District Judge Neals Adopts Special Master Recommendation Dismissing Most Antitrust Claims Against Teva in Copaxone Case

The case centers on Mylan's allegations that Teva illegally protected its $4 billion multiple sclerosis drug Copaxone from generic competition through a five-part anticompetitive scheme. Mylan claimed Teva engaged in false advertising through a "Dispense as Written" campaign, entered exclusionary agreements with pharmacy benefit managers, abused regulatory and judicial processes, shifted the market from 20mg to 40mg formulations, and provided improper copay assistance to Medicare patients. The dispute arose after Mylan launched its generic version in October 2017, following FDA approval of both 20mg and 40mg formulations.

Judge Neals found that while some of Mylan's allegations could proceed—specifically the DAW campaign and exclusionary agreements with PBMs—most of the regulatory and litigation conduct was protected by Noerr-Pennington immunity. As Judge Neals explained, adopting the special master's analysis, Teva's eight citizen petitions filed between 2008 and 2015 were not "objectively baseless" because the FDA denied six as "premature" rather than meritless, and the agency acknowledged the issues "raises complicated scientific and regulatory issues, which we have carefully considered."

The court delivered its harshest language when rejecting Mylan's attempt to characterize routine patent litigation as sham conduct. "Merely losing a case, or a court's portrayal of the basis for the loss in a negative light, is not sufficient to allege that the case was a sham," Judge Neals wrote, noting that Teva's 20mg patent litigation went "all the way up the Supreme Court and remanded to the Federal Circuit," which "does not remotely suggest that it was objectively baseless to initiate."

The case reached Judge Neals after Special Master Faith Hochberg spent over a year analyzing Teva's motion to dismiss, holding oral arguments in December 2023, January 2024, and March 2024. In her 91-page report issued in February 2025, Hochberg applied different legal standards to different aspects of Mylan's claims, using the "objectively baseless" test for Hatch-Waxman-related conduct rather than the more flexible "serial petitioning" standard Mylan preferred. The Third Circuit had previously held in Wellbutrin and AbbVie cases that serial petitioning analysis is "particularly inapt" for pharmaceutical patent disputes.

Mylan's strongest arguments—that Teva's citizen petitions and FDA lawsuit somehow delayed its market entry—foundered on timing issues that Judge Neals found insurmountable. The court noted that Teva's regulatory challenges targeted rival Sandoz's application, not Mylan's, and concluded there were "no facts stated in the Complaint that even remotely plausibly connect the petitioning activity prior to the Sandoz 20mg generic FDA approval, and the two-year gap in agency action approving the Mylan generic." The FDA approved Sandoz's generic in 2015 but didn't approve Mylan's until 2017.

The court did allow significant portions of Mylan's case to survive, finding that allegations about Teva's "Dispense as Written" campaign could constitute actionable false advertising when "coupled with allegations of false statements meant to induce the writing of these prescriptions." Judge Neals also permitted claims about exclusionary rebate agreements with PBMs to proceed under a "rule of reason" analysis, rejecting Teva's argument that only a price-cost test should apply. The court noted these surviving claims alleged "a set of facts from which to plausibly infer that the Rebate Agreements and Switch Agreements adversely affected competition."

Judge Neals granted Teva's motion to strike allegations about foreign regulatory conduct, finding they "will not tend to prove or disprove the claims that will proceed in the case" and would "lead to information of dubious relevance." The court also dismissed with prejudice Mylan's market shift allegations, noting that when Teva allegedly moved the market from 20mg to 40mg Copaxone, "Mylan could not lawfully market either a 20mg or 40mg dose" because it lacked FDA approval. Looking ahead, the surviving DAW and PBM agreement claims will proceed to discovery, while Mylan's related Lanham Act false advertising claim and state law claims also remain viable.