diseases and it wasn't developed because it's not patent protected. So I think we have to think about our IP laws and make sure that we provide an opportunity to develop things regardless of whether they are human invented or AI invented.

Giachino (16:04.0762 - 16:33.0099)

Some exciting times ahead certainly. Speaking of exciting times, I'd be remiss if I failed to mention and congratulate you for your upcoming award. I understand you'll be honored on May 29th at the Asian American Bar Association of New York with the Corporate Leadership Award for outstanding contributions to the IP field and for your unwavering commitment to developing the next generation of diverse leaders in the legal profession. Henry, what does this award mean to you?

Hadad (16:33.0349 - 17:34.0765)

Thanks, Renee. It's very kind of the organization to provide this award. That, and some other awards I've received, to me validate how important the IP laws are. The continued advocacy for stronger intellectual property is really critical and viewed by a large segment of our country as really critical for our continued health economically and internationally.

I do appreciate that recognition, particularly from the Asian American Bar Association of New York. As well as sort of this concept of making sure that we develop the next generation of leaders. We cannot afford to take our feet off the gas pedal and not continue to advocate for predictable and strong IP rights. By developing that next generation of leaders, we know that over time we will continue that good fight because it is so important for our country's future.

Giachino (17:35.0135 - 17:51.0472)

One final question, Henry, that I often ask at the end of our discussions. I want to give you an open mic for your parting thoughts on why we should care about IP protections. In other words, why does IP protection matter - the title of this program?

Hadad (17:51.0592 - 20:06.0982)

Last year marked the 40th anniversary of the passage of the Hatch-Waxman Act. And I think people forget what a momentous piece of legislation that was. It created the generic industry as we know it today. It created the biopharmaceutical industry as we know today. It was a very specific balance of different stakeholder interests - the public, the branded industry and what was then the burgeoning generic industry.

What has happened since then? In the past 40 years, we've seen some of the greatest advances of healthcare in history. We have seen the cure of Hepatitis C. We've seen great advances in treating cardiovascular disease, reducing mortality to what was pretty much a killer for many folks. We've seen reductions in cancer in terms of being able to treat certain types of cancer, making it either manageable or curing it. There's so much more to do in the field of oncology and autoimmune diseases with similar type of advances. AIDS has gone from being a virtual death sentence to something for many patients that is a manageable condition. So that's just a short group of conditions that the innovative industry has addressed.

At the same time, over 90% of all prescriptions are generic. That means those twin needs of promoting innovation and access that were advanced by the Hatch-Waxman Act are fulfilling their goal. Are there things we can do better? Sure. But the concern I've had and continue to have is that balance of interest that we're going to provide you a predictable period of exclusivity and in exchange you're going to give us your data and you're going to allow generic companies to copy that data and then come on the market early. That balance - that grand bargain - is getting a little off on one side. The balance is favoring access versus innovation. What we need to do is make sure that balance is maintained. Ultimately, we will slow down our robust innovation cycle if we don't ensure predictable IP rights are maintained.

Giachino (20:07.0271 - 20:33.0650)

Henry, thank you again for your time today. Thank you for always being an advocate for a strong and predictable IP system that is in fact driving innovation and economic opportunities for all. We appreciate your time today and the work that you are doing as Senior Vice President and Deputy General Counsel at Bristol-Myers Squibb where we know life-saving work is being done.

Thank you for your time today. It's a pleasure. I'd love to have you join me again sometime.

Hadad (20:33.0000 - 20:38.0650)

Thank you very much.