Antitrust Law Daily Wrap Up, ANTITRUST—D.N.J.: Mylan generic Copaxone Sherman Act complaint against Teva partially dismissed, (Apr 14, 2026)

By Justin Marcus Smith, J.D.

A special master concluded that Mylan should tailor its case with regard to exclusionary agreements because there was “fertile ground” for development; however, the court dismissed other allegations, for example, that Teva engaged in sham litigation.

Mylan Pharmaceuticals, Inc. (Mylan) asserted a mix of viable and non-viable Sherman Act Section 2 allegations against Teva Pharmaceuticals Industries, Ltd. (Teva), in connection with the Teva multiple sclerosis drug, Copaxone, held the federal district court Newark, New Jersey, in analyzing a Teva motion to dismiss. The court adopted the special master’s report and recommendation (R&R) in full. The court accordingly declined to dismiss Mylan claims in connection with allegations about a Teva “dispense as written” campaign and exclusionary agreements. In contrast, the court dismissed most of Mylan’s allegations that Teva engaged in sham petitioning and litigation to slow generic forms of Copaxone and allegations about copay arrangements. These dismissals were without prejudice. However, the court also dismissed, with prejudice, the Mylan allegations about a Teva lawsuit against the FDA and that Teva arranged a market shift to 40mg dosage to thwart competitors. The court also struck all allegations that turned on foreign law (Mylan Pharmaceuticals Inc. v. Teva Pharmaceuticals Industries Ltd., No. 2:22-cv-01232-JXN-JSA (D.N.J. Apr. 13, 2026)).

Background. Mylan sued Teva under Section 2 of the Sherman Act alleging that Teva illegally protected its branded injectable multiple sclerosis drug, Copaxone, from generic competition. Mylan makes the generic form of Copaxone, glatiramer acetate (GA). The six-count Mylan complaint included claims for: (1) monopolization and attempted monopolization in violation of the Sherman Act, 15 U.S.C. § 2, and the Clayton Act, 15 U.S.C. §§ 15, 26; (2) violation of the Lanham Act, 15 U.S.C. § 1125(a)(1)(B); (3) tortious interference; (4) unfair competition; (5) trade libel; and (6) violation of the New Jersey Antitrust Act, N.J.S.A. § 56:9-4.

The Teva 20mg Copaxone patents expired in 2014. The FDA approved the Sandoz Abbreviated New Drug Application (ANDA) for generic 20mg GA in 2007. The FDA approved a Teva supplemental NDA (sNDA) for 40mg Copaxone as a pre-filled syringe injectable in 2014. The legal exclusivity for 40mpg Copaxone expired in 2017.

Meanwhile, the FDA approved a Mylan ANDA for generic 20mg GA and an ANDA for generic 40mg GA in 2017. Mylan launched those products shortly thereafter. Mylan said Teva’s conduct significantly delayed the launch of generic 20mg GA, cost Mylan additional sales, restricted Mylan’s share of the GA product market, and spread mistrust of Mylan among consumers. Mylan said it did not get the degree of generic conversion it ordinarily would have in a competitive market when it entered the market with generic 40mg GA.

Mylan alleged Teva engaged in five kinds of anticompetitive conduct to protect Copaxone market share from generic competitors:

1. a “dispense as written” (DAW) campaign;

2. exclusionary agreements with pharmacy benefits managers (PBMs);

3. abuse of regulatory and judicial processes;

4. the “market shift” to 40mg Copaxone; and

5. charitable donation copay assistance.

In March 2022, Teva moved to dismiss the complaint under Fed. R. Civ. P. 12(b)(6) for failure to state a claim and to strike allegations related to foreign regulatory processes under R. 12(f). Mylan opposed, Teva replied, and in August 2023 the court appointed a special master to make a recommendation on Teva’s motion to dismiss.

The special master held oral argument in early 2024 and issued a 91-page recommendation and report (R&R) in early 2025 recommending the court grant Teva’s motion to dismiss in part. The special master made the following recommendations pertinent to the five categories of anticompetitive conduct Mylan alleged:

DAW campaign. The special master rejected Teva’s arguments for dismissal of the DAW campaign allegations, including that the DAW campaign was a legitimate form of competition and that Mylan failed to allege any anticompetitive harm.

Exclusionary agreements. The special master recommended the court deny dismissal as to the allegations of exclusionary agreements. The price-cost test was inappropriate because Mylan alleged more exclusionary conduct than below-cost pricing. The allegations of antitrust injury were not robust, but they were more suited to resolution after discovery.

Abuse of process. The special master recommended dismissing most of the petitioning and litigation allegations from the complaint. Mylan sought to retain them as part of an “overall antitrust scheme.” Teva objected, but the court noted it could consider conduct that did not, on its own, violate Section 2 as part of an overall anticompetitive scheme if: (a) some alleged conduct would violate Section 2; and (b) if Mylan alleged the legal conduct contributed to the overall scheme’s anticompetitive effect.

The special master noted that none of the alleged petitioning and litigation conduct within the sweep of Noerr-Pennington had any connection to other allegedly exclusionary activity. Most of the activity was directed at Sandoz, and all of it predated FDA approval of Mylan’s generic. The special master accordingly concluded that Mylan should tailor and confine its case to its proper scope and added there was enough to be “fertile ground to develop the case and the defenses.”

Teva also moved to strike Mylan’s allegations about foreign regulatory processes. The special master recommended the court grant Teva’s motion to strike because the foreign allegations, some of which were a decade old, all turned on foreign law.

Market shift. The special master recommended the court dismiss, with prejudice, Mylan’s allegations about Teva shifting the market from 20mg to 40mg Copaxone. All events surrounding the purported market shift occurred more than two years before Mylan had FDA approval to sell any GA product. Mylan could not sell either at the time, so the market shift could not have harmed Mylan. The complaint also did not allege that the market shift “supercharged” the anticompetitive effects of the DAW campaign or exclusionary agreements. Accordingly, the special master found the alleged market shift was too disparate in both nature and timing to have plausibly harmed Mylan as part of the same overarching scheme.

Copay assistance. The special master recommended the court dismiss Mylan’s allegations about copay assistance. Mylan essentially sought to morph Department of Justice allegations against Teva into a Sherman Act violation. Teva successfully argued the Anti-Kickback statute has no private right-of-action; that Mylan failed to allege the conduct was exclusionary or caused antitrust injury; and that Teva’s copay assistance program was in place for years before the FDA approved any generic GA products.

R&R adoption. The court adopted the R&R on-the-papers. The special master had already held oral argument. Despite the “breadth and complexity” of the R&R, Mylan’s objections were narrow. Mylan argued the special master erred in concluding (1) that Noerr-Pennington immunity attached to the 20mg Citizen Petitions; (2) that the 20mg Citizen Petitions and 2014 FDA lawsuit could not have delayed Mylan’s approval; and (3) that the foreign allegations should be struck from the complaint.

20mg petitions. The court applied the “objectively baseless” standard to the 20mg citizen petitions. The petitions fell within the ambit of Noerr-Pennington immunity. The question was whether the court should apply the “objectively baseless” or “serial petitioning” standard in determining whether the petitions were shams. The petitions related directly to ANDA approval and the Hatch-Waxman process, and the court analyzed that the “serial petitioning” standard was “particularly inapt” for analyzing Hatch-Waxman conduct.

The court rejected Mylan’s contention that the special master could not make a sham determination at the dismissal stage. Although Noerr-Pennington immunity is indeed fact-sensitive, that does not mean a court may never dismiss on a legal question. There was no dispute here about the predicate facts of the underlying proceedings, and Mylan failed to show they were objectively baseless.

The court said it was satisfied, after reviewing the 20mg citizen petitions and the FDA responses, that Teva had probable cause to file them. Each petition requested the FDA not to approve or accept any ANDA referencing Copaxone 20mg until certain requirements were met, but the FDA did not definitively opine on most of the requests, and TEVA had to re-file the petitions every 150 days.

A reasonable litigant in Teva’s position could have expected some success on the merits, and the first seven Teva petitions were not objectively unreasonable. The FDA denied six of the seven as premature, Teva withdrew one of the seven, and when the FDA denied the eighth, it approved an ANDA and substantively analyzed and rejected Teva’s requests. A reasonable petitioner like Teva could have believed it would succeed on any of the eight petitions. Mylan failed to meet its burden.

Amendment could not cure the legal deficiencies in Mylan’s 20mg citizens petition allegations, so dismissal with prejudice, as the special master had recommended, was appropriate.

2014 FDA lawsuit. Mylan did not and could not plausibly allege a link between a five-day-long Teva lawsuit against the FDA in 2014 and the FDA’s 2017 approval of a broader monopolistic scheme. Teva’s lawsuit against the FDA lasted five days, and the FDA approved Mylan’s 20mg ANDA nearly three years later. Even if Mylan could show the 2014 FDA lawsuit was a sham, it failed to allege the litigation caused the FDA to delay approval of its generic.

Mylan offered no facts plausibly alleging that a five-day-long lawsuit in 2014 caused or even contributed to the FDA approving Mylan’s 20mg ANDA in 2017, especially considering that the FDA approved the Sandoz 20mg ANDA two years earlier. Nor did Mylan plausibly allege that the 2014 FDA lawsuit enhanced the anticompetitive effect of an overall monopolistic scheme. The special master did not err in recommending prejudicial dismissal of the allegations about the 2014 FDA lawsuit.

Foreign allegations. The court disagreed with Mylan’s contention that the special master erred in striking allegations of Teva’s foreign litigation conduct from the complaint. Mylan’s foreign allegations did not relate to this case, nor could they. The Sherman Act generally does not apply to foreign trade or commerce unless it has a direct, substantial, and reasonably foreseeable effect on U.S. domestic, import, or certain export commerce.

Mylan did not allege that any Teva conduct had any effect on American commerce. The foreign allegations would have prejudiced Teva with the burden of foreign discovery. An American jury would also not have been able to easily apply American law to an antitrust market based on foreign evidence about foreign regulators applying foreign laws. Foreign discovery would have confused the issues to the extent the Sherman Act would not have covered Teva’s foreign conduct.

The Case is No. 2:21-cv-13087-JXN-JSA.

Judge: Neals, J.

Attorneys: Jakob Benjamin Halpern (Saiber LLC) for Mylan Pharmaceuticals Inc., Liza M. Walsh (Walsh Pizzi O'Reilly Falanga LLP) for Teva Pharmaceuticals Industries Ltd., Teva Pharmaceuticals USA, Inc., Teva Neuroscience, Inc. and Teva Sales & Marketing, Inc.

Companies: Mylan Pharmaceuticals Inc.; Teva Pharmaceuticals Industries Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Neuroscience, Inc.; Teva Sales & Marketing, Inc.

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