On February 17, 2026, the Court dismissed Sandoz’s Complaint against Amgen in Case No. 2:25-cv-00218 (E.D. Va.) for failure to state a claim under FRCP 12(b)(6).  The Complaint, filed in April 2025, alleged that Amgen had violated antitrust laws, including the Sherman Act and NJ state laws, by unreasonably restraining trade and adversely affecting the market for the direct sale and purchase of etanercept throughout the United States, through purchasing patent rights and prosecuting patents that extended its monopoly on Enbrel^® (etanercept), a drug approved in 1998, through 2029; filing patent infringement lawsuits against biosimilar competitors; and through price increases and rebate bunding arrangements.

Amgen’s Acquisition of Patent Rights

Immunex obtained a co-exclusive license to patents from Roche related to tumor necrosis factor (TNF) inhibitors that covered Immunex’s drug Enbrel^®, effective at Enbrel^®’s launch on November 6, 1998.  Amgen acquired Immunex in 2002, and in 2004, bought the Enbrel^® patent rights Roche had retained in its 1998 license agreement with Immunex.  After obtaining these rights, Amgen prosecuted Roche’s patent applications, resulting in additional patent grants, including U.S. Patent Nos. 8,063,182 (“the ’182 patent”) and 8,163,522 (“the ’522 patent”), with expiration dates of November 22, 2028, and April 24, 2029 respectively.

Amgen’s Assertion of Patents Against Etanercept Biosimilars

In 2016, Amgen asserted the ’182 and ’522 patents, along with additional Amgen patents, against Sandoz’s Enbrel^® biosimilar Erelzi^® (etancercept-szzs) in BPCIA litigation, Case No. 2:16-cv-01118 (D.N.J.).  The litigation resulted in a finding of infringement and validity of the ’182 and ’522 patents, and a permanent injunction was issued against commercialization of Erelzi^® until the expiration of the ’182 and ’522 patents in April 2029.

In 2019, Amgen asserted the ’182 and ’522 patents, along with additional patents, against Samsung Bioepis’s Eticovo^® (etanercept-ykro) in BPCIA litigation, Case No. 2:19-cv-11755 (D.N.J.).  This case resulted in a stipulation of infringement and a final judgment in favor of Amgen, with a permanent injunction preventing the launch of Eticovo^® until April 2029.

Disposition of Antitrust Lawsuit

Amgen asserted that Sandoz’s federal antitrust claim for monopolization under the Sherman Act should be dismissed on numerous grounds, however the Court only considered whether Sandoz was required to bring the claim as a compulsory counterclaim during the 2016 BPCIA litigation.  Under Fourth Circuit precedent, the Court found that Sandoz was required to do so, because the claim arose out of the same transaction or occurrence that was the subject matter of the BPCIA litigation, and it did not require adding another party over whom the court could not acquire jurisdiction.

The Court first found that only the acquisition of patent rights from Roche could properly be considered allegedly anticompetitive conduct, because subsequent patent prosecution and enforcement is protected under the Noerr-Pennington doctrine that exempts from antitrust liability conduct involving petitioning the government.  Patent prosecution before the PTO has been held to be “petitioning” conduct protected under this doctrine.  The Court agreed with Amgen that Sandoz had not given an explanation in the Complaint for how price increases and rebate bundling arrangements were anticompetitive conduct.

In its analysis of whether the claim arose out of the same transaction/occurrence as the BPCIA litigation, the Court considered a four-part test and found on balance, the factors weighed in favor of considering the antitrust claim a compulsory counterclaim:

1. Are the issues of fact and law raised in the claim and counterclaim largely the same? The Court found that the facts of the two cases were strikingly similar, but the legal issues were somewhat different (patent law vs. antitrust law), giving this factor a neutral weight.
2. Would res judicata bar a subsequent suit on the party’s counterclaim, absent the compulsory counterclaim rule? All of the elements of res judicata were met, and this factor weighed in favor of finding the antitrust claim was a compulsory counterclaim.
3. Will substantially the same evidence support or refute the claim as well as the counterclaim? The same witnesses, the lawyers involved in the licensing agreements and patent prosecution, were likely to be called in both trials, weighing in favor of considering the antitrust claim a compulsory counterclaim.
4. Is there any logical relationship between the claim and counterclaim? Given the duplicative facts and evidence, the Court found proceeding to discovery in the antitrust case would “merely indulge Sandoz’s effort to have another bite at the apple and defeat the entire point of the compulsory counterclaim rule,” causing this factor to weigh in favor of considering the claim a compulsory counterclaim.

The Court found that the Supreme Court’s Mercoid exception making the antitrust claim a permissive counterclaim instead of compulsory counterclaim did not apply to this case given Sandoz’s antitrust claim was based on alleged patent invalidity, not patent misuse.

Given the Court found Sandoz had not established a viable federal antitrust claim, it declined to exercise jurisdiction over Sandoz’s state law claims, and dismissed them without prejudice, with leave to file in state court.

For more information on these and other biosimilars and biosimilar patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.