Insights

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.

The Federal Risk and Authorization Management Program (FedRAMP) continues to advance its modernization agenda. On April 8, 2026, FedRAMP released RFC-0031, Updated Incident Communications Procedures for public comment. This RFC proposes replacing the current FedRAMP Incident Communications Procedures (ICP) with what FedRAMP calls “a clear set of reporting requirements … established using a modern rules-based format.” 

On April 6, 2026, the Centers for Medicare and Medicaid Services (CMS) circulated the Announcement of Calendar Year (CY) 2027 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the CY 2027 Rate Announcement) to communicate Medicare Advantage (MA) capitation rates and Parts C and D payment policies. The Rate Announcement announces decisions regarding proposals initially published on January 26, 2026, in CMS’s CY 2027 Advance Notice for MA and Part D. The following is a summary of the most significant issues in the Rate Announcement, with further details below: 

The U.S. Court of Appeals for the Federal Circuit recently decided in Bd. of Trs. of Columbia Univ. v. Gen Digital Inc., No. 2024-1243 (Fed. Cir. 2026) that the district court erred in its denial of judgment as a matter of law as to damages resulting from foreign sales of downloadable software. At Columbia University's request, the jury had been instructed that “Columbia [was] entitled to damages based on sales to customers located outside of the United States if . . . the infringing product sold to those customers was made in or distributed from the United States, even if the infringing product [was] delivered to and used by the customer outside the United States.” The court concluded as a matter of law that the software sold to Gen Digital‘s (Norton) foreign customers was made outside the United States, and therefore the $94 million in foreign sales damages could not stand.

As pharmaceutical weight-loss therapies have surged in popularity, health plans, regulators, and courts have found themselves grappling with a set of increasingly pressing and complex questions: who must cover these drugs, under what circumstances, and for whom?

Organizations facing cyber incidents increasingly encounter follow-on civil litigation alleging failures to implement reasonable security measures. In response, a growing number of states — the most recent being Oklahoma this year — have enacted safe harbor laws designed to both protect consumers and reward organizations that take a proactive, documented, and structured approach to cyber threats.

On March 23, 2026, the Federal Communications Commission (FCC) updated its Covered List—a list of communications equipment and services deemed to pose an unacceptable risk to U.S. national security or the safety and security of U.S. persons—to include consumer-grade routers produced in a foreign country, absent an exemption granted by the U.S. Departments of War (DoW) or Homeland Security (DHS). This designation effectively prohibits the import of all consumer routers that are not produced in the United States.

The National Association of Insurance Commissioners (NAIC) is intensifying its oversight of how insurers use AI — and the pace of regulatory activity shows no signs of slowing. Over the past several months, the NAIC has published a formal Issue Brief staking out its position on federal AI legislation, launched a multistate AI Evaluation Tool pilot aimed at examining insurers’ AI governance programs, and continued to expand adoption of its AI Model Bulletin across state lines. These developments continue a trend towards enhancing regulation; the NAIC adopted AI Principles in 2020 and a Model Bulletin in 2023 clarifying that existing insurance laws apply to AI systems and establishing expectations for governance, documentation, testing, and third-party oversight. That Model Bulletin has now been adopted in approximately 24 states.

False Claims Act (FCA) settlements and judgments hit record highs yet again in FY 2025, surpassing the previous record by over $1 billion and setting a new high-water mark for the number of new FCA cases filed.  These records were built both on existing enforcement priorities such as pandemic-related fraud and healthcare enforcement actions and new guidance from the Executive Branch instructing the Department of Justice to enforce its 2025 priorities including Diversity, Equity, and Inclusion (DEI), civil rights, and customs issues.  Procurement fraud, cybersecurity issues, and small business fraud also remained focal points, with significant settlements in each of those areas.  In the courts, an Eleventh Circuit decision expanded relators’ ability to use discovery to avoid dismissal under Rule 9(b), and a Ninth Circuit ruling clarified a number of customs fraud issues while applying the Supreme Court’s Schutte scienter test.  Debate over the qui tam provisions’ constitutionality continued to grow, with arguments made in multiple circuits, including an Eleventh Circuit oral argument in the appeal of the Middle District of Florida’s Zafirov decision that helped to spark the recent wave of challenges.  Crowell FCA attorneys explain these developments, trends, and what’s next for the FCA in a “Feature Comment” published in The Government Contractor.

On March 11, 2026, U.S. Patent and Trademark Office (USPTO) Director Squires issued a memorandum (2026 memo) to all Patent Trial and Appeal Board (PTAB) users titled “Additional Discretionary Institution Considerations — U.S. Manufacturing and Small Business Use of AIA Proceedings.”[1] In the 2026 memo, the director adds three new factors in determining whether to institute inter partes review (IPR) and post-grant review (PGR) proceedings.[2] The factors focus on domestic manufacturing and the use of these proceedings by small businesses.[3] The memo applies immediately to all pending IPR and PGR proceedings in which the due date for the patent owner’s discretionary brief has not yet elapsed.[4] Patent owners, petitioners with domestic manufacturing ties, and small business petitioners should take note.