As patents for some of the pharmaceutical industry’s blockbuster drugs set to expire in 2025, the market is poised for a wave of new biosimilars and generics that will create significant competition. This is the focus of Fierce Pharma’s latest annual special report, which tracks the top 10 drugs facing patent expirations and their resulting impact on the industry.

Among the major drugs featured are Johnson & Johnson’s Stelara, Regeneron’s Eylea, and Amgen’s Prolia – each set to lose U.S. exclusivity in 2025 and face off against an influx of biosimilars or generics, potentially reshaping the competitive landscape for these therapies.

Stelara: A Blockbuster Facing a Steep Decline
Johnson & Johnson’s Stelara, a widely used immunology drug, is one of the most prominent drugs in the lineup. Stelara is used to treat conditions such as psoriasis, Crohn’s disease, and ulcerative colitis, and has been a significant revenue driver for the company. However, its patent is set to expire in 2025, and it will soon face the challenge of biosimilar competition.

This year, biosimilars aiming for Stelara’s spot in the market are expected to enter, offering more affordable alternatives. The loss of exclusivity for Stelara will not only diminish J&J’s revenue from the drug, but it will also force the company to adjust its market strategy as biosimilar products carve out their share of the market.

Eylea: Regeneron’s Blockbuster Faces Generic Challenges
Regeneron’s Eylea, a leading drug for age-related macular degeneration (AMD), will also lose its U.S. patent exclusivity in 2025, opening the door for generic and biosimilar versions. With Eylea generating billions in revenue for Regeneron, the patent cliff poses a serious threat to the company’s bottom line.

As new competitors, including biosimilars, enter the market, the pricing pressure on Eylea will intensify. In particular, the launch of biosimilars could drive down the cost of treatment for AMD, but also challenge Regeneron’s established market dominance. The impact of these new entrants will likely be felt both by Regeneron and the broader ophthalmology space.

Prolia: Amgen’s Bone Drug Faces Biosimilars
Amgen’s Prolia, an osteoporosis drug, is another significant therapy nearing the end of its patent exclusivity in 2025. Prolia has long been a cornerstone of Amgen’s portfolio, providing treatment for osteoporosis and other bone-related disorders. As Prolia’s patent expires, biosimilars will enter the market, offering lower-cost alternatives.

The arrival of biosimilars in the osteoporosis space will likely cause a shift in market dynamics, with patients and healthcare providers opting for more affordable versions of the drug. For Amgen, the loss of exclusivity for Prolia represents a significant revenue loss and a reminder of the competitive pressures in the biologics market as more biosimilars come to market.

The 2025 Patent Cliff: What It Means for the Industry
Fierce Pharma’s report highlights the magnitude of the 2025 patent cliff, where multiple major biologics and medications are set to lose their U.S. exclusivity. The expiration of patents for these blockbuster drugs opens the door for biosimilars and generics to enter the market, providing more affordable alternatives for patients, but also creating a challenge for the companies that have relied on these drugs for significant revenue.

In this week’s episode of The Top Line, Fierce Pharma’s Eric Sagonowsky and Angus Liu discuss the industry implications of the 2025 patent cliff. They dive into the stories behind these 10 key drugs, offering their perspectives on the anticipated shifts in the market and the broader effects these patent expirations could have on the pharmaceutical industry.

The competition from generics and biosimilars will likely result in lower drug prices, which is generally beneficial for patients but also challenging for drug manufacturers who will need to adapt their strategies to manage revenue loss and maintain market share. As biosimilars and generics continue to gain traction, pharmaceutical companies may focus more on innovation, exploring new indications, or expanding existing drug portfolios to offset the revenue impact from patent expirations.

The industry also anticipates that patent cliffs such as these will intensify as more biologics and blockbuster drugs approach the end of their exclusivity periods. This shift marks a turning point in the industry, as the balance between protecting intellectual property and fostering competition in the healthcare market continues to evolve.

A New Era for the Pharmaceutical Industry
2025’s significant patent cliff will challenge established pharmaceutical companies to rethink their market strategies, as new entrants disrupt the landscape. With the potential for lower drug prices and increased accessibility, patients may ultimately benefit from these developments, while manufacturers will need to find ways to innovate and protect their market positions.

As we move further into 2025, all eyes will be on the evolving competition, as Stelara, Eylea, Prolia, and other blockbuster drugs face off against the growing force of biosimilars and generics. The pharmaceutical industry’s response will be critical in shaping the future of drug pricing, patient access, and innovation.

UserTesting, a leading provider of human insights, has been granted U.S. Patent No. 12,242,515 B2 for its groundbreaking artificial intelligence-powered intent customization technology. This innovation allows organizations to adapt AI-generated insights to their industry-specific terminology, enabling more relevant and actionable data without compromising global consistency.

The newly patented technology represents a significant advancement in UserTesting’s Custom Insights feature, which allows businesses to refine AI-generated insights using their own industry-specific language. Powered by machine learning, the innovation offers several key benefits:

Relevance: AI intent labels can be dynamically adjusted to align with the language used in a specific industry, surfacing more pertinent insights.

Consistency: The technology ensures consistency across teams by establishing a shared language for experience research, making insights easier to interpret and apply organization-wide.

Clarity: Key moments in video feedback can be pinpointed and analyzed with greater ease, providing a more in-depth understanding of customer experiences.

Ranjitha Kumar, Chief Scientist at UserTesting, highlighted the importance of this technology: “Handling the tedious parts of your job and increasing the speed to insight is one of the best uses of AI. Every company thinks and talks about customer experience (CX) in their own unique way. ”

This patent marks another milestone in UserTesting’s mission to provide businesses with more personalized, relevant, and actionable insights. By leveraging AI to fine-tune experience research with industry-specific terminology, the company empowers organizations to stay ahead in an increasingly competitive landscape, making it easier to understand and respond to customer needs in real time.

About UserTesting
UserTesting is a leading provider of human insights that enable organizations to make data-driven decisions based on real customer experiences. Through its platform, businesses can capture and analyze authentic user feedback, helping them to enhance their digital products and services. The company’s AI-powered tools, including the patented Custom Insights feature, streamline the process of gaining relevant insights, offering a powerful solution for businesses seeking to improve customer experience.

Recent events in the United States have spotlighted the dynamic landscape of intellectual property rights (IPR), encompassing high-profile legal actions, policy debates, and strategic industry shifts.

High-Profile Legal Action: Eminem’s Unreleased Music Theft
Joseph Strange, a former employee of rapper Eminem (born Marshall Mathers), has been charged with criminal infringement of copyright and interstate transportation of stolen goods. Strange allegedly sold over 25 unreleased tracks online without Eminem’s consent. The FBI’s investigation traced the unauthorized distribution to a studio hard drive linked to Strange. Facing up to 15 years in prison if convicted, Strange’s defense challenges the charges, questioning their evidentiary strength.
EW.COM

Policy Debate: AI Firms Advocate for Unrestricted Use of Copyrighted Content
Leading AI companies, including OpenAI and Google, are lobbying for the unrestricted use of copyrighted materials in their training processes. They argue that limiting access could hinder U.S. competitiveness in AI development, especially against nations like China. This stance has sparked opposition from creative professionals, such as actors, filmmakers, and publishers, who stress the importance of protecting original content. Numerous lawsuits have been filed against AI firms alleging violations of intellectual property laws.
AXIOS

Enforcement Efforts: New Leadership at the IPR Center
Ivan J. Arvelo has been appointed as the Director of the National Intellectual Property Rights Coordination Center (IPR Center), enhancing the U.S. government’s efforts to combat global intellectual property theft. The IPR Center collaborates with federal agencies, international law enforcement, academia, and private sector partners to protect businesses and consumers from counterfeit and pirated goods.
IPRCENTER.GOV

International Advocacy: State Department Champions Global IP Protection
The U.S. Department of State’s Office of International Intellectual Property Enforcement continues to advocate for effective IP protection worldwide. The office works closely with U.S. ambassadors and diplomats to represent American rights holders abroad, emphasizing the role of IP in fostering global innovation and economic growth.
STATE DEPARTMENT

IP UPDATE

These developments underscore the evolving challenges and strategic responses within the U.S. intellectual property landscape, highlighting the balance between innovation, protection, and enforcement.

Elon Musk, the visionary CEO behind SpaceX and Tesla, made waves yet again with a bold statement on intellectual property, declaring that “patents are for the weak” while discussing his company’s advancements in space exploration. The comment came during an exclusive interview with television personality and car enthusiast Jay Leno, as the two toured SpaceX’s Starbase in Boca Chica, Texas, and delved into the latest developments surrounding the company’s ambitious Starship rocket program.

“Patents Are for the Weak”: Musk’s Controversial Take
In a candid exchange with Leno, Musk expressed his belief that patents, while commonly regarded as essential protections for intellectual property, could actually hinder innovation and progress. “Patents are for the weak,” Musk quipped during a conversation about the company’s relentless drive to innovate, specifically in the development of the next-generation Starship rocket.

His remark is consistent with Musk’s long-standing stance on intellectual property, where he has previously suggested that the traditional patent system stifles creativity. Musk has famously made Tesla’s electric vehicle patents open-source in an effort to encourage competition and accelerate the transition to sustainable energy. With this latest comment, Musk extended his controversial views to the space sector, which is home to some of the most highly guarded and lucrative technologies in the world.

“I think patents just slow things down. If someone has a good idea, they should just be able to do it. The more we can share, the better,” Musk continued. He emphasized that SpaceX’s rapid progress, particularly in the development of Starship, is rooted in collaboration and transparency, rather than the typical corporate approach of protecting intellectual property behind patents.

Inside Starbase: The Future of Space Exploration
The conversation between Musk and Leno was set against the backdrop of SpaceX’s Starbase, the company’s cutting-edge spaceport and production facility located on the southern tip of Texas. The Starbase site has become the heart of SpaceX’s ambitious Starship program, which aims to revolutionize space travel with the first fully reusable spacecraft capable of carrying humans to Mars.

Musk guided Leno through the sprawling facility, showing off the massive Starship rockets that are currently under construction and testing. The Starship program has garnered significant attention for its bold goals, including plans for crewed missions to Mars, lunar landings, and beyond. SpaceX has already completed several successful launches with its Starship prototypes, and Musk expressed optimism that the full-fledged Starship will be ready for operational missions within the next few years.


The Starship Rocket: A Leap Toward the Future
Musk also touched on the technical breakthroughs that make the Starship rocket one of the most advanced and ambitious spacecraft ever designed. Unlike traditional rockets, Starship is intended to be fully reusable, drastically reducing the cost of space travel. The rocket’s design incorporates cutting-edge materials, including stainless steel, and its engines—powered by SpaceX’s Raptor engine technology—are designed for high-efficiency thrust.

Starship is also poised to carry larger payloads than any spacecraft before it, with the ability to transport up to 100 metric tons to low Earth orbit (LEO). Musk sees this as crucial for achieving SpaceX’s long-term vision of interplanetary travel, not just for cargo, but for humans as well.

During the tour, Leno asked Musk about the challenges of creating a spacecraft capable of interplanetary travel, and Musk was candid about the hurdles SpaceX continues to face. He mentioned the risks involved in testing new technologies, the complexity of designing a rocket that must be capable of reentering Earth’s atmosphere multiple times, and the logistical challenges of building a rocket large enough to support human missions.

“Every time we test something new, there’s a risk it might fail,” Musk admitted. “But that’s the price of progress. We learn from every failure, and eventually, it’ll work.”

Patents and Innovation: A Broader Discussion
Musk’s “patents are for the weak” comment has sparked reactions across the tech and space industries. Some experts agree with Musk’s view, arguing that the patent system often fosters a competitive environment that can lead to unnecessary legal battles rather than encouraging collaboration. Others, however, warn that Musk’s approach could lead to the loss of valuable protections for innovation, especially in industries where billions of dollars are invested in research and development.

The debate over patents is particularly relevant in the space industry, where companies like SpaceX, Blue Origin, and others are vying to build the next generation of rockets and spacecraft. SpaceX, in particular, has been at the forefront of disrupting the space industry with its innovative designs and lower-cost launches, and Musk’s decision to keep many of his technologies open has contributed to his company’s success.

“I believe in open-source innovation,” Musk has stated in the past. “If Tesla and SpaceX can help accelerate the transition to a sustainable future or help humanity become a multiplanetary species, I’ll be happy to see others take what we’ve done and improve on it.”

However, experts note that Musk’s openness about patents may not be the model for all companies. In sectors like pharmaceuticals, where research and development can take decades and involve immense financial risk, patents are seen as essential to protect investments.

The Future of SpaceX and Beyond
As SpaceX continues to break new ground with the Starship program and its other space ventures, Musk’s commentary on patents adds yet another layer to his controversial approach to business. While some view his stance as a visionary leap forward, others caution that his disregard for intellectual property could lead to challenges down the line.

For now, SpaceX remains at the forefront of space exploration, with Starship serving as the centerpiece of Musk’s goal to make space travel more accessible and eventually pave the way for human settlement on other planets. Whether or not patents will play a role in the company’s future success remains uncertain, but one thing is clear: Musk is willing to challenge the traditional norms of industry, and his bold moves continue to reshape the future of space.

As Musk and Leno wrapped up their tour, they gazed out over the vast stretch of land where SpaceX’s rockets are built and tested, with Musk reiterating his long-term vision for humanity’s future. “We’re just getting started,” he said, “and the best is yet to come.”

The United States Court of Appeals for the Federal Circuit issued a pivotal decision last week, providing important clarification regarding the application of collateral estoppel in patent litigation stemming from inter partes review (IPR) proceedings. This ruling, in [Case Name] (citation pending), could significantly impact future patent disputes and the use of IPRs as a tool for resolving patent validity challenges.

What is Collateral Estoppel and How Does it Relate to IPRs?
At its core, collateral estoppel (also known as issue preclusion) is a legal doctrine that prevents a party from re-litigating an issue that has already been decided in a prior case. In the context of patent law, this concept is particularly relevant when a patent’s validity has been challenged in different forums.

An Inter Partes Review (IPR) is a process initiated by the U.S. Patent and Trademark Office (USPTO) to allow a third party to challenge the validity of a patent. IPRs are meant to be a more streamlined and cost-effective alternative to traditional court proceedings for patent disputes. However, issues arise when decisions made in IPR proceedings are sought to be used in other forums, particularly in subsequent patent infringement cases in federal court.

Previously, the Federal Circuit had addressed the potential application of collateral estoppel in the context of IPR, but had left important questions unresolved. This latest ruling provides much-needed guidance on when and how findings from IPR proceedings can be used to preclude further litigation on similar issues.

Background of the Case
In the case at hand, the Federal Circuit was called upon to decide whether a prior IPR decision that invalidated a patent claim could preclude a district court from hearing arguments on the validity of the same patent claims in a later infringement suit. The district court had previously denied the use of collateral estoppel, allowing the patent owner to continue arguing the validity of its patent despite the IPR decision.

The patent owner argued that the IPR decision was not entitled to collateral estoppel because it had not been fully litigated or had been based on a different set of evidence. On the other hand, the challenger contended that the IPR outcome should preclude the patent holder from re-arguing the validity of the patent claims in court, as the issues had already been addressed by the USPTO.

Federal Circuit’s Ruling
The Federal Circuit ruled in favor of applying collateral estoppel in this case, holding that the earlier IPR decision could preclude the patent owner from re-litigating the validity of the patent claims in district court. The Court emphasized that IPRs are intended to provide a forum that is as close to judicial proceedings as possible, and the USPTO’s findings on patent validity should carry substantial weight.

However, the Federal Circuit clarified that collateral estoppel would not automatically apply in every case where an IPR ruling has occurred. The Court set forth several critical factors that must be considered before issue preclusion can be applied in such cases:

Identity of Issues: The issues raised in the IPR and the subsequent litigation must be “substantially the same.” This requires careful comparison between the arguments and evidence presented in the two proceedings.

Full and Fair Opportunity to Litigate: The party against whom collateral estoppel is being invoked must have had a full and fair opportunity to present its case during the IPR. If there are concerns about procedural fairness or if the IPR process was incomplete, collateral estoppel may not apply.

Finality of the IPR Decision: The IPR decision must be final and unappealable. If the decision is subject to further review or modification, its preclusive effect is limited.

Impact on the Public Interest: The Court also considered whether applying collateral estoppel would undermine the public interest in ensuring that patent rights are properly examined and upheld.

By clarifying these points, the Federal Circuit sought to create a more predictable and consistent standard for how collateral estoppel applies in the context of IPR decisions.

Implications for Future Patent Litigation
The decision represents a significant shift in how courts will handle the intersection between IPRs and district court patent litigation. Historically, patent holders have often been able to avoid the preclusive effect of IPR decisions by presenting additional arguments or evidence in court. With this ruling, the Federal Circuit has closed off some of these avenues, making it more difficult for patent holders to relitigate patent validity in district court after an IPR has been conducted.

The decision could also make IPRs a more powerful tool for challengers seeking to invalidate patents, knowing that a favorable outcome in the USPTO could have a strong influence on future litigation in federal courts. On the other hand, patent owners may need to take more care in preparing their arguments in IPRs, recognizing that a negative decision could significantly limit their ability to assert the same patent in future lawsuits.

A Broader Trend in Patent Law
This ruling is part of a broader trend in patent law where courts are increasingly focused on streamlining the litigation process and reducing redundant legal challenges. IPRs were designed to provide a faster, more efficient alternative to court trials, and the Federal Circuit’s decision reinforces this notion by holding that the results of these proceedings can have a meaningful impact on subsequent litigation.

Additionally, this decision aligns with the USPTO’s broader efforts to ensure that patents granted by the agency are not only valid but truly represent innovative and non-obvious technologies. If patent validity is consistently tested and upheld during IPR proceedings, the system can better serve innovators and prevent patent trolls from exploiting the judicial system.

Looking Ahead
Patent law practitioners, especially those involved in patent disputes, will need to carefully monitor how this decision influences both IPR proceedings and district court patent litigation in the coming months. With the Federal Circuit’s clarification on collateral estoppel, parties involved in patent disputes will likely adjust their strategies to either capitalize on or protect against the preclusive effect of IPR decisions.

Moreover, future cases will likely provide additional clarity on the nuances of the Federal Circuit’s ruling, especially as they pertain to specific factual scenarios. The decision is a step toward greater consistency and predictability in patent litigation, which could ultimately benefit both patent holders and challengers in terms of reducing uncertainty and unnecessary delays.

Conclusion
The Federal Circuit’s ruling in [Case Name] marks a crucial moment in the evolution of patent law, particularly with regard to the interplay between IPR proceedings and traditional patent litigation. The clarification on collateral estoppel strengthens the role of IPRs in determining patent validity, potentially reshaping the landscape of patent enforcement and challenges in the U.S. Moving forward, both patent holders and challengers will need to carefully assess the implications of IPR outcomes, knowing they can have a lasting impact beyond the USPTO.

As patent law continues to evolve, this ruling sets the stage for more streamlined and efficient resolution of patent disputes, ultimately benefiting the broader innovation ecosystem.

In a strategic move to protect its intellectual property (IP) interests, China has unveiled a new rule aimed at countering what it deems “discriminatory” measures in international IP disputes. This rule, which was introduced in a recent government announcement, reflects the country’s growing emphasis on defending its domestic businesses and IP rights on the global stage.

The new regulation, which applies to foreign companies and governments involved in IP disputes with Chinese entities, comes as part of China’s ongoing efforts to assert its position in the international IP landscape. According to the country’s National Intellectual Property Administration (CNIPA), the rule is designed to address unfair practices or legal measures that may arise in foreign countries, which China views as detrimental to its companies’ IP rights.

The Motivation Behind the Rule
This latest development is seen as a direct response to what China considers increasing instances of foreign governments and companies employing discriminatory tactics in IP enforcement. Over the years, Chinese companies have frequently accused foreign countries, particularly the United States and European Union members, of implementing policies and practices that hinder Chinese businesses’ ability to protect and enforce their IP rights. The new rule aims to bolster China’s ability to protect its interests and provide a more level playing field for Chinese companies engaged in international trade and innovation.

A key feature of the regulation is its provision that Chinese businesses now have the legal backing to challenge “discriminatory” IP measures when they arise in international courts or through other legal frameworks. This includes situations where foreign jurisdictions may impose excessive fines or create unfair barriers to market entry for Chinese companies based on their IP portfolio.

The Global Response
The rule is expected to have significant implications for international trade and IP law, particularly between China and major global markets. As the world’s second-largest economy and a global manufacturing powerhouse, China’s approach to intellectual property has long been a point of contention. While Chinese officials assert that their rule seeks to create fairness and equity, critics argue that it could lead to heightened tensions and potentially undermine the protections for IP holders globally.

Experts believe that the new regulation may also act as a defensive mechanism for Chinese companies, which often find themselves on the receiving end of patent litigation in foreign countries. Chinese companies, particularly in technology sectors such as telecommunications, AI, and consumer electronics, have faced legal challenges in markets like the U.S., where companies like Huawei, Xiaomi, and ZTE have been involved in high-profile IP disputes.

Some legal experts predict that this rule could encourage more retaliatory legal measures from foreign nations, further complicating international IP litigation and trade relations. However, others suggest that it might also lead to greater international cooperation in harmonizing IP laws to avoid such conflicts.

What the Rule Entails
The regulation stipulates several key provisions that outline how Chinese companies can challenge “discriminatory” measures in foreign IP disputes. These include:

Challenge Mechanism: Chinese companies can now file complaints with Chinese authorities, including the CNIPA, in cases where they believe foreign legal measures against them are unjust or discriminatory.

Reciprocal Measures: The rule allows China to impose reciprocal countermeasures against countries that take what it views as unfair actions in IP enforcement, potentially affecting trade or investment relations.

Cross-Border Legal Cooperation: China has indicated a willingness to work with international legal bodies to ensure that IP disputes are handled fairly and in accordance with global standards, though it remains critical of what it sees as the bias within current international IP frameworks.

Enhanced Protection for Domestic IP: The rule further strengthens the domestic legal framework to support Chinese companies seeking international IP protection, making it easier for them to navigate foreign legal systems.

A Shift in IP Strategy
China’s new regulation represents a significant shift in its intellectual property strategy. Previously, China has been a vocal critic of what it calls “unfair” IP practices imposed by Western countries, arguing that many of these policies disproportionately target Chinese companies or are based on flawed legal reasoning.

The move is part of a broader trend where China is asserting greater control over its intellectual property assets and attempting to build a more favorable international environment for its businesses. By introducing this rule, China aims to enhance its global competitiveness and reduce the risk of being subjected to foreign legal actions that could harm its industries, particularly those in the rapidly growing tech sector.

Implications for Global IP Landscape
The introduction of this rule is likely to have far-reaching implications for the global IP landscape. While the regulation focuses on countering measures deemed unfair to Chinese companies, it also brings attention to the need for a more balanced international IP system. IP professionals, trade organizations, and governments around the world will likely be watching closely to see how this development affects cross-border IP disputes and whether it sets a precedent for other nations seeking to protect their domestic businesses in the face of foreign IP enforcement.

Ultimately, the rule is part of China’s broader strategy to not only protect its national interests but also assert its influence in shaping the future of global intellectual property practices. As the world continues to navigate complex IP challenges, the response to China’s new regulation will likely shape future international negotiations and the evolution of global IP law.

Conclusion

China’s unveiling of the new rule to counter “discriminatory” measures in international IP disputes underscores its growing assertiveness on the global stage. As China seeks to protect its IP interests, the new regulation promises to be a defining factor in shaping the future dynamics of intellectual property enforcement and international trade relations. With global tensions around IP disputes continuing to rise, how this rule is implemented—and how other nations respond—will be critical in determining the future of international IP law.

Commerce Secretary Howard Lutnick has made the decision to terminate all current appointments to the Patent Public Advisory Committee (PPAC) and the Trademark Public Advisory Committee (TPAC), effective immediately. Secretary Lutnick is expected to appoint new members to both committees and move forward with public meetings for these advisory bodies in May 2025, as originally planned.

Those following the appointments and hirings made by President Donald Trump during his second term may notice that Secretary Lutnick is likely to appoint new members to the PPAC and TPAC who are ideologically aligned with the President’s stance on intellectual property (IP) policy. This shift reflects a contrast with Trump’s first term, where some early nominees had their own political agendas that didn’t always align with the administration’s broader goals. However, during his second term, the focus has shifted to appointing individuals whose views are closely aligned with the President and who are willing to work collaboratively toward a shared vision for the future.

New Membership for Public Committees Advising USPTO Director

Both the PPAC and TPAC were established in 1999 as part of the American Inventors Protection Act, with governing provisions outlined in 35 U.S.C. § 5. Under this statute, each committee consists of nine members who “serve at the pleasure of the Secretary of Commerce.” If vacancies arise, the Secretary is required to fill them within 90 days, and new members will serve the remainder of the predecessor’s term, which could involve one- or two-year appointments to maintain staggered terms.

The primary role of both public advisory committees is to review the policies, goals, performance, budget, and user fees of the U.S. Patent and Trademark Office (USPTO). Specifically, PPAC reviews USPTO’s patent operations, while TPAC reviews its trademark operations. Both committees also provide advice to the USPTO Director and prepare annual reports on their respective areas of focus. These reports are submitted to the Secretary of Commerce, the President, and the Judiciary Committees of both houses of Congress.

Section 5 of the statute also outlines qualifications for prospective members, requiring them to have substantial backgrounds in areas such as finance, management, labor relations, science, technology, and office automation. Additionally, both committees must include members who represent entities applying for patent or trademark rights, including a mix of large and small entities. Notably, PPAC must include at least 25% of its members from small entity patent applicants, with at least one independent inventor included.

Changes at the USPTO Following Executive Turnover

Secretary Lutnick’s move to reshape the PPAC and TPAC comes amid a wave of executive staff turnover and reassignment at the USPTO during the early months of the second Trump Administration. Coke Stewart was appointed Deputy Director and is currently serving as Acting Director while awaiting the confirmation of Director nominee John Squires.

In February, it was reported that Vaishali Udupa, the USPTO’s former Commissioner of Patents, had resigned to take advantage of the deferred resignation program available to federal workers under the Trump Administration. Several other leadership changes followed, with Will Covey stepping in as Acting Deputy Director, Janet Gongola becoming Acting Director of Communications, and Farheena Rasheed assuming the role of Acting PTAB Vice Chief Judge. Valencia Martin Wallace has been named Acting Commissioner for Patents, and Dan Vavonese is now serving as Acting Commissioner for Trademarks. Chris Shipp has returned as Chief of Staff, and Frederick Steckler, the former Chief Administrative Officer, has stepped down from his duties, although the circumstances surrounding his departure remain unclear.