Brandeis University v. Bio-Rad Laboratories, Inc.

District Court, D. Massachusetts·Decided September 10, 2026·No. 1:25-cv-12780·Unknown

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ____________________________________ ) Brandeis University, ) ) Plaintiff, ) ) ) Civil Action No. 1:25-CV-12780-AK v. ) ) Bio-Rad Laboratories, Inc. ) ) Defendant. ) )

MEMORANDUM AND ORDER ON MOTION FOR LEAVE TO FILE A SECOND AMENDED COMPLAINT

ANGEL KELLEY, D.J. Before the Court is Plaintiff Brandeis University’s (“Plaintiff”) Motion for Leave to File a Second Amended Complaint. [Dkt. 59]. Plaintiff seeks to add an incident of Defendant Bio- Rad Laboratories, Inc.’s (“Defendant”) alleged breach of its agreement with the Plaintiff, and its accompanying factual allegations. Defendant opposes the motion in part. [Dkt. 62]. Defendant agrees to add the new alleged breach, but argues adding allegations to the already pleaded claims would be futile. The Court disagrees, and accordingly, for the reasons below, Plaintiff’s Motion for Leave to File a Second Amended Complaint is GRANTED. As a result, Defendant’s Motion to Dismiss [Dkt. 47] is DENIED AS MOOT. I. BACKGROUND This action arises out of the license agreement (“Agreement”) between Plaintiff and Defendant.1 Under the Agreement, Plaintiff granted Defendant an exclusive license to certain of

1 On December 22, 2011, Plaintiff executed the Agreement with RainDance Technologies, Inc (“RDT”). RDT was acquired by Defendant on about February 11, 2017. After RDT’s acquisition, Defendant inherited the Agreement, and the parties amended the Agreement to substitute RDT. its patents (“Licensed Patents”)2 and permitted Defendant to develop products therefrom (“Licensed Products”).3 In exchange, Defendant agreed to pay royalty fees on the sale of Licensed Products, sublicense the Licensed Patents, and to employ “commercially reasonable best efforts” to produce Licensed Products for commercial sales. [Dkt. 46-1 at § 3.1, 2.2].

Defendant agreed to annually report progress or lack thereof on commercialization of Licensed Patents (“Annual Reports”). [Id. at §§ 3.1, 3.2]. Defendant also agreed to report and account for its and its sublicensees’ use or sales of Licensed Products. [Id. § 4.4, 4.5]. To verify reports, Plaintiff may, with a 14-days’ notice, audit Defendant’s books, ledgers, and records. [Id. § 4.4]. The parties shall inform each other, with reasonable promptness, when either party learns about any third parties’ infringement. [Id. at § 6.1]. To settle any such dispute, Defendant must obtain Plaintiff’s consent. [Id. at § 6.4]. Since entering the Agreement, Defendant did not pay any royalty fees, or report any sale of the Licensed Products, sublicensing, or any third-party’s infringement, including any payments to settle such a dispute. In 2024, Plaintiff learned that Defendant markets certain

products that use methods and structures similar to the Licensed Patents. Defendant allegedly avoided designating the Licensed Products to evade royalty payments. Defendant also invested in competing products even though producing the Licensed Products was commercially and technically feasible. Defendant, thus, allegedly did not exercise reasonable discretion, as Section 3.1 requires, to decide commercially reasonable best efforts to produce the Licensed Products.

2 Plaintiff jointly owns U.S. Patent No. 8,592,221, with third-party President and Fellows of Harvard College, but solely holds all rights, “including filing, prosecution, maintenance, defense, enforcement, and licensing.” [Dkt. 46 ¶ 10-11]. Plaintiff solely owns U.S. Patent No. 8,772,046.

3 Under the Agreement, Licensed Products mean: “any composition or method, the practice, development, manufacture, use, offer for sale or sale of which absent the licenses granted herein, and only for so long as absent such licenses, would, in whole or in part, infringe a Valid Claim of any Patent Right in a territory in which a Valid Claim is enforceable.” [Dkt. 46-1 at 2]. In 2024, Plaintiff also found that Defendant settled a dispute with 10X Genomics, Inc. (“10X Genomics”) for infringement of the Licensed Patents. Under the settlement terms, Defendant granted 10X Genomics an option to obtain a sublicense for the Licensed Patents. In return, Defendant allegedly received consideration. Plaintiff was, however, uninvolved and

unaware of this dispute. Plaintiff alleges this lack of involvement violates, among others, Sections 6.1, 6.3, and 6.4, which required Defendant to notify Plaintiff of the third-parties’ infringement, obtain Plaintiff’s consent before settlement, and share the proceeds. Plaintiff, therefore, invoked its audit rights under the Agreement to verify the Annual Reports, which never disclosed Defendant’s purported commercialization efforts or its litigation with 10X Genomics. Plaintiff notified Defendant, with a list of products of concern, and requested access to its records. Defendant, however, refused access. Plaintiff, thus, formally notified Defendant on November 21, 2024, of its material breaches of the Agreement under Section 9.1. On August 19, 2025, Plaintiff filed this action in Massachusetts Superior Court for Suffolk County, which Defendant removed to this Court on September 26, 2025.

On March 23, 2026, Plaintiff received from Defendant its correspondence with another third party, Quanterix, Inc. (“Quanterix”). Based on this new information, Plaintiff moved to file a Second Amended Complaint (“SAC”). Plaintiff primarily seeks two amendments. First, it adds a new breach, under Section 6.1, for Defendant’s failure to notify Plaintiff with “reasonable promptness” about Quanterix’s infringement of the Licensed Patents. This lack of timely notice and failure to take any action against Quanterix, allegedly deprived Plaintiff of its right to enforce Licensed Patents against Quanterix under Section 6.2. Defendant does not challenge this new cause of action. Second, SAC adds factual allegations to its already pleaded claims. Specifically, it alleges Defendant’s use of Licensed Patents is like Quanterix’s use, which Defendant agrees infringes upon the Licensed Patents. Defendant opposes this addition, arguing such addition would be futile to Plaintiff’s already pleaded claims of breach of the Agreement, breach of the covenants of good faith and fair dealing, and violations of Mass. Gen. Laws. Ch. 93A, § 2.

II. LEGAL STANDARD Once amended as of right, any pleading is amended only “with opposing party’s written consent or the court’s leave.” Fed. R. Civ. Proc. 15(a)(2). Where the opposing party does not consent, “[t]he court should freely give leave when justice so requires.” Id. Rule 15(a) reflects a “liberal amendment policy.” O’Connell v. Hyatt Hotels of P.R., 357 F.3d 152, 154 (1st Cir. 2004). Yet, the leave may be denied where the proposed amendment: (1) is unduly delayed, (2) is in bad faith or dilatory, (3) will cause undue prejudice, or (4) will be futile. See Foman v. Davis, 371 U.S. 178, 182 (1962). Where, as here, futility is at issue, courts inquire whether “the pined-for amendment does not plead enough to make out a plausible claim for relief.” HSBC Realty Credit Corp. (USA) v.

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Brandeis University v. Bio-Rad Laboratories, Inc., (D. Mass. 2026).

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