USPTO

The Public Has Spoken – Again: For a Second Time, Stakeholders Overwhelmingly Oppose Agency Proposals that Would Restrict Access to Inter Partes Review

97% of all comments – and 90% of unique comments – in response to the U.S. Patent and Trademark Office’s (USPTO) Revision to Rules of Practice Before the Patent Trial and Appeal Board (PTAB) oppose the proposed changes. 

Comments responding to the USPTO’s October 17th Notice of Proposed Rulemaking (NPRM) have been posted on regulations.gov on a rolling basis. This analysis reflects comments posted on regulations.gov as of December 16, 2025.

In April 2023, the USPTO released an Advanced Notice of Proposed Rulemaking (ANPRM), outlining a number of proposals that would have dramatically restricted access to inter partes review (IPR) at the PTAB. That ANPRM generated a record-breaking 14,500+ comments; analysis showed that more than 95% of all comments opposed the proposals. Ultimately, the ANPRM was abandoned, and USPTO Director Kathi Vidal took a few minor steps during her tenure to make post-grant patent validity review slightly more accessible compared to the system she inherited, based on the public’s overwhelming feedback.

In October, new USPTO Director John Squires, in a new administration, quickly issued another NRPM that differed from the ANPRM in its specifics and severity, but retread much of the same territory. The current NRPM would fundamentally alter the agency’s approach to considering requests for IPR, and each provision contained therein would make it much more difficult for members of the public to challenge patents.

When comments closed on December 2nd—following a truncated public comment window—the outcome was largely consistent with the public’s response to the ANPRM two years earlier. The USPTO received more than 11,100+ comments, of which 97% of all comments and 90% of unique comments opposed the agency’s proposal.

The second massive wave of opposition to proposals that would limit access to IPRs should be considered not only a repudiation of this NPRM, but also as a rejection of the USPTO’s approach to post-grant review under Director Squires, and before him Acting Director Coke Morgan Stewart, as well as legislative proposals under consideration in Congress, which would have much the same effect. 

Director Squires, through the continuation of Acting Director Stewart's “settled expectations” doctrine, has made IPR virtually inaccessible to petitioners. This is in direct contradiction of the America Invents Act and is being implemented despite overwhelming evidence that the ability to efficiently challenge patents has enormous positive consequences for the American innovation economy. 

Meanwhile, in Congress, a few lawmakers continue to push the PREVAIL Act, which – like the NPRM – would transform the PTAB and dramatically alter the scenarios in which IPR is a viable option for potential petitioners.

What the more than 11,100 comments make clear for the second time is that the American public and stakeholders across the intellectual property community want it to be easier to efficiently challenge invalid patents, not more difficult. 

USPTO leadership and Congress should heed the public will. Indeed, one wonders how many times the American public will have to make its viewpoint clear, or if the Administration will ignore the U.S. public it serves. 

Clear trends are evident from the public's opposition. Among them are a desire for a patent system that prioritizes quality and merit, as well as concerns that the NPRM benefits “patent trolls” and litigation investors at the expense of legitimate innovators and businesses; that it would have negative implications for cornerstone sectors of the economy, like auto and semiconductor manufacturing, and would blunt innovation in rapidly-growing areas, like AI and cryptocurrency; that it would make small- and medium-sized businesses more vulnerable to abuse; that it would increase prescription drug prices; that it poses significant national security concerns and would benefit competitors like China; and, of course, that the NPRM is illegal and hasn’t followed the required rulemaking process. 

These topics, among others, are explored in greater detail below. But one big question remains: The public has spoken; is anyone at the USPTO listening?

Manufacturers, Employers, and A Wide Range of Companies Express Their Opposition

Major manufacturers and high-tech companies weighed in against the NPRM en-masse. Automakers Ford, Rivian, Tesla, Toyota, Honda, Volkswagen, Mercedes-Benz, and the Alliance for Automotive Innovation, among others, all submitted comments opposing the NPRM. 

Their concerns were echoed by a joint comment submitted by a dozen semiconductor manufacturers like Intel, Micron, and Global Foundries, and American companies ranging from Starbucks, Apple, and Amazon to Hewlett Packard Enterprises, Cisco, Ciena, and Roku. They include small companies such as Laminar Research, Intellisense Systems, Core iD, and many, many more—discussed in detail below. 

Comments from major manufacturers and technology companies include:

  • “...The new policy largely removes a key mechanism used to intercept invalid patents, incentivizing increased abuse of the U.S. legal system by now-emboldened NPEs and significantly constraining the United States’ competitive advantage in bringing back domestic semiconductor design and manufacturing relative to other jurisdictions which do not face abusive practices or a comparable risk of unjustified injunctions…” – Advanced Micro Devices, Inc.; Amkor Technology, Inc.; Analog Devices, Inc.; GlobalFoundries U.S. Inc.; Intel Corporation; Lattice Semiconductor Inc.; Micron Technology, Inc.; Samsung Semiconductor, Inc.; Sandisk Corporation; Silicon Laboratories, Inc.; SK Hynix America Inc.; Taiwan Semiconductor Manufacturing Company, Ltd. 

  • “...Ford is deeply concerned about the proposed rule changes. Inter partes review (“IPR”) provides a critical, America-first, cost-effective mechanism to challenge these overbroad or invalid patents. This process ensures agency accountability at the USPTO, and a substantial portion of the cost of the IPR proceeding is borne largely by the Petitioner – not the taxpayer…

  • …These proposed rules would insulate USPTO mistakes or oversights from review, leaving invalid patents in force to be asserted against U.S. companies like Ford. The rules disproportionately benefit foreign applicants and NPEs over U.S. economic activity and job creators...” – Ford Motor Company 

  • “...Tesla believes that the proposed revisions are harmful to U.S. companies and the national economy and, if implemented, will drain U.S. companies of valuable time and money to defend against frivolous lawsuits. The proposed revisions to the rules of practice will bar access to the PTAB and prevent review of weak patents, both of which are needed to protect American intellectual property and U.S. global leadership. As such, we recommend that the USPTO withdraw this proposed rule...” – Tesla, Inc.

A Patent Review System Based on Quality and Merit

An overriding theme of the public’s NPRM commentary is the desire for a patent system that prioritizes a patent’s quality and a petition’s merit over discretionary factors. About half of all comments submitted and nearly 30% of unique comments both oppose the NPRM and contain the term “merit” or “quality.”

Other comments indicative of the broader “quality” and “merit” focuses included:

  • “…most importantly, the IP Section invites the Board to revitalize the concept that a given petition is to be reviewed on its own substantive merit assessed solely against Title 35 of the U.S. Code, independent of external trends...” Bar Association of the District of Columbia, Intellectual Property Section

  • “Earlier this year, the Government Accountability Office found that the Patent Office faces persistent challenges in upholding patent quality standards.

    The GAO's report identified time and resource constraints for patent examiners, a workplace that incentivizes quantity of output over quality of output, and increasingly complex patent applications that are more difficult to consistently make accurate decisions on. The Patent Office has not addressed these glaring concerns and is now eroding its most effective method of reviewing patents that it mistakenly granted. This proposed rule corresponds with the Patent Office Director continuing to use his discretion to deny patent challenges without explanation. The combined outcome is a Patent Trial and Appeal Board that no longer functions and the Patent Office discarding any responsibility it may have previously felt to make sure its patents are high-quality. As a result, the Patent Office is discouraging true innovation and competition.” – Submitted by 130 commenters 

One comment was submitted over 3,000 times, far more than any other. It reads, “I oppose the USPTO’s proposed rule changes for inter partes review (IPR), Docket No. PTO-P-2025-0025. The IPR process must remain open and fair. Patent challenges should be decided on their merits, not shut out because of legal activity elsewhere. These rules would make it nearly impossible for the public to challenge bad patents, and that will harm innovation and everyday technology users.”

Implications for Emerging Technologies 

In addition to manufacturing and technology industry opposition generally, a number of comments raised concerns about the NPRM’s implications for emerging technologies like AI and cryptocurrency in particular.

Commenters note that these industries, which are rapidly advancing and are subject to intense competition abroad, are especially vulnerable to baseless accusations of patent infringement as they scale. The comments emphasize that accessible IPR is an invaluable tool to stave off the waste and abuse that comes from these assertions. They include: 

  • “...Taken together, the Proposed Rule (if finalized in its current form), centralization of IPR institution authority, and rigid Rule 104(b)(4) enforcement, make it dramatically harder, and in many cases impossible, for innovators to efficiently defend themselves against meritless claims. And for digital assets, where foundational technologies are open-source, community driven, and often not documented in patents, these limits are especially damaging. NPEs already target exchanges, developers, and small contributors simply because no one ‘owns’ or controls decentralized systems; meaning one lawsuit can be weaponized against an entire ecosystem...” – Crypto Council for Innovation 

  • “...TechNet strongly urges USPTO to withdraw the NPRM because the proposed changes to the IPR process violate due process and the fundamental patent bargain with the public, undermine the Administration’s stated commitment to global AI dominance, make American companies more vulnerable to foreign competitors, and hurt U.S. economic security…

    …In effect, the proposed rule creates a de facto regulatory barrier that restricts AI innovation as effectively as any formal rule of commerce or export control and allows our U.S. patent system to be weaponized by foreign competitors against American AI progress. This stands in direct contradiction to the President’s policy of promoting American leadership in AI and ensuring that the United States sets the pace of technological advancement...” – TechNet

  • “The Patent Office has recently sent strong signals that it is committed to promoting technologies of the future. But whether it’s an industry like AI or cryptocurrency, the Revision to Rules of Practice Before the Patent Trial and Appeal Board will slow innovation in emerging economic areas. Frivolous patent infringement lawsuits increase costs for defendants, grind the development of new products to a halt, and slow broad technological adoption by consumers. For promising startups breaking into these industries, an unwarranted patent infringement lawsuit can be a death blow, scaring off potential investors and increasing operating costs to an unsustainable level. The Patent Office needs to align its approach to inter partes review with its approach to cutting-edge industries elsewhere. Withdrawing these rules and maintaining inter partes review as a feasible option for stakeholders in emerging technology areas is necessary to achieve the Office’s goal of promoting innovation.” – Submitted by 241 commenters 

Small- and Medium-Sized Enterprises Impact 

It’s not just large manufacturers and high-tech companies that will shoulder the NPRM’s cost. A significant share of comments also share concerns about how small- and medium-sized businesses would fare under the new rules. Nearly 10% of comments oppose the NPRM and contain the phrase “small business” or “small inventor.” 

Comments emphasize that although meritless accusations of patent infringement may harm larger firms, many of them will at least have the resources to fight back. Small- and medium-sized businesses, on the other hand, may not be able to recover from costly district court litigation and desperately need the more efficient patent validity review that the PTAB provides. 

Input related to the NPRM’s especially harmful impact on smaller enterprises include: 

  • “...When weak patents are invalidated through IPR, litigation campaigns targeting hundreds of small retailers never materialize. This protection saves businesses and consumers alike from wasteful legal expenses and inflated technology costs. By contrast, when access to IPR is curtailed, the retail industry becomes a favored target for non-practicing entities (NPEs) that exploit the high cost of litigation to extract nuisance settlements…” – National Retail Federation 

  • “I am a software engineer and small business owner from Broken Arrow, Oklahoma. When misused, software patents stifle innovation and restrict small businesses from truly innovating and growing the United States economy. We have seen far too many times where innovation is stomped out and ended before it could even begin due to patent trolls who contribute nothing back to the economy which they abuse for profit. The IPR empowers small businesses and individuals alike to fight back against patent trolls without having to have millions of dollars in the bank to fund legal fights in court. This proposal will reduce the power of the IPR, destroying the only avenue small businesses like mine have to fight back against patent trolling.” – Anonymous

  • “As a small business owner working in the US defense industry, I am opposed to the USPTO’s proposed rule changes for inter partes review, Docket No. PTO-P-2025-0025. My business and small businesses like mine would be harmed if this passes by removing a path to challenge and remove frivolous patents that are neither valid nor useful to the United States engineering and manufacturing sector. This rule change would make it much easier for patent portfolio trolls to unfairly lock down technologies simply based on their own financial ability to bring suit, not based on merit. Please reconsider this change and support the small and medium sized businesses manufacturing US components in support of our national defense.” – Senseeker Corp.

Threats to National Security and Benefits to Litigation Investors 

Numerous commenters note that changes to PTAB practices that restrict access to IPR create a national security vulnerability where invalid patents can be weaponized against American companies in critical sectors. Often, these concerns also reference the role that litigation investors – including investors based overseas – play in the patent system and how the NPRM would benefit actors who wish to manipulate patents for financial gain, not to further innovation and productive economic activity. 

Similar concerns at the nexus of patents, litigation investors, and national security have been raised in the halls of Congress, with bipartisan legislation introduced to bring additional transparency to third-party litigation funding arrangements.  

In this instance, noting who commented in favor of the NPRM is just as revealing as who submitted comments in opposition to the proposal. The USPTO received a comment from Fortress Investment Group, “voic[ing] our support for the proposed rules set forth in the NPRM.” Fortress is a massive player in intellectual property litigation investment, where it commits billions of dollars annually. (Notably, a number of litigation-funded shell companies put in comments supportive of the regulations, including multiple entities controlled by or receiving funding from Fortress IP.)  Fortress is now a subsidiary of an Abu Dhabi sovereign wealth fund; it is also worth noting the current director worked for Fortress and thus would have a clear conflict ruling on cases affecting their rights. 

Comments highlighting the national security risks that the NPRM poses include: 

  • “... it bears emphasis who will benefit from these policies. It is not ‘small inventors’ or research institutions. It is the wealthy individuals and financial firms that invest in U.S. patent litigation and their associated law firms. Many of these investment enterprises are foreign owned. Investment funds such as PurpleVine that are owned by the Chinese government have been particularly active in U.S. patent assertion campaigns in recent years—as well as Chinese companies such as Huawei that have been sanctioned by the U.S. government, and enterprises such as YMTC that directly compete with (and steal trade secrets from) U.S. manufacturers of critical technologies such as networking equipment and DRAM memory. If the Chinese Communist party were allowed to publish proposed rules in the Federal Register restricting PTAB review, it could hardly do better than the pending NPRM…” – U.S. Manufacturers Association for Development and Enterprise

  • “...The proposed changes would tilt the playing field toward litigation funders, patent trolls, and foreign adversaries, and against the American manufacturers, AI firms, and startups that build and employ here at home. President Trump has rightly declared that U.S. leadership in artificial intelligence is inseparable from America’s national security and economic power. Flooding U.S. innovators with opportunistic patent lawsuits would undercut those priorities at the very moment global competition is intensifying…” – Consumer Technology Association

  • “America’s adversaries are investing in lawsuits and manipulating our court system for their own gain. Putin’s oligarchs have used litigation investment as a way to evade sanctions. Firms based in China have targeted tech companies in American courts. The Patent Office has an opportunity to hold the line and put America First, by standing as a bulwark against these efforts to undermine critical domestic industries.

    Inter partes review is one of the most effective ways to fight back against competitors’ legal attacks by allowing domestic companies to quickly and efficiently dispense with the invalid patents that are being wielded against them. Making IPR less accessible will serve only to benefit those who use the patent system to enrich themselves, not contribute to innovation and growth.

    The Patent Office must understand the risks of implementing these new rules. If we want America to remain competitive on the global stage, we need to do more to keep our adversaries from undermining us. At the Patent Office, that needs to start with keeping IPR as a reliable resource for American companies. – Submitted by 164 commenters

The NPRM Will Increase Prescription Drug Costs

Commenters also correctly point out that the NPRM directly contradicts a key Trump administration priority – reducing prescription drug costs. Submissions note that large drug companies have been known to shroud their products in what are known as “patent thickets,” layers of overlapping low-quality patents that improperly extend a drug company’s monopoly. Via their intellectual property strategies, drug companies can use invalid patents to maintain inflated prices and block fair competition. 

This is another area where support for the NPRM is interesting. While patient advocates, prescription drug affordability groups, and those in favor of generic drug competition oppose the NPRM, PhRMA submitted a comment in favor of the NPRM, noting that it “supports the proposed rules in principle” and “supports the goals expressed in the NPRM.”

Comments submitted in opposition to the NPRM and that are primarily concerned with its impact on prescription drug costs include: 

  • “...Arnold Ventures does not support the proposed rule and urges the USPTO to withdraw it. The proposed rule would severely limit the use of IPRs in the pharmaceutical sector, which would make the pharmaceutical market much less competitive. The IPR process is a critical congressional check on patent quality that is important to promote competition and innovation. If adopted, the rule would extend brand name pharmaceutical company monopolies and lead to higher prices for patients, employers, and taxpayers. This is in direct conflict with the administration’s priority to deliver lower drug prices to American patients by accelerating competition, particularly its recent efforts to bring more competition to the US biosimilar market...” – Arnold Ventures 

  • “...The America Invents Act (AIA) outlined a framework for the PTAB that allows for more efficient, accessible, and affordable challenges to invalid patents. Prior to the creation of the PTAB, invalidating unlawful patents cost millions of dollars in district courts, harmed many communities, and led to patients, patient advocacy organizations, and researchers often lacking standing. The PTAB and Inter Partes Review (IPR) created a much-needed pathway for curbing Big Pharma’s patent abuse and bringing lower-cost generic and biosimilars to market. Instead of gutting one of the best pathways for overturning unlawful patents, the administration should focus on increasing patent quality and ending Big Pharma’s abuse of the patent system…” – Patients for Affordable Drugs

  • “...IPR provides the public with a meaningful opportunity to challenge the validity of invalid pharmaceutical patents before the PTAB. IPR is a critical conduit for the public to participate in the patent system, which directly influences patient health and quality of life. Weak pharmaceutical patents, such as marginal or minor changes to an existing medication, stifle innovation and prevent more affordable generics and biosimilars from entering the market. If pharmaceutical companies are permitted to continually file unnecessary patents to extend their monopolies without the public maintaining the ability to bring these bad patents to IPR, many young adult patients will continue to face the reality of unaffordable prescription drug prices. Maintaining a strong, accessible IPR process is essential to ensuring that the young adult patients have access to affordable medications…” – Generation Patient

Negative Consequences for Software Development and Investment

Also consistent with the public response to the 2023 ANPRM, hundreds of comments opposing the NPRM directly reference the harmful effects it would have on “software” and “open source” development specifically. Comments noted how IPRs help spur software innovation and how they are used by businesses outside of the tech space that are nevertheless targeted with patent infringement lawsuits based on overly-broad software patents. Comments include:

  • “...The proposed changes would hollow out a core safeguard of patent quality by shielding weak patents from review under the IPR process; a mechanism Congress designed in the America Invents Act (AIA) to ensure fairness, efficiency, and accountability in patent validity determinations. By erecting procedural barriers that limit the availability of IPR proceedings before the Patent Trial and Appeal Board (PTAB), the NPRM will undermine the structural integrity of the US patent system itself…

    …BSA members support reforms to the PTAB’s IPR process when those reforms increase predictability, fairness, and legal certainty for all participants. Unfortunately, the NPRM does the opposite. It imposes a one-sided set of restrictions that would advantage patent assertion entities and foreign competitors at the expense of US innovators, manufacturers, and service providers—and, ultimately, the American workers and consumers who depend on them…” – Business Software Alliance

  • “...NPEs continue to target ESA member companies and other leading innovators with U.S. patent litigation, often asserting low-quality patents. For example, in the first nine months of 2025, NPEs filed over 91% of the district court patent cases concerning high-tech industries. Frivolous patent litigation is expensive, time-consuming, and counterproductive to the research and development activities by ESA member companies that help drive growth of the U.S. economy...” – Entertainment Software Association

  • “I am a software developer in my late 30s who has been programming both professionally and as a hobby for over twenty years. One of the greatest strengths of the software development community is its ability to collaborate, improve, and innovate at a rapid pace. Unfortunately, the current state of software patents has been a frequent roadblock for that very innovation. It is far too easy for companies and organizations to use software patents as a way to extort competitors out of money as opposed to being used for good faith protection of their ideas. IPR is one of the few tools that software developers have to push back against such extortion. If anything, I am a firm believer that software developers need STRONGER protections against such tactics; this proposal would make things WORSE. If this proposal were enacted, it would stifle software innovation in the United States. It is a genuine threat to our ability as a country to continue to remain at the forefront of technological innovation. This proposal must be reconsidered. As written, it provides even more power to patent trolling legal firms that serve no purpose other than to extort money out of individuals and businesses in a bad faith exploitation of the software patent landscape. If we want to see the United States push forward in the tech sector, we need to take power AWAY from such firms, not give them more.” – Anonymous

The NPRM is Illegal

Last, but certainly not least, a concerning number of comments spoke to the fact that whatever one thinks of the substance and ultimate impact of the NPRM—it clearly exceeds the USPTO’s authority.

There were two main lanes of critique on this front. First, commenters – including 14 former Members of Congress who helped write and pass the underlying statute – describe the new restrictions on IPR as being in direct conflict with the America Invents Act. Second, commenters note the USPTO’s claims that the NPRM is not economically significant and would not have significant impacts on small businesses do not pass muster. As a result, the USPTO should be required to undergo additional regulatory review, most notably with the Office of Information and Regulatory Affairs (OIRA), which it has not undertaken. 

Comments related to these issues include: 

  • “...The NPRM’s ramifications for small entities and economic significance require additional regulatory analysis that has not yet been conducted.

    Congress alone writes the laws and the executive branch enforces them. In this case, the USPTO does not have the authority to rewrite the AIA–which the undersigned individuals either voted for while serving in Congress or have supported in the years since its passage–or advance an NPRM without adhering to administrative law. We ask that the NPRM be withdrawn and that the USPTO reconsider the contents of its proposal.” – Joint letter from 14 former Members of Congress

  • “...We write, separately, however, to underscore that the USPTO’s proposals to limit patent challenges not only conflict with Congressional intent and exceed the Director’s legal authority, but also undermine President Trump’s policy goal of reshoring manufacturing…” – American Economic Liberties Project

  • “...The Proposed Rule appears to fall within five of the seven categories of regulations specifically targeted for rescission under the Administration’s Ensuring Lawful Governance Executive Order — including rules that lack clear statutory grounding, impose unjustified burdens on regulated parties, impede innovation, or harm small businesses. Under that Order, agencies contemplating such rules must consult the Administrator of the Office of Information and Regulatory Affairs (OIRA) before proceeding…” – Thomas W. Krause, Former USPTO Solicitor

  • “...Executive Order 12866 requires agencies to assess the costs and benefits of a ‘significant regulatory action,’ which is defined as one that will ‘[h]ave an annual effect on the economy of $100 million or more[.]’

    The NPRM claims that ‘[t]his rulemaking has been determined to be not significant under Executive Order 12866.’ Further, the notice contends that ‘[t]he changes in this NPRM are not expected to result in an annual effect on the economy of $100 million or more.’

    Contrary to the Office’s contention, the economic impact of the NPRM will significantly exceed the $100 million threshold. In fact, the NPRM justifies the proposed changes based on the purported significant economic impact of parallel invalidity proceedings on innovation…” – Apple Inc.

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* Analysis applies to comments that were posted on regulations.gov by December 16, 2025 – or 11,112 of the 11,442 comments that the USPTO reports receiving. 

Comments that were critical of non-practicing entities (NPEs), patent assertion entities (PAE) or patent trolls – but did not comment on the specifics of the NPRM – were categorized as opposing the proposed rules. 

Comments that called attention to “efficient infringement,” the issues associated with serial patent challenges, or ways in which the current IPR system may favor larger entities over smaller or individual inventors – but did not comment on the specifics of the NPRM – were categorized as supporting the proposed rules. 

Comments that were generally in favor of making it easier for petitioners to challenge patent validity were categorized as opposing the proposal. Comments that were generally in favor of making it more difficult for petitioners to challenge patent validity were categorized as supporting the proposed rules. 

A small share of comments were categorized as neither supporting nor opposing the NPRM. This is a combination of comments that weigh the pros and cons without coming down primarily on one side, comments that were off topic, and comments whose meaning was indecipherable.

Post-Grant Review Trials

The Financial Poise webinar “Post-Grant Review Trials” features Andrea Shoffstall (Senior Patent Counsel at Unified Patents) as one of the panelists, offering practical insights on strategies and best practices for navigating post-grant proceedings before the USPTO. The panelists discuss how practitioners can effectively manage inter partes and post-grant reviews, emphasizing procedural nuances, litigation coordination, and recent trends impacting patent validity challenges. The discussion helps companies understand, at a high-level, how to protect valuable IP assets, anticipate challenges from competitors, and make informed decisions about pursuing or defending post-grant proceedings as part of a broader patent strategy. For businesses, patents are both key assets and sources of competitive value, making validity disputes potentially game-changing battles.

Read the article here: https://www.financialpoise.com/post-grant-review-trials/

Comments submitted to the USPTO over AI impacts on prior art

Through policy advocacy work with Unified Edge, Unified Patents has submitted comments to the USPTO's request for comments regarding the impact of the proliferation of artificial intelligence (AI) on prior art, the knowledge of a person having ordinary skill in the art, and determinations of patentability made in view of the foregoing.

Unified has suggested that the USPTO may need to be wary of unscrupulous actors creating AI data dumps, including using bulk patent applications at the USPTO itself to create patent thickets.

Read through Unified’s comments by clicking on the button below:

Unified's Comments

Comments to the USPTO submitted regarding terminal disclaimer practice

Through policy advocacy work with Unified Edge, Unified Patents has submitted comments to the USPTO's recent NPRM regarding conditions for obtaining terminal disclaimers to obviate obviousness-type double patenting.

In 2022, the USPTO requested comments regarding USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights. The Office has proposed a rule that would cut down on examiner wear-down and the abusive assertions of obvious variations of continuation patents through current terminal disclaimer practice. Unified has written to support the proposed rule.

Read through Unified’s comments by clicking on the button below:

UNIFIED's COMMENTS

The Public Has Spoken: Stakeholders Overwhelmingly Oppose Proposed Restrictions on Patent Trial and Appeal Board Review

Public comments responding to U.S. Patent and Trademark Office proposals have been posted on regulations.gov on a rolling basis. This analysis has been updated from the original version – July 23, 2023 – to reflect comments posted on regulations.gov as of August 22, 2023.

Before Congress in April, Director Vidal testified that the U.S. Patent and Trademark Office’s (USPTO) recent Advance Notice of Proposed Rulemaking (ANPRM) on the Patent Trial and Appeal Board “contains a myriad of options, and we want to hear from stakeholders not only on how those provisions might affect them, how we should evolve them, but whether we even have the authority to move forward with them.” And boy, did the public respond. The Office heard from more than 14,500 comments, the most on record for any administrative patent-related action in the USPTO’s long history.

The response was overwhelming, broad-based opposition to the ANPRM’s proposals. More than 95% of all public comments—and nearly 85% of unique comments—opposed the proposals, according to analysis by Unified Patents. 

It should not be surprising that stakeholders oppose the ANPRM. New economic analysis found that over the next 10 years the proposals would result in a net decrease in U.S. business activity of -$482.1 million in gross product, a net decrease of -$230.4 million in personal income, a net decrease of -2,000 job-years of employment, and $202.9 million in additional costs to the federal government – between lost tax receipts and higher procurement costs.

As the comments emphasize, proposals that make it more difficult to challenge invalid patents—including new standing requirements for petitioners—would be a drag on the economy, slow innovation, and burden productive businesses with increased costs. The ANPRM feedback shows, rather, that stakeholders would like for the Patent Trial and Appeal Board (PTAB) to be a more accessible, more efficient alternative to litigation, as was provided for in the America Invents Act of 2011. Despite lobbying efforts to the contrary, the record is clear—the ANPRM was wrong-footed, could raise drug prices, would serve to embolden NPEs, and would be a drain on the productive American economy. 

Indeed, Director Vidal has repeatedly emphasized the importance of stakeholder input throughout her tenure; the USPTO now needs to seriously grapple with the public’s concerns, and must question whether to proceed with any rulemaking process that does not roll back ill-advised moves like the NHK-Fintiv and Valve rules, unpopular moves that have only served to limit objective review and the public’s right to petition the government. 

And the USPTO isn’t the only governing body that must heed this clarion call against these motivated “reform” efforts. Just days after the ANPRM’s comment window closed, Senator Thom Tillis (R-NC) and Senator Chris Coons (D-DE), ignoring the clamor, introduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act, a rebranding of the perennial go-nowhere “STRONGER” Act that would institute many of the same unpopular changes included in the ANPRM. 

It would be undemocratic for the USPTO or Congress to justify proceeding with new restrictions for PTAB review on the heels of such a significant and decisive public outcry from stakeholders across a diverse array of sectors and with a wide range of backgrounds. It would serve special interests over a documented and overwhelming opposition; it would raise drug prices, embolden patent trolls, and prevent the USPTO from correcting its own mistakes. And the PTO likely doesn’t have the authority to make good on most of their proposals. In short: it’s bad policy. 

Recurring themes from the thousands of public comments in opposition to the changes are summarized below, and clearly demonstrate the problem with either the USPTO or particular Congressmen proposing them.

Patent Trolls are a Major Concern

The need to protect businesses of all sizes against predatory NPE or patent troll lawsuits is a consistent theme across a majority of the comments. The term “patent troll,” “NPE,” or “non-practicing entities” appears in over 10,500 submissions (more than 73% of all comments), with the overarching concern that, on balance, the proposed changes to PTAB review would benefit patent trolls at the expense of economic growth and innovation. 

Congress originally established the PTAB, in part, as a response to the widely-recognized pattern of abusive patent litigation. Any changes that add new procedural hurdles will leave businesses more vulnerable to costly, bad-faith patent infringement assertions. Public input expressing concern about the new changes further enabling patent trolls includes:

  • “...Over the past few decades, businesses like hotels, restaurants, and retailers have found themselves the target of lawsuits from non-practicing entities (NPEs), sometimes called patent trolls. These NPEs will threaten businesses with claims of patent infringement on vague old patents, which frankly never should have been issued in the first place. The trolls know they have no case, but they’re relying on businesses to make the calculation that it’s cheaper to settle out of court than wage an expensive (even if successful) legal battle.

    IPR is a tool in businesses’ arsenal when it comes to defending against trolls. The program, which was created as part of the 2011 America Invents Act (AIA) allows anyone to file a challenge on an old patent to have it reviewed by the PTAB. Evidence from the first decade of the program shows that it works – 40 percent of patents challenged via IPR are ruled invalid, demonstrating that there is a robust need for a post grant review process at the PTAB.

    Unfortunately, the recent ANPRM threatens to significantly weaken the IPR process, putting businesses like our members at risk. The proposed rules would make changes to a variety of elements of the IPR process, including who can file an IPR, how long they have to file it, and what the standard for instituting an IPR is. All of these proposed changes create uncertainty for small businesses across the county, many of whom now have to worry about emboldened trolls coming after them.” – I. Diaz, Tweedy Mile Association (Nonprofit organization focused on the downtown revitalization of the city of South Gate in Los Angeles County)

  • “...NPEs and PAEs (so called ‘patent trolls’) justify their practices by claiming to be the champion of the small, independent rights-holder. They claim that they give rights-holders the ability to assert their IP against large entities that would otherwise be able to violate at-will, relying on fixed cost staff attorneys and lengthy, costly litigation. 

    I don't dispute these claims. NPEs and PAEs can serve an important function.

    The IPR process, however, has proven to be a successful counterbalance to the incentives that have driven some of these companies into unethical territory and damaged the ability of US companies to innovate and compete.

    It would be a mistake to eliminate or reduce the effectiveness of the IPR. 

    We should be moving in the other direction and expanding this program, which has a decade of proven success.” – Ratio Software, LLC (Software design and development company)

  • “...From COVID precautions, to supply chain issues, to rising inflation rates, to chronic labor shortages, our members have overcome tough odds to continue to provide goods and services to the people of the Granite State. At a time when some of our members are just beginning to see the light at the end of the tunnel, weakening the IPR process will signal to non-practicing entities (NPEs, sometimes known as “patent trolls”) that it is open season on small businesses.

    As you know, there are some bad actors out there who want to abuse the patent system – buying up old, vague patents from the earliest days of the internet, and using them to threaten or sue small businesses for alleged “infringement.” While most of these cases would easily fail in a real legal challenge, for small businesses it is significantly less expensive to settle out of court with a troll than it would be to go through an expensive trial. NPEs count on this, and can use the same old patent to extort thousands and thousands of dollars from retailers and other Main Street companies.” – NH Retail Association (Association representing more than 700 New Hampshire retailers)

PTAB Standing Requirements Would Harm Small- and Medium-sized Entities (SMEs)

Related to the more general patent trolling concern, many comments specifically raised objections to proposals in the ANPRM that would add new standing requirements for who is allowed to petition for PTAB review. More than 1,500 comments contain the specific phrase “standing requirement” and there are many additional comments that describe the same concept in different ways. Similar standing requirement measures are included in the PREVAIL Act, which would limit review to those who have been sued or are threatened with lawsuits. 

New standing requirements would remove the option of petitioning for PTAB review in many situations where a party has a legitimate interest in challenging an invalid patent. In particular, standing requirements seem to target third parties, like Unified Patents, the Texas Association of Realtors, I-MAK, or the Electronic Frontier Foundation, entities that deter abuse by challenging invalid patents. Third-party organizations are oftentimes uniquely positioned to constrain the most abusive patent troll campaigns and protect SMEs, which are most vulnerable to exploitation. 

The USPTO and Congress have both expressed a desire to make changes that serve the best interests of SMEs, small inventors, and under-resourced entities. As the public comments make clear, any new standing requirements that restrict access to the PTAB would have the opposite effect. 

The following comments emphasize the threat that standing requirements pose to SMEs: 

  • “...As you likely know, patent trolls base their business off of purchasing old patents and using them to attack small businesses for alleged “infringement” for things as simple as using a scanner. While these baseless claims have no legal standing, small businesses like mine often end up having to negotiate settlement terms with patent trolls out of court because we cannot afford to fight a prolonged battle in court… 

    …As patent troll cases have continued to rise over the years, federal lawmakers looked to take action against them by enacting the Leahy-Smith America Invents Act (AIA) in 2011. This initiated the Inter Partes Review (IPR) process, which has been pivotal for small businesses to help fight back against frivolous patent infringement cases. Because the AIA did not include a “standing” requirement to file an IPR, larger companies have also been able to file IPRs on patents being used to sue their smaller clients. 

    However, I fear that the recently introduced USPTO rules would seek to undermine IPR. Specifically, the agency has proposed allowing for less time to file an IPR, changing who can file an IPR, and rewriting the standard for instituting a review from “reasonable likelihood” to “compelling merits.” Not only would these changes directly oppose the purpose of the AIA and overstep Congress, but also empower patent trolls to expand their aggressive attacks against businesses like my own…” – M. Feldman, Roof Off Entertainment (Entertainment booking company)

  • “...The restriction on IPR challenges by nonmarket competitors will eliminate an important pathway for invalidating patents asserted against Main Street companies in NPE hold-up campaigns. Despite Congress’s considered decision that patent quality and integrity would be best served by allowing any member of the public to file an IPR, the proposed rules seek to limit who can file a petition. This will be especially injurious to UFPR’s Main Street members and companies like them who have benefited greatly from IPRs brought by others, including trade associations, patent-challenge organizations, and public interest groups. There are many examples of sweeping campaigns by NPEs seeking hold-up nuisance settlements based on invalid patents being stopped by IPR challenges brought by the types of organizations this proposal seeks to derail…” – United for Patent Reform (Business coalition representing over 90 million U.S. employees)

  • “...These petitioning organizations, including Unified Patents and Askeladden, overcome a collective action problem that bedevils patent litigation: when the plaintiff offers to settle for an amount far below the high cost of litigation, no defendant has an incentive to challenge the patent. Some patent assertion entities have filed lawsuits on the same patent over a hundred times—often targeting small business, which are even more likely to settle—before the patent’s claims were finally canceled in a challenge brought by a petitioning organization. If these organizations were prevented from operating, as the ANPRM proposes, these same assertion campaigns would no doubt have continued, repeatedly extracting small but substantial amounts from small businesses and other operating companies based on a patent that never should have issued…” – U.S. Manufacturers Association for Development and Enterprise (Nonprofit association representing companies manufacturing diverse goods in the United States)

The Open-source Community Weighed In Heavily

More than 500 comments referenced “open source” or “open-source,” almost all of which  highlighted the extent to which the proposed changes to post-grant would harm open-source software development. Software patents are a frequent point of contention in subject matter eligibility conversations, since it is an area ripe for overly-broad, abstract patents. This also means that low-quality software patents are valuable tools for patent trolls. Open-source developers and those that use their products are prime targets. 

Comments submitted by the open-source community highlight the need for accessible PTAB review in order to promote new, accessible software innovation:

  • “...Open source projects and their maintainers are uniquely vulnerable to attack by hostile parties such as patent trolls (sometimes called “non-practicing entities”) and companies rent-seeking over so-called standard-essential patents. The projects and their non-profit fiduciary hosts are not of a scale to be able to manage the usual defenses of large corporations, while the individuals themselves may seem worthwhile targets for avaricious litigators. When a project faces a patent attack, it is thus frequently defended by others as a matter of civic duty.

    The rule changes that the Patent and Trademark Office propose would greatly limit the ability of open source projects to be defended by these third parties. This would both chill the innovation and progress arising from open source software - which contributes billions to GDP - as well as embolden malicious litigators seeking reward where they have no claim simply because their victim is unable to defend themselves…” – Open Source Initiative (Public charity advocating for and enabling the benefits of Open Source)

  • “I am from the Linux Foundation and I support the collaborative development of software under free and open source licenses. A sad reality is that non-practicing entities (NPEs) have been targeting users of open source software and open source foundations with patent litigation…

    …I am deeply concerned about the impact of the proposed changes on the open source software community that relies on third-party entities to protect the openly developed commons of technology that we are all dependent upon. There are seemingly political motivations at play here. The ANPRM's proposed expansion of discretionary denials and de facto standing requirements will leave invalid patents in force to be asserted in litigation against open source foundations and companies like ours.” – J. Bonner, Linux Foundation (Linux Foundation provides a neutral, trusted hub for developers to code, manage, and scale open technology projects.)

  • “Nearly all of the rules you proposed will make it harder to challenge poor-quality patents. If implemented, these rules will make it harder to defend open source software against bad patents in the hands of patent trolls. OSS is a pillar of the entire US tech economy, and misguided intellectual property rules like this will hurt growth in the US economy as a whole.” – Gluu Inc. (Gluu curates and commercializes a distribution of the world’s best open-source digital identity infrastructure projects)

Pharmaceutical, Health Tech, and Other Health Care Organizations Spoke out in Opposition

A number of organizations in the pharmaceutical and health industries submitted comments in opposition to the substance of the ANPRM proposals, including Mylan Pharmaceuticals, Fresenius Kabi, Association for Accessible Medicines, Edwards Lifesciences, I-MAK, and Generation Patient.

A core theme in these comments is that weak patents are frequently used to delay medical progress and competition – increasing costs for patients and reducing access to potentially life-saving medicines and technologies. These organizations all align on the importance of protecting existing PTAB processes, so that PTAB review can continue being used as a tool to challenge questionable patents and therefore promote medical innovation.

  • “...In the life sciences industry, weak patents that do not actually claim a novel, innovative invention, can nonetheless delay generic or biosimilar competition for many years. To combat those delays, Mylan has filed well over 100 inter partes reviews (“IPRs”), taking advantage of Patent Trial and Appeal Board’s (“PTAB”) efficient and streamlined process to challenge weak patents that would otherwise delay patient access to life-saving medicines. Those patent challenges have allowed patients to benefit from earlier access to competition for more than $35 billion in annual brand costs…” – Mylan Pharmaceuticals (A global healthcare company that provides critical access to quality lifesaving medicines)

  • “...Inter partes review (“IPR”) and post grant review (“PGR”) each play a critical role in tackling the root cause of inappropriate delays to low-cost competition in the pharmaceutical industry. Fresenius Kabi opposes the proposed ANPRM modifications because they would so significantly undermine such challenges as to actively discourage them. By extension, the ANPRM as currently proposed would delay access to more affordable generics and biosimilars. As a general matter, unfettered access to the PTAB is particularly important in the generic drug and biosimilar industries. Each generic or biosimilar manufacturer should be free to make its best invalidity case to the Office and not risk forfeiting its right to meaningful PTAB review or other remedies available under current law…” – Fresenius Kabi (Specializes in bringing affordable, off-patent medicines to patients with critical and chronic conditions)

  • “...When it is more difficult to challenge patents, especially in the pharmaceutical field, there is more potential harm to Americans when it comes to their ability to access lower cost generics/biosimilars. This leads to an overall impact on the health of Americans and the economy….” – I-Mak (Nonpartisan, not-for-profit, and non-governmental organization working to address structural inequities in how medicines are developed and distributed)

  • “...By creating heightened barriers, these rules stifle competition and unjustifiably drive up prices, particularly for crucial medical treatments we rely on as patients. Moreover, inter partes review fosters innovation by ensuring that patents do not impede future research and development. When invalid patents are challenged, it paves the way for others to build upon existing knowledge and create new, innovative treatments. This promotes a more dynamic and competitive pharmaceutical industry, leading to the development of new medicines and improved healthcare options...” – Generation Patient (A young adult patient led organization that increases the health literacy, confidence, self-management skills, public policy knowledge, and advocacy strategies of young adult patients)

The Proposals Will Drive-up Costs and Hurt the Economy

The specific points of opposition in individual comments vary, but in many cases the overarching sentiment is consistent. Restricting access to the PTAB, as proposed in the ANPRM and PREVAIL Act, will increase costs and directly harm productive participants in the economy. Congress intended for the PTAB to be an open, more efficient alternative to costly litigation and settlements. Rolling back access will be a drag on the economy and a burden for businesses, small and large. 

Business and labor groups, and patent policy experts, submitted comments emphasizing the economic damage and higher costs that the changes to PTAB review would catalyze:

  • “...The proposed changes could have a considerable impact on our economy and the ability of businesses to defend themselves against attacks from patent trolls. 

    Our members are on the forefront of the construction and energy industries in New Hampshire, and around the country. But at a time when the construction industry is only beginning to rebound from the events of 2020, companies are under threat from non-practicing entities. Instead of investing in wages and jobs, companies are spending thousands of dollars settling frivolous lawsuits out of court. These problems will only get worse under the recently proposed rules. 

    A diverse range of industries rely on the Patent Trials and Appeal Board (PTAB) review process as a means to combat low-quality patents, and protect themselves from patent trolls by targeting the bad patents these companies use to go after main street businesses. Unfortunately, the USPTO’s Advanced Notice of Proposed Rulemaking (ANPRM) published on April 20 is poised to undermine this effective instrument by making it harder for businesses to use the Inter Partes Review (IPR) process to defend themselves from unfounded patent lawsuits. Doing so will force businesses to endure costly and prolonged court litigation, draining their limited resources – and putting jobs at risk.” - D. Spechuilli, Laborers Local 976 (Laborers’ International Union chapter based out of Portsmouth, New Hampshire)

  • “Our association is made up of over 1,100 businesses across the South Placer region, including restaurants, retailers, realtors, hospitality and event services, finance and insurance companies, and more. Our members rely on the Patent Trials and Appeal Board (PTAB)’s review process to invalidate patents that never should have been issued in the first place. The recently proposed rules would significantly curtail companies’ abilities to seek PTAB review in many cases when they are sued on invalid patents. Rather than being able to rely on the Inter Partes Review (IPR) system to invalidate bad patents, companies will be forced to go to litigation – spending valuable time and money on expensive lawsuits…

    …With these proposed rules, the USPTO will make it much harder to institute an IPR, and will hurt American businesses and consumers. The changes the ANPRM proposes include shortening the filing deadline for an IPR from the deadline created by the AIA, raising the standard for instituting a review, and even changing who is allowed to file an IPR.

    Businesses relies on the PTAB and the IPR process to help protect them from the high costs associated with frivolous patent litigation. We ask that you reconsider the proposed rules.” – R. Ghadban, Roseville Area Chamber of Commerce (An association made up of over 1,100 businesses across the South Placer region in California)

  • “I strongly oppose any effort to limit the sorts of patents that can be challenged via IPR. The IPR process has proven to work extraordinarily well. It has lowered the cost of resolving the validity of disputed patents by an order of magnitude, without changing the statistics about who wins validity disputes.

    That is a good thing for everyone involved in the system, with one exception: patent trolls who depend on the high cost of litigation to leverage their settlements. Exempting small entities (which includes many large patent litigation farms, in part because of fraudulent concealment of ownership) will eliminate the lowest cost mechanism of resolving patent validity. True small patent owners should welcome a 90% reduction in costs. Only companies whose business model depends on high cost and uncertainty tend to oppose it.” – M. Lemley, William H. Neukom Professor, Stanford Law School (Director, Stanford Program in Law, Science, and Technology)


* Analysis applies to comments that were posted on regulations.gov by August 22, 2023. Comments that were critical of non-practicing entities (NPEs) or patent trolls were categorized as opposing the proposed rules. Taken as a whole, the ANPRM’s provisions would restrict access to Patent Trial and Appeal Board review and make it more difficult to petition for review of patents held by NPEs.