D. Mass. Patent Litigation Update: September 2026

This is part of a series of articles discussing recent orders of interest issued in patent cases by the United States District Court for the District of Massachusetts.

In Value Drug Company v. Alkermes, Inc. et al., No. 1:25-cv-12872-JEK, Judge Kobick granted in part and denied in part Defendants’ motion to dismiss Plaintiff’s claim that Defendants violated the Sherman Antitrust Act by defrauding the USPTO to obtain the patent at issue and thereby delaying generic competition. Defendants moved to dismiss on the ground that the Noerr-Pennington doctrine immunized their patent-enforcement conduct from antitrust liability. Plaintiff invoked the Walker Process fraud exception, which removes that immunity where the antitrust defendant obtained the challenged patent through fraud on the USPTO. To invoke the exception, Plaintiff had to allege that Defendants made materially false representations with intent to mislead the USPTO, but for which the ’499 patent would not have issued.

Specifically, Defendants filed the patent application for Vivitrol, an intramuscular naltrexone injection, in 2005. In 2009, to overcome an obviousness rejection, Defendants submitted a declaration from, Dr. Elliot Ehrich, an employee and the sole inventor, describing the formulation’s results as “unexpected.” The USPTO found the declaration persuasive and issued the patent in 2011. But Plaintiff alleged that Dr. Ehrich had co-authored a 2000 study, published in 2001, reporting similar results, and that Defendants withheld the study during prosecution.

Defendants argued that the complaint failed to plausibly allege either materiality or intent. Separately, Defendants sought dismissal of any claim for damages outside of the four-year statute of limitations.

First, the Court held that Plaintiff plausibly alleged materiality. The USPTO allegedly relied on Dr. Ehrich’s declaration to conclude that no prior art disclosed the claimed formulation and its drug-exposure results. Yet the undisclosed 2000 study allegedly used the same polymer, involved similar dosing, and produced nearly identical results. Accepting those allegations as true, the Court concluded that withholding the study while describing the results as “unexpected” plausibly satisfied but-for materiality.

Second, the Court held that Plaintiff plausibly alleged intent to deceive the USPTO. The complaint alleged that Dr. Ehrich co-authored the 2000 study, knew of its publication but failed to disclose it in the 2005 application, and nonetheless attested in 2009 that the results were “unexpected” despite the 2000 study’s nearly identical results. Given Dr. Ehrich's duty of disclosure in prosecuting the patent, the Court found that those allegations supported a plausible inference that Defendants and Dr. Ehrich deceived the USPTO with the specific intent by withholding the 2000 study and submitting contradictory 2009 declaration.

Third, the Court addressed Defendants’ separate challenge to any claim for damages falling outside the Sherman Act's four-year statute of limitations. In opposing dismissal, Plaintiff argued that it had pled facts sufficient to toll the limitations period under the doctrine of fraudulent concealment, which requires wrongful concealment, failure to discover the operative facts within the limitations period, and diligence in attempting to discover those facts. Plaintiff alleged that it could not have known of its claim until February 2023, when evidence about the 2000 study was presented at trial in Defendants’ patent-infringement suit against another generic manufacturer, Teva. The Court held that Plaintiff failed to plausibly allege diligence because the study had been publicly available since 2001 and Plaintiff could have found it years earlier through its own research into Dr. Ehrich. Additionally, the Court found that Defendants' lawsuit against Teva should have placed Plaintiff on inquiry notice no later than 2020 because the patent at issue was alleged to be invalid in the lawsuit.

Accordingly, the Court granted-in-part and denied-in-part Defendants' motion to dismiss: the antitrust claim survives, but Value Drug cannot recover damages for purchases of Vivitrol made before October 2, 2021.

In MSTM, LLC et al. v. AB SCIEX, LLC, No. 1:23-cv-11121-MRG, Judge Guzman granted-in-part Defendant’s partial motion to dismiss Plaintiffs’ Second Amended Complaint, allowing Plaintiffs’ patent infringement claim under 35 U.S.C. § 271(f) to proceed while dismissing their unjust enrichment claim. The Court also granted Plaintiffs’ motion to compel discovery of worldwide sales information.

Plaintiffs brought this action involving patents directed to mass spectrometry technology. In their Second Amended Complaint, Plaintiffs added an infringement claim under § 271(f), alleging that Defendant exported components of accused products from the United States for assembly abroad. Defendant moved to dismiss the newly added claim, arguing that Plaintiffs failed to identify the specific components exported from the United States or the foreign customers receiving them. Plaintiffs also sought discovery of worldwide sales information concerning the accused products, including revenues from associated components and services.

1. Motion to Dismiss: Patent Infringement Under 35 U.S.C. § 271(f)

The Court found that Plaintiffs’ allegations narrowly satisfied the pleading standard. Although Plaintiffs did not identify the specific exported components or their ultimate recipients, they alleged that Defendant maintained domestic manufacturing and distribution facilities, exported accused products to foreign markets, and shipped components with assembly instructions. Plaintiffs also attached product manuals identifying components of the accused devices. The Court acknowledged that a declaration on which Plaintiffs relied did not establish that components of the accused products were manufactured domestically and exported abroad. Nevertheless, the Court found that Plaintiffs’ allegations concerning domestic manufacturing, international distribution, and component shipments supported a plausible claim of infringement under § 271(f), explaining that “the standard at a motion to dismiss is plausibility not proof.”

The Court, however, expressed reservations about Plaintiffs’ ultimate ability to establish § 271(f) infringement. The Court emphasized that § 271(f) does not cover the exportation of fully assembled products and that instruction manuals alone cannot establish infringement. The Court further explained that § 271(f) does not apply to method claims. Although Defendant sought dismissal of certain challenged claims on that basis, the Court declined to dismiss them before expert discovery, recognizing that apparatus claims, unlike method claims, could support § 271(f) infringement. The Court cautioned against unnecessary discovery concerning method claims and permitted Defendant to renew its arguments at summary judgment.

2. Motion to Dismiss: Unjust Enrichment

The Court granted Defendant’s motion to dismiss Plaintiffs’ unjust enrichment claim, which the Court had previously dismissed. Because Plaintiffs offered no new allegations or arguments warranting reconsideration and conceded dismissal, the Court declined to revisit its earlier ruling.

3. Motion to Compel: Discovery of Worldwide Sales 

On Plaintiffs’ motion to compel, the Court found that worldwide sales information was relevant to Plaintiffs’ potential damages and nonobviousness theories. Defendant opposed discovery concerning foreign sales of accused products manufactured and sold abroad without an identified connection to domestic infringement. Relying on WesternGeco LLC v. ION Geophysical Corp. and Brumfield v. IBG LLC, the Court explained that damages arising from domestic infringement may account for certain foreign activities. The Court also found that revenues from components and services associated with the accused products could be relevant to the Georgia-Pacific reasonable royalty analysis. Although Defendant argued that foreign sales of products manufactured and sold abroad could not support damages absent a domestic act of infringement, the Court concluded that this argument did not preclude discovery.

The Court further found that worldwide sales information could be relevant to commercial success as evidence of nonobviousness. The Court declined to determine whether Plaintiffs could establish domestic acts of infringement resulting in foreign sales, finding that issue inappropriate for resolution on a motion to dismiss or motion to compel. Because the discovery requests were reasonably targeted to the accused products and relatively limited in scope, the Court found them proportional to the needs of the case and emphasized that Defendant could challenge the admissibility of the evidence at a later stage.

Accordingly, the Court denied Defendant’s motion to dismiss Plaintiffs’ § 271(f) infringement claim, granted its motion to dismiss the unjust enrichment claim, and granted Plaintiffs’ motion to compel discovery of worldwide sales.