Fresh From the Bench: Latest Precedential Patent Cases
Contributed by Schwabe Williamson & Wyatt. Originally published on Patexia; republished here as part of the LexDana archive.
CASE OF THE WEEK
Actelion Pharms. Ltd. v. Mylan Pharms. Inc., Appeal No. 2024-1641 (Fed. Cir. May 13, 2026)
In our Case of the Week, the Federal Circuit affirmed a judgment that Mylar’s proposed generic hypertension drug would not infringe patents covering Actelion’s Veletri® medication. The case turned on the district court’s construction of the claim phrase “a pH of 13 or higher,” which the Federal Circuit had vacated in a previous appeal (our short write-up here) after Mylar initially stipulated to infringing. This time, the reviewing panel affirmed the lower court’s construction requiring measurement at a standard temperature of 25±2°C, and affirmed the resulting bench trial determination of non-infringement, either literally or under the doctrine of equivalents.
Actelion’s asserted patents are directed to a freeze-dried composition of epoprostenol, a compound known to be effective in the treatment of hypertension but which can rapidly destabilize in an acidic environment. As relevant here, the patents claim an epoprostenol composition “formed from a bulk solution having a pH of 13 or higher.” pH is a measure of hydrogen ion concentration expressed on a scale of 0-14, with values below 7 being considered acidic and values above 7 being considered alkaline. Because hydrogen atoms dissociate more at higher temperatures, it is known that raising a solution’s temperature can render it more acidic, lowering its pH. Here, the bulk solution of Mylar’s generic would allegedly have a pH above 13 when measured at the refrigerated temperature required for manufacture, but below 13 when measured at the “standard” temperature of 25±2°C.
ALSO THIS WEEK
Read the full summaries via the button below.
MCom IP, LLC v. City National Bank of Florida, Appeal No. 2024-2089 (Fed. Cir. May 15, 2026)
On review of a dismissal of patent claims concerning a “unified electronic banking system,” the Federal Circuit affirmed the district court’s dismissal decision on grounds sounding in patent invalidity, but reversed the lower court’s fee award and imposition of sanctions under 35 U.S.C. § 285 and 28 U.S.C. § 1927...
Bissell, Inc. v. Int’l. Trade Commission, Appeal Nos. 2024-1509, 2024-1709 (Fed. Cir. May 11, 2026)
On review of a Section 337 investigation involving certain wet dry vacuum cleaners, the Federal Circuit affirmed that Bissell had shown a domestic industry based on expert testimony that relied on source code that was not admitted as a trial exhibit. Respondent Tineco argued the ALJ erred because Bissell’s expert relied on the unadmitted source code to opine Bissell’s products practiced its asserted patent claims. The court rejected that argument and held expert testimony may be more extensive than exhibits introduced into the evidentiary record. Citing Federal Rule of Evidence 703, the court explained an expert may base an opinion on facts or data the expert was made aware of or personally observed, even if those facts are not themselves admissible. The court stated it knew of no authority requiring the relied-on materials to be admitted as exhibits for the expert’s opinion to be admissible...
Editors:
Nika Aldrich, IP Litigation Group Leader, Schwabe
Jason A. Wrubleski, Shareholder
Contributors:
Julia Davis, Associate
Jason Evans, Associate
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