THREE RECENT UPDATES 

IP Takeaways From King & Spalding’s 2026 Medical Device Summit 

At this September’s Medical Device Summit, King & Spalding’s medical device practitioners kept returning to one message: IP risk in the device sector is no longer only a patent problem. Trade policy, AI regulation, and aggressive government enforcement now shape how device companies protect their innovations and how they enforce them. Here we highlight some of the sessions most relevant to IP teams.

Section 337: The Underused Weapon Against Copycat Imports. The panel examined the rising tide of counterfeit and substandard “copycat” device imports and the limits of traditional enforcement. ITC Section 337 investigations offer a faster, higher-leverage alternative that reaches trademark infringement, gray-market goods, trade secret misappropriation, and false advertising—not just patents. 

Trade Secrets: Particularity Is Everything. Federal trade secret litigation is rising, and the stakes can be large—one recent jury awarded $452 million in a case involving an adhesive insulin delivery device. Panelists stressed defining trade secrets with particularity, coordinating patent and trade secret positions, and using forensic exit audits, swift enforcement, and strong contractual protections across the U.S., EU, and China.

AI-Enabled Devices: Documentation Is Both Shield and Asset. The FDA’s January 2025 draft guidance recommends lifecycle documentation addressing model design, transparency, and bias. Because submissions must describe model design and its limitations, IP counsel should decide early which algorithmic details to patent, which to keep as trade secrets, and which will inevitably become public.

Tariffs and Border Enforcement: IP Is on CBP’s List. Tariffs are here to stay, and results of the Commerce Department’s September 2025 Section 232 investigation into medical devices, PPE, and consumables are expected imminently. DHS has been directed to strengthen border enforcement, explicitly including intellectual property, with CBP and DOJ coordinating through the new National Fraud Division. Enforcement planning should include exclusion orders enforced by CBP.

Prosecution Discipline and Global Exposure. Common causes of FDA deficiency letters—unclear regulatory narratives, testing gaps, and underestimated predicate differences—can later shape claim construction, so regulatory and patent teams should work from aligned technical narratives. Abroad, the EU Product Liability Directive 2024/2853 may expose sensitive technical information, and antitrust “killer acquisition” scrutiny bears on IP-driven M&A.

PharmaU on November 10, 2026. K&S is excited about its 2026 Pharmaceutical University, happening in West Philadelphia on November 10th. For more than a decade, attendees have raved about the breadth and quality of the programming at K&S's Pharma U. Attendees value the opportunity to network with colleagues from the world’s most sophisticated pharmaceutical and biotech companies as we discuss cutting-edge issues critical to lawyers, executives and managers.

Ninth Circuit Vacates Award Due to Jury Instructions Misaligned with Claims Actually Reaching Jury

In Comet Technologies USA, Inc., et al. v. XP Power, LLC, the Ninth Circuit vacated an approximately $60 million judgment in a trade secret misappropriation case between two manufacturers of computer chip components. The reversal was due to a faulty jury instruction that placed the burden on the defendant to prove that the alleged trade secrets were “readily ascertainable by proper means” despite the federal Defend Trade Secrets Act (DTSA) actually requiring the plaintiff to prove that its secrets were not readily ascertainable. The burden mismatch arose because the plaintiffs originally brought parallel claims under the DTSA and the California Uniform Trade Secrets Act (CUTSA). CUTSA includes trade secrets being readily ascertainable as an affirmative defense that shifts the burden to the defendant. The plaintiffs voluntarily dropped the CUTSA claims mid-trial to streamline the case, leaving the burden-shifting instruction to contradict the DTSA claims that actually reached the jury. The Ninth Circuit found that the error was neither invited nor harmless and remanded for a new trial on liability and damages for certain trade secrets. This case serves as a cautionary reminder that seemingly subtle differences between state trade secret statutes and the DTSA can have dispositive consequences at trial, and that failing to account for conflicting burden-allocation rules may jeopardize an otherwise successful verdict. 

Fed. Circ. Vacates Oil-Well Patent Wins, Narrows “On-Sale” Safe Harbor

In a pair of companion decisions arising from the same casing-flotation patent, the Federal Circuit erased two trial victories for NCS Multistage Inc. and, in the process, delivered useful reminders on the “same term, same meaning” presumption, the limits of reading size into a claim, and when a private sale counts as a “public disclosure” under the America Invents Act (AIA). 

In NCS Multistage Inc. v. Nine Energy Service, Inc., No. 2025-1000 (Fed. Cir. Sep. 14, 2026), the court vacated findings of infringement and no invalidity. The decision first turned on claim construction, with the court invoking the presumption that the same term appearing in different portions of a claim carries the same meaning as well as rejecting the construction of a separate term by the district court. But the most notable holding addressed the AIA’s on-sale and public-disclosure provisions. NCS had defeated a prior art challenge by arguing its own private sale predated the sale of a competing tool later that same year, but the Federal Circuit reversed holding that no reasonable jury could have found the sale to be a public disclosure. 

In the non-precedential decision NCS Multistage Inc. v. TCO Group AS, No. 2024-2379 (Fed. Cir. Sep. 14, 2026), the court left the infringement finding intact, holding that TCO could not appeal a claim construction it had argued for and that it failed to develop its contributory-infringement theory in its post-trial briefing, forfeiting the issue for appeal. The court remanded on invalidity consistent with the Nine decision. 

THREE DEVELOPMENTS WE’RE MONITORING 

Ninth Circuit Narrows DMCA Attribution Claims Against AI Coding Tools

On September 16, 2026, the Ninth Circuit affirmed dismissal of the Digital Millennium Copyright Act (DMCA) claim in Doe v. GitHub, Inc. The plaintiffs are programmers who post open-source code; they allege that GitHub Copilot and OpenAI's Codex, AI coding tools trained on public GitHub code, reproduce their code without the credits, copyright notices and license terms that came with it. The court found the programmers had standing to sue because they plausibly alleged a real risk that the tools would reproduce their code. Their claim still failed: the DMCA bars removing or altering “copyright management information” (CMI), meaning credit and licensing details, from an existing copy of a work, and the complaint itself described a tool that creates new works that never carried that information. The panel said there is no strict “identical copy” requirement, and small cosmetic changes will not protect someone who copies a work and strips its credits. But similarity alone is not enough, and the court refused to turn ordinary copyright claims into DMCA claims, which can carry statutory damages of up to $25,000 per violation. The decision narrows the DMCA as a tool against AI-generated output, but it leaves important questions open: the court took no position on whether Copilot's output infringes copyright, did not decide the plaintiffs' claim that credits were stripped during training (it was dropped as not properly preserved), and left breach-of-contract claims pending in the trial court. Our copyright team will continue to monitor DMCA developments concerning AI. 

Huawei RICO trial

The criminal trial in United States v. Huawei Technologies Co., No. 18-cr-00457 (E.D.N.Y.), is continuing after starting in early September before Judge Ann M. Donnelly. Huawei and three of its subsidiaries are charged with various offenses, including participation in a racketeering conspiracy involving acts of wire fraud, bank fraud, obstruction of justice, theft of trade secrets, money laundering, and copyright infringement. The charges are based on Huawei, per the February 2020 Superseding Indictment, “execut[ing] a scheme to operate and grow the worldwide business of Huawei and its parents, global affiliates and subsidiaries through the deliberate and repeated misappropriation of intellectual property of companies headquartered or with offices in the United Sates…for commercial use.” Specific conduct that the Indictment highlights as part of the scheme includes signing then breaking confidentiality agreements, incentivizing employees to steal competitors’ information through a bonus program, recruiting former employees of companies to gain access to their former employers’ intellectual property, and using proxies, such as professors, to gain access to nonpublic intellectual property. We will be keeping a close eye on the trial and report on any possible intellectual property implications.

The Protect College Sports Act: Status and What It Means for NIL

The Protect College Sports Act (S. 4668), led by Sens. Ted Cruz and Maria Cantwell, would set national rules for college sports. These include a five-year eligibility window, a uniform transfer policy, a revenue-sharing system, a ban on cuts to women's and Olympic sports, and a limited exemption from antitrust law for the NCAA and its member schools. The Senate passed the bill 77-22 on September 28, 2026, but its future is uncertain. House Speaker Mike Johnson has said the House will not take it up until after the midterm elections, and a December 11 government funding deadline will compete for attention. Any differences between the House and Senate versions would also have to be resolved before the new Congress convenes on January 3, after which the process would start over. For intellectual property purposes, the bill would write into federal law athletes' ability to earn money from their name, image and likeness (NIL), and it would replace today's patchwork of state NIL laws and court rulings with one national set of NIL rules. That uniformity could make NIL licensing and sponsorship deals more predictable for athletes, schools and brands. However, the antitrust exemption would limit athletes' ability to challenge NCAA rules on pay caps and NIL deal disclosure in court, and the bill does not say whether athletes are employees, so who holds bargaining power over NIL rights is still contested.