What Does it Mean to Prove Prior Art Date by a Preponderance of the Evidence?

by Dennis Crouch

In CQV Co., Ltd. v. Merck Patent GmbH, No. 2023-1027 (Fed. Cir. Mar. 10, 2025), the Federal Circuit vacated and remanded a PTAB post-grant review (PGR) decision that had upheld the validity of Merck's patent against sales of a commercially available product. This case highlights a significant divergence between the evidentiary standards for proving prior art status in district court litigation versus AIA trials. It also sets up another increasingly common scenario where neither the patentee nor the patent challenger are US entities. Here, Merck is German and CQV is Korean.

Merck's US10647861 covers transparent α-alumina flakes with specific characteristics that are used in pearlescent pigments for various applications including automobile paint. CQV, a competitor in the pigment market, filed a post-grant review petition challenging claims 1-22--arguing that Merck's commercially available Xirallic product (specifically "Sample C") disclosed the invention and rendered the claims obvious.

Unlike in IPR proceedings, where petitioners are limited to patents and printed publications as prior art, PGR allows challenges based on any ground of invalidity, including prior art products that were "on sale" or "otherwise available to the public" as here. This case particularly focuses on how much certainty is required to establish that a product qualified as prior art under the "preponderance of the evidence" standard used in PGR proceedings.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

President Trump Formally Nominates John Squires as USPTO Director

by Dennis Crouch

President Trump has formally nominated John A. Squires to serve as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. The White House announced the nomination on Tuesday, and the Senate received it on Monday, March 10, referring it to the Committee on the Judiciary. The nomination confirms reporting by Dani Kass at Law360 from mid-February that identified Squires as the likely pick.

Squires currently serves as a partner at Dilworth Paxson LLP and brings substantial intellectual property experience to the role, including a nine-year tenure as Chief IP Counsel at Goldman Sachs (2000-2009). He has particularly focused on emerging technologies including artificial intelligence, blockchain, fintech, and cybersecurity.  In addition though, Squires holds chemistry degree from Bucknell. According to reports, Squires beat out several other candidates for the role, including acting USPTO Director Coke Morgan Stewart; Intel's intellectual property policy leader Vishal Amin (who served as IP czar during Trump's first administration); former chief counsel for the Senate subcommittee on IP under Sen. Thom Tillis (R-N.C.) Brad Watts; and Pillsbury Winthrop Shaw Pittman LLP partner Bill Atkins.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Method Claims can Cover an Entire Process Flow – Including All Conditional Branches

by Dennis Crouch

Sierra Wireless, ULC v. Sisvel S.p.A., Nos. 2023-1059, 2023-1085, 2023-1089, 2023-1125 (Fed. Cir. Mar. 10, 2025). 

In this case, the Federal Circuit has vacated and remanded, holding that the PTAB (1) improperly construed the claims and (2) abused its discretion by relying on testimony from an expert witness who did not meet the Board's defined standard for ordinary skill in the art. Both of these holdings will be housed within patent law's extensive closet full of "tricks-and-traps" for the unwary. 


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Descriptive or Highly Descriptive? The Federal Circuit Reviews the iVoters vs iVoterGuide Trademark Dispute

by Dennis Crouch

The Federal Circuit is currently reviewing a trademark opposition dispute, Heritage Alliance & AFA Action, Inc. v. The American Policy Roundtable (Appeal No. 24-1155), centered around two competing marks: IVOTERGUIDE.COM  and IVOTERS.COM. The following are, more than anything, a set of my notes on the case as I'm thinking through its importance.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Back to the Classics: Importing Limitations from the Specification into the Claims

by Dennis Crouch

The fine line between construing claims in light of the specification and improperly importing limitations from the specification represents one of patent law's most persistent interpretive challenges. The Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) established that while claims "must be read in view of the specification," courts must avoid "reading a limitation from the specification into the claim" absent express definition (lexicography) or disavowal.

In IQRIS Technologies LLC v. Point Blank Enterprises, Inc., 2023-2062 (Fed. Cir. Mar. 7, 2025), the Federal Circuit has vacated and remanded a S.D. Fla. grant of summary judgment of noninfringement on this issue, finding that the district court's claim construction improperly limited the term "pull cord."

The case centers on two IQRIS patents, US7814567 and US8256020, which share a common specification and relate to quick release systems for tactical vests worn by soldiers, law enforcement officers, and first responders. The patent propose a "pull cord" that actuates a release hook to detach portions of the vest.

Point Blank and National Molding were accused of infringement based on their "Quad Release" and "Evil Twin" quick-release systems. Both systems have use triggers that the user pulls or flips, that then actuate "Bowden" cables (similar to bicycle brake cables) to release the vest.  One example of this trigger is shown above.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Federal Circuit offers Another Important Expansion of the Domestic Industry Requirement for USITC Jurisdiction

by Dennis Crouch

The United States International Trade Commission (USITC or ITC) operates as an independent, quasi-judicial federal agency the mission of safeguarding US domestic industries from injury caused by foreign imports.  This is a protectionist agency. In the patent context, the ITC exercises its authority under Section 337 of the Tariff Act of 1930, which prohibits the importation of articles that infringe valid U.S. patents. Unlike district courts, the ITC cannot award monetary damages but instead provides exclusion orders that block infringing imports at the border and cease-and-desist orders that prevent domestic sales of previously imported infringing products.  These orders are then enforced by US Customs and Border Protection (CBP), a branch of Homeland Security.  The ITC is attractive to patent holders because of its relatively expeditious "target date" of 16-18 months from institution to final determination (compared to multi-year district court proceedings), its experienced Administrative Law Judges who frequently handle patent matters, the difficulty respondents face in staying ITC investigations during parallel PTAB trial proceedings, and, as mentioned above, the availability of injunctive relief (via exclusion order) despite eBay.

One measure Congress took to ensure the ensures stays on-mission is through the "domestic industry" requirement.  Before the ITC can block infringing imports, the patent holder must to show the existence of a domestic industry "relating to the articles protected by the patent." 19 U.S.C. § 1337(a)(2). This requirement has two components: the "economic prong" and the "technical prong" that we'll dig into later.

When is Transnational Activity Sufficiently Domestic: The Federal Circuit's recent decision in Lashify highlights an ongoing situation with regard to domestic industry.  Lashify, Inc. v. ITC, No. 23-1245 (Fed. Cir. Mar. 5, 2025).  Lashify designs its fake eyelash products in the U.S., but manufactures them abroad, and the question is when domestic non-manufacturing activity is enough to satisfy the domestic industry requirement.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Estoppel Timing and Procedural Traps in Patent Challenges

by Dennis Crouch

In February 2021, Gesture Technology sued several companies, including Apple, LG Electronics, and Google, for infringing its U.S. Patent No. 7,933,431. The patent, which expired in July 2020, covers technology for using cameras to detect user gestures as input for controlling handheld computing devices.  Four IPR petitions followed:

  • Unified Patents filed on May 14, 2021. IPR2021-
    00917;
  • Apple filed on May 21, 2021. IPR2021-00920;
  • LG Electronics and Google later filed "nearly identical" petitions that were joined with Apple's IPR. IPR2022-00091 and IPR2022-00359.

The PTAB instituted the IPRs and ultimately came out with a mixed result - cancelling most of the claims, but leaving a couple standing (claims 11 and 13).  On appeal, the Federal Circuit has now affirmed. Apple Inc. v. Gesture Technology Partners, LLC, No. 23-1475 (Fed. Cir. Mar. 4, 2025) (precedential); Gesture Technology Partners, LLC v. Unified Patents, LLC, No. 23-1444 (Fed. Cir. Mar. 4, 2025) (non-precedential). In the pair of opinions, both authored by Judge Prost, the court focused both on procedural IPR issues as well as substantive patent law issues. In this post, I focus mainly on the court's explanation of the obviousness standards, claim construction under §112 ¶6, IPR jurisdiction over expired patents, and IPR estoppel.  The Federal Circuit explanation here makes sense except for its analysis of estoppel, which comes at the bottom of the post.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

USPTO Withdraws Biden Era AI Strategy

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


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

PTAB Bar Association Advocates for Stability Amid USPTO Turmoil

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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.'"


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

by Dennis Crouch

After 18 years of litigation, the Federal Circuit has once again ruled in the patent infringement case Halo v. PulseThe 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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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).


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

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

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.


To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.