European Court of Justice Upholds Decision Annulling Harmonized Classification and Labeling of Titanium Dioxide
On August 1, 2025, the European Court of Justice (ECJ) issued a judgment upholding the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court annulled the European Commission’s (EC) decision to classify titanium dioxide as a suspected human carcinogen. The French government and the EC appealed the decision, arguing that the court exceeded the limits of permissible judicial review of an EC decision and that the court incorrectly interpreted the concept of “intrinsic properties” as it appears in the Classification, Labeling, and Packaging (CLP) Regulation.
Background
In 2016, the competent French authority submitted a proposal to the European Chemicals Agency (ECHA) to classify titanium dioxide as a category 1B carcinogenic substance (carcinogenic to humans). In 2017, ECHA’s Committee for Risk Assessment (RAC) adopted an opinion classifying titanium dioxide as a category 2 carcinogen (suspected human carcinogen), including the hazard statement “H 351 (inhalation).” On the basis of RAC’s Opinion, the EC adopted Regulation 2020/217, implementing the harmonized classification and labeling of titanium dioxide, recognizing that the substance was suspected of being carcinogenic to humans, by inhalation, in powder form containing one percent or more of particles of a diameter equal to or less than ten micrometers (µm). The transition period for adoption of these changes ended October 1, 2021. The applicants, in their capacity as manufacturers, importers, downstream users, or suppliers of titanium dioxide, brought actions before the General Court for the partial annulment of Regulation 2020/217.
The General Court held that the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. According to the press release, in recognizing that the results of a scientific study on which it based its opinion on the classification and labeling of titanium dioxide were sufficiently reliable, relevant, and adequate for assessing the carcinogenic potential of that substance, RAC committed “a manifest error of assessment.”
ECJ Judgment
According to ECJ’s August 1, 2025, press release, the ECJ “upholds the judgment of the General Court and the annulment of the contested classification of titanium dioxide as a carcinogen.” In its judgment, the ECJ notes that although the lower court erred in finding that “it was for it to assess the appropriateness of the choice of the standard density value of titanium dioxide particles used by the RAC for the purposes of applying the Morrow calculation, it did not err in law in holding that the RAC had failed to take into account all the relevant factors in order to calculate the lung overload for the purposes of the assessment of the Heinrich study by means of that calculation.” The press release states that according to the ECJ, “even though the General Court exceeded the limits of its judicial review, the annulment of the contested classification and labelling is nevertheless justified.” The lower court “was fully entitled to hold that the RAC had failed to take into account all the relevant factors for the purposes of assessing the scientific study in question.”
As reported in our March 11, 2025, blog item, the European Union (EU) Advocate General (EU AG) recommended in February 2025 that the ECJ overturn the lower court’s decision. EU AGs are responsible for presenting, with complete impartiality and independence, opinions in assigned cases, and their opinions are non-binding.
Breastfeeding at Work Redefined: Puerto Rico’s New Code Ushers in Major Changes
Takeaways
The groundbreaking Lactation/Breastfeeding Code, signed into law 08.01.25, repeals Law 427-2000 and replaces it entirely, along with multiple other lactation-related laws.
Employees, regardless of whether part-time or full-time, are now entitled to no less than one paid hour per workday to breastfeed their child or express breastmilk, for a minimum of 12 months after returning from maternity leave.
Employers must notify all employees of their rights under the new code.
Puerto Rico has enacted a groundbreaking Lactation/Breastfeeding Code that consolidates in one statute the rights of breastfeeding employees and the responsibilities of employers across the Island.
Signed into law on August 1, 2025, through Senate Bill 476, the “Código de Lactancia de Puerto Rico” (“Code”), repeals Law 427-2000, which was amended earlier this summer. The new Code establishes, for the first time, a comprehensive public policy in favor of breastfeeding and consolidates workplace protections under a single statute.
The new Code goes beyond mere reorganization. It broadens employee entitlements, strengthens employer obligations, and introduces enhanced enforcement mechanisms — including potential civil and criminal liability for noncompliance.
A New Era of Breastfeeding Protections in Puerto Rico
The Code establishes a modernized and comprehensive framework for addressing lactation in the context of maternal and child health. It sets forth breastfeeding as a matter of public policy, acknowledges the individual’s right to choose to breastfeed, and addresses lactation in the workplace.
The Code includes interpretive mandates to guide its application. It provides that all provisions of the Code, its implementing regulations, and any complementary laws must be interpreted in the manner most favorable to the lactating mother.
To promote clarity and consistency in application, the statute includes an entire article dedicated to definitions, setting out 16 defined terms — some of which are newly introduced, while others expand on prior definitions. These include terms such as “lactating mother,” “extraction of breast milk,” “lactation room,” “full-time and part-time work,” “hygienic,” and “safe space.” These definitions are essential for interpreting the law uniformly across both the public and private sectors.
Expanded Workplace Obligations
The Code establishes obligations for both public and private employers to provide working mothers with the opportunity to breastfeed their child or express milk during a reasonable period each workday. While the period must be reasonable based on the employee’s needs, it sets a statutory minimum: the time allowed for this purpose must not be less than one hour per day and must be treated as time worked — meaning it cannot result in any reduction in pay.
This represents a notable expansion from the prior framework under Law 427-2000, as under the new Code, protections expressly expand part-time employees’ rights, who are now also entitled to no less than one paid hour per workday for lactation purposes.
Unlike the prior Law No. 427-2000, which required the presentation of a medical certificate, the Code explicitly states the use of lactation breaks cannot be conditioned on the presentation of a medical certificate. Additionally, the right to use this time applies for at least 12 months following an employee’s return from maternity leave, with the possibility of further extension by employer policy or mutual agreement.
Finally, the Code reiterates the prohibition of retaliation against employees for exercising their rights, including any form of discipline, demotion, negative evaluations, shift changes, or termination based on the use of lactation time.
Infrastructure and Policy Updates
Every employer is now expressly required to provide a dedicated lactation space that meets specific minimum standards. This space must:
Not be a restroom; and
Be equipped with a locking door, seating, electric outlets, refrigeration for limited use of storing breastmilk, and access to water.
These requirements also apply to government buildings, public schools, the University of Puerto Rico, malls, airports, and service centers with significant foot traffic. Private institutions of post-secondary education are also covered.
Existing employer policies should be reviewed and updated accordingly and be clearly communicated to all employees.
Application to Unionized Private-Sector Employees
The Code explicitly allows collective bargaining agreements in the private sector to expand upon the rights it establishes. However, no collective bargaining agreement may reduce or waive the minimum rights and protections established under the Code. This preserves unions’ ability to improve conditions for their members while safeguarding the baseline rights afforded by statute.
Enforcement and Penalties
The Code significantly strengthens enforcement compared to Act 427-2000 by introducing administrative, civil, and criminal penalties for violations. The Office of the Women’s Advocate and the Department of Labor now share authority to investigate and prosecute noncompliance, with regulations to be issued outlining procedures and fines.
Coordination with Federal Law: The PUMP Act and PWFA
In addition to the requirements imposed by Puerto Rico’s new Code, employers must ensure compliance with federal workplace protections, particularly the Providing Urgent Maternal Protections for Nursing Mothers Act and the Pregnant Workers Fairness Act.
Puerto Rico employers should ensure their policies and facilities comply with both local and federal standards, particularly when federal law offers broader protection or covers workers not protected under local law (e.g., interstate employees or remote workers based outside Puerto Rico).
Next Steps for Employers
In light of this major legislative change, employers in Puerto Rico should take prompt action to ensure compliance. Employers should:
Review and revise internal policies, employee handbooks, and collective bargaining agreements to reflect the new Code;
Inspect and, if necessary, upgrade workplace facilities to meet the physical requirements for lactation rooms;
Provide written notice to all employees of their rights under the new law;
Train HR teams, managers, and supervisors to ensure they understand and respect the protections provided by law; and
Consult with legal counsel regarding eligibility for tax incentives.
This significant legislative shift requires immediate attention from employers operating in Puerto Rico.
Trump Sends Letters to Manufacturers Regarding Most-Favored-Nation Executive Order Requirements
In follow-up to the May 12th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for manufacturers to provide the United States with most-favored-nation pricing for drugs.
The Executive Order gave manufacturers 180 days to negotiate most-favored-nation drug pricing terms with the Department of Health and Human Services (HHS) before the Attorney General and the Chairman of the Federal Trade Commission (FTC) can bring enforcement action against manufacturers for anti-competitive practices. The Executive Order also warned manufacturers that the HHS Secretary and heads of other agencies would consider alternative measures to compel manufacturers to modify drug prices if “significant progress toward most-favored-nation pricing for American patients [was] not delivered.” These measures include, but are not limited to, issuing rulemaking to impose most-favored-nation pricing, certifying to Congress that importation is a viable drug cost-reduction strategy, and modifying or revoking existing drug approvals.
Lack of Progress in Most-Favored-Nation Pricing Negotiations
It appears that manufacturers have not made significant progress towards negotiating the most-favored-nation drug pricing terms. The Letters make clear that President Trump and his Administration are not satisfied with the responses received from manufacturers to date. Specifically, Trump states that the manufacturers’ proposals are primarily “shifting blame and requesting policy changes that would result in billions of dollars in handouts to industry.” In response to the stalled negotiations, President Trump further articulates the Administration’s expectations, stating it will only entertain manufacturer proposals that result in “immediate relief from vastly inflated drug prices” that disadvantage patients in the United States.
In an effort to move the ball forward, the Letters require manufacturers to take the following actions by September 29, 2025:
Provide most-favored-nation pricing for all drugs within such manufacturers’ portfolio to all Medicaid patients;
Enter into a contract with the United States to provide most-favored-nation pricing for newly launched drugs to Medicare, Medicaid, and commercial payers.
Enter into a contract with the United States whereby such manufacturer agrees to repatriate increased revenue earned abroad to lower drug prices for United States patients and taxpayers.
Participate in direct-to-consumer and/or direct-to-business distribution models for high-volume, high-rebate prescription drugs to enable all United States patients to obtain drugs at the lowest cost.
Scope of the MFN Executive Order Requirements
The Letters also seem to narrow the scope of the most-favored-nation pricing requirements. While the Executive Order left ambiguity around its intended applicability, the Letters suggest the most-favored-nation pricing would be limited to (i) drugs used by Medicaid patients across a manufacturer’s portfolio, and (ii) newly launched drugs used by patients whose prescriptions are paid for by Medicaid, Medicare, and commercial payers.
Notably, and in contrast with the narrowed scope of the September 29th requirement for most-favored-nation pricing, the applicability of the direct purchasing requirement is even less clear. The Letters suggest that the September 29th direct purchasing requirement will apply to manufacturers and payers across the board, but only for “high volume, high rebate prescription drugs.” The Letters are silent as to what would be considered the threshold for “high volume” and/or “high rebate” prescription drugs and also fail to clarify who would be entitled to make this determination.
Conclusion
The Letters offer insight into the challenges the administration faces in its efforts to compel manufacturers to change drug pricing practices in a way that lowers costs for United States patients. President Trump emphasizes that the Administration is prepared to “deploy every tool in [its] arsenal to protect American families from continued abusive drug pricing practices.”
Nonetheless, a critical question remains unresolved: what authority, if any, does the Trump Administration have to implement the most-favored-nation requirements without Congressional action?
Although the Letters appear to narrow the scope of the May 12th Executive Order mandates, we expect manufacturers to continue to resist and challenge these requirements.
Illinois Bans AI Therapy, Preserves Human Oversight in Care
On August 4, 2025, Illinois Governor JB Pritzker signed the Wellness and Oversight for Psychological Resources Act into law, which went into immediate effect, and “prohibits anyone from using AI to provide mental health and therapeutic decision-making, while allowing the use of AI for administrative and supplementary support services for licensed behavioral health professionals.” The Act passed each chamber of the Illinois General Assembly before being signed by Governor Pritzker.
The law is designed “to protect patients from unregulated and unqualified AI products, while also protecting the jobs of Illinois’ thousands of qualified behavioral health providers. This will also protect vulnerable children amid the rising concerns over AI chatbot use in youth mental health services.”
The Act comes in response to increasing reports of the risks AI chatbots pose in the mental health space. A news agency reported one example that found “an AI-powered chatbot recommended a ‘small hit of meth to get through this week’ to a fictional former addict.”
The Act does not prohibit the use of AI tools for certain tasks. It specifically allows AI tools to be used for administrative support, which includes: (1) managing appointment scheduling and reminders; (2) processing billing and insurance claims; and (3) drafting general communications related to therapy logistics that do not include therapeutic advice. It also allows the use of AI tools for supplementary support in the provision of mental health services, as long as the licensed professional “maintains full responsibility for all interactions, outputs, and data use associated with the system.”
Prior to using an AI tool for supplementary support in therapy, the licensed professional is required to provide written notice to the patient that AI will be used, the purpose for the use of an AI tool, and obtain? consent to the use of AI during the therapy session. The Act further prohibits a licensed professional from using AI to “(1) make independent therapeutic decisions; (2) directly interact with clients in any form of therapeutic communication; (3) generate therapeutic recommendations or treatment plans without review and approval by the licensed professional; or (4) detect emotions or mental states.”
The Act does not apply to those providing religious counseling, peer support, or self-help materials and education resources available to the public that “do not purport to offer therapy or psychotherapy services.”
The Act provides the Illinois Department of Financial and Professional Regulation with enforcement authority to investigate violations and levy a fine against violators of up to $10,000 per violation.
Montana Expands Workplace Protections for Employees Holding Public Office
Key Highlights:
Montana passed HB 667 amending the state’s law requiring employers to provide unpaid leave, not to exceed 180 days per year, for employees holding public office.
On May 19, 2025, Montana passed HB 667 amending Montana’s law requiring leave for employees holding public office. HB 667 became effective upon passage and applies retroactively to January 1, 2025.
Montana law (M.C.A. § 39-2-104) requires that employers of employees elected or appointed to public office provide those employees with up to 180 days of leave per year for public service. Employers with ten or more employees must restore the public office holder to their position including the same “seniority, status, compensation, hours, locality, and benefits,” that they maintained prior to their leave of absence. An employee on leave must make arrangements to return to work within 10 days following the completion of their service, unless the employee is unable to do so because of illness or disabling injury as confirmed by a physician.
HB 667 made several important amendments to the law:
Employers may not prohibit or restrict employees from seeking election or appointment to a public office or discriminate or retaliate against any employee for seeking election or appointment.
Employers must continue health care benefits during the leave.
While the employee is on leave for public service, the employer cannot require the employee to use other leave or benefits without the employee’s consent
Employers cannot require an employee to perform work while on leave.
Employers may not prohibit an employee on leave from using an employer provided phone, computer, or phone number, if the employer otherwise permits the personal use of such items.
Rhode Island First in Nation to Require Accommodation of Employee’s Menopause, Effective Immediately
Rhode Island is the first state to expressly require employers to provide workplace accommodations for job applicants and employees who are experiencing menopause and menopause-related medical conditions. This requirement went into effect immediately upon the Governor’s signature on June 24, 2025.
The new protections for menopause-related conditions were passed as an amendment to the law that requires employers to provide accommodations for pregnancy-related conditions.
Rhode Island employers are required to engage in a timely, good-faith, interactive process to identify reasonable accommodations for employees who are experiencing menopause symptoms or related medical conditions. However, employers do not have to provide the requested accommodation if they can demonstrate that it would pose an undue hardship on their business.
The law includes a list of possible accommodations that an employer might be required to provide for an employee experiencing a pregnancy-related condition, including accommodations specifically related to pregnancy (e.g., “break time and private non-bathroom space for expressing breast milk”). However, the amendment did not add any new possible accommodations or otherwise identify accommodations specific to menopause. The law specifically mentions one menopause-related condition, “the need to manage the effects of vasomotor symptoms,” commonly known as hot flushes/flashes or night sweats.
The law also requires employers to post a notice in the workplace and provide notice to their employees.. Employers were already required to give this notice informing the employee of their right to be free from discrimination for their pregnancy or childbirth related condition, but that notice must now be updated to include menopause. Notice must be given to new employees on their first day and to any employee who notifies the employer of the employee’s pregnancy or menopause, within ten days of the employer being notified.
Rhode Island employers should review their policies and adapt their accommodation practices to the new requirements.
New York State Adopts New ‘Certificate of Need’ Regulations Increasing Minimum Financial Thresholds for Regulatory Review of Medical Facility Construction Projects
Go-To Guide:
Higher Cost Thresholds for Review: The minimum project costs triggering full, administrative, or limited regulatory review for medical facility construction have been significantly increased—doubling in many cases—streamlining approval for lower-cost or routine projects.
Expanded Expedited/Exempted Projects: More projects now qualify for limited review, written notice only, or are fully exempt from Department review, especially for routine, non-clinical, or infrastructure upgrades under $12 million.
Architectural Self-Certification: Projects up to $30 million can now bypass Department architectural review through self-certification, further accelerating the approval process for qualifying proposals.
Consolidated Applications: Facilities are now required to submit related CON applications together, improving efficiency and reducing administrative burden.
On Aug. 6, 2025, the New York State Department of Health adopted amendments to Certificate of Need (CON) regulations for medical facility construction, raising the financial thresholds that determine which hospital and Article 28-regulated facility projects require state review (10 NYCRR 701.1). These changes are intended to streamline the approval process for routine and non-clinical projects while maintaining oversight of major investments.
These newly adopted regulations are particularly relevant to New York’s general hospitals and other Article 28-regulated facilities seeking to expand and modernize their current infrastructure.
CON Process: Medical Facility Construction Regulations Overview
The Medical Facility Construction CON process applies to new construction, major renovations, and significant equipment purchases at hospitals and Article 28 facilities. It does not apply to changes in ownership or control (such changes are governed separately by the Establishment CON process). Most major projects must be reviewed by the Public Health and Health Planning Council (PHHPC) and approved by the commissioner of Health, though the recent amendments increase the minimum project costs required to trigger each level of regulatory review and approval.
Key Changes to CON Review Thresholds and Processes
Full Review (PHHPC Recommendation and Commissioner Approval Required)
For general hospitals, full review is now required only for projects costing over $60 million or more than 10% of the hospital’s operating costs (up to $150 million), up from the previous $30 million threshold.
For other Article 28 facilities, the threshold rises to projects over $20 million or 10% of operating costs (up to $30 million), from the previous $15 million.
Full review is also triggered by adding more than 10% to the facility’s bed count; introducing or modifying high-level services (e.g., cardiac surgery or organ transplants); projects exceeding administrative review cost thresholds; or any project recommended for disapproval.
Administrative Review (Commissioner Approval Only)
For general hospitals, administrative review now applies to projects costing more than $30 million but not exceeding the greater of $60 million or 10% of operating costs (up to $150 million), previously $10 million to $30 million.
For other facilities, the range is now more than $8 million but not exceeding the greater of $20 million or 10% of operating costs (up to $30 million), up from $6 million to $15 million.
Administrative review also applies to state grant-funded projects, adding or converting beds up to 10% of total, temporary bed additions, certain clinic relocations, and adding methadone or chronic renal dialysis programs.
Limited Review (Lower-Cost, Routine Projects; Abbreviated Department Review)
For general hospitals, limited review covers projects costing $30 million or less, up from $10 million.
For other Article 28 facilities, the threshold is now $8 million or less, up from $6 million.
Limited review applies to proposals such as decertifying beds or services (unless full review is required), adding services not otherwise flagged, converting beds among specified categories, relocating clinics within the same area, and operating or relocating part-time or mobile clinics.
Written Notice Only / No Department Review
Written notice is required for: correcting deficiencies under a previously Department approved plan, minor repairs or equipment purchases up to $12 million, exam room renovations, discontinuing part-time clinic sites, one-for-one equipment replacement regardless of cost, health IT projects, and limited review-eligible projects qualifying for architectural self-certification.
For non-clinical infrastructure projects (e.g., HVAC, fire alarms, roofs, elevators, parking, dietary, waste/sewage disposal, exterior upgrades), no department review or written notice is required if the cost is $12 million or less.
Architectural Self-Certification
Projects up to $30 million may now use architectural self-certification, eliminating department architectural review for these projects.
Application Consolidation
Facilities must now submit programmatically related CON applications together, rather than separately, to improve review efficiency.
New CON Thresholds: Potential Impact on New York Medical Construction Projects
These amendments double or significantly raise the cost thresholds for each level of review and expand the types of projects eligible for expedited or exempted processes. Article 28 facilities should review the new requirements before starting any construction or renovation project and consult the Department of Health with any questions.
Active Shooter Events: Why Communication and Coordination are Key for California Employers
The recent tragic attack at an office building in New York and the loss and pain felt by its survivors and those affected leave many employers wondering what more they can do to protect their employees and locations. In California, most businesses must have a comprehensive Workplace Violence Prevention Plan (WVPP) as a result of a law passed in the aftermath of an active shooter incident. Employers’ WVPPs must include numerous provisions specifically designed to prepare for that specific threat.
Two WVPP requirements are coordination and communication. Employers must “coordinate . . . the plan with other employers, when applicable, to ensure that those employers and employees understand their respective roles . . . .” Each WVPP must also contain procedures to communicate with employees, alerting them to “the presence, location, and nature of workplace violence emergencies.”
The California Division of Occupational Safety and Health (Cal/OSHA) has issued a WVPP model plan and draft proposed regulations, but neither document provides detailed recommendations on how to coordinate a WVPP with another employer or effective emergency communications. This is mostly due to the variety of business types and locations—what works for a standalone retailer will not work for an office building or a construction site. The list of “work practice controls” in Cal/OSHA’s new proposed draft regulation, which essentially mirrors the Model WVPP’s list of workplace hazards and corrections, may offer insight into what employers, especially those in dense locations such as high-rises and office buildings, should consider when coordinating efforts and determining how to best communicate a threat.
First, employers must identify their team member responsible for the WVPP, as required by law, to begin coordinating efforts. Employers should put that person in touch with their counterparts at other relevant locations. For instance, in a high-rise or office building, the relevant counterparts are likely the building manager and the security company. Security professionals often discuss a strategy of “defense in depth” or “rings” that reinforce each other and provide a bulwark if the outer rings are penetrated. In an office building, employers should coordinate with the management and security company on how they will recognize and respond to threats at the outermost ring, and how their security, such as automated security software or other security features, could send information or warnings to tenants.
Second, effective coordination requires thoughtful contingency planning. If building management and security respond to an incident by locking down elevators or exterior doors, consider how this information will reach others. If they lock the elevators and an active shooter enters a stairwell, think about how others will know, so employees can be advised of the best way to protect themselves.
Finally, in an emergency, employers’ communication needs to be simple and effectively reach employees. Communications about threats must convey the presence, location, and nature of the emergency, both to be legally compliant and practically useful. Software and hardware solutions to communicate in an emergency are available, so consider a communication solution that would work in the real world. For example, if the plan is to have the person at the front desk sound an alarm, do the hard but necessary thought-experiment of what happens if that person is unable to alert others.
Ultimately, there is no substitute for the time-consuming and mentally (and emotionally) exhausting work of preparing for what if. Employers should keep in mind that the law also requires employers to review their WVPP annually.
FDA Proposes to Extend Compliance Date for Food Traceability Rule
On August 6, 2025, the U.S. Food and Drug Administration (FDA) announced its proposal to extend the compliance date for the Food Traceability Rule by 30 months to July 20, 2028. FDA stated that the extension is needed to allow full compliance across all regulated sectors.
The final rule establishes additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods that are on the Food Traceability List. The new requirements of the rule are intended to achieve faster identification and removal of contaminated food to better prevent foodborne illnesses and death.
To achieve the full public health benefits of the rule, all covered entities of the supply chain must comply. FDA acknowledged that few entities would be able to meet the rule’s requirements by the initial January 2026 compliance date, partly because all members of the supply chain must be in full compliance in order to work with accurate data. The announcement stated that the “proposal is designed to afford covered entities the additional time necessary to ensure coordination between supply chain partners in order to fully implement the final rule’s requirements—ultimately providing the FDA and consumers with greater transparency and food safety.”
Additionally, FDA issued new tools and Frequently Asked Questions (FAQs) that address the Food Traceability Rule and help covered entities reach compliance. The rule’s webpage now has new FAQs, new examples of traceability plans, new supply chain examples, and At-A-Glance document on the rule, and new translated documents.
Keller and Heckman will continue to monitor this proposal and relay new information.
The Push and Pull of Prosecution Estoppel: How Cancelled Claims Can Affect the Scope of Non-Amended Claims
Prosecution history estoppel may narrow the scope of a claim that was unamended during prosecution, if another closely related claim is amended or cancelled during prosecution.
Background
U.S. Patent No. 8,900,294 (the ’294 patent) owned by Colibri Heart Valve LLC, claims a method for implanting an artificial heart valve. Colibri sued Medtronic CoreValve, LLC, a manufacturer of replacement heart valves, for infringement of the ’294 patent in the U.S. District Court for the Central District of California—alleging that Medtronic was inducing surgeons to perform the claimed method of the ’294 patent with Medtronic’s products.
Initially, the ’294 patent included two independent claims reciting the opportunity-for-do-over method of partial deployment: one claimed pushing out the valve from an outer sheath of the delivery apparatus, and the other claimed retracting the outer sheath to expose the valve. However, during prosecution, the examiner rejected the latter claim for lack of written description. In response, Colibri cancelled the rejected claim. The patent ultimately issued with an independent claim reciting partial deployment by pushing, and no claims expressly reciting partial deployment by retracting. The relevant limitation that was recited in the cancelled claim was “after the advancing step, partially deploying the replacement heart valve device within the patient by retracting the moveable sheath to expose a portion of the replacement heart valve device.” ’294 Patent, Cancelled Claim 39 (emphasis added). As a result, only a limitation reciting pushing out the valve remained, “after the advancing step, partially deploying a distal portion of the replacement heart valve device within the patient by pushing out the pusher member from the moveable sheath to expose the distal portion of the replacement heart valve device.” ’294 Patent at Claim 1 (emphasis added).
In the district court, Colibri only asserted induced infringement against Medtronic. Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, 23-2153, 9 (Fed. Cir. 2025). A special master resolved a claim construction dispute between the parties, adopting Medtronic’s construction that “pushing out the pusher member from the moveable sheath” meant “pressing against the pusher member with a force that moves the pusher member out of the moveable sheath.” Id. at 9-10. The district court adopted the special master’s recommended claim construction.
After claim construction both parties moved for partial summary judgment: Colibri for no invalidity, and Medtronic for invalidity and noninfringement. In its motion, Medtronic argued that prosecution history estoppel (i.e., the cancellation of claim 39) barred Colibri from asserting that under the doctrine of equivalents partial deployment and recovery of the valve is performed by retracting the sheath. Colibri, 23-2153 at 10. The district court adopted the special master’s recommendation that cancelled claim 39 and retained claim 34 (issued claim 1) were separate and distinct. Id. at 11-12. Additionally, the special master distinguished Colibri’s asserted equivalent as “not merely retraction” but instead “a combination of pushing and retracting, so the asserted equivalent . . . differ[ed] from what was set forth in the cancelled claim.” Id. at 12. Accordingly, the district court denied Medtronic’s motion for summary judgment.
During trial Medtronic filed two motions for JMOL seeking, as relevant here, judgment of no equivalents infringement on the ground of prosecution estoppel. Colibri, 23-2153 at 12. The district court did not rule on the motions. The jury ultimately found that Medtronic had induced infringement of claims 1-3 of the ’294 patent and that Medtronic had not proved those claims were invalid, and as result awarded more than $106 million in damages to Colibri. Colibri, 23-2153 at 13. After the verdict, Medtronic renewed its JMOL. In denying Medtronic’s motions, the district court rejected Medtronic’s prosecution history estoppel argument “for the same reasons set forth by the Court during summary judgment proceedings.” Id. at 13. Medtronic appealed, arguing among other things, that the district court erred in denying JMOL of noninfringement.
Issue(s)
Did the district court err in denying Medtronic’s request for judgment as a matter of law and rejecting Medtronic’s prosecution history estoppel arguments that were based on a canceled claim?
Holding
Yes. Medtronic was entitled to judgment as a matter of law of noninfringement of the ’294 patent because prosecution history estoppel narrowed the scope of an asserted claim to exclude an asserted equivalent that was recited in another claim that was cancelled during prosecution.
Reasoning
While Medtronic’s appeal challenged four rulings of the district court: (1) denial of JMOL of invalidity, (2) denial of JMOL of noninfringement, (3) denial of JMOL of no active inducement, and (4) denial of Medtronic’s motion for a new trial on damages, it was undisputed that if the denial of JMOL of noninfringement were reversed, the Federal Circuit would not need to reach Medtronic’s other challenges. Colibri, 23-2153 at 13.
The Federal Circuit applied the Ninth Circuit’s de novo standard for reviewing the district court’s JMOL decision. Colibri, 23-2153 at 13 (citing TEK Global, S.R.L. v. Sealant Systems International, Inc., 920 F.3d 777, 783 (Fed. Cir. 2019). The Federal Circuit noted that the JMOL standard itself, which regards fact issues, requires deference to the factfinder, i.e., JMOL is not to be granted unless “the evidence, construed in the light most favorable to the nonmoving party, permits only one reasonable conclusion, and that conclusion is contrary to the jury’s verdict.” Id. at 13 (citing TVIIM, LLC v. McAfee, Inc., 851 F.3d 1356, 1362 (Fed. Cir. 2017)). However, prosecution estoppel, is not a matter of fact but instead a matter of law, and is decided de novo on appeal according to Federal Circuit law. Id. at 13 (citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1367-68 (Fed. Cir. 2003)(en banc)). Applying the law to Medtronic’s appeal, while Medtronic asserted multiple grounds for challenging the district court’s denial of JMOL determination, the Federal Circuit focused only on the prosecution history estoppel argument for noninfringement, which, if reversed, would moot the other grounds.
Colibri’s Argument that Medtronic’s Prosecution History Estoppel Argument was Waived
Colibri asserted that based on a pre-trial statement, Medtronic waived a prosecution history estoppel argument in by stating “Medtronic is not pursuing the Fifth Affirmative Defense of Prosecution History Estoppel.” Colibri, 23-2153 at 14-15. This statement was made in accordance with a local rule of the Central District of California, which requires that the parties “identify any pleaded claims or affirmative defenses which have been abandoned.” L.R.16-4.6. For three reasons the Federal Circuit held that Medtronic had not waived its JMOL argument based on prosecution history estoppel. See id. at 15-16.
First, while Medtronic’s statement was poorly worded, it could reasonably be understood as Medtronic merely stating it would not repeat at trial, to the jury, an argument that was denied at summary judgment and that involved only a question of law on which no facts needed to be proved at trial. Colibri, 23-2153at 15. The Federal Circuit also acknowledged that Medtronic’s statement included that the contentions made were “based on Medtronic’s current understanding of the parties’ claims in light of the Technical Special Master’s Reports and Recommendations on Summary Judgment . . . . [and do] not constitute a waiver or concession of any aspect of Medtronic’s objections or arguments made in connection with those orders, [nor] does it constitute a waiver of Medtronic’s right to appeal the same.” Id. Medtronic also made a similar disclaimer in its trial brief.
Second, when Medtronic made its motion for JMOL, it explicitly made its prosecution estoppel argument. In response, instead of arguing Medtronic had abandoned the argument, Colibri urged the district court to reject the argument solely based on the merits. As a result, Colibri forfeited the waiver argument “by addressing the claim on the merits without also making a waiver argument.” Colibri, 23-2153at 15 (quoting Norwood v. Vance, 591 F.3d 1062, 1068 (9th Cir. 2010)).
Third, Colibri asserted the waiver defense for the first time in response to Medtronic’s renewed JMOL motion despite having the opportunity to assert the argument in response to the original JMOL motion. Additionally, even when it asserted the argument, Colibri failed to establish any prejudice resulting from the pretrial statement followed by the raising of the issue of law in connection with JMOL. The district court disagreed with Colibri’s waiver contention, and instead directly addressed the motion on the merits. The Federal Circuit also declined to find that Medtronic had waived its prosecution history estoppel argument.
The Merits of Medtronic’s Prosecution History Estoppel Argument
Medtronic argued that the district court erred in concluding that Colibri’s asserted equivalent was distinct and separate from what was recited in cancelled claim 39 and that Colibri’s cancellation of claim 39 was not a narrowing amendment. Colibri, 23-2153 at 16.
In addressing this argument the Federal Circuit began with the district court’s conclusion that the asserted equivalent differs distinctly from what was recited in cancelled claim 39. Colibri, 23-2153 at 17. Colibri argued that claim 39 did not require pushing the inner member (only retracting the movable sheath), and Medtronic’s accused infringing devices require both pushing and retracting. The district court agreed with Colibri holding that Colibri’s “asserted equivalent is not merely retraction” and the asserted equivalent differs from what was set forth in the cancelled claim. Id. at 17.
Colibri’s theory of equivalents hinged on “simple physics,” namely that a relevant artisan would understand that pushing necessarily accompanies retracting, i.e., “there’s absolutely no way to deploy the replacement heart valve without applying opposing forces, [a pushing force and a retracting force].” Colibri, 23-2153 at 17-18. Additionally, claim language in both retained claim 34 (issued claim 1) and cancelled claim 39 further indicate that the relevant artisan would know that pushing necessarily accompanies retraction. Id. at 18. As a result the Federal Circuit held that the special master and the district court were incorrect that Colibri’s asserted equivalent distinctly differed from what was set forth in claim 39 such that the substance dropped when cancelling claim 39 is quite separate from the substance of retained claim 34 (issued claim 1).
Medtronic also argued that Colibri’s cancelling of claim 39 in favor of pursuing limitations that already appeared in retained claim 34 (issued claim 1) was a narrowing amendment giving rise to prosecution history estoppel. Colibri, 23-2153 at 19-25. The Federal Circuit acknowledged that for prosecution history estoppel to apply there must be a narrowing of the claims. However, the Federal Circuit held that narrowing must not necessarily be a “purely formal matter of altering a single claim’s terms,” instead narrowing can exist (as it did here) as a substantive matter, where cancellation of a closely related claim “involving such intertwined terminology that cancelling one claim necessarily communicated that the scope of the other claim was narrowed.” Id. at 19.
The Federal Circuit reiterated its reasoning that the cancellation of claim 39 bears on what can be covered under the doctrine of equivalents by claim 1 because a relevant artisan would understand the “close basic-physics” relationship between of the cancelled and retained claims. Colibri, 23-2153 at 19. Accordingly, the Federal Circuit viewed the district court’s rationale that cancelled claim 39 and retained claim 34 (issued claim 1) were separate and distinct, as reliant on an “entirely formal point” that requires a formal claim relationship between the cancelled and allowed claim (e.g., independent and dependent). Thus, for the district court’s reasoning to justify denying estoppel, formalities must be determinative, which the Federal Circuit held were not.
The Federal Circuit pointed to governing law that “precludes making formalities determinative, to the exclusion of substantive relationships that would be understood by relevant readers.” Colibri, 23-2153 at 20. First, the Federal Circuit noted that “estoppel” is a “rule of patent construction” that requires claims be “interpreted by reference to those claims that have been cancelled or rejected.” Id. at 20 (quoting Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733 (2002)). Furthermore, this principle does not limit estoppel only to situations in which the issued, asserted claim itself was amended, instead the inquiry is the scope of the claims of the patent as a whole, pre- and post-amendment. Id. at 20-21.
Additionally, the Federal Circuit noted that a formalistic approach to the narrowing inquiry was rejected in Honeywell International Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1141-44 (Fed. Cir. 2004) (en banc). In that case, Honeywell argued that rewriting a dependent claim into independent form does not give rise to the presumption of prosecution estoppel because “the scope of the rewritten claims themselves has not been narrowed.” Colibri, 23-2153 at 22 (quoting Honeywell, 170 F.3d at 1141). However, the Federal Circuit rejected that argument, based on the Supreme Court’s decision in Festo. Specifically, a purely formalistic approach “conflates the patentee’s reason for making the amendment with the impact the amendment has on the subject matter.” Id. at 22 (Honeywell 1141-42 & n.7).
The Federal Circuit also cited further case law to support the principle that cancellation of claims for reasons related to patentability in favor of claims with a narrower literal scope has the same presumptive effect on claim limitations as amending the claims directly. Colibri, 23-2153 at 23-24. In other words, when evaluating prosecution history estoppel, claims are not addressed in isolation, considering only whether the asserted claim was amended. Id. at 23. Instead, cancellation of a prior, broader independent claim may give rise to prosecution history estoppel in relation to a narrower claim, depending on the relationship between the scopes of those claims. Id. at 23-24. For all of these reasons the Federal Circuit rejected Colibri’s contention that claim 1 itself needed to be amended for prosecution estoppel to apply.
Conclusion
The Federal Circuit determined that Medtronic was entitled to judgment as a matter of law of noninfringement of the ’294 patent, and reversed the district court’s denial of Medtronic’s motion for JMOL. Accordingly, the grant of JMOL on noninfringement mooted the remaining aspects of the appeal (invalidity, remaining noninfringement arguments, and damages).
Apart from the highlighting the importance of procedural takeaways, mainly addressing arguments believed to be waived early, often, and explicitly; this case was also instructive to patent practitioners particularly. Both in prosecution and when reviewing prosecution history, consideration should be taken when in regard to claim amendments when considering prosecution history estoppel. Specifically, consideration should be taken to how the cancellation of independent claims may affect the scope of claims that have not been amended.
Tennessee Data Privacy Law (TIPA) Effective July 1: Are You Prepared?
July 1 marked the official enforcement date of the Tennessee Information Protection Act (TIPA), the state’s comprehensive consumer privacy law. Signed into law in 2023, TIPA grants consumers specific rights concerning their personal information and regulates covered businesses and service providers that collect, use, share, or otherwise process consumers’ personal information. With all TIPA provisions now enforceable, it is important for regulated companies to understand the law’s comprehensive requirements.
Covered businesses and organizations
TIPA regulates entities that conduct business in Tennessee or produce products or services targeted to Tennessee residents, exceed $25 million in revenue, and meet one of the below criteria:
Control or process information of 25,000 or more Tennessee consumers per year and derive more than 50% of gross revenue from the sale of personal information; or
Control or process information of at least 175,000 Tennessee consumers during a calendar year.
Consumer Rights
TIPA grants consumers (Tennessee residents acting in a personal context only) the rights to confirm, access, correct, delete, or obtain a copy of their personal information, or opt out of specific uses of their data (such as selling data to third parties, using data for targeted advertising, or profiling consumers in certain instances). Companies must respond to authenticated consumer requests within 45 days, with a possible 45-day extension, and they must establish an appeal process for request denials. Controllers, which TIPA defines as companies that (alone or jointly) determine the purpose and means of processing personal information, must also offer a secure and reliable means for consumers to exercise their rights without requiring consumers to create a new account.
Company Responsibilities
Companies must limit data collection and processing to what is necessary, maintain appropriate data security practices, and avoid discrimination. Companies must provide a clear and accessible privacy notice detailing their practices, and, if selling personal information or using it for targeted advertising, disclose these practices and provide an opt-out option.
Opt-In for Sensitive Personal Information
TIPA prohibits processing sensitive personal information without first obtaining informed consent. Sensitive personal information is defined broadly and includes any personal information that reveals a consumer’s racial or ethnic origin, religious beliefs, mental or physical health diagnosis, sexual orientation, or citizenship or immigration status. Sensitive information also includes any data collected from a known child younger than age 13, precise geolocation data (i.e., within a 1,750-foot radius), and the processing of genetic or biometric data for the purposes of identifying an individual.
Controller-Processor Requirements
Processors must adhere to companies’ instructions and assist them in meeting their obligations, including responding to consumer rights requests and providing necessary information for data protection assessments. Contracts between companies and processors must outline data processing procedures, including confidentiality, data deletion or return, compliance demonstration, assessments, and subcontractor engagement. The determination of whether a person is acting as a company or processor depends on the context and specific processing of personal information.
Data Protection Assessments
Companies must conduct and document data protection assessments for specific data processing activities involving personal information. These assessments must weigh the benefits and risks of processing, with certain factors considered. Assessments apply to processing of personal data created or generated on or after July 1, 2024, and in investigations by the Tennessee attorney general, are to be treated as confidential and exempt from public disclosure without a waiver of attorney-client privilege or work product protection.
Major Similarities to CCPA
TIPA shares many similarities with the California Consumer Privacy Act (CCPA), including:
Similar consumer rights;
Contractual requirements between controllers and processors; and
Requiring data protection assessments for certain processing activities.
Affirmative Defense
TIPA provides for an “affirmative defense” against violations of the law by adhering to a written privacy policy that conforms to the NIST Privacy Framework or comparable standards. The privacy program’s scale and scope must be appropriate based on factors such as business size, activities, personal information sensitivity, available tools, and compliance with other laws. In addition, certifications from the Asia-Pacific Economic Cooperation’s Cross-Border Privacy Rules and Privacy Recognition for Processors systems may be considered in evaluating the program.
Enforcement
The Tennessee attorney general retains exclusive enforcement authority, and TIPA expressly states that there is no private right of action. The Tennessee attorney general must provide 60 days’ written notice and an opportunity to cure before initiating enforcement action. If the alleged violations are not cured, the Tennessee attorney general may file an action and seek declaratory and/or injunctive relief, civil penalties up to $7,500 for each violation, reasonable attorneys’ fees and investigative costs, and treble damages in the case of a willful or knowing violation.
Exemptions
The law includes numerous exemptions, including:
Government entities;
Financial institutions, their affiliates, and data subject to the Gramm-Leach-Bliley Act (GLBA);
Insurance companies;
Covered entities, business associates, and protected health information governed by the Health Insurance Portability and Accountability Act (HIPAA) and/or the Health Information Technology for Economic and Clinical Health Act (HITECH);
Nonprofit organizations;
Higher education institutions; and
Personal information that is subject to other laws, such as the Children’s Online Privacy Protection Act (COPPA), the Family Educational Rights and Privacy Act (FERPA), and the Fair Credit Reporting Act (FCRA).
TIPA is just one of seven laws slated to go into effect this year. With three more laws going into effect next year, companies should review and determine whether laws such as TIPA apply to them and take steps to comply now that the law is in effect.
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HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program
On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which participating drug manufacturers provide discounts to healthcare entities eligible to participate in the 340B Program.
Established under Section 340B of the Public Health Service Act, the 340B Program requires pharmaceutical manufacturers to discount the price of outpatient drugs sold to eligible safety net healthcare providers, referred to as Covered Entities (“CEs”). Traditionally, discounts under the 340B Program are applied at the time that CEs purchase the drugs from manufacturers. Under the Pilot Program, CEs would pay full price for the drug at the time of purchase and manufacturers would later pay CEs a rebate reflecting the discount under the 340B Program.
To participate in the Pilot Program, HRSA seeks applications from manufacturers whose products are on the Medicare Drug Price Negotiation Selected Drug List (“MDPNP”), which currently includes 23 drugs at various strengths and dosages. Under the Inflation Reduction Act, effective January 1, 2026, the drugs on the MDPNP are subject to pricing negotiations to lower their costs under Medicare Part D, with additional drugs to be added in future years. According to the Notice, if the Pilot Program continues, HRSA will consider expanding the Pilot Program to other drugs. Manufacturers’ applications to participate are due September 15, 2025, with approvals or denials to be issued by HRSA by October 15, 2025. The Pilot Program will begin on January 1, 2026.
HRSA also seeks comments on the Pilot Program’s structure and application process.
The Pilot Program comes in the wake of various drug manufacturers’ efforts to implement a rebate model for 340B drugs. Manufacturers argue that the rebate model allows them to more effectively verify 340B eligibility, minimize duplicate discounts, and reduce the risk of diversion or other compliance concerns. CEs counter that rebate models add significant administrative burden and cost and delay realization of 340B program savings critical to the financial health of safety net providers. HRSA blocked the rebate models, stating that the rebate models must receive approval by HRSA prior to implementation.[1] Manufacturers quickly filed multiple lawsuits against HRSA’s enforcement action, with split decisions across district and appellate courts.[2] The August 1st Notice stated that the Pilot Program is being introduced to “better understand the merits and shortcomings of the rebate model from stakeholders’ perspectives, and to inform [the Office of Pharmacy Affairs’] consideration of any future 340B rebate models consistent with the 340B statute and the Administration’s goals.”
Drug Manufacturer Application Criteria
Manufacturers’ applications must include a plan, in 1,000 words or less, for implementing their proposed rebate model and minimally address how they will comply with certain criteria outlined in the Notice, including:
All costs for data submission through an IT platform is completely borne by the manufacturer and not passed on to the CEs
60 days’ notice to CEs prior to implementation of the rebate model
Ability for CEs to order the drugs under existing distribution mechanisms and infrastructures (e.g., existing 340B accounts)
Technical assistance and customer services are provided to CEs through the IT platform and manufacturer point of contact
The IT platform is secure and the collection of data is limited to elements necessary for providing the 340B rebates
The IT platform will protect patient identifying information, consistent with HIPAA and other privacy and security laws
CEs can submit and report data for up to 45 days from date of dispense, with allowances for extenuating circumstances and other exceptions
The IT platform will have the capacity to receive data that will filter and use only the data required to effectuate the rebate
The IT platform will provide real-time reconciliation reports to inform CEs of rebate status
The manufacturer will provide periodic reports to HRSA for the agency to evaluate the program’s effectiveness
The Manufacturer will specify whether rebates are paid at the package or unit level
The Manufacturer will pay rebates to CEs within 10 calendar days of data submission
340B rebates will not be denied based on compliance concerns with diversion or Medicaid duplicate discounts
Rebates are only paid on MDPNP drugs
Requested data is limited to certain readily available pharmacy claim fields
Request for Comments
HRSA is also seeking 340B Program stakeholder comments on all aspects of the Pilot Program and specifically is interested in feedback on:
Additional flexibilities or safeguards to optimize the Pilot Program and mitigate adverse, unintended impacts on CEs
Data or reporting elements to improvement implementation and evaluation of the Pilot Program
Potential logistical or administrative implementation issues or burdens
Comments are due by August 30, 2025 and should be submitted electronically via the Federal eRulemaking Portal at https://www.regulations.gov, with reference to HHS Docket No. HRSA-2025-2025-14619.
FOOTNOTES
[1] See, e.g., Letter from HRSA to Johnson & Johnson, dated September 27, 2024.
[2] See, e.g., Eli Lilly & Co. v. Becerra, 88 F.4th 1142 (7th Cir. 2023); Sanofi Aventis U.S. LLC v. United States Dep’t of Health & Human Servs., 570 F. Supp. 3d 129 (D. Del. 2021); AstraZeneca Pharms. LP v. Becerra, 543 F. Supp. 3d 47 (D. Del. 2021); Novartis Pharms. Corp. v. Espinosa, No. 21-cv-01479 (CKK), 2021 WL 5161783 (D.D.C. Nov. 5, 2021); United Therapeutics Corp. v. U.S. Dep’t of Health & Human Servs., No. 21-cv-01686 (TSC), 2021 WL 5178834 (D.D.C. Nov. 5, 2021).