USPTO Life Sciences Listening Session: Remarks of Peter-Anthony Pappas and Henry Hadad

The U.S. Patent and Trademark Office (USPTO) on Monday held the first of three planned Patent Trial and Appeal Board (PTAB)-focused Listening Sessions, this one focused on the PTAB and Life Sciences. Participants in the first panel of the day, who mostly spoke for the branded pharmaceutical industry, discussed the topic of patent thickets and the role of the PTAB in vetting life science patents.

While three of the four panelists spoke in favor of reining in petitioner PTAB practices such as serial petitions and parallel challenges, Robert Cerwinski of the Association for Accessible Medicines (AAM) pushed back on his colleagues’ talking points, turning the conversation to patent owner practices such as “patent thicketing”. Cerwinski said that inter partes reviews (IPRs) and post grant reviews (PGRs) have been a “boon” to the generics and biosimilars industries as well as the public, and that they have become tools for streamlining costly and risky litigation. Despite the other panelists’ remarks noting that much of the data used to support the existence of patent thickets is faulty, Cerwinski said that any invention with “north of 10 patents” on it should be considered a thicket, and that he has taken part in litigation involving as many as 40 patents listed on one branded drug.

Henry Hadad, Senior Vice President, Innovation Law, Bristol Myers Squibb; Dave Korn, Vice President, Intellectual Property and Law, PhRMA; and Peter-Anthony Pappas, Director of Intellectual Property Policy, U.S. Senate Committee on the Judiciary (Senator Tillis) rejected Cerwinski’s assertions and engaged in a lively debate moderated by Austin Mayron, Acting Deputy Solicitor, Office of the Solicitor, USPTO. Below, we include the introductory remarks of both Pappas and Hadad, in full.

The USPTO will host a Listening Session titled “PTAB and High Tech” on Monday, April 20, from 3-5 p.m. ET and one on PTAB Administration and Reform on Monday, May 18, from 3-5 p.m. ET.

Prepared Remarks
Peter-Anthony Pappas
Director of Intellectual Property Policy to Senator Tillis
U.S. Senate Committee on the Judiciary
“USPTO PTAB Listening Session: PTAB and Life Sciences”
March 30, 2026

Thank you for inviting Senator Tillis’ office to participate in this listening session. I appreciate the opportunity to share some thoughts on the importance of strong, clear, reliable, and predictable intellectual property rights, the role that the PTAB should play, and the need for reforms to bring the PTAB back to its original intent.

Given that today’s session is about life sciences, it is important to think about the role of the patent system in such a sector, focusing on patents relating to pharmaceuticals. I last spoke publicly on this topic at the August 4, 2025, joint FTC, DOJ, HHS, and DOC listening session entitled “Lowering Americans’ Drug Prices Through Competition.” That listening session was one of a series held in response to President Trump’s Executive Order No. 14273, entitled “Lowering Drug Prices by Once Again Putting Americans First.”

America’s robust patent system is essential to fostering investments in pharmaceutical innovation and to ensuring accessibility of those medicines to benefit patients and society, both in the short and long terms. While concerns regarding drug affordability are important, so too are the efforts to strengthen the patent system to ensure continued innovation now and well into the future – innovation which is critical to the economic and global competitiveness of our great country and to our national security. And this is only possible with strong, clear, reliable, and predictable IP rights.

As I have noted in other contexts, Article I, Section 8, Clause 8, of the U.S. Constitution grants Congress the enumerated power “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Congress has acted under that power from the earliest days of our nation and this has led to American leadership in every innovative field, including pharmaceuticals and medicine.

How many other countries had the foresight to embed IP into their founding document? America has always set the global bar in terms of IP rights and this cannot be allowed to be undone.

The U.S. leads the world in pharmaceutical innovation, and this leadership is built upon the strength of our patent system, which has enabled countless new and improved medicines, transformed the health of Americans, and fueled tremendous contributions to the economy. When it comes to biomedical innovation, this is no mistake. American exceptionalism in such innovation has been facilitated by carefully crafted policies that sought to achieve this outcome, and by all accounts, they have proven to be a remarkable success.

Given this success, any proposed changes to patent rights or restrictions on their use should be based on a demonstrated need, and robust and reliable data and facts – not false narratives, which have been crafted in such a way to easily mislead those who are not steeped in patent law and/or those who are unwilling to question presented data.

In the pharmaceutical area, those calling for changes to patent rights or for restrictions on their use have not met that heavy burden. We have seen allegations regarding so-called “patent thickets” and “evergreening” that have invariably been based on misleading data that has been thoroughly debunked; yet, such unreliable data has continued to be cited and this has harmfully influenced the policy debate surrounding drug pricing.

As an example, beginning in 2022, Senator Tillis sent letters to the USPTO and the FDA raising questions regarding plain errors in data published, for example, by the group I-MAK. For years, I- MAK and affiliated groups, including certain commonly-funded academics, had claimed in reports and writings that most medicines are covered by dozens or hundreds of patents or patent applications each, allegedly resulting in exclusivity periods that last 30 or more years.

When one looked deeper, however, many of the examples cited in such sources had already gone generic shortly after, or in some cases even before these reports were published. Senator Tillis, while emphasizing the importance of reliable evidence, requested that the USPTO and the FDA conduct a study regarding whether this data – underlying many of the legislative and policy proposals in this area – is reliable. The short story is that this data was found to be inaccurate.

In June 2024, the USPTO alongside the FDA published a report that countered the approach and conclusions raised by these groups. The report refuted various claims made by such groups, including acknowledging the cycle of innovation and confirming that the number of patents may not be predictive of the timing of generic entry. The study also concluded that the methodologies used to tally the quantity of patents claimed by I-MAK were erroneous.

For one thing, the study concluded that it was not appropriate to include abandoned patent applications in the quantity of patents as they do not pose a barrier to competition. It also concluded that a total of all pending and abandoned applications is not a meaningful metric. With respect to periods of exclusivity, the report concluded that the timing of generic competition is not fully reflected by a computation of patents and exclusivities, as it can be affected by other factors. Both academics and innovators, whose products appear in such reports, have refuted the quantity of patents published by I-MAK, as well as the inference that the expiration date of patents is necessarily, or even commonly, an indicator of when generic drugs enter the market.

In fact, both the USPTO and the FDA held listening sessions in January 2023, and the testimony and docket in these listening sessions showed that many of the medicines that I-MAK claimed were covered by “thickets” in fact had quantities of patent listed in the Orange Book in the single digits, and had already become generic. In 2025 the USPTO presented additional analysis that showed that large patent families, that many claim amount to so-called “patent thickets,” may be an issue in other fields, but that they are not actually common in the pharmaceutical industry.

In addition to these troubling data inaccuracies, those who target the patent system as a supposed means by which to lower drug prices often disregard the careful balance that the system strikes between incentives for innovation and access to generic drugs and biosimilars – balances reflected in the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act. It is critical to keep these incentives in focus, as that is what brings new and improved medicines to patients and is what paves the way for generics and biosimilars.

Patents are critical to innovation, as they provide the ability for companies to take risks and invest in innovations across all technologies, including medicines for patients. Companies across all technology sectors seek certainty when choosing how to invest in R&D for the future.

Long-established patent practices such as the use of continuation applications and terminal disclaimers provide that certainty by offering flexibility to encourage broad, early disclosure of inventions while allowing innovators to refine and claim the full scope of patent protection over time as research progresses and commercial embodiments evolve. In return, the public benefits from early access to detailed information about new innovations. I have seen proposals that would prohibit a patent owner from enforcing more than one patent that is connected by a terminal disclaimer. Such a proposal would negate enforcement of valid patent rights, and it raises several policy issues. Courts already have the ability to manage litigation dockets and to streamline litigation.

Senator Tillis, Chairman of the Senate Judiciary IP Subcommittee, has had a laser focus on preserving the incentives in the patent system and is a sponsor of a series of bills to restore and bolster American innovation and provide more certainty for patents within all technology areas. Relevant for today’s discussion is the PREVAIL Act, as it would make important reforms to PTAB proceedings. The bill is intended to bring back balance on PTAB proceedings and to eliminate gamesmanship by bad actors at the PTAB.

Over the years we have seen how the PTAB was instituting a large number of proceedings and cancelling claims at a high rate. This was the case even where there were pending court proceedings evaluating the validity of patents, or when there had been multiple IPR proceedings. Those situations show IPRs not being the congressionally intended efficient alternative to litigation – but rather adding to it and, in many cases, being duplicative. That is the situation, for example, that occurs when a generic company deep in Hatch-Waxman litigation opens a separate proceeding at the PTAB that is additional to the ongoing, progressing litigation in district court.

The PREVAIL Act addresses such issues and I am glad to see the USPTO, with the support of the DOC, addressing serial and duplicative proceedings as well. I believe that the changes that the

USPTO has made and is proposing to make are trending in the right direction and that these changes should not be conflated with drug pricing. That being said, PTAB reform must be codified into law to avoid potential changes in the PTAB with every new Administration.

It is one of the things that I hear the most from inventors and companies large and small – the desire for reliability and predictability at the PTAB. Thus, it is imperative that the PREVAIL Act move forward and I hope to have the USPTO’s support with this effort.

I also want to mention that there are other patent-related bills that have been proposed in the House and Senate – specifically, those that aim to address so-called “patent thickets” and “evergreening” – that are not appropriate ways to address competition concerns, because, again, the evidence does not show that there is a “patent thicket” or “evergreening” problem in the pharmaceutical space. Further, these proposals harmfully reduce incentives for innovation for new medicines and/or R&D.

There is also proposed legislation in the context of “skinny labeling” that would create a safe harbor against induced infringement. Induced infringement is a fact-based matter best handled by the courts – it is not appropriate to encourage patent infringement by creating a safe harbor.

A common theme emerged consistently throughout the 2025 joint listening sessions as disrupting the careful balance built into our IP system. And that is the role of pharmacy benefit managers in blocking access to generics and biosimilars, impeding efficient competition and access in the pharmaceutical market. Efforts to improve the affordability of pharmaceuticals, by increasing generic and biosimilar availability and promoting competition, should include reforms that address misaligned incentives in the U.S. healthcare market.

IP rights are already under siege from foreign bad actors and the last thing that the U.S. needs to do is subject itself to attacks from within.

In conclusion, the U.S. patent system is the envy of other countries. The PTAB is an important part of this system, and I have little doubt that the creation of the PTAB, which was born from the AIA, was well intentioned. However, reforms are necessary. But these reforms are not about drug pricing.

The drugs whose patents are subject to PTAB proceedings, in addition to challenges in court, would – simply put – not exist and thus would not be the subject of our discussion today if it were not for our patent system and the U.S. being the global innovation leader.

Thank you.

Prepared Remarks of Henry Hadad
Chief IP Counsel, Bristol Myers Squibb
“USPTO PTAB Listening Session: PTAB and Life Sciences”
March 30, 2026

Good afternoon and thank you for the opportunity to participate today.

My name is Henry Hadad, and I am the Chief IP Counsel at Bristol Myers Squibb. BMS is an American biopharmaceutical company, first founded in 1858 and headquartered in New Jersey, with research, development, and manufacturing operations across the United States. Our mission, and the focus of our more than 19,000 US-based employees, and our roughly $10B in annual R&D spend, is to discover, develop, and deliver innovative medicines for patients facing serious and life?threatening diseases.

In addition to my role at BMS, I am currently President of the IPO Education Foundation, and President of Interpat, an organization of the chief IP counsels of the global biopharmaceutical companies. While I will draw upon my professional experiences, I am speaking today as an individual who believes that strong and predictable IP rights drive innovation, investment, economic growth and American global competitiveness.

The reliability and predictability of the U.S. intellectual property system are what make it possible for companies like ours to invest an average of $2.6 billion and 10 to 15 years to bring a single new medicine to patients—despite huge failure rates.  Compared to other industries, biopharmaceutical companies receive relatively few patents but these patents are extraordinarily important.  Without patent rights that provide a meaningful and predictable period of exclusivity, the innovation ecosystem that delivers new medicines-an ecosystem that includes research institutions, start-ups, and established companies like BMS- simply would not exist.

Despite this reality, critics too often advance misleading narratives that patent protections stifle competition. In fact, the opposite is true-United States has the most robust generics and biosimilars market in the world. The average time to first generic entry—12 to 14 years—has remained consistent for decades, as confirmed by various academic studies and the USPTO’s June 2024 Drug Patent Study.

I had the privilege of serving on the PPAC from 2023-25, providing the opportunity to work closely with, and learn from, superb USPTO colleagues.  This experience strengthened my belief that the USPTO’s current emphasis on patent quality at initial examination, and on strengthening the predictability of granted patent rights, is the right approach.  I also want to commend the PTAB judges for their professionalism, dedication, and expertise.  Their great on-going work around handling ex parte appeals is reducing application backlogs and improving patent quality.  Moreover, while we are speaking about PTAB generally, my comments today will largely be focused on IPRs rather than PGRs, which take place earlier in the R&D process.

IPR data from 2023–2024 show that once instituted, there was roughly a 70% likelihood of invalidation if there was a decision on the merits, effectively turning IPRs into a coin flip on patent survival once a petition is filed. Those odds are fundamentally incompatible with the long-term, capital?intensive investments required to develop new medicines or any R&D-intensive industry for that matter.

The structure of the IPR system has historically tilted against patent owners, and that imbalance is particularly pronounced in life sciences given the importance of a predictable patent right.  We see relatively few biopharma IPRs, and PTAB decisions often reflect the high quality of these patents.  Nevertheless, a structural asymmetry remains: when facing serial, parallel and duplicative challenges across multiple federal district court and USPTO venues, patent owners must prevail in every forum, while challengers need to succeed only once.

This asymmetry is highlighted in the generic and biosimilar drug context. Under the Hatch?Waxman and the BPCIA processes, Congress already provided carefully calibrated frameworks for adjudicating patent disputes in federal court. Layering IPRs on top of those processes adds uncertainty—not efficiency—and rarely if ever accelerates earlier entry of generic or biosimilar products.

In view of this background, some brief comments on recent USPTO IPR-related policies or those under consideration:

• With respect to the pending NPRM, I support the Director’s proposed reforms to reduce serial, parallel and duplicative challenges and the NPRM’s core principle of encouraging petitioners to choose a single forum for validity challenges.
• I endorse the principle of settled expectations and the concept of quiet title in property rights-recognizing that appropriate time horizons may depend on the specific facts.
• I commend the Director’s efforts to ensure consistency in claim construction between the PTAB and district courts and the clear guidance that it is the Director, not the PTAB, that will make institution decisions as mandated by the AIA statute.
• Last, I support a holistic, Office?wide application of §325(d) which will drive continued efforts to strengthen examination quality by encouraging applicants to present and highlight the closest prior art in exchange for insulation from IPRs over the same art years later. This approach is outlined at length in the 2023 and 2024 PPAC reports, and will lead to higher quality, “born strong” patents.

In sum, I believe the USPTO is moving in the right direction by using the Director’s statutory discretion to curb duplicative, serial, and parallel proceedings and ensure due process. Over the longer term, I support legislative reform—such as the PREVAIL Act—so that patent rights are durable and PTAB proceedings remain balanced, rather than subject to shifting policy views across administrations.  I appreciate USPTO’s engagement on these issues and look forward to continued dialogue on a constructive path forward.

Thank you.