Insights

On September 8, 2026, the U.S. Department of Labor's (DOL) Employee Benefits Security Administration (EBSA) issued “Field Assistance Bulletin No. 2026-03” to clarify compliance with the Mental Health Parity and Addiction Equity Act (MHPAEA) and nonquantitative treatment limitations (NQTL). Under the 2013 final rule implementing MHPAEA, health plans and issuers must use comparable processes, strategies, evidentiary standards, or other factors when applying NQTLs and they cannot apply such methods more stringently to benefits for mental health and substance use disorder (MH/SUD) compared to benefits for general medical and surgical care. While the bulletin doesn’t break much new ground on compliance, it does reaffirm existing enforcement priorities and expectations. 

In a significant and unanimous ruling, the D.C. Circuit upheld the Environmental Protection Agency’s (“EPA”) final rule designating perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”) as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), denying the petitions of seven industry groups seeking to overturn that designation.[1] CERCLA, also known as the “Superfund Statute,” allows EPA to require potentially responsible parties to fund cleanup of hazardous substances.

On July 28, 2026, the Federal Communications Commission (FCC) updated its Covered List, established through the Secure and Trusted Communications Networks Act to include foreign-produced connected power inverters and advanced robotic devices. The designation of these products to the Covered List follows an Executive Branch national security determination that they “pose unacceptable risks to the national security of the United States or the safety and security of United States persons.” Equipment listed on the Covered List is ineligible for FCC equipment authorization, effectively prohibiting the import, sale, or marketing of those products absent an exception or approval. This action comes only months after the FCC added consumer-grade routers to the Covered List on March 23, 2026 and uncrewed aircraft systems (UAS) on December 22, 2025. Taken together, these actions reflect the FCC’s increasingly expansive approach to using its authorities to guard against foreign produced connected technologies that may create vulnerabilities enabling disruption of critical infrastructure, unauthorized access to sensitive information, or cyber intrusions. The shift is a departure from the FCC’s previous focus on equipment and services produced by certain PRC and Russian companies.

On June 18, 2026, the Illinois Department of Labor took a long-anticipated step by adopting comprehensive amendments to 56 Ill. Adm. Code Part 320, the administrative rules implementing the pay transparency requirements of the Illinois Equal Pay Act of 2003 (820 ILCS 112, the Act).

The Department of War (DoW) is immediately suspending Cybersecurity Maturity Model Certification (CMMC) Phase II requirements, which had been scheduled to take effect on November 10, 2026.

On June 4, 2026, Rep. Scott Fitzgerald (R-WI-5) introduced a bill that would limit the ability of people and entities seen as threats to U.S. national security to obtain and enforce patents. If enacted, the Prohibiting Adversarial Patents Act of 2026 (H.R. 9142) would leverage use of patent law as a national security tool, with consequences for companies operating in technology-intensive sectors, including drones, telecommunications, semiconductors, artificial intelligence, and advanced manufacturing. The proposed legislation, currently under review by the U.S. House Judiciary Committee, is particularly focused on persons and entities with connections to the People’s Republic of China.

If a court finds that a patent applicant intentionally misrepresented or withheld material information from the USPTO with the intent to deceive, the consequences are severe, leading to unenforceability of the entire patent (and likely any later patents claiming priority to the unenforceable patent).

On June 17, 2026, the U.S. Department of Justice’s (DOJ( National Security Division (NSD) announced that it had issued a declination for Robert Bosch GmbH (Bosch) relating to potential violations of the Export Control Reform Act, 50 U.S.C. § 4819 (ECRA). Specifically, the DOJ declined to criminally prosecute Bosch’s violations of the Export Administration Regulations’ (EAR) Foreign Direct Product Rule (FDPR), which apparently resulted from two Bosch subsidiaries’ export of products and software manufactured with equipment that was the direct product of U.S. software or technology to Huawei Technologies Co., Ltd. and its “Entity List” affiliates, including Huawei Tech. Investment Co., Ltd., Hong Kong (collectively, Huawei). The same day, the U.S. Department of Commerce Bureau of Industry and Security (BIS) announced a parallel civil administrative settlement with Bosch.

A Kansas federal court held that inconsistent enforcement of trade secret rights can defeat a claim under the Defend Trade Secrets Act (DTSA). In Edelman Financial Engines, LLC v. Mariner Wealth Advisors LLC, No. 2:23-cv-02515-HLT (D. Kan. June 5, 2026), the court applied a selective enforcement theory, holding that when a company does not consistently pursue legal remedies against similarly situated former employees, that inconsistency can be affirmative evidence that it failed to protect its trade secrets. While the selective enforcement theory has appeared in academic hypothetical discussions, the decision appears to be one of the clearest judicial applications of a “selective enforcement” theory in a trade secret case.

On May 13, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a district court judgment of no infringement in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 24-1641. The decision offers important guidance for patent holders and generic manufacturers on the role of industry standards in interpreting scientific terminology during claim construction, prosecution history estoppel, and the disclosure-dedication rule.

The U.S. Court of International Trade (CIT) is having a big year. While the U.S. Supreme Court’s affirmance of the CIT tariff ruling may be at the top of the headlines, the CIT is also making its mark on Hatch-Waxman pharmaceutical litigation. In late April 2026, the U.S. District Court for the District of New Jersey (DNJ) reassigned numerous Hatch-Waxman patent infringement cases involving 10 different drugs to Judge Jennifer Choe-Groves of the CIT, sitting by designation in the District of New Jersey. The cases currently assigned to Judge Choe-Groves relate to several different drug products, including LYNPARZA® (olaparib), RADICAVA ORS® (edaravone), NEXLETOL®/NEXLIZET® (bempedoic acid), ZEJULA® (niraparib), QULIPTA® (atogepant), UBRELVY® (ubrogepant), CREXONT® (carbidopa and levodopa), EVRYSDI® (risdiplam), SUFLAVE® (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), and CAPLYTA® (lumateperone).

For 15 years, the question “Should we file an IPR?” was easy. The answer — almost invariably — was “yes.” High institution rates, a famously skeptical U.S. Patent Trial and Appeal Board (PTAB), and minimal downside made inter partes review (IPR) a nearly reflexive tool in the litigator’s arsenal. U.S. Patent and Trademark Office (USPTO) Director Squires’ precedential decision issued May 14, 2026, in Magnolia Medical Technologies, Inc. v. Kurin, Inc. (IPR2026-00097) provides clarity to that calculus.

On April 30, 2026, USPTO Director John A. Squires issued an updated memorandum superseding the December 4, 2025, guidance on Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs). The USPTO has also created a new position — Deputy Commissioner for Patents focusing on AI Policy, Practice, and Operations — and has welcomed longtime practitioner and private-sector AI expert Barry Schindler to this role. This alert summarizes the key updates and actionable guidance for patent applicants and practitioners.

The appropriate use of AI tools during the claims review process continues to be a major topic of debate within the health care industry — but in recent weeks, emerging litigation has inspired critics to turn their attention specifically to the technology’s application within federal health programs. On March 25, 2026, the Electronic Frontier Foundation (EFF) filed a lawsuit against the Centers for Medicare and Medicaid Services (CMS), citing the agency’s alleged failure to answer a Freedom of Information Act (FOIA) request for records the EFF believes will provide crucial insight into the design, safeguards, vendor relationships, and real-world performance of the Medicare Wasteful and Inappropriate Service Reduction (WISeR) Model, CMS’s  AI-driven prior authorization pilot program for certain Medicare services.

As prescription drug prices continue to soar in the United States, the Supreme Court recently heard the highly anticipated oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the first patent case at the Court since 2023. While the Justices did not seem motivated to make significant changes to the current standards for induced patent infringement, the stakes are high for brand and generic pharmaceutical companies, as each side continues to wrestle with the main dilemma that this case raises: What is the right balance between marketing skinny labels to engage in lawful generic competition and avoiding induced infringement liability?

On April 30, 2026, the DOJ announced the launch of the Fraud Oversight through Careful Use of Statistics initiative (FOCUS) to increase coordination between the Department and the growing host of data miners who sift through publicly available government data to identify patterns of alleged fraud. The launch of FOCUS highlights a growing trend in False Claims Act (FCA) enforcement: civilian data miners with access to public data — but no other connection to the alleged defendants — are filing almost as many qui tam complaints as company insiders.

In Constellation Designs, LLC v. LG Electronics Inc., No. 2024-1822 (Fed. Cir. Apr. 28, 2026), the U.S. Court of Appeals for the Federal Circuit distinguished between two sets of claims under a Section 101 analysis, invalidating one set as result-oriented “optimization” claims that did not recite how to achieve such optimization, but upholding the other set as patent-eligible for reciting specific configurations with defined parameters. The court also confirmed that patentees may prove infringement by combining standards-based and product-specific evidence on a limitation-by-limitation basis.

In mid-April, a bipartisan coalition of 45 State Attorneys General (AG) submitted a formal letter to the U.S. Department of Labor (DOL) expressing their collective support for a proposed rule (Improving Transparency into Pharmacy Benefit Manager Fee Disclosure, or RIN 1210-AB37), which would — if enacted — impose new disclosure obligations on pharmacy benefit managers (PBM) regulated under the Employee Retirement Income Security Act of 1974 (ERISA).

On April 6, 2026, the Centers for Medicare & Medicaid Services (CMS) published its final rule governing the Medicare Advantage (Part C) and Prescription Drug Benefit (Part D) programs for Contract Year (CY) 2027. The final rule is effective June 1, 2026, with most provisions applicable to coverage beginning January 1, 2027, and marketing and communications changes taking effect October 1, 2026. Beyond payment, the rule pursues a broad deregulatory agenda aligned with Executive Order 14192, reversing marketing and enrollment safeguards introduced in 2023 and easing documentation and reporting obligations, while introducing new program integrity requirements.

In Fortress Iron, LP v. Digger Specialties, Inc., No. 24-2313 (Fed. Cir. Apr. 2, 2026), the U.S. Court of Appeals for the Federal Circuit reaffirmed what happens when a patent incorrectly lists the true inventors, and that error cannot be corrected under 35 U.S.C. § 256(b), which requires notice and a hearing for all “parties concerned.” In Fortress, the patent owner sought judicial correction to add an inventor under § 256(b), but that inventor could not be located. Because the missing inventor qualified as a “concerned” party under the statute, the lack of notice and a hearing for that inventor made correction under § 256(b) impossible, and the patents could not be saved from invalidity.