Johns Hopkins Sues Labcorp Over a Digital Karyotyping Patent.

The complaint

The case is The Johns Hopkins University v. Laboratory Corporation of America Holdings, No. 1:26-cv-04566-ABA (D. Md.). Johns Hopkins filed the complaint on October 30, 2026. The docket assigns the case to Judge Adam B. Abelson, lists the cause as patent infringement under 35 U.S.C. 271, and records a jury demand by the plaintiff. The complaint demands a jury on all issues so triable under Rule 38 of the Federal Rules of Civil Procedure.

The complaint describes Johns Hopkins as a Maryland not-for-profit corporation with its principal place of business in Baltimore, Maryland, and Labcorp as a Delaware corporation with its principal place of business in Burlington, North Carolina. It alleges that Labcorp maintains places of business in the District of Maryland, including in Baltimore. It alleges subject matter jurisdiction under 28 U.S.C. 1331 and 1338(a). It alleges that venue is proper under 28 U.S.C. 1400(b) and/or 28 U.S.C. 1391(b) and (c) because Labcorp has a permanent and continuous presence in the district, has committed acts of infringement there, and maintains regular and established places of business there.

What U.S. Patent 7,704,687 covers

The complaint alleges that the USPTO issued U.S. Patent 7,704,687, titled Digital Karyotyping, on April 27, 2010, and that Johns Hopkins is the assignee of the entire right, title, and interest in the patent, including the right to sue for and recover damages for infringement. The issued patent names The Johns Hopkins University as assignee. It was filed on November 13, 2003, as application 10/705,874, and states that, subject to any disclaimer, the term is extended or adjusted under 35 U.S.C. 154(b) by 1063 days. The complaint alleges that the patent was valid and enforceable at all times before it expired on October 11, 2026.

U.S. Patent 7,704,687 covers a method of karyotyping a genome of a test eukaryotic cell. Claim 1 covers sequencing a population of pieces of that genome to provide their nucleotide sequence, matching those pieces in silico to genomic locations using the nucleotide sequence of the pieces, counting the pieces within windows of a selected size throughout the genome to determine the number of pieces as a function of genomic location, where each window comprises a plurality of genomically clustered pieces, and comparing the number of pieces enumerated within each window for the test eukaryotic cell to the average number of pieces in windows of the selected size throughout the genome to obtain piece densities per window, which represent the karyotype of the genome of the test eukaryotic cell. Claim 23 covers the method of claim 1 or claim 9 and adds comparing piece densities per window for the test eukaryotic cell to piece densities of a reference eukaryotic cell. The complaint alleges infringement of one or more claims, including at least exemplary claims 1 and 23, literally and/or under the doctrine of equivalents.

The accused tests

The complaint alleges that Labcorp, itself and/or through its subsidiaries and affiliates, makes, uses, and commercializes noninvasive prenatal tests, and it names three accused products: MaterniT 21 PLUS, MaterniT GENOME, and GENOME-Flex. It alleges that a company Labcorp later acquired launched MaterniT 21 PLUS on or around October 17, 2011, and MaterniT GENOME on or around July 13, 2015, and that Labcorp acquired that company, including the accused tests, on or around July 27, 2016. The complaint alleges that GENOME-Flex launched in 2019. It alleges that Labcorp offers GENOME-Flex only as an add-on to a previously performed MaterniT 21 PLUS test, re-sequencing the saved specimen through the same genome-wide MaterniT GENOME analysis, using that test's deeper sequencing, when anomalies are suspected later in the pregnancy, such as on ultrasound, typically without a redraw, and with results in approximately 72 hours. It alleges that the analysis reports copy-number gains and losses of 7 Mb or larger across every chromosome, together with seven clinically relevant microdeletions smaller than 7 Mb.

The complaint alleges that the accused tests analyze cell-free DNA circulating in maternal plasma, including DNA shed from fetal and placental cells, and that they screen the fetal genome for chromosomal abnormalities. It alleges that Labcorp describes MaterniT 21 PLUS as detecting chromosomal abnormalities including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome), with optional screening for sex chromosome aneuploidies and clinically relevant microdeletions such as 22q (DiGeorge syndrome), and that MaterniT GENOME reports on every chromosome, including any trisomy or monosomy, sex chromosome abnormalities, and partial (subchromosomal) chromosome abnormalities. It alleges that the tests determine a fetal karyotype by dividing a genome into small DNA pieces drawn from across the genome, mapping those pieces to specific chromosomal locations, counting the pieces that fall within windows across the genome, and comparing those counts to detect chromosomal gains and losses such as an extra copy of chromosome 21. For claim 23, it alleges that each accused test compares the results of the counting analysis of the test sample to those of an external human reference to calculate a z-score, which is indicative of copy number variations, including trisomy and monosomy.

Count I, brought by Johns Hopkins against Labcorp, alleges direct infringement under 35 U.S.C. 271(a) by using and performing the three tests, by Labcorp itself or through its wholly owned subsidiary and agent, and by offering the tests for sale and selling them. It alleges induced infringement under 35 U.S.C. 271(b) and contributory infringement under 35 U.S.C. 271(c), including of exemplary claims 1 and 23. The complaint alleges that Labcorp directs and controls that subsidiary and the subsidiary's own wholly owned laboratory subsidiary. It cites a joint statement, made for the purposes of an earlier case against Labcorp in the Western District of Texas, No. 6:20-cv-00969, that Labcorp as parent controls both companies. It alleges, citing a declaration in that case, that all performance and analysis of the MaterniT 21 PLUS and MaterniT GENOME tests are conducted at the subsidiary's laboratories in San Diego, California, by Labcorp employees. It alleges that Labcorp has had actual or constructive knowledge of the patent since at least February 18, 2022, when Labcorp acquired the original licensee and the exclusive license the complaint calls the DK License, and actual knowledge since at least August 10, 2023, when Johns Hopkins informed Labcorp that the patent covers the MaterniT noninvasive prenatal tests. It alleges that the infringement is willful and deliberate.

The license and the alternative contract count

The complaint alleges that on June 29, 2011, Johns Hopkins entered an exclusive, royalty-bearing license to its digital karyotyping patent rights, including the '687 patent, with a Johns Hopkins faculty start-up founded in Baltimore, Maryland. It calls that contract the DK License. It alleges that the license was amended in 2015, as to consideration for sublicensing, and in 2021, as to the royalty calculation, and that the start-up used the licensed technology in its cancer tests and paid Johns Hopkins royalties under the DK License, including a minimum annual royalty.

The complaint alleges that on February 18, 2022, Labcorp acquired the start-up and, with it, the DK License, and assumed the obligation to pay royalties for use of the methods described by the patent. It alleges that Labcorp has administered the license and has continued to pay Johns Hopkins the royalties due for the start-up's cancer test, including a cell-free DNA (plasma) version of that test. It alleges, on information and belief, that the start-up no longer operates as a separate, independent business and that its operations have been absorbed into Labcorp. It alleges that Labcorp has never paid royalties on the MaterniT tests. It alleges that on July 21, 2023, Labcorp said that, after reviewing its noninvasive prenatal offerings, it did not believe the licensed patents covered its current or past noninvasive prenatal tests. It alleges that on August 10, 2023, Johns Hopkins identified the '687 patent and the accused products and said the patent covered them. It alleges that Labcorp denied infringement at a February 28, 2025 meeting, and that on May 19, 2025, Labcorp wrote that it "no longer see[s] that 'education' approach as productive" and declined further discussions.

The complaint alleges that on September 17, 2026, Johns Hopkins notified Labcorp of an intent to terminate the DK License for breach under Section 9.2. It alleges that on September 22, 2026, Labcorp wrote that it does not believe its noninvasive prenatal products practice the Digital Karyotyping patent and disagreed that it had failed to perform any obligation under the license. It alleges that Johns Hopkins terminated the license on October 5, 2026, and that since then Labcorp has had no license or other authorization from Johns Hopkins to practice any claim of the patent.

Count II, brought by Johns Hopkins against Labcorp, alleges breach of the DK License in the alternative to, and in connection with, Count I. The complaint says those allegations are pleaded in the alternative under Federal Rule of Civil Procedure 8(d)(2) and (3) and are not an admission that the license remains in effect or that any accused product is licensed. It alleges that Labcorp assumed the license obligations as the start-up's successor by operation of law, citing Md. Code Ann., Corporations and Associations section 3-114, and by expressly or impliedly assuming them. It alleges breach since at least February 18, 2022, including by failing to pay royalties under Article 3 for the three tests, and that Labcorp continued a willful breach up to and including October 5, 2026, when Johns Hopkins terminated the license under Section 9.2.

The relief requested

Johns Hopkins asks for a judgment that Labcorp has directly and/or indirectly infringed the patent. It asks for damages adequate to compensate for past infringement, no less than a reasonable royalty, together with pre-judgment and post-judgment interest, costs, and other damages under 35 U.S.C. 284. It asks for a judgment that the infringement has been willful and for enhanced damages under section 284, for a declaration that the case is exceptional and for reasonable attorneys' fees and costs under 35 U.S.C. 285, and for an accounting that includes infringing conduct not presented at trial and additional damages for that conduct. For any periods for which patent infringement damages are not awarded, it asks for a judgment that Labcorp breached the DK License and for contract damages no less than the royalties owed, with pre-judgment and post-judgment interest as allowed by law, costs, and other damages permitted by law. It also asks for costs and expenses of the action and for other relief the court deems just and proper.

What to watch next

Watch for Laboratory Corporation of America Holdings' answer or a motion under Rule 12.