FTC Revives Orange Book Listing Challenges
On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in the Food and Drug Administration’s (FDA) Orange Book. The FTC made clear that its prerogative under President Trump’s leadership is to seek “transparent, competitive, and fair healthcare markets.”
The FTC issued renewed warning letters to drugmakers that did not delist previously challenged Orange Book listings, disputing more than 200 patents across 17 brand-name pharmaceuticals. The patents relate to device components of combination drug-device products treating asthma, diabetes, and chronic obstructive pulmonary disease (COPD). The FTC alleges the device patents constitute improper listings that allow brand-name manufacturers to delay – or even prohibit – generic competition. These patents were previously the subject of warning letters the FTC issued in November 2023 and April 2024 to more than a dozen pharmaceutical manufacturers. Although some manufacturers delisted patents in response to the initial warning letters, others chose to continue listing the targeted patents in the Orange Book.
In Depth
BACKGROUND
The FTC issued a policy statement in 2023 under Chair Lina Khan declaring that “improper” pharmaceutical patent listings in the Orange Book may constitute an unfair method of competition in violation of Section 5 of the FTC Act. The patents are listed for the purpose of putting generic rivals on notice to deter patent infringement. The FDA, however, takes only a ministerial role as to listing patents and does not assess whether patents are properly listed in the Orange Book. Following the 2023 policy statement, the FTC issued a series of warning letters to manufacturers.
In the FTC’s recent warning letters, the agency cites the December 2024 US Court of Appeals for the Federal Circuit decision in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC as support for their assertion that the previously identified patents are improperly listed. The Federal Circuit affirmed a lower court’s order requiring Teva to delist five patents associated with its ProAir® HFA inhaler, a drug-device combination product, from the Orange Book. The court found Teva had improperly listed its ProAir HFA inhaler patents in the Orange Book for primarily two reasons:
First, Teva had misinterpreted the requirements set forth in the listing statute by arguing that the term “drug” encompasses any component of an article that treats a disease, and therefore its patents claiming the device components would also “claim the drug.” The Federal Circuit rejected this argument, holding that determining whether a patent is properly listed “requires what amounts to a finding of patent infringement,” and the mere fact that a product could infringe a patent does not mean the patent “claims” the underlying drug.
Second, Teva argued that a patent can be listed when it claims any part of the product other than the active ingredient, and therefore its patents that claim the device component are valid. The Federal Circuit rejected this argument, holding that in order for a patent to claim the “drug” and be listed in the Orange Book, the patent must claim at least the active ingredient of the approved product, as the active ingredient provides the primary mode of action of the drug.
The Federal Circuit subsequently denied Teva’s request for an en banc rehearing in March 2025. Notwithstanding Teva’s petition seeking Supreme Court review, Teva must now delist the five patents.
WHAT’S NEXT
On the day following the Federal Circuit’s opinion, the FTC issued a press release applauding the Federal Circuit’s holding and reiterating its position that, due to the 30-month statutory stay triggered by listing patents in the Orange Book, improper listings can negatively affect competitive conditions permitting generic entry of competing drug products. The press release, however, was issued in the waning days of Chair Khan’s tenure with a Democratic majority at the FTC, and practitioners and industry stakeholders alike questioned whether the FTC’s policy on Orange Book listings would continue under a Republican-led FTC. The recent warning letters suggest that, under current Chair Andrew Ferguson, the FTC appears to be sticking to the prior administration’s policy and remains focused on enhancing competition between brand-name and generic pharmaceuticals to lower healthcare costs.
The Federal Circuit’s decision vindicated the FTC’s position against improper listings in the Orange Book and likely empowered the agency to undertake the most recent enforcement efforts despite the change in administration. The agency’s continued scrutiny of patent listings in the Orange Book indicates it is possible the FTC may pursue enforcement actions concerning its Orange Book challenges in the future. Therefore, brand-name manufacturers are advised to carefully review their current listings, paying particular attention to the underlying claim of the patent, as patents that do not claim the active ingredient in the drug may be considered improperly listed. Brand-name manufacturers are encouraged to proactively seek counsel when conducting such reviews to ensure compliance.
Texas House Approves ‘Make Texas Healthy Again’ Bill
On May 26, 2025, the Texas House passed SB 25 with bipartisan support. SB 25, also known as the ‘Make Texas Healthy Again’ bill, focuses on promoting nutritional awareness and physical education in schools and improving food labeling practices. The bill would also establish a Nutrition Advisory Committee to help establish, develop, and maintain nutritional guidance within the State.
SB 25 also requires food manufacturers to either remove prohibited ingredients listed within the bill—such as Red 40 and titanium dioxide—or place a warning label on the product that reads: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” This language was amended from what was reported on in a previous blog post. The latest version of the bill makes clear that it does not apply to dietary supplements (among other listed situations).
Notably, the bill removed high fructose corn syrup from the list of prohibited ingredients following opposition from numerous food companies after it was introduced. The industry’s opposition letter also urged legislators to remove the warning label requirement, but the proposed amendment did not pass through the House.
SB 25 is now heading to Governor Greg Abbott’s desk to be signed into law. The bill would take effect on September 1, 2025.
House Subcommittees Will Hold Hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology” on June 5
On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The Subcommittees will hear from the following witnesses:
Dr. Drew Endy, Hoover Institution Science and Senior Fellow, Martin Family Fellow in Undergraduate Education for Bioengineering, Stanford University;
Ms. Deborah Gracio, Associate Lab Director, National Security Directorate, Pacific Northwest National Laboratory;
Dr. Stephen Techtmann, Associate Professor of Biological Sciences, Michigan Technological University; and
Dr. Kelvin Lee, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals.
MAHA Report Cites Nonexistent, likely AI-Generated, Studies
The Make America Healthy Again (MAHA) Commission published its report detailing what it claims to be the main causes of chronic diseases. The report is receiving increased scrutiny after News of the United States (NOTUS), a nonprofit digital news site, published an article on Thursday, May 29 stating that many of the citations in the report either had large errors or even cited nonexistent studies. Some cited authors who were contacted by NOTUS were surprised to hear of their citation and denied ever working on the studies referred to in the MAHA Report.
Both The Washington Post and The New York Times published articles later that same day referring to even more errors and inaccuracies. The Washington Post article quoted artificial intelligence experts who suspect that many of the citations in the MAHA Report were likely produced by AI. Indeed, no authors are identified for the MAHA Report itself, which leaves considerable questions as to the scientific accuracy of its findings. The article points to the use of the text “oaicite” (OpenAI Cite) in some of the citation URLs within the report, which is “a marker indicating use of OpenAI, a U.S. artificial intelligence company.” This suggests that the conclusions reached in the report may have preceded the citations.
When asked about the NOTUS article and the potential reliance on AI, White House press secretary Karoline Leavitt referred to any inaccuracies as “minor citation and formatting errors.” The MAHA Report has since been updated to remove the incorrect citations at issue in the NOTUS article.
Separately, following public complaints from a number of grower groups regarding the MAHA Report, The America First Policy Institute (AFPI), a nonprofit think tank that was founded in 2021 by current Secretary of Agriculture Brooke Rollins, released its “Farmers First agenda for responsible nutrition policy” Driving Responsible Nutrition Policy on May 29.
The AFPI paper outlined the following principles:
Federal programs should allow states to incentivize healthier eating.
Federal government must ensure our domestic food supply is transparent, safe, and upholds nutritional integrity.
Federal nutrition programs must be reserved for the truly needy and must aim to restore the dignity of work.
Government and the private sector must collaborate to reduce food loss and waste.
Driving responsible nutrition policy also means supporting the domestic specialty crop sector, including fruit and vegetable farmers.
GLP-1 Receptor Agonists: The Surge of M&A Activity and the Future of Metabolic Health
Over the past decade, the global pharmaceutical industry has witnessed a transformation in the treatment landscape for metabolic disorders, particularly type 2 diabetes and obesity. At the heart of this shift is the explosive rise of GLP-1 receptor agonists, once a niche therapeutic class, now a multi-billion-dollar market shaping the future of chronic disease management. With this surge in clinical and commercial success, the GLP-1 technology space has become a hotbed for mergers and acquisitions (M&A), as major pharma players race to secure their foothold in what many consider the next blockbuster category.
This post explores the strategic drivers, recent deals, and future implications of M&A activity in the GLP-1 sector, unpacking why this field has become a focal point for investment, innovation, and consolidation.
GLP-1: From Diabetes Therapy to Weight Loss Powerhouse
Originally developed to help manage blood sugar in type 2 diabetes, GLP-1 receptor agonists have evolved beyond their initial indications. These drugs mimic the glucagon-like peptide-1 hormone, which enhances insulin secretion, suppresses glucagon, and slows gastric emptying. What made them revolutionary was their ability to induce weight loss, a feature that has become a cornerstone in the battle against obesity, a condition with vast medical, social, and economic implications.
The commercial success of drugs like Novo Nordisk’s semaglutide (Ozempic®, Wegovy®) and Eli Lilly’s tirzepatide (Mounjaro®, Zepbound®) has catalyzed not just clinical excitement but also intense investor and acquirer interest. These medications have demonstrated not only weight loss upwards of 15-20% but also cardiovascular and metabolic benefits, positioning them as game-changers in preventive medicine.
Why the GLP-1 Market Is Attracting M&A Interest
Massive Market Potential: Obesity affects over 890 million adults globally[1], with related comorbidities including diabetes, cardiovascular disease, and certain cancers. Analysts estimate the GLP-1 market could reach US$139 billion annually by 2030.[2]
Pipeline and Platform Expansion: As demand surges, big pharma companies are under pressure to expand their metabolic portfolios. M&A offers a fast-track route to diversify into GLP-1 and adjacent incretin-based therapies (e.g., GIP (Gastric Inhibitory Polypeptide), dual/triple agonists).
Technology Differentiation: Although current GLP-1s are effective, there is a premium on next-generation delivery systems (oral, transdermal, long-acting injectables) and multi-modal agonists. Acquiring innovative biotech firms with proprietary delivery platforms or novel peptide structures provides a competitive edge.
Limited In-House Innovation: Not all big pharma players developed GLP-1 assets internally. As a result, acquiring external innovation, whether through platform technologies or late-stage assets, is becoming a strategic imperative.
Recent M&A Moves in the GLP-1 Landscape
The following transactions illustrate the growing M&A momentum in the GLP-1 space:
Roche’s Acquisition of Carmot Therapeutics (2023):Roche paid US$2.7 billion upfront for Carmot, a clinical-stage biotech with a promising portfolio of incretin-based therapies, including dual GLP-1/GIP agonists. This move positioned Roche to compete in the metabolic disease arena, leveraging Carmot’s small molecule platforms to diversify beyond oncology.[3]
AstraZeneca’s Acquisition of CinCor Pharma (2023):Though primarily targeting hypertension, AstraZeneca’s US$1.8 billion buyout of CinCor included a nod toward combinational potential with metabolic therapies, signaling broader interest in cardiometabolic synergies.[4]
Pfizer’s Strategic Reassessment and Potential for Acquisitions (2024, 2025):After halting internal development of its oral GLP-1 candidate due to tolerability concerns, Pfizer has publicly stated its interest in acquiring external GLP-1 assets. Although no formal deal has closed, analysts speculate an acquisition could be imminent, especially in the wake of divestitures from its COVID-era portfolio.[5], [6]
Novo Nordisk’s Expansion via Catalent Deal (2024):Novo Nordisk’s US$16.5 billion acquisition of Catalent’s fill-finish facilities demonstrates another angle of strategic M&A, ensuring capacity for GLP-1 manufacturing and reducing supply chain risks amid skyrocketing demand.[7]
Beyond Big Pharma: Biotech’s Role as Innovation Engines
Small- to mid-cap biotech firms are proving essential in advancing the next frontier of GLP-1 therapies. These companies are often rich in innovation but resource-constrained, making them prime acquisition targets for larger players. A few noteworthy examples include:
Structure Therapeutics: Developing oral GLP-1R agonists, Structure has seen rapid investor interest post-Initial Public Offering (IPO) and is considered a prime candidate for acquisition due to its differentiated delivery approach.[8]
Terns Pharmaceuticals: The company recently announced positive Phase 1 clinical results for its oral GLP-1R agonist for treating obesity, triggering acquisition rumblings.[9]
Viking Therapeutics: The company is advancing early-stage GLP-1 or dual agonists with strong preclinical profiles and have recently experienced stock price surges on clinical data, fueling acquisition speculation.[10]
Strategic Implications and Risks
Although the M&A landscape in GLP-1 technology is vibrant, it is not without challenges, such as the following:
Supply Chain Constraints: Companies acquiring GLP-1 assets must also manage complex peptide synthesis, formulation, and delivery bottlenecks. This makes CMC (chemistry, manufacturing, controls) and scale-up capabilities a due diligence priority.
Regulatory Scrutiny: With GLP-1s being prescribed off-label for cosmetic weight loss, regulators may impose tighter restrictions, impacting long-term market forecasts.
Valuation Pressure: As competition intensifies, valuations are soaring. This poses a risk of overpaying for early-stage assets with limited clinical data. Strategic buyers must carefully weigh scientific promise against commercial risk.
Patent Life and Biosimilar Threats: The first-generation GLP-1s are already facing biosimilar competition timelines. Acquirers must assess exclusivity windows and invest in lifecycle management strategies.
The Future of M&A in the GLP-1 Arena
Looking ahead, several trends are likely to shape the next wave of M&A, including the following:
Combination Therapy Focus: Expect acquisitions targeting companies developing dual/triple agonists (GLP-1/GIP/Glucagon) to address broader metabolic endpoints.
Digital and Companion Tech Integration: Companies integrating wearables or AI-driven metabolic monitoring may become attractive M&A targets for firms aiming to offer holistic obesity/diabetes management solutions.
Emerging Markets Expansion: Firms with strong distribution in Asia, Latin America, or Africa may see M&A interest as acquirers look to expand the global footprint of GLP-1 therapies.
Conclusion
The GLP-1 revolution is not only transforming the treatment of diabetes and obesity, it is also reshaping the strategic priorities of the pharmaceutical industry. With blockbuster sales, novel delivery technologies, and growing clinical applications, GLP-1s have become a magnet for M&A. For investors, innovators, and pharma executives alike, the current M&A wave in the GLP-1 sector represents both opportunity and inflection, one that will define the metabolic health market for years to come.
As GLP-1 technology continues to evolve, one thing is certain: the race to acquire the next breakthrough is only just beginning.
[1] World Health Organization, Obesity and overweight, May 7, 2025; https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight#:~:text=In%202022%2C%201%20in%208,million%20were%20living%20with%20obesity.
[2] TD Securities, GLP-1 Market: The Pipeline Expands, Mar. 10, 2025; https://www.tdsecurities.com/ca/en/glp1-market-the-pipeline-expands#:~:text=Global%20sales%20of%20GLP%2D1,from%20sales%20posted%20in%202024.
[3] “Roche to acquire Carmot Therapeutics for $2.7bn,” Pharmaceutical Technology, Dec. 3, 2023; https://www.pharmaceutical-technology.com/news/roche-to-acquire-carmot-therapeutics/.
[4] “AstraZeneca to buy US-based CinCor Pharma for $1.8bn,” Pharmaceutical Technology, Jan 10, 2023; https://www.pharmaceutical-technology.com/news/astrazeneca-buy-cincor-pharma/#:~:text=AstraZeneca%20has%20signed%20a%20definitive%20agreement%20to%20buy,CinCor%20Pharma%20for%20%2426%20per%20share%20in%20cash.
[5] A. Zank, “Pfizer CFO talks strategic growth through acquisitions,” CFO Brew, Sept. 24, 2024; https://www.cfobrew.com/stories/2024/09/24/pfizer-cfo-talks-strategic-growth-through-acquisitions.
[6] M. Lee, “Pfizer Eyes $20 Billion Revenue From Acquisitions Amid Patent Cliff Challenges,” AInvest, Jan. 14, 2025; https://www.ainvest.com/news/pfizer-eyes-20-billion-revenue-from-acquisitions-amid-patent-cliff-challenges-25011010cf8550e9ae82e13f/.
[7] “Novo completes $16.5bn takeover of Catalent,” PharmaPhorum, Dec. 2024; https://pharmaphorum.com/news/novo-completes-165bn-takeover-catalent.
[8] “Structure Therapeutics Announces First Patients Dosed in Phase 2b ACCESS Clinical Study Evaluating Oral Small Molecule GLP-1 Receptor Agonist, GSBR-1290, for Obesity,” Global Newswire, Nov. 13, 2024; https://www.globenewswire.com/news-release/2024/11/13/2980634/0/en/Structure-Therapeutics-Announces-First-Patients-Dosed-in-Phase-2b-ACCESS-Clinical-Study-Evaluating-Oral-Small-Molecule-GLP-1-Receptor-Agonist-GSBR-1290-for-Obesity.html.
[9] “Terns Pharmaceuticals Announces Positive Phase 1 Clinical Trial Results with TERN-601 Once-Daily Oral GLP-1R Agonist for the Treatment of Obesity,” Global Newswire, Sept. 9, 2024; https://www.globenewswire.com/news-release/2024/09/09/2942701/0/en/Terns-Pharmaceuticals-Announces-Positive-Phase-1-Clinical-Trial-Results-with-TERN-601-Once-Daily-Oral-GLP-1R-Agonist-for-the-Treatment-of-Obesity.html.
[10] “Viking Therapeutic’s new GLP1 impresses at ObesityWeek 2024,” GLP1.Guide, Nov. 4, 2024; https://glp1.guide/content/viking-therapeutics-new-glp1-impresses-at-obesity-week-2024/.
Key Takeaways From the SEC Enforcement Forum West
At the 2025 Securities Enforcement Forum West, senior SEC officials, enforcement counsel, private practitioners, and industry experts gathered to share insights on the current direction of securities enforcement. A major focus of this year’s discussion: insider trading. Below are key takeaways from the insider trading panel’s discussion on where enforcement priorities are headed under the Atkins Commission.
1. Insider Trading Enforcement Will Ramp Up, But Narrow Down
Recent statements of SEC Commissioners and Enforcement officials have made it quite clear: insider trading enforcement is not going anywhere under the Chairman Paul Atkins administration, to be led by a soon-to-be appointed Enforcement Director. In fact, one can expect that the number of insider trading cases will stay steady or increase, though the focus of the investigations will shift and narrow. This was a unanimous sentiment from the insider trading panel.
2. Fencing In “Creative” Insider Trading Theories
Following acting Enforcement Director Sam Waldon’s suggestion that “creative” enforcement actions will be reined in under the Atkins SEC (“Creativity is probably not where we want to be”), novel insider trading theories, such as “shadow trading” claims — trading in another company’s shares on the basis of material nonpublic information (MNPI) learned about one’s own company —as represented by a recent biotech case, will likely be on the chopping block. To be sure, shadow trading is an aggressive theory, and one that the new Commission likely will not champion, if for no other reason than the line-drawing question: where should the SEC or the courts draw the line on the vast potential liability of shadow traders, and how far removed does an unrelated company have to be from a trader’s employer to allow him to trade freely in that same industry? Expect that the Atkins-led SEC will fence in that new frontier of insider trading.
3. Reemphasis on Traditional Insider Trading Claims
On the other hand, in its return to retail, “bread and butter” enforcement touted by SEC officials, and following up on the DOJ’s Galeotti Memo’s emphasis on foreign conduct affecting U.S. victims, we can expect a heightened focus on insider trading rings, especially those located overseas. For example, the SEC senior counsel presenter on the panel discussed a recently filed case in the District of Massachusetts, in coordination with the DOJ. In that case the SEC charged a German national and a Singaporean national for participating in an international insider trading ring that involved coded and disappearing messages, cash drops, and other traditional forms of deception and fraud to gain nearly $18 million in illegal profits. The SEC counsel also pointed to a traditional insider trading case involving a biotech executive’s trading in front of negative FDA news. These traditional types of insider trading cases likely will increase. In fact, the economist on the panel stated that thus far in the new year, after the January 22, 2025, inauguration, the SEC has filed twelve insider trading actions. If extrapolated to the full year, this will be the largest insider trading count in 12 years.
4. To Be Determined: Hybrid Claims Involving Rule 10b5-1 Trading Plans
Corporate SEC enforcement practitioners will be closely tracking insider trading claims involving Rule 10b5-1 plans, which allow corporate insiders to trade securities under a forward-looking written plan when they are not aware of material nonpublic information.1 10b5-1 plans have gained widespread popularity among corporate insiders. For example, in 2021, the SEC reported that approximately 5,800 officers and directors at 1,600 companies traded under Rule 10b5-1 plans. Under the Gensler-led SEC, likely due to their growing popularity, the SEC and DOJ signaled that they were concerned that executives were abusing Rule 10b5-1 plans and using them as tools to engage in insider trading under the veil of statutory protections. In December 2022, the SEC adopted several amendments and new disclosure requirements, including strict blackout periods, intended to address what it perceived may be abuses in Rule 10b5-1 area.2 On the Enforcement side, in June 2024 a jury convicted the former CEO of a company for allegedly engaging in an insider trading scheme in which he fraudulent used Rule 10b5-1 trading plans to trade company stock while holding MNPI. The 10b5-1 criminal insider trading case, which was filed in parallel with the SEC, was the first of its kind for DOJ.
These Rule 10b5-1 claims represent a hybrid type of insider trading action, that combines some novel, expansive, “creative” elements, but also “bread and butter” fraud elements involving abuse of corporate inside information. All in all, given the dual tensions, one can expect that 10b5-1 cases will continue, though they likely will be limited to particularly egregious cases with smoking-gun admissions from corporate insiders or fact patterns in which an insider suddenly entered into a 10b5-1 plan in front of bet-the-company corporate news. But one can also expect that harder to prove, more removed, Rule10b5-1 cases will not flourish under the Atkins SEC. It is a far more difficult task for SEC or DOJ trial counsel to prove to a jury that an executive intentionally set up or abused a 10b5-1 plan to take advantage of MNPI, than that the executive simply tipped or traded on MNPI himself or herself. There is a whole second level of intent and factual manipulation to be proven under the required standards of proof.
Regardless, given the complexity, risks, and recent attention to this issue, corporate compliance professionals would be wise to check with experienced legal counsel when creating or revising their 10b5-1 plans and internal corporate trading programs.
Conclusion
As SEC enforcement priorities shift and refocus under the Atkins Commission, insider trading investigations and litigation will remain front and center, though the scope and type of such claims will narrow. For corporate employers, retaining experienced counsel to assist in drafting and revising Rule 10b5-1 plans, and also to run internal investigations to assist companies in rooting out and self-reporting suspected fraudulent actors, is not only prudent, but essential.
See former SEC Commissioner Allison Herren Lee, Stock Trading Plans Should Prevent – Not Enable – Insider Trading: Statement on Proposed Amendments to Rule 10b5-1 (Dec. 15, 2021).
See SEC Adopts Amendments to Modernize Rule 10b5-1 Insider Trading Plans and Related Disclosures (Dec. 14, 2022).
Workplace Strategies Watercooler 2025: The Nuts and Bolts of Drug and Alcohol Testing [Podcast]
In this installment of our Workplace Strategies Watercooler 2025 podcast series, shareholders Christina Mallatt (Indianapolis), who co-chairs the firm’s Drug Testing Practice Group, and Brent Kettelkamp (Minneapolis) discuss the history of drug testing and the current dynamics of this complex and rapidly evolving field. Brent and Christina focus on the implications of legal marijuana use and the growing prevalence of opioid use, whether legal or otherwise. The speakers also explore how employers can establish and enforce effective and legally compliant drug and alcohol testing policies and protocols that are specifically tailored to meet their workplace safety requirements and align with their company culture.
Beijing IP Court Releases 2024 Annual Cases
On April 30, 2025, the Beijing IP Court (BIPC) released their list of 2024 annual cases including 7 IP-related cases and 1 antitrust case. The Court explained that the cases “cover the four major intellectual property trial areas of patents, trademarks, copyrights, and competition and monopoly, involving innovative achievements in emerging industries in key areas such as medicine, communications, seed industry, platform economy and data. These cases reflect five major characteristics: increasing efforts to protect industrial innovation in key areas, cracking down on intellectual property infringements, helping to build a high-level socialist market economic system, serving the development of the intellectual property rule of law, and contributing Chinese wisdom to world intellectual property governance.”
Press conference releasing the 2024 annual cases.
The original text is available here via social media as the BIPC seems to be geoblocked as of the time of writing.
As summarized by the BIPC:
Case Ⅰ: Standard-Essential Patent Infringement and Royalty Rate Dispute——Assisting a Renowned Enterprise in the Communications Field to Reach a Global Settlement1. Case InformationPlaintiff: X CompanyDefendant: X Guangdong Mobile Communications Company.2. Basic FactsBoth parties to this case are renowned enterprises in the field of communications. At the time of this trial, the two parties had been engaged in licensing negotiations for many years over the 3G and 4G standard – essential patent portfolios, and there were numerous related parallel litigations in various jurisdictions globally, including infringement claims and tariff claims. The plaintiff is the holder of the invention patent titled ‘Base Station Device, Mobile Station Device and Communication Method’. It claims that the patent involved is a standard – essential patent of the LTE communication standard, and believes that the defendant’s acts of manufacturing, selling and offering for sale the two models of mobile phones involved constitute an infringement of the patent right involved, and requests the court to order the defendant to stop the infringing acts.The plaintiff did not file a claim for damages and stated that the purpose of its lawsuit was to advance the licensing negotiations. The defendant filed a counterclaim in the dispute over the royalties of the standard essential patents in this case, requesting the court to make a judgment on the licensing conditions, including but not limited to the licensing royalties, within the scope of mainland China for the 3G and 4G standard essential patents which the plaintiff owns and has the right to license for the intelligent terminal products manufactured and sold by the defendant. After trial, the Beijing Intellectual Property Court held that the counterclaim filed by the defendant met the acceptance conditions, thereby accepted the defendant’s counterclaim and actively promoted the joint trial of the two lawsuits, and finally facilitated the two parties to successfully reach a global patent cross – licensing agreement. On the same day, the parties applied for the withdrawal of this case and the counterclaim respectively on the grounds of reaching a settlement, and the Beijing Intellectual Property Court ruled to approve the withdrawal of the lawsuit by both parties.3. Judgment GistWhen a standard-essential patent holder files a patent infringement lawsuit, requesting the court to order the implementer to stop infringing the patent involved, and the implementer files a counterclaim, requesting the court to rule on the licensing conditions of the standard – essential patent portfolio including the patent involved, the court may take into account the fact that both the counterclaim and the original claim need to examine the same fact, that is, the licensing negotiation matters between the patent holder and the implementer regarding the patent involved and the related standard – essential patent portfolio.The counterclaim should be accepted and jointly tried, in a situation where there is a high degree of correlation between the counterclaim and the original claim.4.Typical SignificanceUnder civil procedure law theory, the relationship between the counterclaim and the original claim serves as the basis for their joint trial. The closer the substantive legal relationship between the original claim and the counterclaim, the more necessary it is to jointly try them in the same case. Article 233 of the “Interpretation of the Supreme People’s Court Concerning the Application of the Civil Procedure Law of the People’s Republic of China (Amended in 2022)” (referred to as the Judicial Interpretation Concerning the Civil Procedure Law) stipulates the acceptance conditions for counterclaims, stating that if the counterclaim and the original claim are based on the same legal relationship, there is a causal relationship between the claims, or the counterclaim and the original claim are based on the same fact, the people’s court should jointly try them. Generally, the counterclaims and original claims accepted by the people’s court are based on the same legal relationship or the same fact, but there are certain particularities in the field of standard – essential patents.A patent that must be used to implement a certain technical standard is called a standard-essential patent. With the vigorous development of the digital economy, standard-essential patent technologies are widely applied in fields such as mobile communication, intelligent connected vehicles, and the Internet of Things. A smart terminal product often contains thousands of standard – essential patents. Against the backdrop of intensified market competition and accelerated technological iteration, licensing negotiations and disputes surrounding standard-essential patents are increasing day by day. In a standard-essential patent infringement case, the right basis usually only involves one or several patents, and the alleged infringing product is also specific. However, in actual licensing negotiations, the two parties often conduct negotiations concerning the entire standard – essential patent portfolio of the patent holder and all related products of the implementer. This leads to a situation where a standard – essential patent infringement lawsuit and a royalty rate lawsuit are not consistent in the scope of patents and products involved. So, on the surface, it does not meet the general acceptance conditions for counterclaims in the civil procedure law. This is exactly the case in this lawsuit. Based on this, the Company claimed that the counterclaim filed by the Mobile Communications Company should not be accepted, and further claimed that the original claim and the counterclaim did not involve the same fact because it did not request the calculation and payment of infringement damages based on the licensing fees in this case.In response to this claim, the court referred to the previous judicial practice of standard – essential patent trials, comprehensively considered the trial ideas and judgment logic of standard – essential patent infringement lawsuits and royalty rate lawsuits, and held that in an infringement lawsuit involving standard-essential patents, whether to order the defendant to stop the infringement is not only determined by whether the defendant has implemented the patent involved without permission, but also by whether the negotiating parties have violated the FRAND obligation. To determine whether the patent holder has violated the FRAND licensing obligation and whether the implementer has violated the obligation of good faith negotiation, in addition to examining the negotiating behaviors of both parties, it is also necessary to examine whether the licensing conditions proposed by both parties during the negotiation process are obviously unreasonable. These licensing conditions are not only for the patent involved, but for all 3G and 4G standard-essential patents for which the X Company has the right to grant licenses. To determine whether the licensing conditions proposed by both parties are obviously unreasonable, it is necessary to determine the reasonable range of licensing conditions, and the trial content of the royalty rate lawsuit for standard-essential patents is exactly the licensing conditions.Based on this special trial logic, although the counterclaim and the original claim in this case are not based on the same legal relationship, there is a causal connection between them, and both are closely related to the fact of the licensing negotiation between the two parties. On this basis, the Beijing Intellectual Property Court held that the the counterclaim should be accepted and jointly tried.The acceptance of the counterclaim aligns with the interests of the parties, which was mutually acknowledged by both sides. The essence of standard -essential patent disputes is to promote negotiation consensus through litigation confrontation, and seek negotiation benefits through litigation procedures. In this case, on the one hand, the patent holder has already initiated an infringement lawsuit and sought injunctive relief in advance, on the other hand, the patent implementer hopes that the court will rule on the licensing conditions. If the counterclaim of the patent implementer is not accepted, it can only initiate another subsequent lawsuit, and a new lawsuit may still need to go through complex and time-consuming procedures such as service of process in foreign-related cases and objections to jurisdiction. This is not only inefficient, but also the sequence and speed of the two lawsuits may affect the negotiating positions of the two parties. Facts have proved that the joint trial of the two lawsuits promoted the two parties to successfully reach a global cross-licensing agreement and subsequent cooperation plan, which resolved the long-standing patent disputes between the two parties and achieved a win-win cooperation between the two parties.This case not only delves deep into the application of the law and clarifies the conditions for the joint trial of a standard-essential patent infringement lawsuit and a counterclaim for standard-essential patent royalties, but also adheres to the judicial concept of “promoting negotiation through trial and substantially resolving disputes”, promoting the substantial resolution of disputes, maximizing the interests of both parties, and promoting industrial licensing. The fair and efficient trial of this case demonstrates the high level and professionalism of China’s judicial protection of intellectual property rights, and reflects the wisdom and responsibility of Chinese courts in the new era in resolving international disputes, as a useful reference for the trial of similar cases in the future.
Case Ⅱ: Administrative Litigation Case Regarding the Invalidation of the Patent Right for “A Crystalline Form of Rocuronium Bromide”—— Assessing the Inventiveness of a Pharmaceutical crystalline form Patent Based on Technical Effects1. Case InformationPlaintiff: Chengdu Xin X pharmaceutical companyDefendant: National Intellectual Property AdministrationThird Party: Wang XX2. Basic FactsThe plaintiff is the patentee of an invention patent titled “A Crystalline Form of Rocuronium Bromide”. The third party filed a request with the National Intellectual Property Administration to declare the patent invalid. The National Intellectual Property Administration issued a decision under appeal declaring the entire patent invalid. Then the patentee filed an administrative lawsuit with the Beijing Intellectual Property Court, claiming that this patent achieved unexpected technical effects and had been commercialized and marketed with actual industrial value, and that the Claim 1 of this patent is inventive and the decision under appeal is incorrect. After the trial, the Beijing Intellectual Property Court held that crystalline form A of rocuronium bromide in this patent had better technical effects compared to the rocuronium bromide solid disclosed in the prior art, and that this patent is inventive and the decision under appeal was incorrect in this regard. Accordingly the court ruled to revoke the decision under appeal and ordered the National Intellectual Property Administration to make a new examination decision. After the judgment was pronounced, none of the parties appealed, and the first-instance judgment of this case has taken effect.3. Judgment GistWhen assessing the inventiveness of a pharmaceutical crystalline form patent, even if obtaining the crystalline form itself is obvious, it doesn’t necessarily mean it lacks inventiveness. It’s still necessary to consider its technical effects compared to the prior art. If the crystalline form achieves better technical effects than the prior art, and these effects are closely related to the formation of the medicine, it can be determined that the crystalline form patent is inventive.4. Typical SignificanceThe pharmaceutical and healthcare industry is not only a core component of China’s strategic emerging industries but also an important area related to people’s livelihood and well-being. Its sustainable development has a profound impact on the overall economic and social situation. As a typical technology – intensive industry, the pharmaceutical field is characterized by high investment in research and development, long cycles, and high risks. Therefore, intellectual property protection plays a prominent role in stimulating technological innovation, improving drug accessibility, and promoting industrial upgrading.Pharmaceutical patents are the most core intellectual property achievements of pharmaceutical enterprises. Regarding a certain drug, the patents obtained by pharmaceutical enterprises for different technical solutions form a complete patent system, including the effective active compound as well as the corresponding crystalline form and the composition. This system is like a “firewall” or a “moat”, and it effectively ensures that pharmaceutical enterprises can fully realize the commercial interests of the drug during the patent exclusivity period, enhancing their market competitiveness. The crystalline form patent in question in this case is a common type of pharmaceutical patent. The crystalline form usually refers to the solid existence form of the drug’s active compound. Due to different crystallization conditions and processes, the active compound of the same drug may yield crystalline forms with different spatial structures and molecular arrangements. This phenomenon of polymorphism in drugs is very important for drug research and development, because different crystalline forms exhibit different physical and chemical properties. This not only affects the preparation, processing, and storage of the drug, but also affects the dissolution and release characteristics of the drug in the human body, thus affecting the efficacy and safety of the drug. On the one hand, the selection of the crystalline form is of great significance for drugs. On the other hand, enterprises have invested a large amount of manpower and financial resources in the research and development of crystalline forms. Therefore, original research pharmaceutical companies usually include the crystalline form, compound, composition, and other inventions in the scope of patent applications together to form a multi-level and all-round pharmaceutical patent protection system.Generic pharmaceutical companies will also increase their efforts in researching the crystalline forms of known active compounds of drugs, and strive to avoid the crystalline form patents of original research pharmaceutical companies, in order to compete in the market for this drug. It can be seen how important crystalline form patents are for pharmaceutical enterprises and the pharmaceutical industry.As the exclusive jurisdiction court for administrative cases regarding patent authorization and confirmation across the country, the Beijing Intellectual Property Court has always attached great importance to the trial of administrative cases of requests for invalidation of patents related to pharmaceutical crystalline forms. By applying the rules of inventiveness judgement correctly, the judgment of this case clarifies the factors to be considered for the technical effects of pharmaceutical crystalline form patents, providing a reference and guidance for the decision of such cases.In this case, it is fully recognized by the court that the prior art has a strong demand as well as provide inspiration on forming crystalline forms of known active compounds and changing known crystalline forms. Compared with the process of creating a compound from scratch, the development of crystalline forms usually results from multiple attempts to use different crystallization methods for known active compounds. crystalline form inventions usually use the general properties of crystals known to those skilled in the art and conventional crystal preparation methods, which makes it extremely difficult for the technical means of such patents themselves to meet the requirement of non-obviousness in the inventiveness judgment. If the exclusive protection of an invention patent is granted merely because there are technical effects predictable by those skilled in the art, it is obviously inconsistent with the contribution made by the inventor to the prior art. There have always been different understandings in practice on how to consider the role played by the technical effects of crystalline forms in the inventiveness judgment. The judgment of this case proposes the rule that to determine whether a crystalline form has achieved technical effects that make it inventive compared with the prior art, it is possible to consider whether the technical effects recorded in the specification are related to the finished medicine.The technical effects described should be specific rather than general physical and chemical properties, such as purity, melting point, and hygroscopicity. If the recorded technical effects are highly related to the finished medicine and the marketed drug uses this crystalline form, it can be considered that it has beneficial technical effects. Correspondingly, the crystalline form patent is inventive and should be protected by the Patent Law.This case is a typical example of Beijing Intellectual Property Court’s active implementation of the innovation-driven development strategy based on the judicial practice of the pharmaceutical and healthcare industry. For the inventiveness judgment of drug-related patents, within the framework of the current rules system, it is necessary to comprehensively consider the relationship between marketed drugs and technical effects, fully protecting the interests of patent holders. The specific judicial rules of this case are helpful to promote the continuous innovation and development of the pharmaceutical industry, thus providing judicial support for ensuring the accessibility of medicines for the people and promoting the implementation of the Healthy China Strategy.
Case Ⅲ: Administrative Litigation Case Involving Invalidation of the “Dou Hai Yin” Trademark Right——Recognizing the Core Service Trademark of XX Internet Platform Enterprise as Well-Known1. Case InformationPlaintiff: Beijing XX Network Technology Co., Ltd. (hereinafter referred to as “XX Network Company”)Defendant: National Intellectual Property AdministrationThird Party: Shanghai XX Technology Co., Ltd. (hereinafter referred to as “XX Technology Company”)2. Basic FactsXX Technology Company applied for registration of the trademark “Dou Hai Yin” on August 31, 2018, which was approved for use in Class 39 services including “travel reservations.” On January 4, 2022, XX Network Company filed an invalidation request on the grounds that the disputed trademark violated Article 13 of the Trademark Law of the People’s Republic of China (prohibition against imitation of well-known trademarks). The National Intellectual Property Administration reviewed the case and determined that the “Dou Yin” trademark claimed by XX Network Company has a short period of use and insufficient evidence to prove it had achieved well-known status. It thus ruled to maintain the disputed trademark. XX Network Company refused to accept the ruling and filed an administrative lawsuit with the Beijing Intellectual Property Court. The court held in its first-instance judgment that although the “Dou Yin” trademark had been used for less than two years before the application date of the disputed trademark, the Dou Yin App had experienced explosive growth with short videos and social platforms as the core business since its launch in September 2016. By June 2018, it had become the top domestic short-video platform with a market penetration rate of 29.8%, reached over 500 million monthly active users (MAU) by July 2018, and accumulated over 3.1 billion total downloads by September 2018. In this case, XX Technology Company used promotional slogans such as “Check-in with Dou Yin,” demonstrating obviously malicious intent to free-ride on XX Network Company’s goodwill. So the “Dou Hai Yin” trademark should be deemed an imitation of “Dou Yin,” violating paragraph 3 of Article 13 of the Trademark Law. The Beijing Intellectual Property Court revoked the administrative ruling. The National Intellectual Property Administration filed an appeal against the decision, and the Beijing High People’s Court issued a final judgment rejecting the appeal and upholding the original judgment.3. Judgment GistWhen determining whether a trademark in the internet sector has achieved well-known status, courts must fully consider the internet industry’s unique characteristics and comprehensively assess factors such as the actual use effects of the trademark, market coverage, user growth rate, and other multidimensional criteria to evaluate whether the trademark meets the standard of being “widely recognized by the relevant public.”4. Typical SignificanceThe platform economy has emerged as a pivotal engine driving the digital transformation of the real economy and unleashing new-quality productive forces. Platform enterprises rapidly accumulate market reputation through technological innovation and business model updates, with their highly influential brand value in particular becoming a core competitiveness driving innovative development. As the trademark of these enterprises hold enormous commercial value, the more well-known a trademark becomes, the more likely it is to be targeted for malicious registration or free-riding.In China’s trademark registration system, protection for registered trademarks is confined to identical or similar goods/services. To combat cross-class malicious registrations, rights holders must prove their trademark has achieved “ wide recognition by the relevant public” to obtain cross-class protection for a well-known trademark. A well-known trademark, as the highest embodiment of corporate goodwill, represents consumers’ utmost trust in product quality and service standards—it is not merely an honorary title. In judicial practice, courts apply the principles of “ case-by-case determination” “passive protection” and “ protection as needed” to dynamically examine well-known trademark recognition. This approach balances precise strikes against cross-class bad-faith registrations with avoiding over-expansion of protection that could stifle market innovation. This case establishes adjudication rules for the recognition and protection of well-known trademarks in the internet sector:First, Significantly Shortening the Traditional Time-in-Use Requirement for Well-Known Status. Under the Provisions on the Recognition and Protection of Well-Known Trademarks issued by the former State Administration for Industry and Commerce, evidence proving a registered trademark’s well-known status must demonstrate at least three years of registration or five years of continuous use. In this case, the National Intellectual Property Administration initially denied recognition primarily because the “Dou Yin” trademark had been in use for a short period before the disputed trademark’s application. The judgment of this case which is based on the trademark law and judicial interpretations pointed out that with the innovative advantages of short video content distribution and algorithmic recommendation mechanism, Dou Yin APP has shown exponential growth in users and downloads in a short period of time, and rapidly accumulated a wide user base and market influence, and the cycle of its trademark popularity formation has been significantly shortened. If the traditional length-of-use requirement of the recognition standard is applied mechanically, it will be inconsistent with the development law of the Internet industry and the actual influence of the trademark.Second, Deepening Analysis of Well-Known Status Recognition in the Traffic Era. With the popularization of the Internet, short videos, artificial intelligence and other technologies, it has become a common business model for merchants to obtain economic benefits by attracting public attention. This case combines the characteristics of the “attention economy” of the Internet with an in-depth analysis of the considerations for the determination of well-known trademarks as stipulated in Article 14, Paragraph 1 of the Trademark Law of the People’s Republic of China. Beijing Intellectual Property Court holds that important indicators with the characteristics of the internet industry, such as the number of daily and monthly active users, average online duration, and market penetration rate, should be used as the basis for determining “the degree of recognition among relevant public.” Taking into account the characteristics of the internet environment, such as fast information dissemination, wide reach, tendency for explosive growth, and the common revenue model in the internet industry where users are acquired for free and income is generated through advertising and other means, the Court will assess adjudication factors such as “duration of continuous use” and “promotional efforts.”Third, Reasonably Defining the Scope of Protection for Internet Well-Known Trademarks. In this case, XX technology company, as an Internet practitioner providing travel information and other services through the Internet platform, used the trademark “Dou Hai Yin”with obvious intention of imitating and climbing, objectively weakened the identification function of the company’s trademark “Dou Yin”, improperly seized the goodwill resources legally accumulated by others, and constituted a substantial damage to the rights and interests of well-known trademarks. Therefore, it was determined that the trademark of the platform Company has reached the status of well-known, and the cross-class protection was in line with the principle of case-by-case and on-demand determination.This case provides clear judicial guidance for recognizing well-known trademarks in the internet sector, demonstrating courts’ firm support for the healthy development of high-value brands. By reasonably defining the boundaries of well-known trademark protection and regulating competition in the digital economy, it also guides platform enterprises and tech innovators to enhance trademark strategy and protection awareness, offering tangible judicial safeguards for high-quality development of new productive forces.
Case Ⅳ: Trademark Infringement and Unfair Competition Dispute Involving the “Lao Ban” Mark— Crackdown on Full-Chain Counterfeit Trademark Infringement1.Case InformationPlaintiff: Hangzhou X Electric Co., Ltd. (hereinafter referred to as “X Electric Company”)Defendants: Chaozhou X Ceramics Factory (hereinafter referred to as “X Ceramics Factory”), Chaozhou X Intelligent Technology Co., Ltd. (hereinafter referred to as “X Tech Company”), Lü X, Chen X, and Wu X2.Basic FactsThe plaintiff, X Electric Company, is the exclusive owner of the registered trademark “Lao Ban”, which is approved for use on Class 11 goods including kitchen range hoods. The five defendants, via multiple business entities including X Ceramics Factory (a sole proprietorship operated by Chen X), X Tech Company (jointly held by the married couple Lü X and Wu X), with other entities such as a Guangdong-based kitchen and bath company (which was suggested to be deregistered during litigation) and a Hong Kong-registered company solely directed by Lü X and in their individual capacities, used the marks “Lao Ban” “LAOBAN WEIYU” and “www.LAOBAN WEIYU.net” on sanitary ware products such as toilets, showers, and sinks. Meanwhile, the Defendants repeatedly used the term “Lao Ban” in their company names, personal or corporate account names, and store names. The plaintiff alleged that the collective actions of the five defendants infringed its exclusive trademark rights and constituted acts of unfair competition. Accordingly, it sought injunctive relief and joint compensation of RMB 5 million for economic losses and RMB 290,000 for reasonable expenses. Upon trial, Beijing Intellectual Property Court found that the five defendants had engaged in trademark infringement and unfair competition, and ordered them to cease the infringing activities and jointly pay the plaintiff RMB 5 million in damages and RMB 150,000 in reasonable costs.The defendants appealed, but Beijing High People’s Court dismissed the appeal and upheld the original judgment.3.Judgment GistWhere a company shareholder deregisters a company during litigation without legally liquidating it and has made relevant commitments at the time of deregistration, the shareholder shall bear corresponding legal liability for the company’s pre-deregistration acts of infringement.If a company committing the infringement was jointly funded by a married couple during their marriage, and no proof or agreement of property division exists between them, the company’s ownership may be deemed substantively unified. Accordingly, in line with rules applicable to single-member limited liability companies, the shareholder couple may be held jointly liable with the company for the infringement-related debts.4.Typical SignificanceAs a core intellectual property asset of a business, a trademark symbolizes its market competitiveness and serves as a vital tool for distinguishing the source of goods and services, building commercial reputation, and establishing brand recognition among consumers. The protection of trademark rights lies at the heart of China’s Trademark Law and is a key aspect of intellectual property protection. It plays a critical role in fostering a sound business environment and safeguarding fair market competition. Beijing Intellectual Property Court has jurisdiction over first-instance civil cases involving the recognition of well-known trademarks within Beijing, as well as other second-instance civil trademark cases. Since its establishment, the court has adjudicated over 3,200 first- and second-instance trademark infringement cases. In adjudicating such cases, the Court has consistently applied trademark laws and judicial interpretations with rigor and accuracy, distilled judicial principles from individual cases and unified standards of adjudication, adhering firmly to the principle of “strict protection” and continuously strengthening judicial safeguards for trademark rights.The development of new technologies and new business models has posed challenges to the legal system for trademark protection. Especially in the context of the digital economy and the diversification of commercial entities, the hidden and interconnected characteristics of trademark infringement subjects have become increasingly prominent. How to correctly understand the legislative intent and legal provisions, accurately identify trademark infringement behaviors that involve novel forms and complex associations, and ensure that all types of entities maliciously engaging in infringement along the entire chain bear corresponding legal liabilities—so as to create an effective deterrent against trademark infringement—is a critical issue worthy of attention and study in the adjudication of such cases. In this respect, the present case has made a valuable exploration and provides effective solutions to difficult judicial issues such as the determination of joint infringement and the attribution of infringement liability in trademark disputes.Based on the correct identification of the trademark infringement act, the judgment in this case adopts a penetrating adjudication approach, and employs a combination of institutional measures such as piercing the veil of shareholder liability and expanding joint and several liability. These measures significantly increase the cost of trademark infringement and effectively curb full-chain infringement behaviors that exploit legal loopholes to construct “firewalls” of liability, thus preventing infringers from concealing their identity and escaping responsibility.This case made meaningful breakthroughs in the following aspects and provided substantive guidance for resolving complex issues in trademark infringement disputes.Firstly, Piercing the Corporate Veil to Address “Shell Company” Infringement. According to the basic theory of company law, each shareholder of a limited liability company shall be liable for the company to the extent of the capital contribution subscribed for by it. In intellectual property infringement lawsuits, including those involving trademark infringement, an increasing number of infringing parties have used this fundamental principle of company law as a shield to evade liability by establishing companies—sometimes even cross-border or across different jurisdictions—they provide a “legal shell” for actual infringers to escape liability. The judgment in this case creatively applies Article 20 of the Provisions of the Supreme People’s Court on Several Issues Concerning the Application of the Company Law of the People’s Republic of China (II) to clearly define the scope of liability borne by shareholders who carry out simplified deregistration of a company without liquidation during the course of litigation. During the proceedings of this case, Chen X and Wu X, the shareholders of a Guangdong-based kitchen and bath company, implemented a simplified deregistration. Although formally extinguished the company’s legal status, the judgment pierced the corporate veil by examining the correlation between the shareholders’ signed commitment letters and their undertakings to assume debt liability, thereby holding the shareholders accountable. This effectively curbed the malpractice of actual infringers maliciously deregistering companies to avoid debts, and imposed punishment on infringing acts that exploit the formation and unlawful deregistration of companies to achieve a “getaway” from liability.Secondly, establishing a judicial standard of recognizing spouse-owned companies as sole proprietorships and refining the evidentiary rules for asset commingling. When determining the liability of the defendant, the Tech Company, the court went beyond the literal interpretation of Article 63 of the Company Law of the People’s Republic of China (2018 Amendment), and, in light of the joint shareholding by the spouses and the absence of any property division, held that the entirety of the company’s equity essentially derived from a single property interest, which was jointly owned and exercised as a single property right, with the equity interest exhibiting substantive unity and alignment of economic interests, thereby construing the company as a de facto single-shareholder limited liability company, and, pursuant to the principle of asset commingling, imposed joint and several liability on both spouses—the two shareholders—for the infringing acts committed by the company. This judgment established a judicial review standard that infers asset commingling from the common origin of shareholding, thereby effectively curbing infringing conduct that seeks to evade legal liability through intricate equity structures.Thirdly, establishing a framework for joint liability among related entities to crack down on industrial-scale infringement. In response to the coordinated infringing acts conducted by five defendants across different regions and legal entities, the case adopted a comprehensive adjudicative approach combining “behavioral relevance” and “concerted intention,” which involved examining factual elements such as cross-shareholding among the entities and shared trademark usage, and further relied on evidentiary chains including trademark licensing arrangements and coordinated online-offline sales activities among the defendants, to ascertain their shared intent to commit joint infringement. The adjudicative reasoning provides valuable guidance in resolving the complex issue of establishing joint infringement across a fragmented chain of “manufacturing–sales–brand operation.”This judgment systematically applied a multi-dimensional set of legal instruments, including the Company Law, Trademark Law, and the Civil Code, and achieved three major breakthroughs in the judicial determination of trademark infringement subjects: a shift from reviewing individual entities to examining related parties, an elevation from formal compliance assessment to substantive illegality determination, and an evolution from imposing individual liability to regulating joint and several liability. This innovation in adjudicative philosophy not only enhances the judicial protection of trademark rights, but also serves as a paradigm for establishing a robust regime of strict intellectual property protection.
Case V : Copyright Infringement Dispute involving over a hundred paintings that allegedly plagiarized works including Fallen Leaves.——Determination of Copyright Infringement of Artworks1. Case InformationAppellant (the defendant in the first instance): Ye XXAppellee (the plaintiff in the first instance): Xi XX2.Basic FactsThe Plaintiff Xi XX, a Belgian painter, alleged that the Defendant Ye XX had plagiarized over a hundred paintings created since 1993 over a span of 25 years, including artworks such as Fallen Leaves to which the Plaintiff held copyright. The Beijing Intellectual Property Court, after conducting a holistic comparison of the accused infringing paintings with the 13 copyrighted artworks involved in the case, along with comparative analyses of partial element combinations and individual element analyses, concluded that the 122 accused infringing paintings exhibited substantial similarity to the 13 copyrighted artworks in terms of visual artistic effects. Consequently, the court ruled that Ye XX’s acts of creating, publishing, and auctioning the disputed paintings infringed Xi XX’s exclusive rights to the 13 copyrighted artworks, including reproduction rights, modification rights, attribution rights, and distribution rights. Accordingly, the Beijing Intellectual Property Court ordered Ye XX to cease the infringement, make a public apology, rectify adverse effects, and compensate for economic losses amounting to 5 million RMB yuan. Ye XX filed an appeal, but the Beijing High People’s Court dismissed the appeal and upheld the original judgement.3.Judgment GistTo determine whether a work of art constitutes substantial similarity, it is generally assessed through a holistic examination and comprehensive evaluation of the artistic expression embodied in the work. This process focuses on visual characteristics such as constituent elements, specific expressions and the overall visual effect, which collectively define the work’s creative manifestation. If the differences between two artworks are merely minor in their entirety to the extent that an ordinary observer would tend to overlook such distinctions unless intentionally searching for them, such works may be deemed substantially similar.When a large number of copyrighted works and allegedly infringing works are involved in the comparison, all works under dispute should be considered holistically. Meanwhile, factors such as the author’s creative history, methods, and style should be comprehensively evaluated to determine of the extent of infringement, which serves as the basis for establishing the standards for damages compensation.4. Typical SignificanceArtworks carry the cultural connotations and artistic styles of a specific era and are an important component of the cultural industry. Protecting the copyright of artworks not only safeguards and inspires creators but also is of significant importance for promoting the standardized development of the cultural and artistic sector and enhancing a nation’s cultural soft power. This case is a typical copyright infringement case which clarifies two aspects of judicial rules: Ideas and expressions in artworks should be distinguished based on creative principles and characteristics, and judgment of substantial similarity should take into account the visual imagery characteristics of artworks.First, considerations regarding the differentiation between ideas and expressions in artworks.
The first consideration is the creative principles of artworks. The creative process of artworks is a gradual process of transforming ideas into expressions. Before the final completion of artworks, authors typically engage in ideational activities such as material collection and creative conceptualization. These mental processes generally extend from before the initiation of the creative act through the entire creative journey, encompassing the author’s subjective observations of specific objects, social phenomena, and personal life experiences, as well as their individual perspectives and emotional insights. Additionally, the final artistic outcome is closely intertwined with the author’s technical proficiency, artistic vision, and aesthetic sensibilities. Through external expressions in specific forms, the author finalizes and publicizes the aesthetic imagery within their consciousness, enabling others to appreciate, evaluate, and understand their artistic attainments and aesthetic preferences through the medium of the artwork. Objectively, this process also defines the scope of expressions protected by copyright.The characteristics of artworks should also be considered. According to the definition in the Implementing Regulations of the Copyright Law, the expression of an artwork primarily lies in the artistic representation objectively presented through the organic integration of aesthetic elements such as composition, lines, colors, and forms. The artistic image of an artwork is manifested as a visual image, characterized by visual immediacy, definiteness, and visibility. Copyright protection for artistic works focuses more on the external form of expression rather than the specific depicted content, which distinguishes it significantly from the protection of literary works that places greater emphasis on the substantive written content.Second, the criteria for determining substantial similarity between artworks.In copyright infringement disputes involving artworks, determining whether there is substantial similarity between the allegedly infringing works and the copyrighted works should involve comparing whether the choices, selections,arrangements, and designs made by the author in the expression of the artworks are the same or similar. As previously mentioned, artistic works are a form of visual art, and thus the external form of expression they embody constitutes the essence of their value. While different types of artistic works may cater to audiences with varying characteristics and levels of appreciation, once an artwork is publicly disclosed, it primarily targets the general public for appreciation and evaluation.Therefore, the determination of whether two artistic works constitute substantial similarity should be based on the perspective of ordinary observers. This involves a holistic assessment and comprehensive judgment of the visual characteristics of both the copyrighted artwork and the allegedly infringing artwork. If the two works only exhibit minor differences in details that would only be noticeable to ordinary observers through deliberate searching and comparison, then it can be concluded that the works constitute substantial similarity.After the judgment took effect, the defendant voluntarily issued a public apology in Legal Daily, a Chinese newspaper, marking the resolution of a five-year, cross-border copyright dispute over artistic works. The judgment undertook a total of 303 comparative analyses between over 100 allegedly infringing artworks and the copyrighted works, examining them across multiple dimensions including compositional elements, modes of expression, and overall aesthetic effect, ensuring no detail was overlooked. On this foundation, the court conducted a comprehensive assessment of potential infringement by integrating factors such as the author’s creative history, methodologies, and stylistic idiosyncrasies. Through this process, it fastidiously demarcated the boundary between permissible artistic reference and infringing plagiarism in artworks. The judgment ultimately safeguarded the copyright rights of the Belgian artist in strict accordance with legal provisions. While providing valuable guidance for the adjudication of similar cases, the judgment also demonstrates a judicial stance of equal protection for the lawful rights and interests of foreign entities, thereby conveying the spirit of justice, transparency, and openness inherent in the rule of law.
Case VI: The First Case on Administrative litigation Involving Anti-Monopoly Review of Concentrations Between Undertakings——First Judicial Clarification of Concentrations Between Undertakings Review Standards
[Omitted]
Case VII: The First Case Involving Validity Confirmation of Data Intellectual Property Registration Certificates in an Anti-Unfair Competition Dispute——First Judicial Recognition of the Legal Effect of a Data Intellectual Property Registration Certificate1. Case InformationAppellant (Defendant in the First Instance): Yin X (Shanghai) Technology Co., Ltd. (hereinafter referred to as Yin X Company)Appellee (Plaintiff in the First Instance): Shu X (Beijing) Technology Co., Ltd. (hereinafter referred to as Shu X Company)2. Basic FactsShu X Company, having lawfully obtained authorization, collected a Mandarin Chinese speech dataset totaling 1,505 hours and registered it with a Data Intellectual Property Registration Certificate. Shu X Company sued Yin X Company for providing a 200-hour subset of this dataset without permission, alleging infringement of data property rights, copyright, trade secrets, and unfair competition, and sought damages of over RMB 700,000 yuan. The court of first instance ruled that the dataset constituted a trade secret and found Yin X Company liable for disclosing and using it unlawfully, ordering compensation of 102,300 RMB.Yin X Company appealed, arguing that the dataset had been open-sourced before the alleged conduct occurred and therefore lacked secrecy, which did not qualify as a compilation due to lack of originality, and the alleged conduct did not constitute unfair competition. The Beijing Intellectual Property Court, on appeal, held that the Data Intellectual Property Registration Certificate could serve as preliminary evidence of Shu X Company’s lawful acquisition and property interest in the dataset. However, since the dataset was publicly available, it did not meet the criteria for trade secret protection. Furthermore, the dataset’s selection and arrangement lacked originality and did not constitute a compilation.Nonetheless, Shu X Hui X Company invested significant technology, capital, and labor in collecting and organizing the data, resulting in commercially valuable entries that conferred competitive advantages and business opportunities. These interests deserved protection under the Anti-Unfair Competition Law. Yin X Company failed to follow the terms of the open-source license, violated commercial ethics, harmed Shu X Company ’ s interests and the competitive market order, and thereby committed an act of unfair competition under Article 2 of the Anti-Unfair Competition Law. The appellate court corrected the erroneous finding on trade secrets but upheld the lower court ’ s compensation ruling and dismissed the appeal.3.Judgement GistThe Data Intellectual Property Registration Certificate may serve as preliminary evidence of a data holder’s proprietary interest in the dataset and of the dataset’s lawful origin and collection. Without the data holder’s consent, no party may publicly disseminate a dataset lawfully and substantially collected by the holder. Where a data holder has open-sourced a dataset, whether a user complies with the license terms is a critical factor in assessing whether the use violates commercial ethics in the data services field.If the dataset is publicly available and features original selection or arrangement of content, it is preferably protected as a compilation under copyright law. If the dataset is not readily accessible to those in the relevant field, it may be protected as a trade secret. If the dataset is public and lacks originality in its selection or arrangement, it does not qualify for copyright or trade secret protection, but may be protected under Article 2 of the Anti-Unfair Competition Law depending on the circumstances.4.Typical SignificanceAs the digital economy becomes deeply integrated into production and daily life, data is increasingly recognized as a core production factor. Efficient circulation and secure protection of data are crucial for stimulating market innovation. The data registration system, by standardizing the registration of rights related to data ownership, processing, and commercialization, lays the groundwork for the market-based allocation of data resources. On one hand, it uses public disclosure and credibility mechanisms to clarify rights boundaries, reduce verification costs and legal risks in data transactions, and provide a “base map ” for cross-industry and cross-regional data flows. On the other, it recognizes and protects legitimate input by data processors, incentivizing real innovation in data collection, cleaning, and labeling, thereby promoting the transformation of data from a “resource” into an “asset.” This case is the first in China to examine the legal effect of a Data Intellectual Property Registration Certificate. The appellate judgment, guided by the policy directive in the “Opinions of the CPC Central Committee and the State Council on Establishing a Data Infrastructure System to Better Leverage the Role of Data as a Production Factor ” (the “ 20 Measures on Data ” ), which calls for “ exploring new approaches to data property rights registration,” responds to the regulatory needs of the data registration regime through judicial innovation, establishing a legal foundation for the healthy development of the data element market.In recent years, the Beijing Intellectual Property Court has handled a diverse and technically complex range of data rights cases, 95% of which involved unfair competition, covering emerging disputes like data scraping, trade secret protection, and open-source data and involving AI training datasets and speech datasets. The appellate ruling in this case establishes rules for judicial protection of data rights, especially in clearly defining the legal effect of registration certificates and guiding corporate data protection strategies.First, it affirms the preliminary evidentiary effect of Data Intellectual Property Registration Certificates. Such certificates can initially prove lawful possession and source legitimacy, unless rebutted by contrary evidence. However, this recognition must be understood in three ways: (1) the certificate’s effect is case-specific and rebuttable; (2) its weight depends on the registration agency’s qualifications, review standards, and content; and (3) data holders may assert rights by other means even without registration. This balanced approach both affirms the role of registration and preserves judicial restraint.Second, it establishes a tiered path for protecting enterprise data rights based on the dataset ’ s legal nature. Datasets with original selection or arrangement are protected by copyright law; non-public datasets meeting trade secret criteria fall under relevant unfair competition provisions; and public datasets lacking originality but involving substantial input may be protected under Article 2 of the Anti-Unfair Competition Law. In this case, although the dataset did not qualify as a trade secret due to its public nature, the court recognized Shu X Company’s lawful investment and certificate-based proof, and penalized Yin X Company’s breach of the open-source license under the unfair competition framework, establishing boundaries for “ethical use and respect for prior investment” in the use of public data.Third, it strengthens regulatory constraints on the circulation of open-source data. The ruling explicitly states for the first time that users must strictly comply with open-source license terms, and unlicensed commercial use constitutes unfair competition. This rule addresses the tension between free use and rights protection in an open-source context and establishes clear expectations for enterprises to unlock data value through open-source licenses by affirming that legitimate open-sourcing does not equate to relinquishing rights, while emphasizing that unauthorized commercial exploitation in violation of the agreement terms will still incur legal liability.This case marks a transition in China toward coordinated governance through data rights registration and judicial protection. It provides clear behavioral guidance for data processors and signals to the market that the development and utilization of data must occur within the rule of law. Legitimate rights are protected, and violations carry consequences. With continued accumulation of such judicial principles, China’s data element market is poised to develop into a legally regulated environment where “ registration has standards, transactions have legal grounds, and disputes have solutions,” laying a strong foundation for high-quality growth in the digital economy.
Case VIII: “FL218” Corn Plant Variety Right Invalidity Administrative Dispute——Clarifying Novelty, Specificity Standards and Burden of Proof in Plant Variety Invalidity Procedures1. Case InformationPlaintiff: Hui X Seed Industry Co., Ltd. Of ZunYi city, GuiZhou Province. (hereinafter referred to as Hui X Company）Defendant: The Reexamination Board for New Varieties of Plants, Ministry of Agriculture and Rural Affairs (hereinafter referred to as The Reexamination Board for New Varieties of Plants)Third Party: Hubei Kang X Seed Industry Co., Ltd.2. Basic FactsThe disputed variety in this case is a new corn variety named “FL218” for which Company K holds the plant variety rights. Hui X Company filed a request for invalidation with the Reexamination Board for New Varieties of Plants, which made the decision to maintain the validity of the disputed plant variety right. Hui X Company disagreed and filed an administrative lawsuit with the Beijing Intellectual Property Court, arguing that the disputed variety is the same as the parent varieties of several approved corn varieties, such as “Eyu 16” and that prior to the application date, the disputed variety had already been widely produced and sold, and was used as a parent to breed other corn varieties. The other varieties bred from it were also widely produced and sold, thus the involved variety had lost its distinctness and novelty, therefore the decision was incorrect. Furthermore, the Reexamination Board for New Varieties of Plants did not accept Hui X Company’s application to identify that the disputed variety and other varieties ’ parent plants were the same variety, claiming procedural violations. After hearing the case, the Beijing Intellectual Property Court found that the procedures were not improper, and the conclusion of the decision was correct, thus dismissing Hui X Company ’ s claim. Hui X Company appealed, and the Supreme People’s Court made a final ruling, dismissed the appeal and upheld the original judgment.3. Judgement GistThe examination of the novelty of a new plant variety involves determining whether the variety was sold or promoted prior to the application date. The act of using a variety as a parent to breed hybrids does not constitute commercialization. Furthermore, commercialization activities pertain to the protected variety itself, not to hybrids bred using that variety as a parent. Therefore, the sale of hybrids, in principle, cannot be regarded as the sale of the parent variety.The examination of distinctness for a new plant variety determines whether the variety is clearly distinguishable from known varieties. In invalidation proceedings for plant variety rights, the invalidation petitioner bears the burden of proof regarding the existence of clear distinctness, and the Reexamination Board for New Varieties of Plants is not obligated to conduct investigations.4. Typical SignificanceSeeds are the “ chips ” of agriculture, and the seed industry is a core national industry that plays a crucial role in agricultural stability and national food security. Intellectual property protection in the seed industry is vital for its revitalization and prosperity, and it is an indispensable part of the intellectual property protection system. Plant variety rights, as a major component of intellectual property rights in the seed industry, focus on the protection of reproductive materials, namely seeds. It has been proven that granting exclusive rights to seeds that are clearly distinguishable from other known varieties and have not been sold or promoted before the application date—thus possessing the characteristics of specificity and novelty as stipulated in the Seed Law of the People’s Republic of China — strengthens intellectual property protection for plant varieties, providing breeders with a fair economic return for their innovative contributions. This, in turn, effectively increases breeding activity and encourages breeding innovation.In the legal system governing plant variety rights, the authorization and invalidity review of plant variety rights are key procedures. The Reexamination Board for New Varieties of Plants is the administrative authority responsible for conducting these reviews. Whether the variety applicant, the variety right holder, or the party petitioning for invalidation of the plant variety right, all may file an administrative lawsuit with the Beijing Intellectual Property Court if they are dissatisfied with the decisions made by the Reexamination Board for New Varieties of Plants.The Beijing Intellectual Property Court, as the exclusive court with nationwide jurisdiction over this type of special and “ niche ” intellectual property administrative dispute, has established a multi-disciplinary technical fact-finding mechanism led by academicians from agricultural science institutions, and a specialized review system for seed industry cases. By leveraging the advantages of a specialized court, the court actively explores a judicial protection model for intellectual property in the seed industry that aligns with its unique characteristics, having heard a number of landmark administrative cases regarding plant variety right authorization and confirmation. This case is a typical example, and the judgment provides clear guidance on the standards for assessing novelty and specificity of plant varieties and the burden of proof in the plant variety invalidity process.Unlike the novelty requirement for patents, there is only one way to destroy the novelty of a new plant variety, namely through public sale or promotion in the market. This judgment starts from the intrinsic meaning of the novelty characteristic of new plant varieties and strictly adheres to the provisions of the Seed Law of the People’s Republic of China and the Regulations on the Protection of New Plant Varieties of the People’s Republic of China. It clarifies that sales and promotional activities should be accurately understood as actions that enable relevant technicians to obtain propagating materials in the market. The act of using propagating materials as parent plants to breed other hybrid varieties should not be broadly interpreted as sales or promotional activities. Furthermore, the sales or promotional activities that undermine novelty only apply to the protected variety itself, not to hybrid varieties bred using it as a parent.The “clear distinction” of a new plant variety from known varieties constitutes its distinctness. This distinctness must be scientifically demonstrated through field trial results. In this ruling, the court carefully examined the methods for proving distinctness, including the requirement to submit field test reports when applying for variety rights. It clarified that in invalidation proceedings, the party seeking invalidation bears the burden of proving that the disputed plant variety lacks distinctness, while the administrative authority is not obligated to conduct its own investigations. Simply requesting a field examination from the Plant Variety Review Board does not fulfill this burden of proof. By clarifying the allocation of the burden of proof, this decision helps standardize the review process for plant variety right invalidations.This judgment also serves as a reminder to industry participants that they must accurately understand the legal system surrounding plant variety protection. While legally protecting their innovative crops and commercial outcomes, they must also properly utilize the plant variety invalidity procedure, actively fulfilling their burden of proof, and discharging their evidentiary obligations in accordance with the law. This will help resolve disputes amicably and maintain the effective operation of the plant variety protection system, promoting the high-quality development of China’s seed industry and ensuring that the Chinese people always keep our food security firmly in our own hands.
Healthcare Preview for the Week of: June 2, 2025
Reconciliation in the Senate
Congress is back from recess this week and the focus is on the Senate’s consideration of the House-passed reconciliation bill. Much of this work will be done behind the scenes, for example ensuring that provisions are consistent with the Byrd Rule. Senate Republicans must strike a delicate balance because they only have a three-vote margin, so they will need to come to near-full consensus to pass the bill, while also maintaining enough of the original provisions for it to get through the House again. And they are still trying to get a finished product to the President’s desk by July 4.
We are still waiting for an official, complete score from the Congressional Budget Office (CBO), but expect it to be released in the next few days. The CBO score will include the interactive effects of the various policies, including updated figures for the deficit and anticipated coverage losses, both of which are likely to be higher than earlier estimates.
Senators Collins (R-ME), Hawley (R-MO), Justice (R-WV), Moran (R-KS), and Murkowski (R-AK) have spoken out against the effects of various Medicaid provisions in the bill. In contrast, Senators Johnson (R-WI), Paul (R-KY), Lee (R-UT) and Rick Scott (R-FL) have spoken out against the bill not doing enough to cut future deficits. We’ll see if the updated CBO analysis brings out more concerns from additional senators.
Senate Democrats are united in opposition to the bill. Over the weekend, Senate Minority Leader Schumer (D-NY) sent an open letter to Senate Democrats outlining their opposition – with concerns about the Medicaid and ACA changes being front and center.
While that is the focus in the Senate, the House will be in session beginning on Tuesday and is scheduled to consider the H.R. 2483, the SUPPORT for Patients and Communities Reauthorization Act of 2025 in the full House. This bill has always been bipartisan, but it has faced Democratic opposition as it moved through the Energy and Commerce Committee this year because of the broader cuts impacting mental health and substance use disorder services being pursued by the Trump Administration.
The fiscal year (FY) 2026 appropriations process also begins this week. Last Friday, the Administration released the budget in brief and additional information to fill out their “skinny budget” submission, but many details are still missing. The Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies hold a hearing on Thursday. The major health health-related considerations will not happen until later in July when the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies is scheduled to meet.
The U.S. Department of Health and Human Services (HHS) budget highlights include:
$95 billion for HHS, a $31 billion, or 25% decrease from FY 2025 levels.
$14 billion in budget authority for the new Administration of a Healthy America (AHA), which HHS estimates to be a $6 billion cut compared to the current funding levels for all the programs that will be transferred to AHA. The Budget in Brief includes an overview of all the programs from the Health Resources and Services Administration, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Office of the Assistant Secretary for Health that will now be included in AHA, but many details are still missing.
$3.1 billion in budget authority for the Food and Drug Administration, a $409 million cut compared to FY 2025 levels.
$4.1 billion in budget authority for the Centers for Disease Control and Prevention, a $550 million cut compared to FY 2025 levels.
$27.5 billion in budget authority for the National Institutes of Health, a $17 billion cut compared to FY 2025 levels.
$3.5 billion in budget authority for the Centers for Medicare & Medicaid Services, a $673 million cut compared to FY 2025 levels.
Today’s Podcast
In this week’s Healthcare Preview, Debbie Curtis joins Maddie News to discuss forthcoming CBO scores and what the Senate margin means for ongoing reconciliation discussions.
Chemical Policy Crossroads: MAHA Report’s Assessment Calls for Reform Amid Deregulatory Trends
In response to President Trump’s February 13, 2025, Executive Order (EO) 14212, “Establishing The President’s Make America Healthy Again Commission,” the White House issued part of what is being called “The MAHA Report” (with MAHA an acronym for Make America Healthy Again), entitled “Make Our Children Healthy Again: Assessment” (the Assessment) on May 22, 2025. Section One of the Assessment, “The Shift to Ultra-Processed Foods,” includes the Commission’s thoughts on the U.S. agricultural system, food additives, food industry regulation, and government food programs, while Section Two of the Assessment, “The Cumulative Load of Chemicals in our Environment,” includes its take on chemical exposures and pathways, corporate influence, and highlights some top concerns. The Assessment’s core messages add yet another element of business uncertainty that chemical stakeholders would be wise to note.
Section Two calls upon the public and private sectors, but especially the National Institutes of Health (NIH), to enhance understanding of the cumulative effects of multiple exposures on children’s health. Specifically, it highlights concerns related to:
Per- and Polyfluoroalkyl Substances (PFAS);
Microplastics;
Fluoride;
Electromagnetic Radiation (EMR);
Phthalates;
Bisphenols; and
Crop Protection Tools (including pesticides, herbicides, and insecticides).
The Assessment’s call-out of fluoride is particularly notable, citing studies that suggest a correlation between fluoride exposure and reduced intelligence quotient (IQ) scores in children. Some of the cited studies have been criticized for methodological flaws, misinterpretations, and incorrect understandings of key scientific fields. For instance, a systematic review and meta-analysis published by the American Medical Association in JAMA Pediatrics in January 2025 found an inverse association between high levels of fluoride exposure and children’s IQ scores, but the authors acknowledged limitations in the data and cautioned against drawing definitive conclusions or — perhaps most importantly — applying the findings to the U.S. population. The authors note that none of the included studies were conducted in the United States (45 of the 74 studies were conducted in China, where fluoride levels are generally higher than those in the United States), and the study does not account for the impact of other factors — including socioeconomic status — that might be expected to influence the findings.
Regarding pesticides, the Assessment specifically names chlorpyrifos, atrazine, and glyphosate as examples presenting notable risks from modern agricultural production methods. Section One of the Assessment spends much time on the problems said to be associated with the modern U.S. food production system: ultra-processed foods (UPF), nutrition, and typical industry practices. The result is disproportionate risks from the American diet compared to other Western countries, such as France or Germany. Like the fluoride example, there are footnotes citing studies to raise these concerns, although the established data about pesticide residues are found to be compliant with the requirements of the Food Quality Protection Act (FQPA). The safety standard in FQPA is that there is a reasonable certainty of no harm from pesticide residues, which is contrary to the Assessment’s tone that the food supply and its components are causing widespread harm to the consuming public.
The Assessment itself states that “a large-scale FDA study of pesticide residues (2009-2017) found the majority of samples ( >90%) were compliant with federal standards. More recent data from the USDA’s Pesticide Data Program found that 99% of food samples tested in 2023 were compliant with EPA’s safety limit.” If the Assessment’s unlikely point is that the U.S. government’s own safety thresholds are too low a bar, it is never explicitly stated. Indeed, it takes extra care in Section Two to point out that U.S. farmers (and U.S. consumers) rely on these crop protection tools, and that “actions that further regulate or restrict crop protection tools beyond risk-based and scientific processes set forth by Congress must involve thoughtful consideration of what is necessary for adequate protection.” The whiplash continues in the very next paragraph, as pesticide manufacturers are specifically called out for the “corporate influence” that comes from private corporations conducting environmental toxicology and epidemiology studies.
In addition to often feeling misaligned with itself, the Assessment also appears to be misaligned with other federal agencies, particularly the U.S. Environmental Protection Agency (EPA). While the Assessment advocates for stricter controls and greater regulatory oversight of certain chemicals, it argues against key regulations in the food industry and does not address the resource constraints faced by agencies like EPA, nor President Trump’s “Unleashing Prosperity Through Deregulation” Presidential Action. Notably, on March 12, 2025, EPA Administrator Lee Zeldin announced 31 deregulatory actions, touted as “the greatest and most consequential day of deregulation in U.S. history” and reflecting a broader governmental trend toward deregulation. Yet the Assessment calls for “the current regulatory framework [to be] continually evaluated to ensure that chemicals and other exposures do not interact together to pose a threat to the health of our children.” This juxtaposition highlights a disconnect between the Assessment’s recommendations and the current regulatory climate, inviting uncertainty in the business community.
Although both Administrator Zeldin and U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. have emphasized the importance of interagency coordination, it is unclear whether the Assessment reflects broad interagency deliberations and collaboration with key regulatory bodies. The Assessment has several instances where, after extensive condemnation of the modern food system, inserted is an ode to American farmers and farming: “Farmers are the backbone of America — and the most innovative and productive in the world. We continue to feed the world as the largest food exporter.” Such accolades apparently are the sole contribution of the U.S. Department of Agriculture (USDA) during the interagency review process. This siloed approach may undermine the efficacy of the Assessment’s recommendations and their potential implementation, creating further confusion for the regulated community.
Despite EPA’s prime position to play a critical role in moving forward with many of the Assessment’s goals, it is, along with USDA, notably absent from the list of agencies that the U.S. Department of Health and Human Services (HHS) press release cite as being “on the front lines” to “act swiftly to close research gaps and drive decisive action” associated with the Assessment. What agencies made the list of “agencies [that] will lead the charge”? NIH, the U.S. Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS).
Ultimately, the Assessment’s final recommendations, which it calls “Next Steps — Supporting Gold-Standard Scientific Research and Developing a Comprehensive Strategy,” is distilled into a ten-point list:
Addressing the Replication Crisis: NIH should launch a coordinated initiative to confront the replication crisis, investing in reproducibility efforts to improve trust and reliability in basic science and interventions for childhood chronic disease.
Post-Marketing Surveillance: NIH and FDA should build systems for real-world safety monitoring of pediatric drugs and create programs to independently replicate findings from industry-funded studies.
Real-World Data Platform: Expand the NIH-CMS autism data initiative into a broader, secure system linking claims, electronic health records (EHR), and environmental inputs to study childhood chronic diseases.
AI-Powered Surveillance: Create a task force to apply artificial intelligence (AI) and machine learning to federal health and nutrition datasets for early detection of harmful exposures and childhood chronic disease trends.
GRAS Oversight Reform: Fund independent studies evaluating the health impact of self-affirmed Generally Recognized As Safe (GRAS) food ingredients, prioritizing risks to children and informing transparent FDA rulemaking.
Nutrition Trials: NIH should fund long-term trials comparing whole-food, reduced-carb, and low-UPF diets in children to assess effects on obesity and insulin resistance.
Large-scale Lifestyle Interventions: Launch a coordinated national lifestyle-medicine initiative that embeds real-world randomized trials — covering integrated interventions in movement, diet, light exposure, and sleep timing — within existing cohorts and EHR networks.
Drug Safety Research: Support studies on long-term neurodevelopmental and metabolic outcomes of commonly prescribed pediatric drugs, emphasizing real-world settings and meaningful endpoints.
Alternative Testing Models: Invest in New Approach Methodologies (NAM), such as organ-on-a-chip, microphysiological systems, and computational biology, to complement animal testing with more predictive human-relevant models.
Precision Toxicology: Launch a national initiative to map gene-environment interactions affecting childhood disease risk, especially for pollutants, endocrine disruptors, and pharmaceuticals.
These recommendations, and the Assessment as a whole, coincide with President Trump’s May 23, 2025, EO 14303, “Restoring Gold Standard Science.” Once again demonstrating a lack of alignment between key players, the Assessment may not hold up to that “Gold Standard,” as even the White House acknowledges problems within the assessment (subsequently explained as “formatting issues”), and The New York Times and other news outlets report that the Assessment includes fake citations and faulty references. Many of the original 522 citations in the Assessment are reported to reference papers/studies that are mislabeled, contain incorrect publishing information, were not written by the cited author, include authors who did not work on the paper or omit researchers who had, or simply do not exist, with some correctly cited papers inaccurately summarized.
The errors have called into question the rigor of the Assessment and – given the type of errors made – led to claims that it may have been, at least in part, authored by AI. For an Assessment with a first “next step” of “improv[ing] trust and reliability in basic science,” it’s a stumble right out of the gate. The Assessment has no public authors. The White House has since uploaded a new copy of the Assessment with corrections. The MAHA Commission’s Make Our Children Healthy Again Strategy, in which it is expected to develop policy recommendations, is due in August 2025, with the White House requesting $500 million in funding from Congress to cover the cost of the MAHA initiative.
The Swiss Federal Supreme Court Bans References to Animals in Plant-based Foods
On May 2, 2025, the Swiss Federal Supreme Court ruled that designations referring to animal species are not allowed to label plant-based meat substitutes (here is the official press release, in French, 2C_26/2023). The full judgment is not yet available, so we cannot provide a more in-depth analysis of the arguments of Switzerland’s supreme judges, and the information below is based solely on the press release.
In 2021, the Zurich Cantonal Laboratory banned a company from labelling its pea protein meat substitutes with names referring to animal species; the company appealed this ban, and the Administrative Court of the Canton of Zurich decided in its favor in 2022, allowing the use of references to animal meat in its products. However, in its judgment of May 2, 2025, the Federal Supreme Court upheld the appeal filed by the Federal Department of Home Affairs, annulling the first instance decision of the Zurich Administrative Court and thus ruling against the company.
According to the press release, food products destined for consumers made exclusively with vegetable proteins (i.e., those usually defined as ‘plant-based meat’) cannot be designated by names of animal species, even if these are accompanied by an indication specifying the vegetable origin of the product, such as ‘planted chicken,’ ‘chicken-like,’ ‘pork-like,’ ‘vegan pork,’ or ‘vegan chicken.’ In fact, the term ‘chicken’ refers to poultry; therefore, it cannot be used for products that do not contain a meat component, as it would be misleading for consumers. In other words, plant-based products alternative to meat must be labelled in such a way as to enable the consumer to recognize the type of foodstuff and to differentiate it from products that they aim to substitute.
BETO Updates 45ZCF-GREET Model to Incorporate New Methods of Alternative Fuel Production
On May 30, 2025, the U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced that it “removed barriers to domestic bioenergy production by updating its 45ZCF-GREET modeling tool to account for new feedstocks and methods of production, including ethanol from corn wet-milling and natural gas from coal-mine methane.” According to BETO, these measures will allow a wider range of farmers and companies to do business in the alternative fuels market. BETO notes that the U.S. Department of the Treasury adopted the 45ZCF-GREET model to help transportation fuel producers assess their eligibility for 45Z, also known as the Clean Fuel Production Credit, a provision in the Internal Revenue Code that provides tax credits for the production of certain clean transportation fuels. The latest GREET® (Greenhouse gases, Regulated Emissions, and Energy use in Technologies) model, updated user manual, and a log of all changes are available online. For questions on how to use the model, contact [email protected].