USPTO Withdraws Biden Era AI Strategy

Patent

The USPTO has withdrawn its artificial intelligence strategy document published in January 2025, just days before the presidential transition. Acting Director Coke Morgan Stewart recently indicated the strategy has been removed because it was “driven in part by Biden executive orders” that have since been rescinded by the Trump administration.

This move is part of a broader reassessment of federal AI policy following President Trump’s executive order on January 23, 2025, titled “Removing Barriers to American Leadership in Artificial Intelligence.” This new EO outlines a fundamental shift in approach, emphasizing “America’s global AI dominance” rather than the previous focus on “safe, secure, and trustworthy development.”

USPTO AI Strategy

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PTAB Bar Association Advocates for Stability Amid USPTO Turmoil

Patent

by Dennis Crouch

The PTAB Bar Association has issued an urgent plea to Congressional leaders and Commerce Secretary Howard Lutnick advocating for stability at the Patent Trial and Appeal Board amid significant disruptions at the USPTO. [Letter to Congress][Letter to Lutnick]. Meanwhile, Acting Director Coke Morgan Stewart recently addressed the patent community at Gene & Renée Quinn’s IPWatchdog LIVE 2025 event, offering reassurances about the Office’s operations despite ongoing challenges. (more…)

The Last Word: ParkerVision’s Reply Brief Makes Final Push for Supreme Court Review of Rule 36

Patent

by Dennis Crouch

The Supreme Court is poised to decide whether to grant review in the pair of R.36 cases that have been pending now since last fall, ParkerVision and Island IP.  These cases challenging the Federal Circuit’s practice of issuing one-word “AFFIRMED” judgments under Rule 36 without providing any explanation. ParkerVision’s reply brief was filed on February 28, 2025 rests on a straightforward statutory interpretation: 35 U.S.C. § 144 requires the Federal Circuit to “issue to the Director its mandate and opinion” when deciding appeals from the Patent Trial and Appeal Board (PTAB). I agree with ParkerVision on this point — the term “opinion” is a legal term of art that unambiguously requires a court to explain its reasoning—something a one-word affirmance plainly fails to do.  What was fairly amazing about the opposition brief, filed last month by the Chinese electronics giant TCL, is the absence of any direct push-back against central statutory interpretation question.  As ParkerVision notes, “Respondents concede the question presented. They do not dispute that § 144 of the Patent Act requires the Federal Circuit to decide an appeal from the Patent Trial and Appeal Board (PTAB) by issuing an ‘opinion.'” (more…)

Second-Guessing the Jury: The Federal Circuit’s Flawed Take on Enhanced Damages in Halo v. Pulse

Patent

by Dennis Crouch

After 18 years of litigation, the Federal Circuit has once again ruled in the patent infringement case Halo v. Pulse.  The February 28, 2025 opinion, authored by Judge Bryson, deals with enhanced damages, attorney fees, prejudgment interest, and the denial of a new damages trial.  On the biggest issue, punitive damages, I explain why the Federal Circuit was wrong in affirming the district court’s refusal to enhance damages.  In my view, the Federal Circuit sidestepped the practical implications of the jury’s willfulness, treating the verdict as a checkbox rather than a meaningful  factual finding for enhanced damages.

Read on for my full analysis. (more…)

OpenEvidence v. Pathway: The Legal Battle Over AI Reverse Engineering

Patent

Guest Post by Professor Camilla Hrdy (Rutgers Law)

Can generative AI models like ChatGPT be “reverse engineered” in order to develop competing models? If so, will this activity be deemed legal reverse engineering or illegal trade secret misappropriation?

I have now written a few articles exploring this question, including Trade Secrecy Meets Generative AI and Keeping ChatGPT a Trade Secret While Selling It Too. But when I first asked this question a year and a half ago, I was getting responses purely in the negative. I asked a panel at a trade secret conference at Georgetown in 2023, “Can ChatGPT be reverse engineered?” Several members of the panel laughed.  I would talk to AI experts, and the answer I got was along the lines of: “it’s not going to happen.”

But one of my students, Devin Owens at Akron Law, who has both a patent law and a computer science background, insisted to me that reverse engineering was possible using “model extraction attacks.”  A model extraction attack entails imputing a massive number of queries into a “target AI model” and using the target’s responses to train a new model that mimics the original’s behavior and functionality.  Devin wrote a student note about this, arguing that AI models are so vulnerable to extraction attacks that they can’t really be “owned” by anyone.

Now it seems clear that at least partial reverse engineering of generative AI models is indeed possible, and of increasing concern to AI developers. (more…)

The Fintiv Pendulum Swings Again: More Discretionary Denials Coming Soon

Patent

The pendulum of the mind
alternates between sense and nonsense,
not between right and wrong. 
– Carl Jung (Memories, Dreams, Reflections)

By Dennis Crouch

In a significant policy shift, Acting USPTO Director Coke Stewart has rescinded the June 21, 2022, Vidal memorandum that had significantly curtailed discretionary denials of PTAB post-grant proceedings. This rescission signals a potentially dramatic return to broader PTAB discretion in denying institution of inter partes reviews (IPRs) in cases with parallel district court litigation. I believe we can expect a significant uptick in discretionary denials of IPR institution petitions. And, patent holders in district court will be looking for ways to quickly move cases forward in order to provide evidence that IPR denial is appropriate.

The tersely worded announcement from the USPTO simply directs parties to once again rely on PTAB precedent for guidance, specifically highlighting the precedential PTAB decisions of Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) and Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020). The announcement further states that any portions of PTAB or Director Review decisions relying on the now-rescinded Vidal Memorandum shall not be binding or persuasive.

Since its creation under the AIA, the PTAB has rapidly established itself as America’s most active patent litigation forum — and the only one that is effectively risk-free for patent challengers. Before the AIA created the IPR system, district courts rarely invalidated patents on obviousness grounds because of the doctrine’s technical complexity that often went beyond the span of generalist federal judges and juries. PTAB judges are hired for their willingness and ability to dig deeply into complex obviousness arguments involving the combination of multiple references. Over the past decade, the PTAB has invalidated tens of thousands of patent claims as obvious. To put this in perspective, I am fairly confident the PTAB has invalidated more patent claims on obviousness grounds in its short life than all federal courts combined since the founding of our patent system in 1790.  AIA Trials have been a huge shock to the patent system — a shock that has almost entirely favored patent challengers.  Thus, Director Stewart’s new policy change is important as it is likely to redirect access to this powerful alternative forum. (more…)

Ninth Circuit Rejects Patent Misuse Defense in Minimum Royalty Dispute, Setting Up Potential Supreme Court Review

Patent

by Dennis Crouch

The vast majority of patent appeals are heard by the U.S. Court of Appeals for the Federal Circuit. Such cases typically include at least one claim or compulsory counterclaim “arising under” U.S. patent laws. However, patent-related issues occasionally arise in contexts outside the Federal Circuit’s jurisdiction, notably in breach-of-license disputes involving patent misuse. One such case is the recent Ninth Circuit decision, C.R. Bard, Inc. v. Atrium Medical Corp., 112 F.4th 1182 (9th Cir. 2024).

The Bard dispute highlights ongoing issues surrounding patent misuse and specifically invokes the Supreme Court’s influential decisions in Brulotte v. Thys Co., 379 U.S. 29 (1964), and Kimble v. Marvel Entertainment, LLC, 576 U.S. 446 (2015). (more…)

The USPTO’s Innovation Double Standard: Which Diversity Initiatives Survive

Patent

by Dennis Crouch

I sometimes have difficulty following doublethink. The recent implementation of the Republican Administration’s executive orders on diversity initiatives has created a nuanced and seemingly contradictory landscape in federal agencies, including the USPTO.

In January 2025, the White House issued executive orders “Ending Radical And Wasteful Government DEI Programs And Preferencing” and “Ending Illegal Discrimination and Restoring Merit-Based Opportunity.” These orders were followed by a February 5, 2025 memorandum from the Office of Personnel Management providing additional guidance on implementation. At the same time, the White House has repeatedly offered statements and other executive actions that focus particularly on protecting and “defending women.”

The USPTO’s implementation response has been notably selective. (more…)

Federal Circuit Denies Patent Agent Registration for Former USPTO Examiner Who Failed to Disclose Workplace Suspension

Patent

by Dennis Crouch

I am teaching professional responsibility this semester and it is fascinating to read about all the different ways legal professionals can stumble on their own feet. In a recent nonprecedential decision, the Federal Circuit upheld the USPTO’s denial of a former patent examiner’s application to register as a patent practitioner. Behnamian v. Stewart, No. 24-1139 (Fed. Cir. Feb. 26, 2025). [24-1139.OPINION.2-26-2025_2473270]

The case highlights the importance of candor and truthfulness in registration applications and the high ethical standards expected of those seeking to practice before the USPTO. (more…)

USPTO Facing Additional Cuts: What’s Core vs. Expendable

Patent

by Dennis Crouch

As federal agencies begin to respond to the new Republican Administration’s agency reorganization directive, the USPTO finds itself in an unusual position. Unlike many federal agencies, the USPTO operates primarily on user fees rather than appropriated funds. However, this self-funding status does not exempt the agency from the new “Department of Government Efficiency” (DOGE) initiative requiring agencies to develop plans for “large-scale reductions in force” (RIFs) by March 13, 2025.  opm-omb-memo-guidance-on-agency-rif-2-26-2025.

Depending on how Commerce Secretary Howard Lutnick and Acting USPTO Director Coke Stewart interpret and implement these directives, the impact on USPTO operations could be extremely disruptive. Lutnick has indicated he is in favor of major reductions in force, although not speaking directly about the USPTO. These negotiations continue behind closed doors while patent examiners, practitioners and applicants continue to sit in limbo about potential impacts on examination quality, processing times, and the stability of the U.S. patent system.

A new February 26, 2025 memorandum from OMB and OPM directs agencies to take serious steps toward shrinking their activity, workforce, and physical footprint.  Agencies have been directed to focus on “maximum elimination of functions that are not statutorily mandated.” The memo notes that agencies should narrowly interpret statutory requirements:

Agency leadership must confirm statutes have not been interpreted in a way that expands requirements beyond what the statute actually requires. Instead, statutes should be interpreted to cover only what functions they explicitly require.

An important note here is that much of the USPTO operation is guided by precedential cases that are effectively already interpreting the statutes. This would seemingly guide any interpretation offered by the agency director.  Although some of this may seem dramatic, the Agency is part of the executive branch, and thus subject to the direction of the President and his sworn duty to “take Care that the Laws be faithfully executed.”  Cuts are ongoing, but major systemwide upheavals are unlikely for several more weeks. We should know more after the March 13 agency deadline.

The memo from OPM creates a framework for analyzing which USPTO functions might be vulnerable to cuts — some aspects of this are discussed in below.  The rest of this post talks through various USPTO functions — considering ones that are statutorily mandated versus those that are discretionary as one approach to seeing where cuts might occur. (more…)

Corporate Shells and Legal Loopholes: The Dewberry Decision’s Trickster Legacy

Patent

by Dennis Crouch

In a unanimous decision released today, the Supreme Court has vacated a $43 million trademark infringement award against Dewberry Group, potentially creating a roadmap for corporate structuring to minimize trademark liability. Dewberry Group, Inc. v. Dewberry Engineers Inc., 604 U.S. ___ (2025). Justice Kagan, writing for the Court, held that when awarding the “defendant’s profits” under the Lanham Act, courts can only include profits “properly ascribable to the defendant itself” – not those of its legally separate, non-party corporate affiliates. While the decision reinforces traditional corporate law principles, it raises serious concerns about the practical enforcement of trademark rights in an era when establishing multiple corporate entities is increasingly simple and commonplace.  23-900_Dewberry Decision.

Mythological trickster figures such as the Coyote or Loki operate at the boundaries of justice — and are known for exploiting gaps between rules and reality in ways that allow for both ambiguity and transformation.  Writing in Carl Jung’s posthumous book, Joseph Henderson gave a harsh rendition of the trickster: “he [the trickster] is cruel, cynical, and unfeeling.”  Man and his Symbols (1964).   I see Dewberry as a trickster opinion – not necessarily good or bad – but one that creates a tension between legal formalism and practical reality, inviting clever structuring that follows the letter of the law while potentially undermining its purpose.  There is always a reckoning after the trickster acts as we come to grips with the gap between what the law says and what justice requires.  For example, the opinion here may ultimately prompt legislative reconsideration of how trademark remedies function in the modern corporate landscape. (more…)

Patent Office News and Turmoil

Patent

by Dennis Crouch

February 2025 has brought unprecedented changes to the USPTO as part of the broader Republican transformation of the Federal Government. This post highlights six key developments affecting the US patent systems:

  1. Leadership exodus following early retirement incentives;
  2. Billionaire influences on USPTO operations;
  3. New examiner productivity reporting requirements and surveillance concerns;
  4. Uncertainty surrounding the USPTO Director nomination;
  5. Impacts of return-to-office mandates on patent operations; and
  6. Hiring freezes, loss of workers, the growing patent backlog, and likely push toward AI solutions.

We are living in a politically divided world and it is easy to read bias into straightforward reporting—my intent here is simply to convey what’s happening at the USPTO as accurately as possible, regardless of political implications.

1. Early Retirement Pressure and Leadership Exodus

The USPTO has experienced a significant leadership vacuum following abrupt emails earlier this February encouraging early retirement of all Federal employees, and an unusual level direct outside communication and control of employees from OPM/DOGE.  Several key USPTO leaders appear to have accepted these offers, including former Commissioner for Patents Vaishali Udupa, Commissioner for Trademarks David Gooder, and senior leader Tom Krause.  The “Fork” deal offered to pay these individuals through September despite no longer having any responsibilities at the agency.  For these leaders, at least a portion of their reason for departure was the end of the work-from-home option.  Will Covey has stepped in as Acting Deputy Director of the USPTO.  He has been part of the General Counsel’s office for many years, including substantial time as Director for the Office of Enrollment and Discipline.

My understanding is that examiners who accepted the deal are still doing their daily grind and have not been directly notified of when they can stop.  Based upon second hand information, that date appears to be very soon (March 1, 2025). That timing (mid bi-week) suggests that the decision is once again being imposed on the USPTO.  I would advise examiners to keep doing their job until told otherwise in this confusing time; some in management will be looking for a mechanism to not pay the entire 7-month bonus.

So far, there is no word from the USPTO on how many individuals (1) opted into the fork; (2) have already left the agency voluntarily; (3) were fired or terminated; or (4) had their job offers withdrawn. (more…)

Republican Administration Maintains Exclusivity Stance in GLP-1 (Tirzepatide) Compounding Dispute

Patent

by Dennis Crouch

Since late 2022, the extraordinary demand for glucagon-like peptide-1 receptor agonists (GLP-1s) like Eli Lilly’s tirzepatide (marketed as Mounjaro for diabetes and Zepbound for weight loss) has created a persistent nationwide shortage. This shortage opened a temporary but lucrative opportunity for compounding pharmacies, which the Federal Food, Drug, and Cosmetic Act permits to produce copycat versions of branded drugs during officially declared shortages. In December 2024, the FDA abruptly determined that the tirzepatide shortage had resolved and removed these products from its shortage list, effectively terminating compounders’ legal authority to produce these drugs. With the recent transition to the Trump administration—whose leader has repeatedly criticized pharmaceutical companies for “getting away with murder” on pricing and specifically targeted the cost of weight loss medications—I have wondered whether the FDA might reverse course under new leadership and side with compounders offering lower-priced alternatives.  The FDA’s new court filing indicates that the agency is standing firmly with patent holders and the drug approval system that grants market exclusivity.  [FDA Brief ZepBound]

The compounding pharmacies have been providing much cheaper versions of the drugs and apparently different dosing regimens.

A number of plaintiffs sued the FDA in 2024, seeking a preliminary injunction to permit ongoing compounding. Outsourcing Facilities Ass’n v. U.S. Food & Drug Admin., No. 4:24-cv-00953-P (N.D. Tex. filed 2024).   In its brief opposing the preliminary injunction, the FDA defends its data-driven conclusion that “Lilly’s supply is currently exceeding demand and will meet or exceed projected demand across all strengths of Mounjaro and Zepbound.” The FDA’s determination relied heavily on confidential data provided by Lilly. I expect that this brief will effectively end the case for the plaintiffs, although they will likely continue to fight for some time. (more…)

Privilege Gone Too Far? How a 250-Year-Old Privilege Cost Atturo $10 Million

Patent

by Dennis Crouch

A new petition for certiorari in Atturo Tire Corp. v. Toyo Tire Corp. highlights an interesting procedural quirk in Illinois law that may require Supreme Court intervention to resolve an important state law question about the scope of litigation privilege. The case started as a patent importation dispute that Toyo filed with the ITC against various tire manufacturers, but not against Atturo. Toyo settled those cases with provisions requiring the settling parties to stop selling Atturo’s tires. After Atturo won a $10 million jury verdict under Illinois law for tortious interference and related claims, the Federal Circuit reversed based on Illinois’ absolute litigation privilege.  Atturo believes the scope of litigation privilege should be referred to the Illionois Supreme Court.  But, the Supreme Court’s rules only allows certification from the US Supreme Court or Seventh Circuit — that meant that the Federal Circuit could not certify the case.

Atturo has asked the Supreme Court to exercise its unique certification authority to get definitive guidance from the Illinois Supreme Court. See Ill. Sup. Ct. R. 20(a).

Read my post about the Federal Circuit’s original decision here: Dennis Crouch, Treading Carefully: Federal Circuit Expands “Absolute Litigation Privilege” and Affirms Trade Dress Invalidity in Toyo Tire v. Atturo Tire, Patently-O (October 6, 2024).

The rest of this post talks through both the scope of litigation privilege and the certification process.

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Bane and Antidote: Copyright Statute of Limitations

Patent

by Dennis Crouch

Statutes of limitations occupy a peculiar position in our legal system – both shield and sword. While they play a vital role in promoting social stability by preventing stale claims and encouraging prompt resolution of disputes, their rigid application can sometimes feel like permitting theft by other means. When an otherwise valid claim is barred simply because time has passed, the law effectively transforms a wrongful act into a permitted one.  The Supreme Court recognized this tension nearly 150 years ago in Wood v. Carpenter, acknowledging that statutes of limitations were both “bane and antidote,” necessary for societal order yet potentially harsh in their operation. 101 U.S. 135 (1879). This fundamental tension is particularly acute in copyright cases where the limitations period is quite short – only three years and where creative works can be exploited for years before their owners discover the infringement. (more…)

The Doctrinal Merger No One Asked For: How Enablement Swallowed Utility

Patent

by Dennis Crouch

The Federal Circuit’s recent decision in In re McLeay offers a glimpse into the evolving relationship between utility and enablement in patent law.  Although the decision is short and non-precedential, I think it offers some important insights on how both the USPTO and Federal Circuit judges are thinking about the issues.

In affirming the USPTO’s rejection of claims for treating COVID-19 with aerosolized ribavirin, the court’s February 18, 2025 ruling (No. 23-2338) shows that the Full Scope Enablement Doctrine has effectively assumed the gatekeeping role traditionally assigned to Section 101’s Utility Doctrine — especially for pharmaceutical treatment claims. This shift reflects a broader pattern where enablement requirements under Section 112 are increasingly shouldering the substantive work of ensuring inventions are genuinely useful—work that the relatively permissive Utility Doctrine has largely abandoned.  I enjoyed the case also noting that it was argued by the patent applicant’s twin brother Bart McLeay (Kutak Rock LLP). (more…)

Reimagining Patent Examination: A (Half-Baked) Proposal for Pre-Filing Certification

Patent

by Dennis Crouch

In 2025, the Trump administration is in the process of substantially reducing the federal workforce while also signaling interest in increasing reliance on Artificial Intelligence in federal government operations. In this environment of rapid transformation, where once-unthinkable changes are becoming daily realities, the opportunity for radical reform of government institutions has never, in my lifetime, been more tangible.

Amid this dramatic reshaping of federal operations, I wanted to explore a potential structural reform: allowing patent applicants to obtain pre-filing certification of their applications through rigorous outside examination equivalent to USPTO standards. This certification could then facilitate expedited examination at the USPTO, similar to how the Patent Prosecution Highway (PPH) program operates for international applications, but with important distinctions that could make it more effective.  The U.S. patent examination system faces persistent challenges of long pendency times, substantial unpredictability, variable quality despite the USPTO’s continued efforts at improvement, and high costs. Although not without potential serious concerns, the proposal could address many of these elements.

The core idea is straightforward:

Before filing, applicants would submit their application to a certification entity that would conduct a thorough prior art search and patentability analysis.  There may be a certification process – that requires the entity to meet quality metrics parallel to those used by the USPTO internally. Applications certified as meeting patentability requirements would then be eligible for highly streamlined USPTO registration process.

Although AI tools would not be a required element of this process, I expect that they would be integral to the process of both certification entities and patent applicants seeking to navigate this new system effectively. Modern AI systems, particularly those built on large language models and specialized patent examination databases, could dramatically enhance the preliminary examination process by identifying relevant prior art, conducting an analysis for both anticipation and obviousness, suggesting claim amendments, and flagging potential §112 issues.  Leaving quality aside for a moment, the benefit of the AI system is its potential cost effectiveness and its timeliness. In particular, this process could compress the examination process into a single day rather than the multi-year scenario that 95% of applicants face.

While this proposal is primarily a thought experiment, its greatest value may be in demonstrating how AI-driven preliminary analysis and immediate feedback could be implemented within the USPTO’s existing framework to improve patent examination. (more…)

New USPTO Leadership on the Horizon: Lutnick Confirmed as Commerce Secretary, Squires Expected as Director

Patent

by Dennis Crouch

Yesterday, the Senate voted to confirm Howard Lutnick as Secretary of Commerce. Lutnick, has been CEO of Cantor Fitzgerald and a prolific inventor named on over 400 U.S. patents. Commerce has a wide coverage, including housing the USPTO.

Meanwhile, Dani Kass at Law360 is reporting that John A. Squires, currently a partner at Dilworth Paxson and former chief IP counsel at Goldman Sachs, is expected to be nominated as the next USPTO Director.  Like Lutnick, Squires has extensive fintech experience.

The Director position requires presidential nomination and Senate confirmation under 35 U.S.C. § 3(a)(1). The statute specifically requires that the Director be a U.S. citizen with a professional background and proven ability in patent or trademark law.  I expect that Sec. Lutnick will play a key role in advancing Squires’ potential nomination through the process.

Squires brings significant private sector IP experience to the potential role. At Goldman Sachs, he founded and led the investment bank’s intellectual property practice from 2000 to 2009. This was at the same time that Lutnick at CantorFitz was deeply involved on the technical side.  Squires’ practice at Dilworth Paxson has continued to focus on emerging technologies including AI, blockchain, and fintech.  He also previously helped to create the Fortress’ IP Investment group’s $4 billion.

Although Squires has not published his list, I expect that the following will be some of his focal points as he jumps into the fray:

  1. Ensuring the patent system is both accessible and valuable to small startups.
  2. Expanding patent eligibility through legislation, especially for Software/Fintech.
  3. Expanding the use of AI tools in the examination process to create a more efficient and predictable process.
  4. Reducing the backlog and patenting delays.
  5. Considering ways to link the patent system with national security.

The USPTO had expanded a number of DEIA related initiatives under Directors Iancu and Vidal. Those have been eliminated already and so are unlikely to be a focus of Squires’ tenure.

Generic Drugs, Skinny Labels, and Liability for Off Label (Infringing) Use

Patent

by Dennis Crouch

I mentioned in a recent post that Hikma’s petition for writ of certiorari was due on Valentines Day, February 14 2025.  The company has now filed its petition and it des a powerful job of presenting the problems of the Federal Circuit’s “skinny label” decision.  Hikma particularly asks the Court to clarify when marketing a generic drug with a “skinny label” can trigger liability for actively inducing patent infringement under 35 U.S.C. 271(b). Petition for Certiorari – Hikma v Amarin.

The case centers on Hikma’s generic version of Amarin’s Vascepa (icosapent ethyl), which was originally approved to treat a form of heart disease, severe hypertriglyceridemia (SH). While that use is no longer patent-protected, Amarin later obtained patents covering Vascepa’s use for the somewhat overlapping category of reducing cardiovascular (CV) risk. Following established practice under the Hatch-Waxman Act, Hikma obtained approval for and ultimately launched its generic version with a “skinny label” that carved out the still-patented CV indication. See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012) (explaining Congress designed this system “to speed the introduction of low-cost generic drugs to market”).  This situation is extremely important because the majority of new FDA approvals are for new uses of already approved drugs.

We want a system that works to both incentivize development of further uses of the known drugs — and that allows for low cost access for uses that are no longer protected by patent rights.  I also want to recognize here that drug prices for patented uses can be prohibitively expensive for individuals, while insurers and pharmacy benefit managers are looking for ways to lower their cost and stay competitive. So, any system we have in place needs to recognize these strong incentives and the pragmatic realities driving behavior in the pharmaceutical marketplace.  In other words, the system needs to maintain the practical viability of skinny labels without unduly trampling valid patent rights. The current situation creates an unsustainable political tension around new uses for existing medicines.  In order to be politically acceptable, we’re going to need a system that continues to permit wide use of the old drugs.  Otherwise we’ll see mounting pressure to eliminate new use patents that many see as improper evergreening that blocks legitimate generic entry. (more…)

Supreme Court Patent Challenges February 2025

Patent

by Dennis Crouch

The Supreme Court’s 2024-2025 patent docket has a growing number of cases awaiting consideration. I count fifteen pending cases that could reshape multiple facets of patent law. At the heart of this term lies a set of challenges to the Federal Circuit’s Rule 36 summary affirmance practice, with five separate petitions (ParkerVision, Island IP, ATOS, Audio Evolution Diagnostics and Converter Manufacturing) arguing that the court’s frequent use of one-word affirmances undermines transparency and violates statutory requirements for reasoned decision-making and demands supervision from the Supreme Court. This procedural theme extends beyond Rule 36 to encompass broader questions about how patent cases should be adjudicated, with three petitions (BBiTV, Island IP, and Brumfield) challenging the Federal Circuit’s approach to resolving factual disputes at summary judgment, particularly in patent eligibility cases. Impact Engine and Audio Evolution Diagnostics also challenge the eligibility framework, with Audio Evolution specifically questioning whether medical diagnostic machine patents should be considered abstract ideas under Alice/Mayo.

Two cases raise what I see as core substantive patent law issues outside of eligibility:

  • Converter Manufacturing questions the court’s long-standing approach to prior art enablement.
  • Celanese raises questions the the scope of the on-sale bar under the America Invents Act, particularly for secret processes.

These substantive challenges are complemented by cases addressing remedial issues, including DISH Network‘s questions about attorney fee liability and IPR-related costs, and Provisur‘s challenge to the Federal Circuit’s review of jury willfulness findings.

The following list loosely categorizes the pending cases and you’ll find details about each via the hyperlink.

Federal Circuit Rule 36 Challenges

Patent Eligibility Cases

Other Core Patent Law Issues

Additional Procedural & Remedial Issues

Pending/Potential Filings

(more…)